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  • Glycerine for Skin: Benefits, Uses, Side Effects and How to Apply It

    Glycerine for Skin: Benefits, Uses, Side Effects and How to Apply It

    Glycerine is a clear, thick liquid used in moisturisers, lotions, soaps and some medicines. It is also called glycerol, and the two names describe the same substance. On skin it acts as a humectant, a type of ingredient that draws in and holds water.

    It is sold in India both as a plain liquid in a bottle and as one ingredient among several in creams and lotions. The strength printed on a pack matters, because what a product does to skin depends on how much glycerine it contains.

    Is glycerine good for skin, and what are its benefits? 

     Glycerine Benefits For Skin

    Yes, mainly for holding water in the outer layer and protecting skin that is dry, chapped or cracked.

    The U.S. FDA’s final order for skin protectant drug products[1] recognises glycerin as a skin protectant active ingredient. Products in that category may state that they temporarily protect minor cuts, scrapes and burns. They may also state that they help prevent and temporarily protect chapped or cracked skin.

    A 2020 review of nonprescription moisturisers[2] describes humectants such as glycerin as hydrating skin by attracting and binding water.

    Use What the evidence says
    Dry skin in atopic dermatitis A 2025 review of emollient studies[3] reports that a 20% glycerol cream, applied twice daily for four weeks by 24 people with atopic dermatitis, raised skin capacitance and lowered water loss through the skin compared with its vehicle.
    Very dry skin in dialysis patients A phase 3 trial[4] of a cream containing glycerol 15% and paraffin 10% recorded a response in 60.2% of 235 patients with moderate to severe uraemic xerosis, against 41.0% on the vehicle.
    Hand dermatitis from wet work In a crossover trial in 32 fabric workers[5], a cream containing 20% glycerin applied twice daily for two weeks lowered hand eczema severity and water loss by about 20%, and raised skin capacitance by about 20%.
    Chapped or cracked skin Labelling for a glycerin 40% ointment on DailyMed[6] states that the product helps prevent and temporarily protects chafed, chapped or cracked skin and lips.
    Facial skin A double-blind split-face trial[7] in 31 women aged 55 to 75 applied a 20% glycerol emulsion twice daily for four months. Hydration measured at the crow’s feet rose further than on the placebo side, while the two sides did not differ significantly on wrinkle visibility.

    The 2020 review excluded studies of single ingredients such as glycerol. Most of the evidence above therefore describes tested formulations rather than plain glycerine.

    How much glycerine is used on the skin? 

    glycerine concentration on skin

    There is no single amount that applies to every use of glycerine on skin.

    The FDA order sets a concentration range rather than a dose. It lists glycerin at 20% to 45% for products sold as skin protectants.

    A figure such as glycerin 20% describes how much glycerine is in that product. It is product information, not an instruction about how much to apply.

    Individual labels sit at different points in that range. DailyMed lists a glycerin 20% gel[8] alongside the glycerin 40% ointment.

    Neither label gives a measured quantity. The gel label says to apply liberally as often as necessary. The ointment label says to apply as needed.

    How do you apply glycerine on the face and body? 

    How do you apply glycerine

    Moisturising products are generally applied to skin that has just been washed and dried.

    The NHS[9] advises applying an emollient as soon as the skin has been patted dry, so that it is absorbed properly. It also advises smoothing the product on rather than rubbing it in, following the direction of hair growth. That helps stop hair follicles becoming blocked.

    The NHS also says it is especially important to apply an emollient to the hands and face, because they are more exposed than the rest of the body.

    The NHS says emollients can be applied as often as a person likes. It suggests at least three or four times a day.

    That page describes emollients as a group and does not name glycerol.

    How long can glycerine be used? 

    That depends on whether the product is a cosmetic moisturiser or a skin protectant.

    The FDA order carries a warning that a doctor should be seen if the condition lasts more than seven days. The glycerin 40% ointment label repeats that boundary. It tells users to stop and ask a doctor if the condition worsens, or if symptoms clear up and return within a few days.

    The glycerin 20% gel label sets a longer boundary. It advises discontinuing use if the condition worsens or does not improve within 10 to 14 days.

    The two labels set different limits. The limit printed on the pack in hand is the one that applies to it.

    Also Read: Best Skincare Products & Routine for Sensitive Skin

    What side effects can glycerine cause? 

    Glycerine side effects

    Glycerine is generally well tolerated on skin, and the side effects reported in trials were local ones.

    The phase 3 trial of the glycerol and paraffin cream recorded irritation or erythema in 2.1% of patients. Worsened itching affected 1.3%, and blisters at the site of application 0.9%. The crossover trial in fabric workers reported no adverse effects among its 32 participants.

    Both glycerin labels on DailyMed are marked for external use only.

    Why glycerine is kept away from the eyes 

    Both DailyMed glycerin labels carry an eye warning. The glycerin 40% ointment label states that the product should not get into the eyes. The gel label advises avoiding contact with them.

    Both labels also direct anyone who swallows the product to get medical help or contact a poison control centre.

    Who should be careful with glycerine? 

     glycerine who should not used

    Very young children, deep wounds and serious burns are the situations these labels single out.

    Situation What to do
    Babies under six months The FDA order requires skin protectant products containing glycerin to carry a statement that a doctor should be asked before use in children under six months. The glycerin 40% ointment label carries the same line.
    Deep or puncture wounds and animal bites Both DailyMed glycerin labels state that the product should not be used on deep or puncture wounds, or on animal bites.
    Serious burns The glycerin 40% ointment label states that it should not be used on serious burns.
    Wound care The glycerin 20% gel label lists stasis ulcers, pressure ulcers, first and second degree burns and post-operative incisions among its uses, and sets a review point at 10 to 14 days.

    If you are using glycerine on skin that is broken or not healing, ask a doctor or pharmacist which product is appropriate.

    Does glycerine appear in medicines as well as cosmetics? 

    Yes. Glycerol is also used as an excipient in medicines.

    The EMA’s annex on excipients in labelling[10] lists glycerol, also written as E422, by route of administration. For an oral medicine the threshold is 10 g per dose. Above that, the leaflet states that glycerol may cause headache, stomach upset and diarrhoea.

    For a rectal medicine the threshold is 1 g, with a note that glycerol may have a mild laxative effect.

    That annex covers glycerol swallowed or given rectally. It carries no cutaneous entry, so it says nothing about glycerine applied to skin.

    Glycerine in Indian cosmetic and drug rules 

    Most glycerine products sold for skin in India are regulated as cosmetics rather than as medicines.

    CDSCO[11] gives the definition of a cosmetic under the Drugs and Cosmetics Act, 1940. It covers anything applied to the human body for cleansing, beautifying, promoting attractiveness or altering the appearance.

    Manufacture is licensed by State Licensing Authorities, and imports are registered by the Central Licensing Authority under the Cosmetics Rules, 2020.

    The 20% to 45% range quoted earlier describes a U.S. standard. No Indian regulatory source setting a permitted glycerine concentration for skin was retrieved, so it should not be read as an Indian requirement.

    Where can you buy glycerine online? 

    Medkart lists glycerine as a plain liquid and inside moisturising creams and lotions.

    Plain glycerine appears in small packs such as Glycerin 50 GM, in larger bottles such as Glycerin 400 ML, and under the glycerol name as Glycerol Liq 200 ML.

    Cream and lotion products include Glicerina Cream from Atopic Laboratories, Aquasoft Cream from Ajanta Pharma and Secalia Lotion from Micro Labs. Availability and pack size differ between products and can change.

    Products sharing the Glycerin 15% w/w composition are grouped on one page. Medkart’s medicine comparison tools line up alternatives on:

    • Active ingredient
    • Strength
    • Dosage form
    • Manufacturer
    • Pack size
    • Current price

    The wider personal care range and the full medicines catalogue carry other moisturising products, and Medkart branches can be found through the store locator. Medkart highlights WHO-GMP certified manufacturers for the medicines it lists.

    If you are not sure which product suits your skin, ask a pharmacist before buying.

    Key takeaways 

    • Glycerine and glycerol are two names for the same substance, used on skin as a humectant.
    • The U.S. FDA recognises glycerin as a skin protectant active ingredient at 20% to 45%.
    • A percentage on a pack describes what the product contains and is not an instruction about how much to apply.
    • Trials of creams containing 15% to 20% glycerol reported better skin hydration and less water loss through the skin.
    • The NHS advises applying an emollient to skin that has just been patted dry, and smoothing it on rather than rubbing it in.
    • Side effects reported in trials were local, and included irritation, redness and worsened itching in a small share of patients.
    • Skin protectant labels containing glycerin tell users to ask a doctor before use in children under six months.
    • Most glycerine skin products sold in India are regulated as cosmetics under the Cosmetics Rules, 2020.

    FAQs 

    Q. Does glycerine remove tan? 

    No retrieved source supports that. The permitted claims for a glycerin skin protectant cover protecting chapped or cracked skin rather than skin tone. The trials described above measured hydration and water loss rather than pigmentation. Anyone concerned about a change in skin colour should raise it with a doctor.

    Q. How soon does glycerine make a difference to dry skin? 

    The trials measured change over weeks rather than days. The fabric workers applied their cream twice daily for two weeks before hydration and water loss were reassessed. The atopic dermatitis cream ran twice daily for four weeks, and the dialysis trial measured its main result after 28 days. None of these trials reported the effect of a single application.

    Q. Does a higher percentage of glycerine work better? 

    The retrieved trials do not answer that. They tested glycerol at 15% and at 20%, while the FDA range for skin protectants runs up to 45%. No retrieved study compared two concentrations against each other in the same participants. A higher figure on a pack cannot be read as a better result.

    Q. Is glycerine better than urea for dry skin? 

    It depends on the measure. The 2025 review reports one trial in 109 people with atopic dermatitis where urea cream produced lower water loss through the skin than the glycerine cream. In a second trial in 197 people, improvement in dryness was similar between the two, and glycerine caused less smarting.

    Q. How long has glycerine been tested for continuous use? 

    Two of the retrieved trials ran for about four months, one in dialysis patients and one on facial skin. Both are far longer than the review points printed on skin protectant labels, which are set for a specific complaint rather than for daily moisturising.

    Q. Does glycerine need to be diluted before use on skin? 

    No retrieved source describes a dilution for use at home. The products covered by the FDA standard and by the trials above contained glycerine within a finished cream, gel or ointment. None of them used the neat liquid. A pharmacist can say how a particular pack of plain glycerine is meant to be used.

    References 

    Medical disclaimer: This article gives general information only. It does not replace advice from a doctor or pharmacist. No medicine or supplement should be started, stopped or changed without advice from the prescriber or a qualified pharmacist.

  • Giloy (Guduchi): Benefits, Uses, Side Effects and Safety

    Giloy (Guduchi): Benefits, Uses, Side Effects and Safety

    Giloy is the common name for Tinospora cordifolia, a climbing shrub used in Ayurveda under the name Guduchi.

    Its use rose sharply during the COVID-19 pandemic. So did a set of published reports linking it to liver injury.

    What is giloy? 

    Giloy

    Giloy is Tinospora cordifolia, a plant of the Menispermaceae family. A 2023 review in the Chinese Journal of Integrative Medicine[1] describes it as a herbaceous vine, or climbing deciduous shrub.

    LiverTox[2], the United States National Institutes of Health database on drug-induced liver injury, records that extracts of the leaves, roots and bark are used.

    LiverTox names more than 60 compounds in Tinospora species, including lactones, steroids, flavonoids, lignans, alkaloids and the characteristic clerodane-type furanoditerpenoids. It identifies the clerodane diterpenoids as the probable cause of the liver injury set out below.

    What is the nutritional value of giloy? 

    Giloy is taken as a herb rather than eaten as a food, so nutrient figures describe the dried plant rather than a dose.

    A 2024 review of giloy leaves[3] gives about 5.2 g of protein and about 52 g of fibre per 100 g of dehydrated leaves. It lists calcium and iron among the minerals present. A 2023 review of the stem in food[4] reports protein and dietary fibre, with vitamin C, calcium and iron in small concentrations.

    Both sets of figures are per 100 g, and a typical daily dose is a small fraction of that weight. No Indian food composition entry for giloy could be retrieved for this article.

    What are the benefits and uses of giloy? 

    Giloy benefits and uses

    Giloy has a long list of traditional uses and a much shorter list of tested ones. The 2023 review lists fevers, jaundice, diabetes, dysentery, urinary infections and skin diseases among its traditional applications.

    The same review names anti-diabetic, immune-modulatory, antiviral, antioxidant and hepatoprotective effects among the pharmacological properties studied. The stem, the leaf and the root are all used.

    LiverTox records a similar list. It names diabetes, rheumatism, jaundice, malaria, asthma, depression, pain and urinary tract infections, with recent use aimed at COVID-19.

