Generic Medicine Info
Should be taken with food.
Hypervitaminosis A; hyperlipidaemia or excessively elevated blood lipid values. Hepatic impairment. Pregnancy and lactation. Concomitant use with tetracyclines and vitamin A (including dietary supplements).
Special Precautions
Patient with diabetes mellitus, existing or at high risk of hypertriglyceridaemia (e.g. family history of or those with lipid metabolism disorder, obesity, increased alcohol intake), dry eye syndrome; history of depression or psychiatric disorders; genetic predisposition for bone loss (e.g. history of childhood osteoporosis conditions, osteomalacia, other disorders of bone metabolism) including those with anorexia nervosa. Avoid blood donation during and for at least 1 month after treatment; aggressive chemical dermabrasion and cutaneous laser treatment during and for 5-6 months after treatment and wax depilation during and for at least 6 months after treatment. Patient taking medications that may cause drug-induced osteoporosis or osteomalacia and/or affect vitamin D metabolism (e.g. systemic corticosteroids, anticonvulsants). Avoid concurrent use with topical keratolytic or exfoliative anti-acne agents. Not indicated for prepubertal acne. Severe renal impairment. Children. Some oral products or formulations are not interchangeable; refer to specific product guideline for further information. Topical: Patient with history of photoallergy or photodermatitis, skin cancer (personal or family history); with concomitant rosacea or perioral dermatitis. Application to sensitive skin areas (e.g. neck). Delay therapy in patients with sunburn until resolved. Avoid application to eczematous skin. Patient Counselling This drug may reduce your ability to see at night, be cautious when driving or operating machinery during night-time. Women of child-bearing potential must use proven contraceptive methods (1 or 2 methods) 1 month before starting treatment, during the entire course, and 1 month after stopping treatment. Avoid or minimise prolonged exposure to sunlight or UV rays, if exposure cannot be avoided, use sunscreen (with protection factor of at least SPF 15) or wear protective clothing. Monitoring Parameters Screen for pregnancy before starting (2 tests with sensitivity of ≥25 milliunits/mL), every month during treatment, at the end of the entire course and 1 month after discontinuation of treatment. Monitor LFTs and fasting lipid tests (before treatment and weekly or biweekly until treatment response is established), CBC with differential and platelet count, sedimentation rate (at baseline), blood glucose, creatine phosphokinase. Assess for signs and symptoms of depression, mood alteration, psychosis, aggression, severe skin reactions, and changes in vision.
Adverse Reactions
Significant: Hearing impairment, tinnitus; corneal opacities, dry eyes, keratitis, decreased tolerance to contact lenses, decreased night vision; decreased bone mineral density, osteoporosis, osteopenia, bone fractures, delay in healing of bone fractures, skeletal hyperostosis, premature epiphyseal closure, calcification of tendons and ligaments; photosensitivity, benign intracranial hypertension (pseudotumour cerebri), hypersensitivity reactions (e.g. anaphylactic reactions, allergic vasculitis often with purpura of the extremities and extracutaneous involvement), inflammatory bowel disease (including regional ileitis), severe (haemorrhagic) diarrhoea; arthralgia, myalgia, increased serum creatinine phosphokinase (particularly in patients undertaking vigorous physical activity); hepatitis, mild to moderate increase in liver enzymes, transient chest pain, acute pancreatitis, lipid abnormalities (e.g. increased serum triglycerides and cholesterol, decreased HDL), new onset or worsening of depression, psychosis, mood alterations, anxiety; dry skin and lips, neutropenia, impaired glucose control. Irritation, redness, peeling, or discomfort (topical). Rarely, agranulocytosis; suicidal ideation, aggressive and/or violent behaviours. Blood and lymphatic system disorders: Anaemia, thrombocytopenia, thrombocytosis. Eye disorders: Blepharitis, conjunctivitis, eye irritation. General disorders and administration site conditions: Application site erythema, pruritus or irritation, localised tenderness (topical). Investigations: Increased RBC sedimentation rate. Musculoskeletal and connective tissue disorders: Back pain (particularly in adolescents). Nervous system disorders: Headache. Renal and urinary disorders: Haematuria, proteinuria. Reproductive system and breast disorders: Rarely, sexual dysfunction including erectile dysfunction and decreased libido. Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, epistaxis, nasal dryness. Skin and subcutaneous tissue disorders: Cheilitis, dermatitis, localised exfoliation, pruritus, rash erythematous, skin fragility, acute exacerbation of acne (during initial treatment); exfoliation, burning sensation or stinging of the skin, skin pain (topical).
Potentially Fatal: Severe skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme). Rarely, haemorrhagic pancreatitis, rhabdomyolysis, suicide attempts, suicide.
Drug Interactions
May increase risk of local irritation with topical keratolytic or exfoliative anti-acne agents. Benzoyl peroxide may reduce the therapeutic efficacy of topical isotretinoin.
ATC Classification
D10BA01 - isotretinoin ; Belongs to the class of systemic retinoid preparations used in the treatment of acne.
D10AD04 - isotretinoin ; Belongs to the class of topical retinoid preparations used in the treatment of acne.
Disclaimer: This information is independently developed by CIMS based on isotretinoin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by
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