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These brands contain the same active ingredient (Isotretinoin). Same strength and form. Confirm the switch with your doctor or pharmacist.
Indications & Uses
Aknill 10 Soft Gelatin Capsule is indicated for:
Pharmacology
Isotretinoin works by altering the cell cycle, cell differentiation, cell survival, and apoptosis. Through these actions it reduces sebum production, which helps prevent blocked pores and limits the growth of acne causing bacteria. Both isotretinoin and its metabolite, 4 oxo isotretinoin, significantly reduce sebum production. Isotretinoin itself has little to no affinity for retinol binding proteins (RBPs) or retinoic acid nuclear receptors (RARs). Tretinoin and 4 oxo tretinoin, however, do bind to the RAR gamma receptor, and this is thought to play a part in how isotretinoin helps treat acne.
Isotretinoin triggers apoptosis in sebocytes, the cells that produce sebum, further lowering sebum output. It also reduces the formation of comedones by lowering hyperkeratinization, though the exact mechanism behind this is not known. Isotretinoin does not kill acne causing bacteria directly, but by shrinking sebum ducts it makes the surrounding environment less favorable for their growth. It may also boost certain immune mechanisms and change how monocytes move toward sites of inflammation, helping to reduce inflammation overall.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Isotretinoin capsules should be taken with food, once or twice a day. Treatment should only be prescribed by, or carried out under the supervision of, doctors experienced in using systemic retinoids for severe acne who fully understand the risks of Isotretinoin therapy and the monitoring it requires.
Adults, including adolescents and elderly patients: therapy is usually started at 0.5 mg per kg of body weight daily. Both how well the medicine works and the side effects it causes are related to dose and vary from person to person, so the dose needs to be adjusted individually during treatment. For most patients the dose falls somewhere between 0.5 and 1.0 mg/kg per day. How long remission lasts, and how likely acne is to return, depends more on the total dose received over the whole course than on either the length of treatment or the daily dose. Studies show that little extra benefit is gained from a cumulative dose beyond 120 to 150 mg/kg. The length of the treatment course therefore depends on the daily dose chosen, and a course of 16 to 24 weeks is normally enough to bring the acne into remission. Most patients clear completely with a single course. If the acne clearly returns afterward, a further course using the same daily and cumulative dose can be considered. Because improvement can continue for up to 8 weeks after stopping treatment, a repeat course should not be started until at least that much time has passed.
Patients with severe kidney impairment: treatment should begin at a lower dose, for example 10 mg a day, and can then be increased up to 1 mg/kg per day or to the highest dose the patient can tolerate.
Children: Isotretinoin is not indicated for prepubertal acne and is not recommended for patients under 12 years of age, since there is not enough data on how well it works or how safe it is in this age group.
Patients who cannot tolerate the standard dose: if a patient has severe difficulty tolerating the recommended dose, treatment can continue at a lower dose, though this usually means a longer course and a greater chance of the acne returning. To get the best possible result in these patients, the dose should generally be kept at the highest level they can tolerate.
Side Effects
Some of the side effects of Aknill depend on the dose. They usually go away once the dose is changed or the treatment is stopped, though a few can continue after treatment has ended. The most commonly reported unwanted effects are dryness of the skin and of the mucous membranes. This shows up as dry lips (cheilitis), a dry nose with nosebleeds (epistaxis) and dry eyes with conjunctivitis. How often each effect occurs was worked out from pooled clinical trial data covering 824 patients, together with post-marketing data. Frequency is grouped as follows: Very common (³1/10), Common (³1/100 to <1/10), Uncommon (³1/1,000 to <1/100), Rare (³1/10,000 to <1/1,000), Very rare (³1/10,000 to <1/1,000) and not known (cannot be estimated from the available data). Infections Very rare: Gram positive (mucocutaneous) bacterial infection. Blood and lymphatic system disorders Very common: anaemia, increased red blood cell sedimentation rate, thrombocytopenia, thrombocytosis. Common: neutropenia. Very rare: lymphadenopathy. Immune system disorders Rare: allergic skin reaction, anaphylactic reactions, hypersensitivity. Metabolism and nutrition disorders Very rare: diabetes mellitus, hyperuricaemia. Psychiatric disorders Rare: depression, depression aggravated, aggressive tendencies, anxiety, mood alterations. Very rare: abnormal behaviour, psychotic disorder, suicidal ideation, suicide attempt, suicide. Nervous system disorders Common: headache. Very rare: benign intracranial hypertension, convulsions, drowsiness, dizziness. Eye