    What does the clinical evidence show? 

    Less than the traditional list suggests. The 2023 review states that large-scale clinical studies are still needed.

    Use What the evidence says
    Immune effects in HIV A randomised, double-blind, placebo-controlled trial[5] gave 300 mg three times daily for six months to 68 people. Sixty per cent on the extract reported fewer symptoms against 20 per cent on placebo, but CD4 count did not improve in either group.
    The wider pharmacology The 2023 review reports anti-diabetic, antiviral and immune-modulatory activity from laboratory and animal work, and calls for large-scale clinical studies to establish efficacy in people.
    Giloy leaves The 2024 review of giloy leaves reports that leaf extracts stimulate immune cells including natural killer cells, B cells and T cells. It states that these findings come from laboratory and animal work, and reports no human trials of leaf-based products.
    Everyday immunity No source retrieved for this article establishes that giloy prevents or shortens an ordinary infection in a healthy adult.

    The trial authors add two caveats of their own. Six months may not have been long enough to judge, and not all the objective measures backed up what patients reported.

    How do you use giloy, and how much? 

    Common Forms of Giloy

    Giloy is used as tablets, capsules, powders and juices, and no one dose applies to everyone. LiverTox records a typical dose of 400 to 1,000 mg daily across the forms sold over the counter, which include solutions, powders, capsules and tablets.

    The HIV trial used 900 mg a day, under supervision and with monitoring.

    A strength printed on a pack describes the amount of extract in that product. It is product information, not an instruction about how much to take. What suits a particular person is a question for a doctor or a qualified Ayurvedic practitioner.

    When should you take giloy, and for how long? 

    No source retrieved for this article gives a time of day. The Ministry of AYUSH publishes a technical dossier on Guduchi, and neither that document nor the Ministry’s press statements could be opened while researching this article.

    On duration there is more to go on. The HIV trial ran for six months under medical supervision. LiverTox reports that liver injury appeared between a few weeks and six months after starting.

    Long unsupervised use is the pattern the reports describe most often. Anyone planning to take giloy for more than a few weeks should agree that with a doctor first.

    Also Read: What Is Shatavari? A Complete Guide to Its Uses and Health Benefits

    What side effects can giloy cause? 

    Giloy Side Effects

    The side effect that matters most is liver injury. LiverTox describes the pattern as hepatocellular, with ALT and AST between 10 and 50 times the upper limit of normal.

    It records more than 50 reported cases since 2017, most of them during the COVID-19 period. Autoantibodies were frequent, sometimes with features of autoimmune hepatitis on liver biopsy.

    Severity ranges widely. LiverTox describes cases from minimally symptomatic enzyme rises, through mild hepatitis that settled on stopping, to severe hepatitis, acute liver failure and deaths.

    What do the liver injury reports say? 

    An Indian case series described six people who developed hepatotoxicity after self-medicating with giloy. The Ayurveda community responded that the patients had probably taken Tinospora crispa, a look-alike species known to harm the liver. The authors then confirmed by DNA analysis[6] that the plant taken was Tinospora cordifolia. They concluded it had caused an autoimmune-like hepatitis, or unmasked a latent autoimmune liver disease.

    A rebuttal in the same journal[7] argued the other way. It cites animal work finding the aqueous extract non-toxic up to 2,000 mg per kg by mouth. It also cites a trial in healthy volunteers taking 500 mg for 21 days, with normal results. It adds that diabetes and hypothyroidism, and the medicines used for them, are confounders, and that baseline liver function was not reported.

    A 2023 case report in Cureus[8] sits with the first group. A woman taking a supplement containing 900 mg of Tinospora cordifolia extract developed symptoms after four to five weeks, with ALT at 1,336. Stopping it, with a short course of prednisone, returned her liver tests to baseline within three months.

    LiverTox has since given Tinospora its highest likelihood score, listing it as a well established cause of clinically apparent liver injury. Where sources disagree this way, the useful response is not to pick a side but to know the warning signs.

    Who should be careful with giloy? 

    Situation What to do
    Existing liver disease LiverTox reports that cases appear more frequent and more severe in people with pre-existing liver disease, often as acute-on-chronic injury that worsens the underlying condition. Giloy should not be started without a doctor’s agreement.
    An autoimmune condition The Cureus patient had Hashimoto’s thyroiditis, and the authors suggest autoimmune disease deserves further investigation as a risk factor.
    Long unsupervised courses LiverTox puts time to onset between a few weeks and six months. The published cases describe self-medication rather than prescribed courses.
    Raw stem bought loose Tinospora crispa resembles Tinospora cordifolia and is known to harm the liver. Loose stem carries an identification risk that a labelled product does not.
    New symptoms while taking it Fresh tiredness, nausea, loss of appetite, dark urine or yellowing of the eyes is a reason to stop giloy and see a doctor that week.

    Can giloy interact with other medicines? 

    No formal interaction studies were retrieved for this article.

    The nearest thing the sources offer is indirect. People taking medicines for diabetes and hypothyroidism were among those in the liver injury cases, which the rebuttal treats as a confounder rather than an interaction.

    That is a reason to tell a prescriber what you are taking rather than to assume the two are unrelated.

    Where can you buy giloy online? 

    Medkart lists giloy products in its Ayurvedic range. Guduchi capsules from Himalaya Wellness carry Tinospora cordifolia extract, and Shanshamani Vati from Zandu is built on the same herb.

    Giloy also appears inside combination formulations. Kofol Immunity tablets and Ojus syrup both list Guduchi among their herbs, and Immumor syrup lists Giloy alongside tulsi and ashwagandha.

    The Ayurvedic products category and the Ayurvedic composition listing show what is stocked, and Medkart’s medicine comparison tool places products side by side. Medkart states that the medicines it sells are sourced from WHO-GMP certified manufacturers.

    Giloy products appear in the medicines index and are sold without a prescription, so a doctor or pharmacist should be told before one is added to regular medicines.

    Key takeaways 

    • Giloy is Tinospora cordifolia, known in Ayurveda as Guduchi.
    • Its traditional uses are wide, and the evidence tested in people is much narrower.
    • A 2023 review states that large-scale clinical studies are still needed to prove efficacy.
    • LiverTox records a typical dose of 400 to 1,000 mg daily for products sold over the counter.
    • No source retrieved for this article gives a best time of day to take it.
    • LiverTox lists Tinospora as a well established cause of clinically apparent liver injury.
    • A published case series and a published rebuttal disagree about how strong that link is.
    • Fresh tiredness, nausea, dark urine or yellow eyes while taking giloy calls for stopping and seeing a doctor.

    FAQs: Common Questions About Giloy 

    Q. Is giloy the same thing as Guduchi? 

    Yes. LiverTox records giloy as the Hindi name and Guduchi as the Sanskrit name for the same plant. Guduchi is the form used on most Indian product labels, and seeing both on one pack does not mean two ingredients.

    Q. Is giloy juice as effective as giloy tablets? 

    No retrieved source compares the forms against each other. LiverTox gives a single dose range of 400 to 1,000 mg daily across solutions, powders, capsules and tablets together, rather than a separate figure for each form. The choice between a juice and a tablet is therefore not one the published evidence settles.

    Q. How soon after starting giloy could liver trouble appear? 

    Not immediately, which is part of why it gets missed. The Cureus patient developed symptoms after four to five weeks. Someone who has taken it for a fortnight without trouble has not cleared the window.

    Q. Does stopping giloy reverse the liver injury? 

    Usually, though not always. LiverTox describes the injury as typically self-limited, with chronic damage not clearly described. The same source also records severe hepatitis, acute liver failure and deaths, so this is not a reason to wait and see.

    Q. Is a labelled tablet safer than raw giloy stem? 

    On identification, yes. A labelled product from a known manufacturer names the species it contains, and a bundle of stem bought loose does not. Since a look-alike species is known to harm the liver, knowing which plant is in the pack is the practical difference.

    Q. Can giloy be taken to prevent colds and flu? 

    No source retrieved for this article supports that. The published human trial was in HIV-positive patients and measured symptoms and blood counts. Immune-modulatory activity in a laboratory is a different claim from preventing an illness in a person.

    Q. Should someone already taking giloy stop? 

    That is a decision for their doctor, not for an article. What the sources support is knowing the warning signs, avoiding long unsupervised courses, and being more cautious where there is existing liver disease or an autoimmune condition. Anyone with symptoms should stop and seek advice rather than finish the pack.

    References 

    Medical disclaimer: This article gives general information only. It does not replace advice from a doctor or pharmacist. No medicine or supplement should be started, stopped or changed without advice from the prescriber or a qualified pharmacist.

  • PCOD (PCOS): Symptoms, Causes, Diagnosis and Treatment

    PCOD (PCOS): Symptoms, Causes, Diagnosis and Treatment

    PCOD is the name Indian readers search for when periods turn irregular, unwanted hair appears, or pregnancy is not happening. It names a hormone condition rather than a test result.

    The name needs sorting out first, because it has changed.

    What does PCOD stand for, and what is it called now? 

    Nothing the sources use. None of them uses PCOD, and the condition’s clinical name has recently changed. The NHS[1] now calls it polyendocrine metabolic ovarian syndrome, or PMOS, and states that PMOS used to be called polycystic ovary syndrome, or PCOS.

    Not every source has moved. The World Health Organization[2] fact sheet still uses polycystic ovary syndrome. MedlinePlus[3] gives the alternative names as PCOS and Stein-Leventhal syndrome.

    No source retrieved for this article treats PCOD as a clinical term, so this article uses the names the sources use.

    MedlinePlus describes a set of symptoms caused by a hormone imbalance, and the NHS states there is no cure but treatments can help.

    What are the symptoms of PCOD? 

    PCOD Symptoms

    They cluster around periods, hair, skin and fertility, and vary widely.

    Feature What the sources say
    Periods The NHS lists irregular periods or long gaps between them. The WHO adds that periods may be absent altogether, and that some people have heavy, long or painful ones.
    Hair The NHS lists excess hair growth, called hirsutism, and also hair loss. The WHO describes female-pattern baldness or thinning alongside excess facial or body hair.
    Skin Oily skin and acne appear on both lists. The NHS also names thick, dark patches of skin, called acanthosis nigricans.
    Fertility Both name difficulty getting pregnant.
    Mood and energy The NHS lists mental health problems including depression and anxiety, and feeling very tired.

    These are features the sources associate with the condition, not a test anyone can apply to themselves.

    What causes PCOD? 

    PCOD Causes

    Nobody knows. Both the NHS and the WHO state plainly that the cause is unknown.

    What they describe instead are things that travel with it. The NHS says it may involve hormones such as insulin and testosterone not working properly, and notes a link with family history. MedlinePlus names genetics, raised androgen levels and insulin resistance, and the WHO adds that a family history of type 2 diabetes also raises risk.

    How is PCOD diagnosed? 

    PCOD Diagnosis or tests

    By meeting two of three criteria, after tests a doctor arranges. The WHO gives the three as signs of high androgens, irregular or absent periods, and polycystic ovaries on ultrasound.

    The 2023 international guideline[4] keeps that structure and adds one option: in adults, a blood test for anti-Müllerian hormone may replace the ultrasound. It says that test should not be used alone, and that both it and the scan should not be done, to limit over-diagnosis.

    The guideline advises against the scan in adolescents.

    The NHS describes the practical route: blood tests for hormone levels and insulin resistance, and an ultrasound scan of the ovaries for patients over 18.

    How common is PCOD in India? 

     PCOD Common in India

    Common, and Indian estimates differ sharply depending on the criteria applied. An Indian Council of Medical Research task force study[5] assessed 8,993 women aged 18 to 40 across eight states, published in JAMA Network Open in 2024.

    It found a weighted national prevalence of 7.2 per cent by the older NIH 1990 criteria, and 19.6 per cent by the Rotterdam 2003 criteria. Among the women who met the criteria, 91.9 per cent had dyslipidaemia.

    A 2022 systematic review in Cureus[6] pooled eleven Indian studies and gave lower figures: 11.33 per cent by Rotterdam and 5.8 per cent by NIH criteria. The WHO estimates 10 to 13 per cent of reproductive-aged women worldwide are affected.

    Also Read: Maximum Delay in Periods if not Pregnant: How Long is Normal?

    How is PCOD treated? 

    PCOD Treatment

    There is no cure, and treatment targets whichever features are causing trouble. The WHO states that treatments can improve quality of life, assist with fertility, and reduce endometrial cancer risk.

    For irregular cycles and excess hair growth, the guideline names combined oral contraceptive pills as first-line drug treatment in adults. The NHS also lists the progestogen-only pill and the intrauterine system.

    Metformin has a narrower place: the guideline says it should be considered in adults with a body mass index of 25 kg/m² or above. It adds that metformin and active lifestyle intervention have similar efficacy.

