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These brands contain the same active ingredient (Isotretinoin). Strength and form may differ — confirm substitution with your doctor or pharmacist before switching.
Indications & Uses
Retigel is indicated for:
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 associated with the use of Aknill are dose-related. The side effects are generally reversible after altering the dose or discontinuation of treatment, however some may persist after treatment has stopped. The following symptoms are the most commonly reported undesirable effects with Aknill: dryness of the skin, dryness of the mucosae e.g. of the lips (cheilitis), the nasal mucosa (epistaxis) and the eyes (conjunctivitis).The incidence of the adverse events was calculated from pooled clinical trial data involving 824 patients and from post-marketing data. Frequency categories are defined as 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, red blood cell sedimentation rate increased, 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 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: Transaminase increased; Very rare: Hepatitis Skin and subcutaneous tissues disorders: Very Common: Pruritus, rash erythematous, dermatitis, cheilitis, dry skin, localised exfoliation, skin fragility (risk of frictional trauma), Rare: Alopecia, Very Rare: Acne fulminans, acne aggravated (acne flare), erythema (facial), exanthema, hair disorders, hirsutism, nail dystrophy, paronychia, photosensitivity reaction, pyogenic granuloma, skin hyperpigmentation, sweating increased. Musculo-skeletal 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), epiphyses premature fusion, exostosis, (hyperostosis), reduced bone density, tendonitis. Renal and urinary disorders: Very Rare: Glomerulonephritis. General disorders and administration site conditions: Very Rare: Granulation tissue (increased formation of), malaise. Overdose Aknill is a derivative of vitamin A. Although the acute toxicity of Aknill is low, signs of hypervitaminosis A could appear in cases of accidental overdose. Manifestations of acute vitamin A toxicity include severe headache, nausea or vomiting, drowsiness, irritability and pruritus. Signs and symptoms of accidental or deliberate overdosage with Aknill would probably be similar. These symptoms would be expected to be reversible and to subside without the need for treatment. Pharmaceutical precautions Store in a cool and dry place protected from light.
Cautions & Contraindications
Warnings & Precautions
Contraception: Female patients must be provided with comprehensive information on pregnancy prevention and should be referred for contraceptive advice if they are not using effective contraception. As a minimum requirement, female patients at potential risk of pregnancy must use at least one effective method of contraception. Preferably the patient should use two complementary forms of contraception including a barrier method. Contraception should be continued for at least 1 month after stopping treatment with Aknill, even in patients with amenorrhea. Pregnancy testing: According to local practice, medically supervised pregnancy tests with a minimum sensitivity of 25mIU/mL are recommended to be performed in the first 3 days of the menstrual cycle, as follows. Prior to starting therapy: In order to exclude the possibility of pregnancy prior to starting contraception, it is recommended that an initial medically supervised pregnancy test should be performed and its date and result recorded. In patients without regular menses, the timing of this pregnancy test should reflect the sexual activity of the patient and should be undertaken approximately 3 weeks after the patient last had unprotected sexual intercourse. The prescriber should educate the patient about contraception. A medically supervised pregnancy test should also be performed during the consultation when Aknill is prescribed or in the 3 days prior to the visit to the prescriber, and should have been delayed until the patient had been using effective contraception for at least 1 month. This test should ensure the patient is not pregnant when she starts treatment with Aknill. Follow-up visits: Follow-up visits should be arranged at 28 day intervals. The need for repeated medically supervised pregnancy tests every month should be determined according to local practice including consideration of the patient’s sexual activity and recent menstrual history (abnormal menses, missed periods or amenorrhea). Where indicated, follow-up pregnancy tests should be performed on the day of the prescribing visit or in the 3 days prior to the visit to the prescriber. End of treatment: Five weeks after stopping treatment, women should undergo a final pregnancy test to exclude pregnancy. Prescribing and dispensing restrictions: Prescriptions of Aknill for women of childbearing potential should be limited to 30 days of treatment and continuation of treatment requires a new prescription. Ideally, pregnancy testing, issuing a prescription and dispensing of Aknill should occur on the same day. Dispensing of Aknill should occur within a maximum of 7 days of the prescription. Male patients: The available data suggest that the level of maternal exposure from the semen of the patients receiving Aknill, is not of a sufficient magnitude to be associated with the teratogenic effects of Aknill. Male patients should be reminded that they must not share their medication with anyone, particularly not females. Additional precautions: Patients should be instructed never to give this medicinal product to another person, and to return any unused capsules to their pharmacist at the end of treatment. Patients should not donate blood during therapy and for 1 month following discontinuation of Aknill because of the potential risk to the foetus of a pregnant transfusion recipient. Psychiatric disorders: Depression, depression