disorders Very common: blepharitis, conjunctivitis, dry eye, eye irritation. Very rare: blurred vision, cataract, colour blindness (colour vision deficiencies), contact lens intolerance, corneal opacity, decreased night vision, keratitis, papilloedema (as a sign of benign intracranial hypertension), photophobia, visual disturbances. Ear and labyrinth disorders Very rare: hearing impaired. Vascular disorders Very rare: vasculitis (for example Wegener's granulomatosis, allergic vasculitis). Respiratory, thoracic and mediastinal disorders Common: epistaxis, nasal dryness, nasopharyngitis. Very rare: bronchospasm (particularly in patients with asthma), hoarseness. Gastrointestinal disorders Very rare: colitis, ileitis, dry throat, gastrointestinal haemorrhage, haemorrhagic diarrhoea and inflammatory bowel disease, nausea, pancreatitis. Hepatobiliary disorders Very common: increased transaminase. Very rare: hepatitis. Skin and subcutaneous tissue disorders Very common: pruritus, erythematous rash, dermatitis, cheilitis, dry skin, localised exfoliation, skin fragility (risk of frictional trauma). Rare: alopecia. Very rare: acne fulminans, acne aggravated (acne flare), facial erythema, exanthema, hair disorders, hirsutism, nail dystrophy, paronychia, photosensitivity reaction, pyogenic granuloma, skin hyperpigmentation, increased sweating. Musculoskeletal and connective tissue disorders Very common: arthralgia, myalgia, back pain (particularly in children and adolescent patients). Very rare: arthritis, calcinosis (calcification of ligaments and tendons), premature fusion of the epiphyses, exostosis (hyperostosis), reduced bone density, tendonitis. Renal and urinary disorders Very rare: glomerulonephritis. General disorders and administration site conditions Very rare: increased formation of granulation tissue, malaise.
Cautions & Contraindications
Warnings & Precautions
Contraception Women taking Aknill (isotretinoin) must be given full information on preventing pregnancy. If they are not already using effective contraception, they should be referred for contraceptive advice. At the very least, a woman who could become pregnant must use one effective method of contraception. It is better to use two complementary methods, one of them a barrier method. Contraception should carry on for at least 1 month after Aknill is stopped, even if the woman has amenorrhea. Pregnancy testing Following local practice, medically supervised pregnancy tests with a minimum sensitivity of 25mIU/mL are recommended, done in the first 3 days of the menstrual cycle, as set out below. Before starting therapy: to rule out pregnancy before contraception begins, an initial medically supervised pregnancy test should be done, and its date and result recorded. If the patient does not have regular menses, the timing of this test should reflect her sexual activity, and it should be done about 3 weeks after she last had unprotected sexual intercourse. The prescriber should educate the patient about contraception. A medically supervised pregnancy test should also be done at the consultation when Aknill is prescribed, or in the 3 days before the visit to the prescriber. This test should be delayed until the patient has been using effective contraception for at least 1 month, and it should confirm she is not pregnant when she starts Aknill. Follow-up visits: these should be arranged at 28 day intervals. Whether a pregnancy test is needed every month should be decided according to local practice, taking into account the patient's sexual activity and recent menstrual history (abnormal menses, missed periods or amenorrhea). Where a test is indicated, it should be done on the day of the prescribing visit or in the 3 days before it. End of treatment: five weeks after stopping treatment, women should have a final pregnancy test to exclude pregnancy. Prescribing and dispensing restrictions Prescriptions of Aknill for women who could become pregnant should be limited to 30 days of treatment, and continuing treatment needs a new prescription. Ideally the pregnancy test, the prescription and the dispensing of Aknill should all happen on the same day. Dispensing should take place within 7 days of the prescription at most. Male patients The available data suggest that the exposure a woman would get from the semen of a man taking Aknill is not large enough to be linked with the teratogenic effects of Aknill. Male patients should be reminded not to share their medicine with anyone, and particularly not with women. Additional precautions Patients should be told never to give this medicine to another person, and to return any unused capsules to their pharmacist at the end of treatment. They should not donate blood during therapy or for 1 month after stopping Aknill, because of the possible risk to the foetus of a pregnant woman who receives the transfusion. Psychiatric disorders Depression, worsening of depression, anxiety, aggressive tendencies, mood changes and psychotic symptoms have been reported in patients treated with Aknill. Very rarely, suicidal ideation, suicide attempts and suicide have also been reported. Particular care is needed in patients with a history of depression. All patients should be