    Where the difficulty is getting pregnant, the guideline names letrozole as the first-line drug for ovulation induction. The NHS lists clomifene and laparoscopic ovarian drilling.

    Every one of these is a prescription decision.

    How is PCOD managed with diet and exercise? 

    PCOD diet and exercise

    With both, and the guideline is unusually clear that the benefit does not depend on losing weight.

    It recommends lifestyle intervention for everyone with the condition, whether exercise alone or diet and exercise with behavioural strategies.

    On amount, the guideline points to general population targets: 150 to 300 minutes a week of moderate activity, or 75 to 150 of vigorous, plus muscle-strengthening twice weekly.

    The two sources differ on intensity. The guideline finds no evidence that one type or intensity beats another, while the NHS advises avoiding high-intensity exercise because it can make symptoms worse.

    The guideline also records that many women with the condition meet weight stigma in healthcare, and says the harm that does should be recognised.

    Is there a recommended diet for PCOD, and foods to avoid? 

    No single diet, and no list of foods to avoid. The guideline finds no evidence that one diet composition beats another for metabolic, hormonal, reproductive or psychological outcomes.

    It recommends any composition consistent with healthy-eating guidelines, tailored to the person’s own food preferences. The NHS advice is a balanced diet, with weight loss suggested where someone is overweight.

    When should you see a doctor? 

    See a doctor if you think you might have the condition, or if symptoms are affecting your everyday life, work and relationships. That is the NHS threshold, and it does not require every feature above.

    Situation What to do
    Periods that are irregular, very infrequent or have stopped Raise it at an appointment rather than waiting. The 2023 guideline records that premenopausal women with the condition have a markedly higher risk of endometrial hyperplasia and endometrial cancer.
    Difficulty getting pregnant Both the NHS and the WHO list this among the reasons to seek help, and the fertility treatments named above all need a prescriber.
    Excess hair growth, hair loss or acne affecting daily life The NHS names these among the symptoms to see a GP about where they affect everyday life.
    Low mood or anxiety The NHS lists mental health problems among the features of the condition, and the same threshold applies.
    A family history of type 2 diabetes Mention it. The guideline records raised risk of impaired glucose tolerance and type 2 diabetes regardless of body mass index.

    Do not wait until the list is complete. The WHO estimates around 70 per cent of affected women worldwide are undiagnosed.

    What this article cannot tell you 

    Whether you have it. The diagnosis needs two of three criteria, and two of those three need a blood test or a scan.

    It also cannot say which treatment suits any individual, because everything named above is addressed to clinicians. The choice depends on age, test results, whether pregnancy is wanted, and other conditions.

    The 2023 guideline was published before the renaming, so it uses PCOS throughout, as does the WHO fact sheet.

    Where can you buy prescribed medicines on Medkart? 

    Every medicine named above is prescription-only, so this is about filling a prescription rather than choosing a treatment.

    Medkart lists products whose labels name PCOS, and each is marked as needing a prescription. Four are built on inositol: Mychiro tablets from USV, Myocyst M from Akums, which pairs it with sustained-release metformin, Met PCO Care from Akumentis, and Ovagrace sachets from Mankind.

    Metformin is listed on its own too, as Glycomet tablets from USV. Nothing here says any of these treats the condition. Availability, pack size and price differ between products and can change.

    Medkart states that the medicines it sells are sourced from WHO-GMP certified manufacturers. Medkart’s medicine comparison tool sets products side by side once something has been prescribed, and the medicines index and search page show current stock. Points worth comparing on a prescription:

    • Active ingredient
    • Strength
    • Dosage form
    • Manufacturer
    • Pack size

    Nothing listed here should be started, stopped or changed without the prescriber’s advice.

    Key takeaways 

    • The NHS now calls the condition polyendocrine metabolic ovarian syndrome, and says it used to be called polycystic ovary syndrome.
    • The WHO fact sheet and the 2023 international guideline still use the name PCOS.
    • No source retrieved for this article uses PCOD as a clinical term.
    • Diagnosis needs two of three criteria, and a doctor arranges the tests that settle them.
    • An Indian task force study found a national prevalence of 7.2 per cent by NIH criteria and 19.6 per cent by Rotterdam criteria.
    • There is no cure, and treatment targets whichever features are causing trouble.
    • The guideline names lifestyle change for everyone with the condition, and says the benefit does not depend on weight loss.
    • Irregular periods, difficulty conceiving, or symptoms affecting daily life are all reasons to see a doctor.

    FAQs: Common Questions About PCOD 

    Q. Do you need cysts on your ovaries to have it? 

    No, and that is part of what the new name is getting at. The scan finding is one of three criteria, and only two are needed, so the diagnosis can be made without it.

    Q. Is yoga recommended for PCOD? 

    Not by any source retrieved for this article. The 2023 guideline does not mention yoga, meditation or other mind-body practices, and neither the NHS nor the WHO fact sheet names them. That is silence rather than a finding against yoga, so this article cannot say what it does for the condition.

    Q. Can teenagers be diagnosed with it? 

    With more caution than adults. The 2023 guideline states there are no definitive criteria for polycystic ovary morphology on ultrasound in adolescents. Where features are present but the full criteria are not met, it advises reassessment at or before eight years after the first period.

    Q. Does it always cause weight gain? 

    No. Weight gain and difficulty losing weight sit on the NHS symptom list, but they are not universal. In the Indian task force study, 43.2 per cent of the women who met the criteria had obesity, so most did not. The guideline records raised diabetes risk regardless of body mass index.

    Q. What other health checks might a doctor suggest? 

    Metabolic and cardiovascular ones. The guideline considers women with the condition at increased cardiovascular risk, and notes more obstructive sleep apnoea independent of body mass index. The NHS adds high blood pressure and non-alcoholic fatty liver disease.

    Q. Why do Indian prevalence figures differ so much? 

    Because the criteria count different things. The NIH 1990 definition is narrower than the Rotterdam 2003 definition, so the same population yields a smaller number. Hence one study reporting both 7.2 and 19.6 per cent for the same women.

    Q. Does it affect only the ovaries? 

    No, which is the reason behind the new name. MedlinePlus describes hormone imbalance affecting the ovaries and many other body systems. The NHS names hair growth, periods, fertility and mood among the things it touches.

    References 

    Medical disclaimer: This article gives general information about polycystic ovary syndrome, now also called polyendocrine metabolic ovarian syndrome, and is not a diagnosis. It cannot tell any individual whether they have the condition, how severe it is, or which treatment suits them, because those decisions need a doctor and the right tests. Anyone with the symptoms described here should see a doctor rather than self-treat, and no medicine or supplement should be started, stopped or changed without advice from the prescriber or a qualified pharmacist.

  • Ciprofloxacin: Uses, Dosage, Side Effects & Precautions

    Ciprofloxacin: Uses, Dosage, Side Effects & Precautions

    Ciprofloxacin is the generic name of an antibiotic used for certain bacterial infections. It is a prescription medicine in India, sold under several brand names as tablets and as a liquid.

    Those tablets are made by many different companies. The active ingredient is the same across them, but the strength, pack size and price are not.

    What is ciprofloxacin? 

    Ciprofloxacin

    Ciprofloxacin is an antibiotic. MedlinePlus[1] places it in a class of antibiotics called fluoroquinolones and explains that it works by killing bacteria that cause infections.

    The NHS[2] describes it as a broad-spectrum antibiotic available only on prescription. The same page says the tablets and liquid are used only when no other antibiotic is suitable, because of a risk of serious and long-term side effects.

    Its status in India is set by the Drugs Rules, 1945[3]. Ciprofloxacin hydrochloride appears at entry 113 in Schedule H, the schedule of prescription drugs. Rule 97 requires the pack to carry the symbol Rx and a warning against retail sale without a doctor’s prescription.

    What are the main ciprofloxacin uses? 

    ciprofloxacin uses

    Ciprofloxacin is used for certain bacterial infections. MedlinePlus says it treats or prevents them, and names plague and inhalation anthrax among the infections covered.

    DailyMed’s label[4] lists a long set of approved adult uses. They include urinary tract infections, lower respiratory tract infections, acute sinusitis, skin infections, bone and joint infections, infectious diarrhoea and typhoid fever.

    The NHS names urinary tract infections, chest infections including pneumonia, skin and bone infections, sexually transmitted infections, and eye and ear infections.

    Popular brands containing ciprofloxacin 

    Several ciprofloxacin brands are sold in India. The company names below are those shown on the Medkart listing for each pack.

    Brand Name Active Ingredient Available Strengths / Forms* Manufacturer / Company
    Ciplox Ciprofloxacin 250 mg and 500 mg tablets Cipla Pharmaceutical Company Limited
    Cifran Ciprofloxacin 500 mg tablets Sun Pharmaceutical Industries Ltd
    Ciprobid Ciprofloxacin 500 mg tablets Cadila Pharmaceuticals Private Limited
    Ciprodac Ciprofloxacin 500 mg tablets Cadila Pharmaceuticals Private Limited
    Alcipro Ciprofloxacin 500 mg tablets Alkem Laboratories Limited
    Zoxan Ciprofloxacin 500 mg tablets F D C India Limited

    Examples of listed strengths and forms, not a complete catalogue. Product ranges can change.

    Availability and pack size differ between products. The range sold under any one brand can change.

    How is ciprofloxacin dosage decided? 

    There is no one dose that applies to every ciprofloxacin prescription. The infection, its severity and kidney function all come into it.

    NHS guidance on how and when to take ciprofloxacin[5] describes tablets of 100 mg, 250 mg, 500 mg and 750 mg. There is also a liquid containing 250 mg in 5 ml. It gives a usual range of 250 mg to 750 mg twice a day. Children and people with kidney problems take lower amounts.

    A strength such as ciprofloxacin 500 mg describes the amount of active ingredient in that product. It is product information, not a dosing instruction.

    DailyMed sets different amounts and durations for each infection. For an acute uncomplicated urinary tract infection it gives 250 mg every 12 hours for three days. What applies to one person is a decision for the prescriber.

    Why does antibiotic resistance matter? 

    ciprofloxacin antibiotic resistance

    Resistance grows when antibiotics are used where they are not needed. DailyMed states that using ciprofloxacin only for infections that are proven or strongly suspected to be bacterial reduces the development of drug-resistant bacteria.

    MedlinePlus states that antibiotics such as ciprofloxacin will not work for colds, flu or other viral infections. It advises taking the medicine until the prescription is finished, even when the person feels better.

    NHS guidance on common questions about ciprofloxacin[6] says it is very important to keep taking it until the course is finished. It also says a doctor should be told if there is no improvement after two to three days, or if things get worse at any point.

    Also Read: Doctors must mention Reason while Prescribing Antibiotics

    What are the common ciprofloxacin side effects? 

    ciprofloxacin side effects

    Feeling sick and diarrhoea are the most commonly reported effects. NHS guidance on ciprofloxacin side effects[7] reports them in more than 1 in 100 people, along with a bad taste in the mouth.

    MedlinePlus lists nausea, vomiting, diarrhoea, stomach pain, heartburn, pale skin and unusual tiredness among its common effects.

    The NHS lists serious effects that happen in less than 1 in 100 people, and says to stop the medicine and contact a doctor about any of them, including:

    • Pain or swelling in joints or tendons, often starting in the ankle or calf
    • Pins and needles, tingling, numbness or burning pain, especially in the legs or arms
    • Mood or behaviour changes, confusion, or problems with memory
    • Diarrhoea with blood or mucus
    • An irregular or fast heartbeat, or sudden breathlessness

    DailyMed adds that diarrhoea caused by Clostridioides difficile can appear months after treatment ends, and that skin can react strongly to sun or ultraviolet light during treatment.

    Why the fluoroquinolone warnings matter 

    Ciprofloxacin carries a boxed warning covering four risks. DailyMed names tendinitis and tendon rupture, peripheral neuropathy, central nervous system effects, and worsening of muscle weakness in myasthenia gravis.

    MedlinePlus states that the tendon risk runs during treatment and for up to several months afterwards. It adds that nerve damage may not go away after the medicine is stopped. DailyMed advises avoiding ciprofloxacin in anyone with a known history of myasthenia gravis.

    The European Medicines Agency[8] restricted this class of antibiotics after reviewing disabling and potentially long-lasting side effects. It advises stopping a fluoroquinolone and contacting a doctor at once at the first sign of tendon pain, joint swelling or nerve symptoms. The NHS states that ciprofloxacin is not prescribed for more than three months at a time.

    Who should be careful with ciprofloxacin? 

    Most people can take it, but several situations need raising first. NHS guidance on who can and cannot take ciprofloxacin[9] says most adults and children aged 1 year and over can take or use it.

