Isotretinoin 20mg Capsules
Isotretinoin 20mg Capsules – Prescribing Information
Please refer to full Summary of Product Characteristics (SmPC) before Prescribing
Presentation: Oval shaped, maroon coloured, opaque soft gelatin capsules imprinted with ‘RR’ in black edible ink containing orange-yellow coloured oily suspension
Indications: Severe forms of acne resistant to adequate courses of standard therapy with antibacterials and topical therapy
Dosage: Isoretinoin should only be prescribed by or under the supervision of physicians with expertise in the use of systemic retinoids. The capsules should be taken with food once or twice daily. Adults: The starting dose is 0.5 mg/kg daily, and the dose adjusted on an individual basis. For most patients, the dose ranges from 0.5-1.0 mg/kg per day.
Long-term remission and relapse rates are closely related to the total dose administered. No substantial additional benefit occurs beyond a cumulative dose of 120-150 mg/kg. A usual treatment course is 16-24 weeks. Usually remission occurs after a single treatment course. In a relapse a further course can be given. Further improvement can be seen up to 8 weeks after finishing treatment, so another course should not be given until at least this time. Children: not indicated in patients less than 12 years of age. Patients with severe renal insufficiency: Treatment should be started at a lower dose (e.g. 10 mg/day) and increased up to 1 mg/kg/day or until the patient is receiving the maximum tolerated dose. Patients with intolerance: Continue treatment at a lower dose at the highest tolerated dose.
Contraindications: Pregnancy and breastfeeding, and in women of child bearing potential unless all of the conditions of the Pregnancy Prevention Programme are met (see section 4.4. of the SmPC), hypersensitivity to isotretinoin or any of the excipients, including peanut and soya. Also in patients with hepatic insufficiency, very high blood lipid values, hypervitaminosis A and receiving concomitant treatment with tetracyclines.
Warnings and Precautions:This medicinal product is TERATOGENIC.
Isotretinoin is contraindicated in women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met. Prescriptions for women of childbearing potential should be limited to 30 days. Continuation of treatment requires a new prescription. Ideally, pregnancy testing and dispensing of isotretinoin should occur on the same day up to 7 days.
Male patients: the level of maternal exposure from the semen is too small to be teratogenic. Male patients must not share their medication with anyone, particularly not females.
Additional precautions: Patients must never give isotretinoin to anyone else and must return any unused capsules to their pharmacist. Patients should not donate blood during therapy and for 1 month after discontinuation.
Educational material: The Marketing Authorisation Holder will provide educational material to reinforce the warnings about teratogenicity and to provide advice on contraception and the need for pregnancy testing. Full patient information, as in the Pregnancy Prevention Programme, should be given to all patients.
Psychiatric disorders: Particular care in patients with a history of depression. All patients should be monitored for depression and referred for treatment if necessary. Symptoms may not resolve on discontinuation so further evaluation may be necessary.
Skin and subcutaneous tissues disorders: Worsening of acne is occasionally seen initially but this subsides with continued treatment, usually within 7 – 10 days, and usually does not need dose adjustment. Exposure to intense sunlight or to UV rays should be avoided and concurrent administration with topical keratolytic or exfoliative anti-acne agents. Aggressive chemical dermabrasion and cutaneous laser treatment should be avoided for 5-6 months after the end of the treatment and wax depilation for at least 6 months Advise patients to use a skin moisturiser and a lip balm from the start of treatment.
Eye disorders: Dry eyes, corneal opacities, decreased night vision and keratitis usually resolve after discontinuation of therapy. Intolerance to contact lenses may occur. Patients experiencing visual difficulties should be referred to an ophthalmologist. Withdrawal of isotretinoin may be necessary.
Musculo-skeletal and connective tissue disorders: Myalgia, arthralgia and increased serum creatine phosphokinase, especially in patients doing vigorous physical activity. Bone changes including premature epiphyseal closure, hyperostosis, and calcification of tendons and ligaments have occurred after several years of treatment at very high doses, much higher than for the treatment of acne.
Benign intracranial hypertension: Isotretinoin should be discontinued immediately.
Hepatobiliary disorders: Check liver enzymes before treatment, 1 month after initiation, and 3 monthly thereafter. Transient reversible increases in liver transaminases occur, which may be clinically relevant, consider reducing dose or discontinuation.