watched for signs of depression and referred for suitable treatment if necessary. Stopping Aknill may not be enough to relieve the symptoms, so further psychiatric or psychological evaluation may be needed. Skin and subcutaneous tissue disorders An acute flare of acne is occasionally seen early in treatment. It settles with continued treatment, usually within 7 to 10 days, and does not usually need a dose adjustment. Intense sunlight and UV rays should be avoided. Where needed, a sun-protection product of at least SPF 15 should be used. Aggressive chemical dermabrasion and cutaneous laser treatment should be avoided for 5 to 6 months after the end of treatment, because of the risk of hypertrophic scarring in atypical areas and, more rarely, post-inflammatory hyper- or hypopigmentation in the treated areas. Wax depilation should be avoided for at least 6 months after treatment, because of the risk of epidermal stripping. Aknill should not be used together with topical keratolytic or exfoliative anti-acne agents, as local irritation may increase. Patients should be advised to use a skin moisturising ointment or cream and a lip balm from the start of treatment, as Aknill is likely to dry the skin and lips. Severe skin reactions (for example erythema multiforme (EM), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)) have been reported after marketing in association with Aknill. These can be hard to tell apart from other skin reactions, so patients should be told the signs and symptoms and monitored closely. If a severe skin reaction is suspected, Aknill should be stopped. Allergic reactions Anaphylactic reactions have rarely been reported, in some cases after earlier topical exposure to retinoids. Allergic skin reactions are reported infrequently. Serious cases of allergic vasculitis have been reported, often with purpura (bruises and red patches) of the extremities and involvement outside the skin. Severe allergic reactions call for interruption of therapy and careful monitoring. Eye disorders Dry eyes, corneal opacities, decreased night vision and keratitis usually clear up after therapy is stopped. Dry eyes can be eased with a lubricating eye ointment or tear replacement therapy. Contact lenses may become uncomfortable, and the patient may need to wear glasses during treatment. Decreased night vision has also been reported, and in some patients it began suddenly. Withdrawal of Aknill may be necessary. Musculo-skeletal and connective tissue disorders Myalgia, arthralgia and raised serum creatine phosphokinase values have been reported in patients taking Aknill, particularly those doing vigorous physical activity. Bone changes, including premature epiphyseal closure, hyperostosis, and calcification of tendons and ligaments, have occurred after several years at very high doses given for disorders of keratinisation. In these patients the dose levels, duration of treatment and total cumulative dose generally far exceeded those recommended for acne. Benign intracranial hypertension Cases of benign intracranial hypertension have been reported, some of them involving tetracyclines taken at the same time. The signs and symptoms are headache, nausea and vomiting, visual disturbances and papilloedema. Patients who develop benign intracranial hypertension should stop Aknill immediately. Hepatobiliary disorders Liver enzymes should be checked before treatment, 1 month after it starts, and then every 3 months, unless more frequent monitoring is clinically indicated. Transient and reversible rises in liver transaminases have been reported. In many cases the values stayed within the normal range and returned to baseline during treatment. If transaminase levels stay clinically raised, a lower dose or stopping treatment should be considered. Renal insufficiency Renal insufficiency and renal failure do not affect the pharmacokinetics of Aknill, so it can be given to patients with renal insufficiency. Even so, they should be started on a low dose and titrated up to the maximum tolerated dose. Lipid metabolism Serum lipids (fasting values) should be checked before treatment, 1 month after it starts, and then every 3 months, unless more frequent monitoring is clinically indicated. Raised serum lipid values usually return to normal when the dose is reduced or treatment is stopped, and may also respond to dietary measures. Aknill has been linked with a rise in plasma triglyceride levels. It should be stopped if hypertriglyceridaemia cannot be kept at an acceptable level or if symptoms of pancreatitis appear. Levels above 800mg/dL or 9mmol/L are sometimes associated with acute pancreatitis, which may be fatal. Gastrointestinal disorders Aknill has been linked with inflammatory bowel disease (including regional ileitis) in patients with no earlier history of intestinal disorders. Patients with severe (hemorrhagic) diarrhoea should stop Aknill immediately. High risk patients In patients with diabetes, obesity, alcoholism or a lipid metabolism disorder who are treated with Aknill, more frequent checks of serum lipids and/or blood glucose may be needed. Raised fasting blood sugars have been reported, and new cases of diabetes have been diagnosed during Aknill therapy.