    Situation What to do
    A previous reaction to a fluoroquinolone The NHS says to speak to a doctor first after any allergic reaction to ciprofloxacin, or any serious side effect with ciprofloxacin or another fluoroquinolone. DailyMed contraindicates it after hypersensitivity to ciprofloxacin or any quinolone.
    Myasthenia gravis DailyMed’s boxed warning covers worsening muscle weakness, and it says ciprofloxacin should be avoided in anyone with a known history of the condition.
    Aorta problems The NHS says to speak to a doctor first about an abdominal aortic aneurysm or another aorta problem, including where a family member has had one.
    Heart rhythm problems The NHS lists a fast, pounding or irregular heartbeat among the situations to raise before starting.
    Mental health conditions The NHS says to mention depression, anxiety, suicidal feelings or any other mental health condition first.
    Epilepsy, kidney problems or diabetes The NHS lists all three, and notes that ciprofloxacin can affect blood sugar.
    Tendon or connective tissue disorders The NHS lists previous tendon problems, rheumatoid arthritis, Behcet’s disease and Marfan syndrome among the situations to raise first.

    The NHS also says to mention pregnancy, plans to become pregnant, or breastfeeding. DailyMed contraindicates ciprofloxacin alongside tizanidine.

    Generic ciprofloxacin vs brand-name ciprofloxacin 

    Generic ciprofloxacin vs brand-name ciprofloxacin

    Generic and branded ciprofloxacin contain the same active ingredient. The US FDA[10] states that a generic medicine matches the brand-name medicine on active ingredient, strength, dosage form and route of administration, and is bioequivalent to it.

    The FDA adds that approved generics provide the same clinical benefit and risks as their brand-name counterparts. That is the U.S. FDA standard, and an India-specific regulatory source is needed before making the same claim about an Indian product.

    Products can still differ in manufacturer, inactive ingredients, appearance and price. The same active ingredient and strength alone do not prove that two products are interchangeable. A doctor or pharmacist should confirm any switch between brands.

    Buy or compare ciprofloxacin tablets on Medkart 

    Medkart sells ciprofloxacin products online from several manufacturers and lists them as prescription items. Its composition listings for ciprofloxacin 500 mg and ciprofloxacin 250 mg show what is stocked at each strength. Medkart states that the medicines it sells are sourced from WHO-GMP certified manufacturers.

    Medkart’s medicine comparison tool places products side by side, and the medicines index lists what is in stock. The details a reader can compare include:

    • Active ingredient
    • Strength
    • Dosage form
    • Manufacturer
    • Pack size
    • Current price

    Any suggested alternative should be discussed with a doctor or pharmacist before changing a prescribed antibiotic.

    Key takeaways 

    • Ciprofloxacin is an antibiotic in the fluoroquinolone group and works by killing bacteria.
    • Ciprofloxacin hydrochloride is listed at entry 113 in Schedule H of India’s Drugs Rules, 1945, which makes it a prescription drug.
    • The NHS states that ciprofloxacin tablets and liquid are used only when no other antibiotic is suitable.
    • A strength such as ciprofloxacin 500 mg is product information, not an instruction about how much to take.
    • Feeling sick and diarrhoea are among the most commonly reported side effects.
    • The boxed warning covers tendinitis and tendon rupture, nerve damage, central nervous system effects and worsening of myasthenia gravis.
    • Tendon pain, joint swelling or nerve symptoms are a reason to stop the medicine and contact a doctor at once.
    • Antibiotics do not work for colds, flu or other viral infections, and a prescribed course is meant to be finished.

    FAQs: Common Questions About Ciprofloxacin 

    Q. How quickly does ciprofloxacin start working? 

    Most people feel better within a few days. NHS guidance on common questions says how quickly it works depends on the infection. A bone infection can take a week or longer before there is any improvement. A doctor is the right person to tell if progress is slower than expected.

    Q. What happens if a dose of ciprofloxacin is missed? 

    It depends on how close the next dose is. NHS guidance on how and when to take ciprofloxacin says a missed dose should be taken as soon as it is remembered, unless the next one is nearly due. In that case the missed dose is skipped and the normal schedule resumes. The same guidance says never to take a double dose to catch up.

    Q. Why should dairy products be avoided around a dose? 

    Because they can stop the medicine working properly. NHS guidance on how and when to take ciprofloxacin says to avoid dairy products such as milk, cheese and yoghurt, because they affect how the medicine works. The same guidance says the tablets should be swallowed whole with plenty of water rather than chewed.

    Q. Is it safe to drink alcohol while taking ciprofloxacin? 

    Yes. NHS guidance on common questions about ciprofloxacin states that alcohol can be drunk while taking it. Anyone unsure how that sits with their other medicines should ask a pharmacist.

    Q. Can ciprofloxacin be given to a child? 

    Sometimes, and only on a prescription. The NHS says most adults and children aged 1 year and over can take or use ciprofloxacin. DailyMed approves it for children aged 1 to 17 years for complicated urinary tract infections and kidney infections. It notes a higher rate of joint and tissue problems in children. A doctor decides whether it is the right choice.

    Q. What happens if too much ciprofloxacin is taken? 

    It can cause harm. The NHS says taking too much ciprofloxacin can cause feeling sick, being sick, diarrhoea, an irregular heartbeat, or seizures in people with epilepsy. Anyone who has taken more than the prescribed amount should contact a doctor, a pharmacist or a hospital straight away.

    References 

    Medical disclaimer: This article provides general information and does not replace advice from a doctor or pharmacist. Ciprofloxacin is an antibiotic listed in Schedule H of India’s Drugs Rules, 1945, so ciprofloxacin products in India are prescription medicines. Brands with the same composition should only be substituted under the guidance of a healthcare professional or pharmacist because product details and approved indications can differ.

  • Chamomile Tea: Benefits, Uses, How to Make It and Side Effects

    Chamomile Tea: Benefits, Uses, How to Make It and Side Effects

    Chamomile tea is an infusion made by pouring boiling water over the dried flower heads of the chamomile plant. In India the plant is a permitted nutraceutical ingredient, and in Europe the flower is a registered traditional herbal medicine.

    The plant behind almost all of it is Matricaria recutita, also written Matricaria chamomilla and known as German chamomile. Most human trials on chamomile tested a concentrated extract in a capsule rather than the drink.

    What is chamomile tea? 

    Chamomile tea

    Chamomile tea is an infusion of dried chamomile flower heads in hot water. The European Medicines Agency[1] defines the herbal substance as Matricaria recutita L., flos, meaning the flower and no other part of the plant.

    What people use it for is broader than what it is registered for. The National Center for Complementary and Integrative Health[2] lists the common cold, indigestion, anxiety and insomnia among the things chamomile is promoted for.

    What are the benefits and uses of chamomile tea? 

    benefits and uses of chamomile tea

    The EMA recognises chamomile flower for a small set of minor complaints, and only as a traditional herbal medicine.

    Only one of the five registered uses involves drinking the infusion. The others are a mouth rinse, a skin wash, a local irrigation and a steam inhalation.

    Use What the evidence says
    Minor digestive complaints The EMA registers the flower, taken by mouth as an infusion, for minor gastro-intestinal complaints such as bloating and minor spasms. The registration rests on long-standing use, not on trial results.
    Anxiety A trial in the Journal of Clinical Psychopharmacology[3] randomised 57 outpatients with mild to moderate generalised anxiety disorder to a standardised extract or placebo for eight weeks. Anxiety scores fell further on chamomile, at p equal to 0.047. The trial used capsules, not tea.
    Mouth and throat The EMA registers an infusion of 1 to 5 g in 100 ml of water for minor ulcers and inflammation of the mouth and throat, used for rinsing and gargling rather than swallowed.
    Skin and sunburn It also registers the flower for minor skin inflammation including sunburn, superficial wounds and small boils, applied as a wash or an impregnated dressing.
    Common cold For cold symptoms the monograph gives 3 to 10 g in 100 ml of hot water as a steam inhalation, which is not a drinking use.

    Does chamomile tea help with weight loss? 

    No. Weight is not among the uses the EMA registers. A 2021 review of chamomile in obesity and metabolic syndrome[4] states that no clinical trials of chamomile in the management of obesity were available to its authors.

    The review describes laboratory and animal work on carbohydrate digestion and energy metabolism instead. Its authors treat chamomile as a promising candidate, while noting that any effect is likely to be moderate because plant polyphenols are poorly absorbed when swallowed.

    How do you make chamomile tea? 

    chamomile tea Making Tips

    As an infusion. The EMA’s patient leaflet template for herbal teas[5] sets out the method in standard terms.

    Boiling water is poured over the flowers, and the tea is left to steep for a set period, usually 5 to 15 minutes where nothing else is specified. The vessel is kept covered with a lid and stirred at intervals. The liquid is then strained through a tea strainer.

    The same document notes that infusion suits leaves, flowers and delicate plant parts, while roots and barks are simmered or soaked instead.

    What is the recommended dosage of chamomile tea? 

    There is no one amount that applies to everyone. For the flower brewed as a tea, the monograph gives adolescents, adults and the elderly a single dose of 1.5 to 4 g in 150 ml of boiling water. It puts the frequency at 3 to 4 times a day.

    Smaller single doses are set out for children, taken 2 to 4 times a day:

    • 6 months to 2 years: 0.5 to 1.0 g
    • 2 to 6 years: 1.0 to 1.5 g
    • 6 to 12 years: 1.5 to 3.0 g

    A weight printed on a pack of tea bags describes how much flower each bag holds. It is product information, not an instruction about how much to drink.

    India regulates the ingredient rather than the brew. The Food Safety and Standards Authority of India[6] lists Matricaria chamomilla as a permitted nutraceutical ingredient in Schedule VI, Part B. The entry covers an aerial parts extract, sets no daily range, and describes a manufactured product rather than flowers brewed at home.

    When should you drink chamomile tea? 

    No source retrieved for this article gives a best time of day. The monograph sets a frequency of 3 to 4 times daily and says nothing about morning or evening.

    Does chamomile tea help with sleep? 

    Sleep is why people ask, and the sources disagree.

    The NCCIH reports that a 2019 review found only one insomnia study, and that it showed no benefit. A pilot trial in BMC Complementary and Alternative Medicine[7] gave 34 adults with chronic primary insomnia 270 mg of chamomile extract twice daily for 28 days. Total sleep time and sleep efficiency did not differ significantly from placebo, though time to fall asleep shortened by about 16 minutes.

    A trial in the Journal of Education and Health Promotion[8] found the opposite. Seventy-seven nursing home residents aged over 60 took 400 mg capsules twice daily, after lunch and after dinner, for four weeks. Sleep quality scores improved against the control group, and the authors name the absence of blinding and of a placebo group among the study’s limits.

    All three used capsules of extract, so their schedules are not schedules for a cup of tea.

    Also Read: Ashwagandha for Men: Benefits for Energy, Strength & Hormones

    How long can you drink chamomile tea? 

    The EMA sets a checkpoint rather than a maximum. If symptoms last more than one week, the monograph says a doctor or a qualified health care practitioner should be consulted. The same applies if symptoms get worse.

    No source retrieved for this article sets a limit on chamomile drunk as an ordinary beverage.

    What side effects can chamomile tea cause? 

     chamomile tea side effects

    Allergic reactions are the effect the sources single out. The EMA records hypersensitivity reactions, including severe ones, and puts their frequency at not known.

    Among the severe reactions it names breathlessness, Quincke’s disease, vascular collapse and anaphylactic shock. These were reported after mucosal contact with liquid chamomile preparations.

    The NCCIH describes chamomile as likely safe by mouth in the amounts commonly found in teas and other foods. It lists nausea, dizziness and allergic reactions as uncommon effects. The EMA adds that no case of overdose has been reported.

    Who should be careful with chamomile tea? 

    The clearest case is an allergy to plants in the daisy family. Four other situations call for care.

    Situation What to do
    An allergy to daisies, marigolds or ragweed The EMA contraindicates chamomile in anyone with hypersensitivity to it or to other plants of the Asteraceae family. The NCCIH notes that reactions are more likely in people allergic to ragweed, chrysanthemums, marigolds or daisies.
    Pregnancy and breastfeeding The sources disagree. The EMA states that safety during pregnancy and lactation has been established for the comminuted flower used as a tea, but not for the extracts, whose use it does not recommend. The NCCIH says little is known about either.
    Babies under six months The EMA has not established oral use of the herbal tea below six months of age, on general grounds of nutrition and fluid intake.
    Regular prescribed medicines Interactions have been reported for concentrated preparations. A pharmacist should be told what is being taken before chamomile becomes a daily habit.
    Hormonal contraception The NCCIH notes that chamomile may have oestrogen-like effects, and that these might reduce the effectiveness of birth control pills.
    Breathlessness, swelling or faintness after drinking it The EMA lists these among reported severe reactions. They call for stopping the tea and getting medical help the same day.