Renal insufficiency: Start on a low dose and titrate up to the maximum tolerated dose.
Lipid metabolism: Check fasting lipids at beginning of treatment, at 1 month and then at 3 monthly intervals. Raised lipids usually return to normal on dose reduction or discontinuation of treatment or dietary measures. Discontinue if hypertriglyceridaemia cannot be controlled or if symptoms of pancreatitis occur.
Gastrointestinal disorders: Inflammatory bowel disease may occur. Discontinue treatment immediately in patients with severe (haemorrhagic) diarrhoea.
Allergic reactions: Anaphylactic reactions occur rarely, in some cases after previous topical exposure to retinoids. Allergic cutaneous reactions are reported infrequently. Serious cases of allergic vasculitis have been reported. In severe allergic reactions interrupt treatment and monitor.
High Risk Patients: In patients with diabetes, obesity, alcoholism or a lipid metabolism disorder, more frequent checks of serum values for lipids and/or blood glucose may be necessary. Elevated fasting blood glucose and new cases of diabetes may occur.
Interactions: Patients should not take vitamin A or tetracyclines as concurrent medication.
Pregnancy and lactation: Pregnancy is an absolutecontraindication due to teratogenicity. If pregnancy occurs during treatment or in the month following, there is a great risk of very severe serious foetal malformation. Stop treatment and refer to a specialist for assessment. Contra-indicated in breastfeeding.
Adverse Reactions: Some of the side effects are dose-related and are generally reversible.
Very common (>= 1/10) Anaemia, increased ESR, thrombocytopenia, thrombocytosis, blepharitis, conjunctivitis, dry eye, eye irritation, elevated transaminase , cheilitis, dermatitis, dry skin, localised exfoliation, pruritus, rash erythematous, skin fragility (risk of frictional trauma), arthralgia, myalgia, back pain (particularly adolescent patients) triglycerides increased, high density lipoprotein decreased.
Common (>= 1/100, < 1/10) Neutropenia, headache, epistaxis, nasal dryness, nasopharyngitis, raised cholesterol, raised blood glucose, haematuria, proteinuria.
Rare (>= 1/10 000, < 1/1000) Allergic skin reaction, anaphylactic reactions, hypersensitivity, depression, depression aggravated, aggressive tendencies, anxiety, mood alternations, alopecia.
Very Rare (<= 1/10 000:): Gram positive (mucocutaneous) bacterial infection, lymphadenopathy, diabetes mellitus, hyperuricaemia, abnormal behaviour, psychotic disorder, suicidal ideation, suicide attempt, suicide, benign intracranial hypertension, convulsions, drowsiness, blurred vision, cataract, colour blindness (colour vision deficiencies), contact lens intolerance, corneal opacity, decreased night vision, keratitis, papilloedema (a sign of benign intracranial hypertension), photophobia, hearing impaired, vasculitis (for example Wegener’s granulomatosis, allergic vasculitis), bronchospasm (particularly in patients with asthma), hoarseness, colitis, ileitis, dry throat, gastrointestinal haemorrhage, haemorrhagic diarrhoea and inflammatory bowel disease, nausea, pancreatitis, hepatitis, acne fulminans, acne aggravated (acne flare), erythema (facial), exanthema, hair disorders, hirsutism, nail dystrophy, paronychia, photosensitivity reaction, pyogenic granuloma, skin hyperpigmentation, sweating increased, arthritis, calcinosis (calcification of ligaments and tendons), epiphyses premature fusion, exostosis, (hyperostosis), reduced bone density, tendonitis, glomerulonephritis, granulation tissue (increased formation of), malaise, creatine phosphokinase increased.
Legal Category: POM
Marketing Authorisation Number, Package quantities and basic NHS price: PL 14894/0162. Pack size:30
Marketing Authorisation Holder: Ranbaxy (UK) Limited, Building 4, Chiswick Park, 566 Chiswick High Road,
London W4 5YE, United Kingdom.
Further information is available from Ranbaxy (UK) Limited, Building 4, Chiswick Park, 566 Chiswick High Road,
London W4 5YE, United Kingdom.
Date of Preparation: September 2007
Adverse events should be reported to Ranbaxy on 020 8280 1986. Information on Adverse Event Reporting can also be found at www.yellowcard.gov.uk