aggravated, anxiety, aggressive tendencies, mood alterations, psychotic symptoms, and very rarely, suicidal ideation, suicide attempts and suicide have been reported in patients treated with Aknill. Particular care needs to be taken in patients with a history of depression and all patients should be monitored for signs of depression and referred for appropriate treatment if necessary. However, discontinuation of Aknill may be insufficient to alleviate symptoms and therefore further psychiatric or psychological evaluation may be necessary. Skin and subcutaneous tissues disorders: Acute exacerbation of acne is occasionally seen during the initial period but this subsides with continued treatment, usually within 7-10 days, and usually does not require dose adjustment. Exposure to intense sunlight or to UV rays should be avoided. Where necessary a sun-protection product with a high protection factor of at least SPF 15 should be used. Aggressive chemical dermabrasion and cutaneous laser treatment should be avoided in patients on Aknill for a period of 5-6 months after the end of the treatment because of the risk of hypertrophic scarring in atypical areas and more rarely post inflammatory hyper or hypopigmentation in treated areas. Wax depilation should be avoided in patients on Aknill for at least a period of 6 months after treatment because of the risk of epidermal stripping. Concurrent administration of Aknill with topical keratolytic or exfoliative anti-acne agents should be avoided 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 cause dryness of the skin and lips. There have been post-marketing reports of severe skin reactions (e.g. erythema multiforme (EM), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)) associated with Aknill use. As these events may be difficult to distinguish from other skin reactions that may occur, patients should be advised of the signs and symptoms and monitored closely for severe skin reactions. If a severe skin reaction is suspected, Aknill treatment should be discontinued. Allergic reactions: Anaphylactic reactions have been rarely reported, in some cases after previous topical exposure to retinoids. Allergic cutaneous reactions are reported infrequently. Serious cases of allergic vasculitis, often with purpura (bruises and red patches) of the extremities and extracutaneous involvement have been reported. Severe allergic reactions necessitate interruption of therapy and careful monitoring. Eye disorders: Dry eyes, corneal opacities, decreased night vision and keratitis usually resolve after discontinuation of therapy. Dry eyes can be helped by the application of a lubricating eye ointment or by the application of tear replacement therapy. Intolerance to contact lenses may occur which may necessitate the patient to wear glasses during treatment. Decreased night vision has also been reported and the onset in some patients was sudden. Withdrawal of Aknill may be necessary. Musculo-skeletal and connective tissue disorders: Myalgia, arthralgia and increased serum creatine phosphokinase values have been reported in patients receiving Aknill, particularly in those undertaking vigorous physical activity. Bone changes including premature epiphyseal closure, hyperostosis, and calcification of tendons and ligaments have occurred after several years of administration at very high doses for treating disorders of keratinisation. The dose levels, duration of treatment and total cumulative dose in these patients generally far exceeded those recommended for the treatment of acne. Benign intracranial hypertension: Cases of benign intracranial hypertension have been reported, some of which involved concomitant use of tetracyclines. Signs and symptoms of benign intracranial hypertension include headache, nausea and vomiting, visual disturbances and papilloedema. Patients who develop benign intracranial hypertension should discontinue Aknill immediately. Hepatobiliary disorders: Liver enzymes should be checked before treatment, 1 month after the start of treatment, and subsequently at 3 monthly intervals unless more frequent monitoring is clinically indicated. Transient and reversible increases in liver transaminases have been reported. In many cases these changes have been within the normal range and values have returned to baseline levels during treatment. However, in the event of persistent clinically relevant elevation of transaminase levels, reduction of the dose or discontinuation of treatment should be considered. Renal insufficiency: Renal insufficiency and renal failure do not affect the pharmacokinetics of Aknill. Therefore, Aknill can be given to patients with renal insufficiency. However, it is recommended that patients are 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 the start of treatment, and subsequently at 3 monthly intervals unless more frequent monitoring is clinically indicated. Elevated serum lipid values usually return to normal on reduction of the dose or discontinuation of treatment and may also respond to dietary measures. Aknill has been associated with an increase in plasma triglyceride levels. Aknill should be discontinued if hypertriglyceridaemia cannot be controlled at an acceptable level or if symptoms of pancreatitis occur. Levels in excess of 800mg/dL or 9mmol/L are sometimes associated with acute pancreatitis, which may be fatal. Gastrointestinal disorders: Aknill has been associated with inflammatory bowel disease (including regional ileitis) in patients without a prior history of intestinal disorders. Patients experiencing severe (hemorrhagic) diarrhoea should discontinue Aknill immediately.High Risk Patients: In patients with diabetes, obesity, alcoholism or a lipid metabolism disorder undergoing treatment with Aknill, more frequent checks of serum values for lipids and/or blood glucose may be necessary. Elevated 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.