    Can chamomile tea interact with medicines? 

    Possibly, and what has been reported involves concentrated preparations rather than a cup. The EMA reports interactions based on effects on CYP450 in patients after kidney transplantation who took high doses for about two months. For skin, mouth, inhalation and bath use it reports none.

    The NCCIH reports interactions between chamomile and warfarin, a blood thinner, and with some medicines that the liver breaks down.

    Neither source describes an interaction study on chamomile tea at ordinary drinking strength.

    Where can you buy chamomile tea online? 

    Medkart is a pharmacy, so chamomile appears there mostly as an ingredient inside a formulated product.

    Periods Care tea bags from Taparia Tea Company name chamomile among their herbs. On the skin side, Dermsilk cream from Cure N Cure Pharmaceutical and Urtiplex lotion from Charak Pharmaceuticals both list chamomile extract. So does Gentle Baby Shampoo from Himalaya Wellness.

    The Ayurvedic products category and the Ayurvedic composition listing show the wider herbal range. Availability, pack size and price differ between products and can change.

    Medkart states that the medicines it sells are sourced from WHO-GMP certified manufacturers. Medkart’s medicine comparison tool places products side by side, while the medicines index and the search page show what is in stock. Points worth comparing on a herbal pack include:

    • Botanical name of the plant
    • Whether the pack is pure chamomile or a blend
    • Weight of flower per bag
    • Manufacturer
    • Pack size

    Chamomile products are sold without a prescription, so a doctor or pharmacist should be told before one joins a set of regular medicines.

    Key takeaways 

    • Chamomile tea is an infusion of the dried flowers of Matricaria recutita, known as German chamomile.
    • The EMA registers it as a traditional herbal medicine, which means the use rests on long-standing use rather than trials.
    • Only one of its five registered uses is a drink, for minor digestive complaints such as bloating and spasms.
    • The monograph gives adults a single dose of 1.5 to 4 g in 150 ml of boiling water, 3 to 4 times a day.
    • An infusion is steeped for 5 to 15 minutes under a lid, then strained.
    • No source retrieved for this article gives a best time of day to drink it.
    • The sleep and anxiety trials used capsules of concentrated extract, not the tea.
    • Allergy is the main reported risk, and it is more likely in people who react to daisies, marigolds or ragweed.

    FAQs: Common Questions About Chamomile Tea 

    Q. Is the chamomile in a tea bag the same as the chamomile in a capsule? 

    No, and the difference matters more than it looks. A tea bag holds the dried flower, while a capsule holds an extract concentrated many times over. The EMA treats them as separate preparations with separate amounts, and reaches different conclusions about them in pregnancy.

    Q. Why does the water need to be boiling? 

    For hygiene as much as for flavour. The EMA’s leaflet template notes that boiling water lowers the microbial load carried by dried plant material, which is not sterile. Water that has gone off the boil does less to that load.

    Q. Can brewed chamomile tea be kept and drunk later? 

    For a short while, and cold. The same EMA template says a herbal infusion should be drunk soon after it is made, and otherwise kept covered in the fridge for no more than 24 hours. A pot left standing at room temperature all day falls outside that advice.

    Q. Is German chamomile the same as Roman chamomile? 

    They are different plants sold under a shared name. The EMA monograph and the FSSAI listing both name Matricaria recutita, and the NCCIH says chamomile refers primarily to German chamomile. No source retrieved for this article covers Roman chamomile, so nothing here should be assumed to apply to it.

    Q. Can chamomile tea replace a prescribed medicine for anxiety or sleep? 

    No. The anxiety trial tested a standardised extract in people with mild to moderate symptoms, and its authors said the findings do not extend to severe cases. The registered use for the drink covers minor digestive complaints and nothing more. Any change to prescribed treatment is a decision for the prescriber.

    Q. Do loose flowers and tea bags need different handling? 

    Slightly. The EMA notes that herbal teas come both loose and in sachets, and gives each a different final step. Loose flowers are stirred and strained, with the residue pressed to yield more liquid. A sachet is gently squeezed instead.

    References 

    Medical disclaimer: This article gives general information only. It does not replace advice from a doctor or pharmacist. No medicine or supplement should be started, stopped or changed without advice from the prescriber or a qualified pharmacist.

  • Bioequivalence: How Generic Medicines Are Tested and Approved in India

    Bioequivalence: How Generic Medicines Are Tested and Approved in India

    Bioequivalence is the test that decides whether a generic medicine can stand in for the product it copies. It compares how much of the active ingredient reaches the bloodstream, and how fast.

    Generic medicines are approved on that comparison rather than on fresh trials in patients. The rules governing the comparison are set by regulators, and they differ in detail between countries.

    What is bioequivalence? 

    What is bioequivalence

    Bioequivalence is a comparison between two formulations of the same active ingredient. India’s New Drugs and Clinical Trials Rules, 2019[1] define a bioequivalence study as one establishing the absence of a statistically significant difference in the rate and extent of absorption. That comparison is made against a reference formulation with the same active ingredient.

    The World Health Organization[2] frames it as two products being bioequivalent when their bioavailabilities are similar to such a degree that the same effects can be expected from both. It treats Cmax and tmax as the measures of rate, and the area under the curve as the measure of extent.

    The US FDA[3] states the same idea more plainly. A generic drug is bioequivalent when it delivers the same amount of active ingredient at the same rate and to the same extent as the brand-name drug.

    What is a generic medicine? 

    A generic medicine is a copy of a brand-name medicine that has already been approved. The FDA’s summary of generic drug facts[4] states that a generic must have the same active ingredient, strength, dosage form and route of administration as the brand-name drug.

    It must also be made under the same strict standards, carry the same label with certain exceptions, and be bioequivalent to the brand-name medicine. The FDA states that approved generics work in the same way and provide the same clinical benefit and risks as their brand-name counterparts.

    Those statements describe the United States regulatory standard. An India-specific regulatory source is needed before making the same claim about a particular Indian product.

    What does a bioequivalence study measure? 

    Bioequivalence Study

    A bioequivalence study measures the active ingredient in the blood over time. WHO names the measures that matter and the range the result has to fall inside.

    Measure What it shows
    Cmax The highest concentration the active ingredient reaches. WHO treats this as one of the two measures of the rate of absorption.
    tmax The time at which that highest concentration is reached. It is the second measure of rate.
    Area under the curve The total exposure over time, which WHO treats as the measure of the extent of absorption.
    90% confidence interval The statistical result. WHO states the interval for the geometric mean ratio should normally fall within 80 to 125% for log-transformed data.

    The underlying quantity is bioavailability. The New Drugs and Clinical Trials Rules define a bioavailability study as one assessing the rate and extent to which a drug is absorbed from a formulation. The definition covers the drug becoming available in the systemic circulation, or at the site of action.

    Those acceptance limits are the WHO figures, and an Indian regulatory source setting the same numbers was not available for this article. WHO states that the primary concern in a bioequivalence assessment is to limit the risk of a false declaration of equivalence.

    How is a bioequivalence study run? 

    Bioequivalence Study Work

    The study compares a test product against a comparator. WHO defines the comparator product as the one the generic is intended to be interchangeable with in clinical practice, and normally that is the innovator product.

    WHO states that bioequivalence studies should generally be performed with healthy volunteers rather than with patients. The FDA’s description of an abbreviated new drug application[5] says much the same, measuring how long the generic takes to reach the bloodstream in healthy volunteers.

    WHO lists four ways of assessing equivalence:

    • Comparative pharmacokinetic studies in humans
    • Comparative pharmacodynamic studies in humans
    • Comparative clinical trials
    • Comparative in vitro tests

    In a pharmacokinetic study the active ingredient or its metabolites are measured over time in a biological fluid such as blood, plasma, serum or urine.

    Who approves bioequivalence studies in India? 

    CDSCO oversees them. The CDSCO BA/BE Division[6] is responsible for regulatory oversight, for the evaluation of bioavailability and bioequivalence studies, and for the approval of BA/BE study centres in India.

    Stage What happens
    Protocol review The CDSCO BA/BE Division evaluates the study protocol before the study begins.
    Ethics Committee review Under the New Drugs and Clinical Trials Rules, an Ethics Committee reviews the protocol, and every member signs a declaration that there is no conflict of interest.
    Registration The same rules state that a bioavailability or bioequivalence study requires registration from the authorities specified in rules 8 and 17.
    Approval or NOC The Division grants approval or a no objection certificate, including for studies conducted only for export.

    The Division also assesses therapeutic equivalence and interchangeability between the test product and the reference or innovator product.

    Why do generic medicines cost less? 

    Generic Medicines Cost

    Generic makers do not repeat the original trials. The FDA states that generic applicants do not have to repeat the animal and clinical studies required for the brand-name medicine.

    Competition then does the rest. The FDA states that a single competitor can cut the price by about 30%, and that around five competitors bring the reduction to nearly 85%.

    Those figures describe the United States market. Indian prices are set under a different system, which that source does not describe.

    Also Read: How reliable are generic medicines? Why do generic medicines cost less?

    When is a bioequivalence study not needed? 

     in-vitro testing vs in-vivo study

    Not every generic needs a study in people. WHO describes a biowaiver as an approval granted on evidence of equivalence rather than through in vivo equivalence testing.

    Comparative in vitro tests sit among the four methods WHO lists for assessing equivalence. Whether that route is open for a particular product is a regulatory decision, and not something that can be read off a pack.

    The limits of a bioequivalence result 

    A bioequivalence result is about absorption, not about everything on the pack. The FDA states that generics may contain different inactive ingredients, and that in rare cases those can affect absorption or how well someone tolerates the product.

    WHO frames bioequivalence as a comparison between a multisource product and its comparator. That single comparison is what the approval rests on.

    Any switch between products should be discussed with a doctor or pharmacist.

    How to compare generic and branded medicines on Medkart 

    Medkart groups products by composition, so that everything sharing an active ingredient and strength appears in one place, with the manufacturer shown for each. Composition pages cover molecules such as:

    Medkart[7] states that the medicines it sells are sourced from WHO-GMP certified manufacturers. Medkart’s medicine comparison tool places products side by side, and the medicines index lists what is in stock. The details a reader can compare include:

    • Active ingredient
    • Strength
    • Dosage form
    • Manufacturer
    • Pack size
    • Current price

    Any change from a prescribed product should be discussed with a doctor or pharmacist first.

    Key takeaways 

    • Bioequivalence compares the rate and extent to which an active ingredient is absorbed from two formulations.
    • India’s New Drugs and Clinical Trials Rules, 2019 define a bioequivalence study as establishing the absence of a statistically significant difference in that absorption.
    • The comparison is made against a reference formulation, which is normally the innovator product.
    • Cmax and tmax describe the rate of absorption, and the area under the curve describes the extent.
    • WHO states the 90% confidence interval should normally fall within 80 to 125% for log-transformed data.
    • The CDSCO BA/BE Division oversees these studies in India and approves the study centres.
    • Generic medicines cost less partly because the original animal and clinical studies are not repeated.
    • A bioequivalence result covers absorption, and inactive ingredients can still differ between products.

    FAQs: Common Questions About Bioequivalence 

    Q. Who takes part in a bioequivalence study? 

    Healthy volunteers, rather than patients. WHO states that bioequivalence studies should generally be performed with healthy volunteers. Where a product is intended for use in both sexes, it says the sponsor should include both males and females. Clear inclusion and exclusion criteria have to be set out in the study protocol.

    Q. Why is the comparator usually the innovator product? 

    Because that is the product whose evidence already exists. WHO states the comparator will normally be the innovator product, for which efficacy, safety and quality have been established. The generic is measured against that established product rather than against an unproven one.

    Q. Does a bioequivalence study prove that a generic is safe? 

    It stands in for that evidence rather than generating it fresh. WHO describes a bioequivalence study as a surrogate for clinical evidence of the safety and efficacy of the multisource product. The underlying safety and efficacy evidence belongs to the comparator product it was measured against.

    Q. What is an abbreviated new drug application? 

    It is the application route for a generic in the United States. The FDA states that an abbreviated new drug application contains the data submitted for the review and potential approval of a generic drug product. It is called abbreviated because applicants are generally not required to include animal and human data establishing safety and effectiveness.

    Q. Are two generics of the same medicine compared with each other? 

    Not as part of the route described in the guidance. WHO frames a bioequivalence study as a comparison between a multisource product and a comparator product, which is normally the innovator. The sources used for this article do not describe a head-to-head comparison between two generic products. A doctor or pharmacist is the right person to ask about moving between them.

