Generic Medicine Info
Should be taken with food.
Pregnancy and lactation (oral). Concomitant use with tetracyclines, vitamin A, retinoids and anti-fibrinolytic agents (e.g. tranexamic acid, aminocaproic acid, aprotinin).
Special Precautions
Patient with history of depression; eczema, sunburn, personal or family history of skin cancer, considerable sun exposure (e.g. due to occupation, inherent sensitivity to sunlight), fish allergies (topical). Avoid application to eyes, mouth and nose (topical). Lactation (topical). Children. Renal and hepatic impairment. Patient Counselling Oral: This drug may cause dizziness or severe headache, if affected, do not drive or operate machinery. Topical: Avoid or minimise exposure to sunlight (including sunlamps), if exposure cannot be avoided, use sunscreens or protective clothing over treated areas. Monitoring Parameters Perform bone marrow cytology to confirm t(15;17) translocation or presence of PML/RARα fusion protein; pregnancy test 1 week prior to therapy and every month during treatment. Monitor CBC with differential, coagulation profile, LFTs, triglycerides and cholesterol levels frequently. Closely monitor cardiac, CNS, and respiratory status frequently during treatment; signs of depression, and acute promyelocytic leukaemia (APL) differentiation syndrome (e.g. monitor volume and pulmonary status, temperature, respiration).
Adverse Reactions
Significant: Venous thrombosis, MI, pseudotumor cerebri/benign intracranial hypertension (children), hypercholesterolaemia or hypertriglyceridaemia (reversible), hypercalcaemia, psychiatric disorders (e.g. depression, anxiety, mood alterations), elevated LFT, Sweet's syndrome (acute febrile neutrophilic dermatosis); hypersensitivity reactions, photosensitivity (topical), skin irritation (e.g. excessive dryness, redness, swollen, blistered), application site reactions (e.g. feeling of warmth, dry skin, peeling, burning, stinging, pain). Blood and lymphatic system disorders: Thrombocytosis, basophilia. Cardiac disorders: Arrhythmia, chest pain. Ear and labyrinth disorders: Impaired hearing. Eye disorders: Visual disturbances, conjunctival disorders. Gastrointestinal disorders: Dry mouth, nausea, vomiting, diarrhoea, abdominal pain, constipation, pancreatitis, cheilitis. General disorders and administration site conditions: Chills, malaise. Investigations: Increased blood creatinine. Metabolism and nutrition disorders: Decreased appetite. Musculoskeletal and connective tissue disorders: Bone pain. Nervous system disorders: Headache, dizziness, paraesthesia. Psychiatric disorders: Confusional state, insomnia. Respiratory, thoracic and mediastinal disorders: Nasal dryness, asthma, respiratory failure. Skin and subcutaneous tissue disorders: Rash, pruritus, hyperhidrosis, erythema, alopecia, hypo-/hyperpigmentation (temporary). Vascular disorders: Flushing.
Potentially Fatal: APL differentiation syndrome/retinoic acid syndrome, leukocytosis, QTc prolongation leading to torsade de pointes.
ROUTE(S) : Topical: C
Drug Interactions
Oral: May potentially alter pharmacokinetics with CYP450 inducers (e.g. rifampicin, glucocorticoids, phenobarbital, pentobarbital) and CYP450 inhibitors (e.g. ketoconazole, cimetidine, erythromycin, verapamil, diltiazem, ciclosporin). Topical: May increase risk of skin irritation with topical medications, medicated or abrasive soaps, shampoos, cleansers, permanent wave solutions, electrolysis, hair depilatories or waxes, cosmetics with strong drying effect, products with high concentrations of alcohol, astringents, spices or lime, and preparations containing sulfur, resorcinol, benzoyl peroxide or salicylic acid.
CIMS Class
Acne Treatment Preparations / Cytotoxic Chemotherapy / Other Dermatologicals
ATC Classification
L01XF01 - tretinoin
D10AD01 - tretinoin ; Belongs to the class of topical retinoid preparations used in the treatment of acne.
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