Contraindications
Isotretinoin must not be used by women who are pregnant or breastfeeding. It must not be used by women of childbearing potential unless every condition of the Pregnancy Prevention Programme is met. It must also not be used by patients who are hypersensitive to Isotretinoin or to any of its excipients, and it must not be used by patients with impaired liver function, markedly raised blood lipid levels, hypervitaminosis A, or those being treated at the same time with tetracyclines. For a woman of childbearing potential, this medicine may be used only when all of the following Pregnancy Prevention Programme conditions are satisfied. She has severe acne, such as nodular or conglobate acne or acne carrying a risk of permanent scarring, that has not responded to adequate courses of standard therapy with systemic antibacterials and topical treatment. She understands the risk of the drug causing birth defects. She understands the need for careful follow-up every month. She understands and accepts the need for effective contraception, used without interruption, starting 1 month before treatment begins, continuing throughout treatment, and continuing for 1 month after treatment ends. At least one, and preferably two, complementary forms of contraception should be used, including a barrier method. Even if she has amenorrhea, she must still follow all the advice on effective contraception. She should be capable of complying with these effective contraceptive measures. She has been informed of and understands the possible consequences of pregnancy and the need to seek medical advice quickly if there is any risk of pregnancy. She understands and accepts the need for pregnancy testing before starting treatment, during treatment, and 5 weeks after treatment ends. She has confirmed that she understands the hazards and precautions associated with the use of Isotretinoin. These conditions also apply to women who are not currently sexually active, unless the prescriber judges there are compelling reasons to conclude that no risk of pregnancy exists. The prescriber must confirm that the patient meets all the pregnancy prevention conditions listed above, including confirming that she has an adequate level of understanding, and the patient must acknowledge these conditions in turn. Before starting treatment, the patient must have used at least one, and preferably two, effective contraceptive methods, including a barrier method, for at least 1 month, and she must continue using effective contraception throughout treatment and for at least 1 month after treatment stops. Negative pregnancy test results must be obtained before treatment, during treatment, and 5 weeks after treatment ends, and the dates and results of these tests should be recorded.
Pregnancy & Breastfeeding
Isotretinoin must never be used during pregnancy. If a woman does become pregnant while taking Isotretinoin, or within a month of stopping it, her baby faces a high risk of severe, serious birth defects. These include problems with the brain and spinal cord (such as hydrocephalus, a small head, or abnormalities of the cerebellum), an abnormally shaped face, cleft palate, ear defects (including a missing outer ear or a small or absent ear canal), eye defects (such as an abnormally small eye), heart and blood vessel defects (including tetralogy of Fallot, transposition of the great vessels, and septal defects), and abnormalities of the thymus and parathyroid glands. The chance of miscarriage is also increased. If pregnancy occurs while a woman is being treated with Isotretinoin, the medicine must be stopped immediately, and she should be referred to a doctor who specialises in, or has experience with, birth defects for assessment and guidance. Because Isotretinoin dissolves readily in fat, it is very likely to pass into breast milk. As this could harm a nursing infant, Isotretinoin must not be used by breastfeeding mothers.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Drug Interactions
Common questions about Aknill 10 Soft Gelatin Capsule 10 mg
What is Aknill 10 Soft Gelatin Capsule 10 mg Capsule?
Aknill 10 Soft Gelatin Capsule 10 mg Capsule is a medicine that contains Isotretinoin. It is made by Incepta Pharmaceuticals Ltd. (Dhamrai Unit). It belongs to the Oral retinoids for Acne group of medicines.
What is Aknill 10 Soft Gelatin Capsule used for?
Aknill 10 Soft Gelatin Capsule is used for: Acne Vulgaris.
What are the side effects of Aknill 10 Soft Gelatin Capsule?
Some of the side effects of Aknill depend on the dose. They usually go away once the dose is changed or the treatment is stopped, though a few can continue after treatment has ended.
Can I take Aknill 10 Soft Gelatin Capsule during pregnancy or while breastfeeding?
Isotretinoin must never be used during pregnancy. If a woman does become pregnant while taking Isotretinoin, or within a month of stopping it, her baby faces a high risk of severe, serious birth defects. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Can I take other medicines with Aknill 10 Soft Gelatin Capsule?
Some medicines can interact with Isotretinoin, for example: Minocycline Hydrochloride, Dithranol + Boric Acid + Salicylic Acid, Progesterone, Benzoyl Peroxide. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Aknill 10 Soft Gelatin Capsule?
Aknill 10 Soft Gelatin Capsule is a prescription (Rx) medicine. Take it as your doctor advises.