    Q. Does a generic have to look like the brand? 

    No. The FDA states that generic medicines may differ from the brand in minor cosmetic ways such as colour. It adds that these differences do not affect how the medicine works. A change in the look of a pack is therefore not by itself a reason to doubt it, and a pharmacist can confirm what has changed.

    References 

    Medical disclaimer: This article gives general information only. It does not replace advice from a doctor or pharmacist. No medicine should be started, stopped or changed without advice from the prescriber or a qualified pharmacist.

  • Isabgol: Benefits, Dosage, Uses and Side Effects

    Isabgol: Benefits, Dosage, Uses and Side Effects

    Isabgol, also known as psyllium or ispaghula husk, is a fibre used mainly to relieve constipation. It absorbs water in the intestine and forms a gel-like mass that makes stool softer and increases its bulk.

    Isabgol comes from the outer covering of the seeds of Plantago ovata. Plain psyllium husk is available alongside products that contain other ingredients, so the directions can differ from one formulation to another.

    What are the benefits and uses of isabgol? 

    Constipation is the best-established use of isabgol. Psyllium holds water as it moves through the intestine, producing a softer, bulkier stool that is easier to pass.

    Its medical uses extend beyond routine constipation.

    Use What the evidence says
    Habitual constipation The European Medicines Agency[1] recognises ispaghula husk for treating habitual constipation.
    Making stools easier to pass The EMA also recognises its use where softer stools are desirable, including with anal fissures, haemorrhoids and after surgery involving the anus or rectum.
    Increasing fibre intake Ispaghula husk[2] can be used where more dietary fibre is advisable, including in people with irritable bowel syndrome who also have constipation.
    High cholesterol The EMA says it can be used with diet in people with high cholesterol. Studies reviewed by the agency found small reductions in blood cholesterol. This use requires medical supervision.
    Diarrhoea MedlinePlus[3] notes that doctors may also prescribe psyllium for diarrhoea.

    These uses do not all call for the same approach. For example, someone using psyllium for high cholesterol is using it for a different purpose from someone treating occasional constipation.

    What is the recommended dosage of isabgol?

    For adults, older people and adolescents over 12, the EMA monograph gives a daily dose of 7 to 11 g of ispaghula husk, taken in one to three doses, for habitual constipation and situations where softer stools are desirable.

    That figure refers to the ispaghula husk itself. A flavoured preparation, combination product or Ayurvedic formulation can contain other ingredients and may carry different directions.

    For powders and granules, the amount of liquid matters as much as the quantity of fibre. MedlinePlus advises mixing psyllium powder or granules with 240 ml, or 8 oz, of liquid immediately before use and drinking at least that amount of liquid with the dose. DailyMed labels for psyllium products similarly instruct users to mix the dose with a full glass of liquid, stir briskly and drink it promptly.

    A practical way to read the general guidance is:

    • Amount: For plain ispaghula husk, the EMA monograph gives 7 to 11 g a day for adults and adolescents over 12, divided into one to three doses
    • Liquid: Powder or granules should be taken with enough liquid; MedlinePlus specifies at least 240 ml with the dose
    • Preparation: Mix shortly before taking it and drink promptly before it becomes thick
    • Product directions: Follow the pack if its dose or preparation instructions differ, particularly for combination formulations

    When should you take isabgol? 

    The EMA advises taking ispaghula husk during the day and not immediately before bedtime. It should generally be separated from other medicines by at least 30 minutes to one hour.

    Some medicines need a longer gap. MedlinePlus specifically advises keeping psyllium at least three hours away from digoxin, salicylates such as aspirin, and nitrofurantoin.

    If you take regular medicines, ask a pharmacist what spacing applies to them.

    How long can you take isabgol? 

    For constipation being treated without medical supervision, ongoing symptoms deserve attention.

    The EMA advises speaking with a doctor or pharmacist if constipation has not resolved after three days. MedlinePlus advises against taking psyllium for longer than one week unless a doctor tells you to continue.

    Longer use can be appropriate in some circumstances. NHS[4] guidance for the ispaghula product Fybogel notes that a doctor may recommend extended use for more serious constipation or when ispaghula is being used to increase dietary fibre.

    Also Read: Top 10 High Fiber Rich Foods for Better Digestion

    What side effects can isabgol cause? 

    Wind and bloating are the main common side effects reported with ispaghula husk. Isabgol is generally safe for most people, but some may experience:

    • Gas and bloating
    • Stomach cramps or discomfort
    • Changes in bowel movements
    • Constipation if taken without enough water
    • Difficulty swallowing in rare cases

    To reduce the risk of side effects, take isabgol with plenty of water.

    Why enough liquid matters 

    Psyllium swells after absorbing liquid. If it is taken without enough fluid, it can expand and block the throat or food pipe. DailyMed[5] advises people with existing swallowing difficulty not to use psyllium products carrying this warning and to seek immediate medical attention for chest pain, vomiting, difficulty swallowing or difficulty breathing after a dose.

    Who should be careful with isabgol? 

    Some symptoms and health conditions need to be considered before psyllium is used.

    Situation What to do
    Difficulty swallowing or problems with the throat Speak with a doctor or pharmacist before use. Psyllium expands with liquid and can cause obstruction.
    Rectal bleeding Seek medical advice rather than continuing to self-treat constipation.
    A sudden change in bowel habits lasting more than two weeks The EMA advises against using ispaghula husk without medical assessment in this situation.
    Known intestinal blockage or narrowing Psyllium may be unsuitable and needs medical assessment.
    Regular medicines or supplements Tell the doctor or pharmacist what you take because psyllium can affect how some medicines are used or absorbed.

    MedlinePlus also advises discussing psyllium use with a clinician if you have conditions such as diabetes, heart disease, high blood pressure or kidney disease.

    Can isabgol interact with medicines? 

    Yes. Psyllium can affect some oral medicines, which is why spacing between doses may be needed.

    The EMA gives a general interval of at least 30 minutes to one hour before or after other medicines. MedlinePlus gives a three-hour interval for certain medicines, including digoxin, salicylates and nitrofurantoin.

    Medicine-specific advice takes priority, so people taking regular treatment should ask a pharmacist about the interval that applies to their medicines.

    Where can you buy isabgol online? 

    On Medkart, isabgol options currently span 50 g to 400 g pack sizes, with powder, husk churan and liquid formulations listed. The range includes plain ispaghula husk products as well as Ayurvedic isabgol formulations from different manufacturers, with manufacturing and quality credentials including GMP, Schedule M, and WHO-GMP compliance verified for relevant generic medicine manufacturers.

    That gives you several points to compare before choosing a product:

    • Ingredients and strength
    • Formulation
    • Pack size
    • Manufacturer
    • Current price
    • Stock availability

    For medicines, Medkart’s Compare Medicines tool can show price information and suggest alternatives based on similar active ingredients and therapeutic uses. Medkart advises discussing a suggested alternative with a healthcare provider before changing a medicine.

    Key takeaways

    • Isabgol, psyllium and ispaghula husk are names used for the same type of fibre.
    • Its main established use is relief of constipation.
    • The EMA monograph gives 7 to 11 g per day for adults and adolescents over 12 for habitual constipation, divided into one to three doses.
    • Psyllium powder and granules need enough liquid. MedlinePlus specifies at least 240 ml with a dose.
    • Wind and bloating are common side effects.
    • Psyllium should be kept separate from some medicines.
    • Difficulty swallowing, rectal bleeding or persistent constipation calls for medical advice.

    FAQs 

    Q. Is isabgol the same as psyllium husk? 

    Yes. Isabgol is a common Indian name for psyllium or ispaghula husk. The medicinal material comes from the seed coat of Plantago ovata[6].

    Q. How much water should you drink with isabgol? 

    MedlinePlus advises mixing psyllium powder or granules with 240 ml, or 8 oz, of liquid and drinking at least that amount with the dose. The directions on the product pack should also be followed.

    Q. Can isabgol be taken at night? 

    The EMA advises taking ispaghula husk during the day and not immediately before bedtime.

    Q. Can isabgol be taken every day? 

    It may be used regularly in some circumstances, but the duration depends on why it is being taken. MedlinePlus advises not taking psyllium for longer than one week unless a doctor tells you to, while NHS guidance notes that longer use may be recommended for some patients.

    Q. How long does isabgol take to work? 

    For the ispaghula husk product Fybogel, the NHS says it usually takes two to three days to work.

    Q. Can isabgol be taken with other medicines? 

    Psyllium needs to be separated from some medicines. The EMA advises a general gap of 30 minutes to one hour, while some medicines require longer spacing.

    Q. What happens if isabgol is taken without enough water? 

    Psyllium can swell and obstruct the throat or food pipe if taken without enough liquid. Difficulty swallowing or breathing after taking it requires immediate medical attention.

    References 

    1. https://www.ema.europa.eu/en/documents/herbal-summary/ispaghula-husk-summary-public_en.pdf
    2. https://en.wikipedia.org/wiki/Psyllium
    3. https://medlineplus.gov/druginfo/meds/a601104.html
    4. https://www.nhs.uk/medicines/fybogel-ispaghula-husk/
    5. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f8b1c831-6fd0-4a58-9726-4e0f986c8084
    6. https://www.ema.europa.eu/en/medicines/herbal/plantaginis-ovatae-seminis-tegumentum

    Medical disclaimer: This article gives general information only. It does not replace advice from a doctor or pharmacist. No medicine or supplement should be started, stopped or changed without advice from the prescriber or a qualified pharmacist. 

  • Azithromycin Uses, Dosage, Side Effects & Precautions

    Azithromycin Uses, Dosage, Side Effects & Precautions

    Azithromycin is the generic name of a prescription antibiotic sold under several brand names. It belongs to the macrolide group and is used for selected bacterial infections. The medicine comes in different strengths and forms. Its prescribed dose depends on the infection, the patient and the product being used.

    A prescription may show azithromycin as the active ingredient while the medicine pack carries a separate brand name. The active ingredient is the part of the medicine responsible for its medical effect. This distinction matters when patients compare brands, strengths and prices.

    What is Azithromycin?

    Azithromycin is the generic active ingredient, not a brand name. It belongs to a group of antibiotics called macrolides. MedlinePlus[1] explains that it treats bacterial infections by stopping the growth of bacteria.

    DailyMed classifies azithromycin as an azalide, a subgroup of macrolide antibiotics, and lists oral tablets containing azithromycin as the active ingredient.

    An Azithromycin generic medicine can therefore be sold under a manufacturer’s own trade name while still containing azithromycin.

    What are the main azithromycin tablet uses?

    Azithromycin is prescribed for selected infections caused by bacteria. MedlinePlus and the NHS[2] list uses that include certain chest, ear, sinus, throat and skin infections, as well as some sexually transmitted bacterial infections.

    For someone asking what is azithromycin used for, the diagnosis matters. Azithromycin is appropriate only for infections where the bacteria involved are susceptible to it.

    It does not treat viral illnesses such as the common cold or flu. DailyMed[3] states that azithromycin should be used for infections that are proven or strongly suspected to be bacterial.

    Popular Brands Containing Azithromycin

    Several Azithromycin brand names are available in India.

    The brand name identifies the commercial product. The active ingredient remains azithromycin. Manufacturer, strength, dosage form, inactive ingredients, pack size and price can differ across products.

    Azithromycin composition and available strengths

    Azithromycin composition identifies azithromycin as the active ingredient and states how much is present in a tablet or a measured quantity of liquid.

    Brand Name Active Ingredient Available Strengths / Forms* Manufacturer / Company
    Azithral Azithromycin 250 mg and 500 mg tablets; 100 and 200 liquid products Alembic Pharmaceuticals Ltd.
    Zithromax Azithromycin 250 mg and 500 mg tablets; 100 mg/5 mL and 200 mg/5 mL oral suspension Pfizer
    Azee Azithromycin 250 mg and 500 mg tablets; other oral formulations Cipla Ltd.
    Azax Azithromycin 250 mg and 500 mg tablets Sun Pharmaceutical Industries Ltd.
    Azicip Azithromycin 250 mg and 500 mg tablets; oral suspension products Cipla Ltd.
    Azibest Azithromycin 250 mg and 500 mg tablets; 100 mg and 200 mg suspension products Blue Cross Laboratories Ltd.

    *Examples of listed strengths and forms, not a complete catalogue. Product ranges can change.

    Alembic’s current price list[4] includes Azithral 250 mg and 500 mg tablets along with liquid formulations. Pfizer’s Zithromax label lists 250 mg and 500 mg tablets and two oral-suspension concentrations. Cipla identifies both Azee[5] and Azicip[6] as azithromycin products. Current listings identify Sun Pharma with Azax and Blue Cross Laboratories with Azibest.
    A strength such as Azithromycin 500 mg describes the amount of active ingredient in that product. It is product information, not a dosing instruction.

    Generic Azithromycin vs Brand-Name Azithromycin

    Patients searching for the generic equivalent of Azithromycin are usually looking for another medicine containing azithromycin in the prescribed strength and dosage form. Azithromycin itself is already the generic name of the active ingredient.

    Under India’s CDSCO[7] framework, bioequivalence compares a test medicine with a reference product by looking at the rate and extent at which the medicine is absorbed. CDSCO states that BA/BE studies are used to assess therapeutic equivalence and interchangeability, as well as the safety and tolerability of generic formulations compared with their reference products.

    Products can still differ in manufacturer, inactive ingredients, appearance, packaging and price. The same active ingredient and strength alone do not prove that two individual products are interchangeable, so a prescribed medicine should only be switched after a doctor or pharmacist has checked the products.

    How is azithromycin dosage decided?

    There is no one dose that applies to every azithromycin prescription. The amount and treatment schedule depend on the infection, the patient’s age and other clinical factors. DailyMed[8] notes that recommended doses and treatment durations vary between approved indications.

    The medicine is available in several strengths, including 250 mg and 500 mg tablets. A product labelled 500 mg tells the patient the tablet strength. The prescription determines how that strength is used.

    For how to take azithromycin, patients should follow the prescription and the instructions supplied with their particular formulation.

    What are the common azithromycin side effects?

    Nausea, diarrhoea, vomiting and stomach pain are among the side effects listed by MedlinePlus and the NHS. Headache can also occur.

    Medical attention is needed for more serious symptoms, including:

    • Difficulty breathing or swallowing
    • A severe skin reaction or swelling
    • A fast or irregular heartbeat or fainting
    • Yellowing of the skin or eyes
    • Severe, persistent or bloody diarrhoea

    Azithromycin also needs extra consideration in people with certain heart rhythm problems, liver or kidney problems, or myasthenia gravis.

    Some medicines interact with azithromycin. The NHS[9] specifically advises discussing medicines that affect heart rhythm and lists examples including digoxin, warfarin and some antacids.

    Why does antibiotic resistance matter?

    Using antibiotics where they are not needed helps resistant bacteria survive and spread. This can make bacterial infections harder to treat later.

    DailyMed advises restricting azithromycin to proven or strongly suspected bacterial infections. MedlinePlus also warns that using antibiotics for viral illnesses increases the risk of infections that resist antibiotic treatment.

    Buy or compare Azithromycin tablets on Medkart

    Medkart sells Azithromycin tablets online in different strengths from several manufacturers and highlights WHO-GMP-certified medicines and quality credentials for its generic medicine range. The current range includes 100 mg, 250 mg and 500 mg tablets, along with oral suspension formulations. Availability, pack size and price differ between products.

    For patients looking for alternate medicines for brands with similar composition, Medkart’s medicine comparison tools make it easier to check:

    • Active ingredient
    • Strength
    • Dosage form
    • Manufacturer
    • Pack size
    • Current price

    The Compare Medicines tool can also show medicines with similar active ingredients and therapeutic uses and compare their prices. Any suggested alternative should be discussed with a doctor or pharmacist before changing a prescribed medicine.

    Key takeaways

    • Azithromycin is the generic active ingredient found in several branded prescription antibiotics.
    • It is a macrolide antibiotic used for selected bacterial infections.
    • 250 mg and 500 mg describe medicine strengths, not a universal patient dose.
    • Common side effects mainly involve the digestive system.
    • Existing heart, liver or medicine-interaction concerns should be discussed with the prescriber.
    • A pharmacist or doctor should confirm any change between azithromycin products.

    FAQs: Common Questions About Azithromycin

    Q. Is azithromycin an antibiotic?

    Yes. Azithromycin is a macrolide antibiotic used for selected bacterial infections. It does not treat viral infections such as colds or flu.

    Q. Is Azithromycin a generic medicine?

    Yes. Azithromycin is the generic name of the active ingredient. Different companies sell medicines containing it under separate brand names.

    Q. Which brands contain Azithromycin?

    Examples in the client brief include Azithral, Zithromax, Azee, Azax, Azicip and Azibest. The exact strengths and formulations available under each brand can change.

    Q. Can I switch between Azithromycin brands?

    A doctor or pharmacist should confirm the switch. The active ingredient and strength need to match the prescription, and formulation or other product details can differ.

    Q. Are generic Azithromycin tablets as effective as branded ones?

    Approved generic medicines are assessed against regulatory requirements for equivalence to their reference product. The FDA states that FDA-approved generics[10] provide the same clinical benefit and risks as the corresponding brand-name medicine.

    That statement describes the U.S. FDA standard. An India-specific regulatory source is needed before making the same regulatory claim about a particular Indian product.

    References

    1. https://medlineplus.gov/druginfo/meds/a697037.html
    2. https://www.nhs.uk/medicines/azithromycin/about-azithromycin/
    3. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=7e7c2f49-449c-4ba2-98ae-0ff0c040614c
    4. https://alembicpharmaceuticals.com/assets/pdf/APL-Revised-MRP-List-GST-2.0-wef-22nd-Sep-25-V1.pdf
    5. https://www.ciplamed.com/product-index/azee-tablets/
    6. https://www.ciplamed.com/product-index/azicip-tablets/
    7. https://cdsco.gov.in/opencms/opencms/en/Home/
    8. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=db52b91e-79f7-4cc1-9564-f2eee8e31c45
    9. https://www.nhs.uk/medicines/azithromycin/side-effects-of-azithromycin/
    10. https://www.fda.gov/drugs/generic-drugs/generic-drugs-questions-answers

    Medical disclaimer: This article provides general information and does not replace advice from a doctor or pharmacist. Azithromycin is a prescription antibiotic. Brands with the same composition should only be substituted under the guidance of a healthcare professional or pharmacist because product details and approved indications can differ.

  • Cetirizine Uses, Dosage, Side Effects & Precautions

    Cetirizine Uses, Dosage, Side Effects & Precautions

    Cetirizine is the generic name of an antihistamine used for allergy symptoms. It is a prescription medicine in India, sold under several brand names and in more than one form.

    Tablets, syrups and drops are made by many different companies. The active ingredient is the same, but strength, pack size and price are not.

    What is cetirizine? 

    Cetirizine is an antihistamine. MedlinePlus[1] explains that it works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

    The NHS[2] describes it as a medicine that helps the symptoms of allergies. MedlinePlus lists its oral forms as tablets, chewable tablets, capsules, orally disintegrating tablets and syrup.

    Its status in India is set by the Drugs Rules, 1945[3]. Cetirizine hydrochloride appears at entry 104 in Schedule H, the schedule of prescription drugs. Rule 97 requires the pack to carry the symbol Rx and a warning against retail sale without a doctor’s prescription.

    What are the main cetirizine uses? 

    cetirizine uses

    Cetirizine is used for allergy symptoms. MedlinePlus lists relief of sneezing, a runny nose, itching of the nose or throat, and red, itchy or watery eyes. It also lists use for hives.

    The NHS names hay fever, conjunctivitis, eczema, hives, reactions to insect bites and stings, and some food allergies.

    DailyMed[4] describes an over-the-counter cetirizine tablet as temporarily relieving symptoms due to hay fever or other upper respiratory allergies. That is a United States label. It does not describe the approved indications of any Indian product.

    Popular brands containing cetirizine

    Cetirizine Popular brands Name

    Several cetirizine brands are sold in India. The company names below are those shown on the Medkart listing for each pack.

    Brand Name Active Ingredient Available Strengths / Forms* Manufacturer / Company
    Cetzine Cetirizine 10 mg tablets Dr Reddy’s Laboratories Limited
    Alerid Cetirizine 10 mg tablets Cipla Pharmaceutical Company Limited
    Zyrtec Cetirizine 10 mg tablets Dr Reddy’s Laboratories Limited
    Okacet Cetirizine 10 mg tablets Cipla Pharmaceutical Company Limited
    CZ3 Cetirizine 10 mg tablets Lupin Limited
    Setimed Cetirizine 10 mg tablets Zee Laboratories Ltd
    Cetriz Cetirizine 10 mg tablets Wellcure Lifesciences

    Examples of listed strengths and forms, not a complete catalogue. Product ranges can change.

    Availability and pack size differ between products. The range sold under any one brand can change.

    Cetirizine composition and available strengths 

    Cetirizine tablets are commonly sold at a strength of 10 mg. NHS guidance on how and when to take cetirizine[5] also describes a liquid labelled either 5 mg per 5 ml or 1 mg per 1 ml.

    A strength such as cetirizine 10 mg describes the amount of active ingredient in that product. It is product information, not a dosing instruction.

    Medkart’s listings for cetirizine 10 mg and cetirizine 5 mg show tablets, capsules and drops among the forms stocked.

    How is cetirizine dosage decided?

    There is no one dose that applies to every cetirizine prescription. Age, the product and the person all come into it.

    DailyMed’s directions for a 10 mg over-the-counter tablet give one tablet once daily for adults and children aged 6 and over, with a limit of one tablet in 24 hours. Adults aged 65 and over, children under 6, and people with liver or kidney disease are directed to ask a doctor.

    The NHS states that adults and children aged 12 and over usually take 10 mg once a day, and that children under 12 take a lower dose twice a day.

    A prescriber decides what is appropriate for a particular person.

    Also Read: Allergy Relief Tablets: Top Options for Fast Results

    What are the common cetirizine side effects? 

    Sleepiness and tiredness are the most commonly reported side effects. NHS guidance on cetirizine side effects[6] reports them in more than 1 in 10 people.

    The same page lists headaches, a dry mouth, feeling sick, feeling dizzy, diarrhoea, a sore throat, and sneezing or a blocked nose in more than 1 in 100 people. MedlinePlus lists drowsiness, excessive tiredness and dry mouth as its common effects.

    The NHS advises contacting a doctor about bruising more easily than normal, or bleeding that takes longer than usual to stop. It advises emergency help for signs of a serious allergic reaction, including:

    • Swelling of the lips, mouth, throat or tongue
    • Breathing very fast or struggling to breathe
    • A tight throat or trouble swallowing
    • Skin, lips or tongue that look blue, grey or pale
    • Sudden confusion, drowsiness or dizziness

    Why drowsiness matters 

    Cetirizine is grouped with the non-drowsy antihistamines, and the NHS notes that some people still find it makes them feel quite sleepy. NHS guidance on common questions about cetirizine[7] says it seems more likely to cause sleepiness than loratadine, desloratadine or fexofenadine.

    MedlinePlus warns that cetirizine may make a person drowsy, and says driving or operating machinery should wait until the effect is known. DailyMed adds that alcohol, sedatives and tranquillisers may increase drowsiness.

    Can cetirizine interact with other medicines? 

    Yes. NHS guidance on taking cetirizine with other medicines[8] states that some medicines can increase the chance of side effects.

    That guidance names three groups to check first: medicines that cause drowsiness, medicines that cause a dry mouth, and medicines that make it difficult to pass urine. DailyMed separately directs anyone taking tranquillisers or sedatives to ask a doctor or pharmacist first.

    The NHS advises against taking two antihistamines together unless a doctor has recommended it. It says there is not enough information to establish that herbal remedies are safe with cetirizine.

    Anyone on regular treatment should tell a doctor or pharmacist, including about herbal remedies and supplements.

    Who should be careful with cetirizine? 

    Some people need advice before taking cetirizine at all. NHS guidance on who can and cannot take cetirizine[9] says most adults can take it, and sets out what needs a check first.

    Situation What to do
    A previous allergic reaction The NHS says to mention any previous allergic reaction to cetirizine or to any other medicine. DailyMed states that the product should not be used by anyone who has reacted to it, to its ingredients, or to an antihistamine containing hydroxyzine.
    Kidney failure The NHS lists kidney failure among the conditions to raise before taking cetirizine. DailyMed directs people with liver or kidney disease to ask a doctor before use.
    Epilepsy or seizure risk The NHS lists epilepsy, or another health problem carrying a risk of seizures, as a reason to speak to a doctor or pharmacist first.
    Difficulty passing urine The NHS lists trouble passing urine among the situations that need advice before starting.
    An allergy test coming up The NHS says cetirizine can affect allergy test results, and that stopping it a few days beforehand may be needed.
    Pregnancy or breastfeeding NHS guidance on cetirizine in pregnancy and breastfeeding[10] says it can be taken in pregnancy and is one of the better antihistamine choices while breastfeeding. DailyMed says a health professional should be asked if pregnant, and that the product is not recommended while breastfeeding.

    The two sources differ on breastfeeding, so the advice for a particular product and person should come from a doctor or pharmacist.

    The NHS also sets out UK age limits, with liquid on prescription from age 1 and tablets from age 6. In India the Schedule H listing means a prescription is required at any age.

    Generic cetirizine vs brand-name cetirizine 

    Generic Cetirizine vs Brand-name Cetirizine

    Generic and branded cetirizine contain the same active ingredient. The US FDA[11] states that a generic medicine matches the brand-name medicine on active ingredient, strength, dosage form and route of administration, and is bioequivalent to it.

    The FDA adds that approved generics provide the same clinical benefit and risks as their brand-name counterparts. That is the U.S. FDA standard, and an India-specific regulatory source is needed before making the same claim about an Indian product.

    Products can still differ in manufacturer, inactive ingredients, appearance and price. The same active ingredient and strength alone do not prove that two products are interchangeable. A doctor or pharmacist should confirm any switch between brands.

    Buy or compare cetirizine tablets on Medkart 

    Medkart sells cetirizine products online in several brands and forms, including cetirizine tablets and branded packs such as Cetrine, and lists them as prescription items. Medkart states that the medicines it sells are sourced from WHO-GMP certified manufacturers.

    Medkart’s medicine comparison tool places products side by side, and the medicines index lists what is in stock. The details a reader can compare include:

    • Active ingredient
    • Strength
    • Dosage form
    • Manufacturer
    • Pack size
    • Current price

    Any suggested alternative should be discussed with a doctor or pharmacist before changing a prescribed medicine.

    Key takeaways 

    • Cetirizine is an antihistamine that works by blocking the action of histamine.
    • It is used for allergy symptoms such as sneezing, a runny nose, itchy or watery eyes, and hives.
    • Cetirizine hydrochloride is listed at entry 104 in Schedule H of India’s Drugs Rules, 1945, which makes it a prescription drug.
    • A strength such as cetirizine 10 mg is product information, not an instruction about how much to take.
    • Sleepiness or tiredness is reported in more than 1 in 10 people taking cetirizine.
    • Medicines that cause drowsiness, a dry mouth or difficulty passing urine should be checked with a pharmacist first.
    • Kidney failure, epilepsy and an upcoming allergy test are among the reasons to seek advice before starting.
    • Generic and branded cetirizine share the same active ingredient, but two individual products are not automatically interchangeable.

    FAQs: Common Questions About Cetirizine 

    Q. How quickly does cetirizine start working? 

    Within about an hour. NHS guidance on common questions says a person should start to feel better within an hour of taking cetirizine. How often the medicine is needed after that is a question for the prescriber.

    Q. What happens if a dose of cetirizine is missed? 

    It depends on how close the next dose is. MedlinePlus says a missed dose should be taken as soon as it is remembered, and skipped if it is almost time for the next one. Where a child takes a dose twice a day, the NHS says a missed dose can be given within four hours, and that a double dose should never be given to catch up.

    Q. Do cetirizine tablets need to be swallowed whole?

    Yes. The NHS says cetirizine tablets should be swallowed whole with a drink of water, milk or squash, and not chewed. It also says the liquid should be measured with the syringe or spoon supplied, because a kitchen spoon does not give the right amount.

    Q. What happens if someone takes an extra cetirizine tablet by accident? 

    The NHS describes cetirizine as generally very safe and says an extra dose is unlikely to cause harm. It still advises seeking advice when a child has taken more than the recommended amount, or when an adult has symptoms such as a headache or a fast heartbeat.

    Q. Can cetirizine be taken for a long time? 

    It can, but the NHS advises taking it only when it is needed. The same guidance says long-term use is unlikely to do harm, while noting a small risk of severe itching if the medicine is stopped suddenly after long daily use. MedlinePlus lists that itching among the effects to report to a doctor.

    Q. Is cetirizine a brand name? 

    No. Cetirizine is the name of the active ingredient. A brand name is the name a company gives its own product containing that ingredient. The NHS lists Allacan, Benadryl Allergy, Piriteze Allergy and Zirtek Allergy as UK brand names for cetirizine, and Indian packs carry a different set again.

    References 

    Medical disclaimer: This article provides general information and does not replace advice from a doctor or pharmacist. Cetirizine is an antihistamine listed in Schedule H of India’s Drugs Rules, 1945, so cetirizine products in India are prescription medicines. Brands with the same composition should only be substituted under the guidance of a healthcare professional or pharmacist because product details and approved indications can differ.

  • Bioequivalence: How Generic Medicines Are Tested and Approved in India

    Bioequivalence: How Generic Medicines Are Tested and Approved in India

    Bioequivalence is the test that decides whether a generic medicine can stand in for the product it copies. It compares how much of the active ingredient reaches the bloodstream, and how fast.

    Generic medicines are approved on that comparison rather than on fresh trials in patients. The rules governing the comparison are set by regulators, and they differ in detail between countries.

    What is bioequivalence? 

    Bioequivalence is a comparison between two formulations of the same active ingredient. India’s New Drugs and Clinical Trials Rules, 2019[1] define a bioequivalence study as one establishing the absence of a statistically significant difference in the rate and extent of absorption. That comparison is made against a reference formulation with the same active ingredient.

    The World Health Organization[2] frames it as two products being bioequivalent when their bioavailabilities are similar to such a degree that the same effects can be expected from both. It treats Cmax and tmax as the measures of rate, and the area under the curve as the measure of extent.

    The US FDA[3] states the same idea more plainly. A generic drug is bioequivalent when it delivers the same amount of active ingredient at the same rate and to the same extent as the brand-name drug.

    What is a generic medicine? 

    A generic medicine is a copy of a brand-name medicine that has already been approved. The FDA’s summary of generic drug facts[4] states that a generic must have the same active ingredient, strength, dosage form and route of administration as the brand-name drug.

    It must also be made under the same strict standards, carry the same label with certain exceptions, and be bioequivalent to the brand-name medicine. The FDA states that approved generics work in the same way and provide the same clinical benefit and risks as their brand-name counterparts.

    Those statements describe the United States regulatory standard. An India-specific regulatory source is needed before making the same claim about a particular Indian product.

    What does a bioequivalence study measure? 

    A bioequivalence study measures the active ingredient in the blood over time. WHO names the measures that matter and the range the result has to fall inside.

    Measure What it shows
    Cmax The highest concentration the active ingredient reaches. WHO treats this as one of the two measures of the rate of absorption.
    tmax The time at which that highest concentration is reached. It is the second measure of rate.
    Area under the curve The total exposure over time, which WHO treats as the measure of the extent of absorption.
    90% confidence interval The statistical result. WHO states the interval for the geometric mean ratio should normally fall within 80 to 125% for log-transformed data.

    The underlying quantity is bioavailability. The New Drugs and Clinical Trials Rules define a bioavailability study as one assessing the rate and extent to which a drug is absorbed from a formulation. The definition covers the drug becoming available in the systemic circulation, or at the site of action.

    Those acceptance limits are the WHO figures, and an Indian regulatory source setting the same numbers was not available for this article. WHO states that the primary concern in a bioequivalence assessment is to limit the risk of a false declaration of equivalence.

    How is a bioequivalence study run? 

    The study compares a test product against a comparator. WHO defines the comparator product as the one the generic is intended to be interchangeable with in clinical practice, and normally that is the innovator product.

    WHO states that bioequivalence studies should generally be performed with healthy volunteers rather than with patients. The FDA’s description of an abbreviated new drug application[5] says much the same, measuring how long the generic takes to reach the bloodstream in healthy volunteers.

    WHO lists four ways of assessing equivalence:

    • Comparative pharmacokinetic studies in humans
    • Comparative pharmacodynamic studies in humans
    • Comparative clinical trials
    • Comparative in vitro tests

    In a pharmacokinetic study the active ingredient or its metabolites are measured over time in a biological fluid such as blood, plasma, serum or urine.

    Who approves bioequivalence studies in India?

    CDSCO oversees them. The CDSCO BA/BE Division[6] is responsible for regulatory oversight, for the evaluation of bioavailability and bioequivalence studies, and for the approval of BA/BE study centres in India.

    Stage What happens
    Protocol review The CDSCO BA/BE Division evaluates the study protocol before the study begins.
    Ethics Committee review Under the New Drugs and Clinical Trials Rules, an Ethics Committee reviews the protocol, and every member signs a declaration that there is no conflict of interest.
    Registration The same rules state that a bioavailability or bioequivalence study requires registration from the authorities specified in rules 8 and 17.
    Approval or NOC The Division grants approval or a no objection certificate, including for studies conducted only for export.

    The Division also assesses therapeutic equivalence and interchangeability between the test product and the reference or innovator product.

    Why do generic medicines cost less? 

    Generic makers do not repeat the original trials. The FDA states that generic applicants do not have to repeat the animal and clinical studies required for the brand-name medicine.

    Competition then does the rest. The FDA states that a single competitor can cut the price by about 30%, and that around five competitors bring the reduction to nearly 85%.

    Those figures describe the United States market. Indian prices are set under a different system, which that source does not describe.

    Also Read: How reliable are generic medicines? Why do generic medicines cost less?

    When is a bioequivalence study not needed? 

    Not every generic needs a study in people. WHO describes a biowaiver as an approval granted on evidence of equivalence rather than through in vivo equivalence testing.

    Comparative in vitro tests sit among the four methods WHO lists for assessing equivalence. Whether that route is open for a particular product is a regulatory decision, and not something that can be read off a pack.

    The limits of a bioequivalence result 

    A bioequivalence result is about absorption, not about everything on the pack. The FDA states that generics may contain different inactive ingredients, and that in rare cases those can affect absorption or how well someone tolerates the product.

    WHO frames bioequivalence as a comparison between a multisource product and its comparator. That single comparison is what the approval rests on.

    Any switch between products should be discussed with a doctor or pharmacist.

    How to compare generic and branded medicines on Medkart 

    Medkart groups products by composition, so that everything sharing an active ingredient and strength appears in one place, with the manufacturer shown for each. Composition pages cover molecules such as:

    Medkart states that the medicines it sells are sourced from WHO-GMP certified manufacturers. Medkart’s medicine comparison tool places products side by side, and the medicines index lists what is in stock. The details a reader can compare include:

    • Active ingredient
    • Strength
    • Dosage form
    • Manufacturer
    • Pack size
    • Current price

    Any change from a prescribed product should be discussed with a doctor or pharmacist first.

    Key takeaways 

    • Bioequivalence compares the rate and extent to which an active ingredient is absorbed from two formulations.
    • India’s New Drugs and Clinical Trials Rules, 2019 define a bioequivalence study as establishing the absence of a statistically significant difference in that absorption.
    • The comparison is made against a reference formulation, which is normally the innovator product.
    • Cmax and tmax describe the rate of absorption, and the area under the curve describes the extent.
    • WHO states the 90% confidence interval should normally fall within 80 to 125% for log-transformed data.
    • The CDSCO BA/BE Division oversees these studies in India and approves the study centres.
    • Generic medicines cost less partly because the original animal and clinical studies are not repeated.
    • A bioequivalence result covers absorption, and inactive ingredients can still differ between products.

    FAQs: Common Questions About Bioequivalence 

    Q. Who takes part in a bioequivalence study? 

    Healthy volunteers, rather than patients. WHO states that bioequivalence studies should generally be performed with healthy volunteers. Where a product is intended for use in both sexes, it says the sponsor should include both males and females. Clear inclusion and exclusion criteria have to be set out in the study protocol.

    Q. Why is the comparator usually the innovator product? 

    Because that is the product whose evidence already exists. WHO states the comparator will normally be the innovator product, for which efficacy, safety and quality have been established. The generic is measured against that established product rather than against an unproven one.

    Q. Does a bioequivalence study prove that a generic is safe? 

    It stands in for that evidence rather than generating it fresh. WHO describes a bioequivalence study as a surrogate for clinical evidence of the safety and efficacy of the multisource product. The underlying safety and efficacy evidence belongs to the comparator product it was measured against.

    Q. What is an abbreviated new drug application? 

    It is the application route for a generic in the United States. The FDA states that an abbreviated new drug application contains the data submitted for the review and potential approval of a generic drug product. It is called abbreviated because applicants are generally not required to include animal and human data establishing safety and effectiveness.

    Q. Are two generics of the same medicine compared with each other? 

    Not as part of the route described in the guidance. WHO frames a bioequivalence study as a comparison between a multisource product and a comparator product, which is normally the innovator. The sources used for this article do not describe a head-to-head comparison between two generic products. A doctor or pharmacist is the right person to ask about moving between them.

    Q. Does a generic have to look like the brand? 

    No. The FDA states that generic medicines may differ from the brand in minor cosmetic ways such as colour. It adds that these differences do not affect how the medicine works. A change in the look of a pack is therefore not by itself a reason to doubt it, and a pharmacist can confirm what has changed.

    References 

    Medical disclaimer: This article gives general information only. It does not replace advice from a doctor or pharmacist. No medicine should be started, stopped or changed without advice from the prescriber or a qualified pharmacist.