Tretinoin


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult: PO Acute promyelocytic leukaemia Induction of remission in previously untreated patients and those who have relapsed from or refractory to standard chemotherapy: 45 mg/m2 daily in 2 equally divided doses, continued until complete remission. Max treatment duration: 90 days. Dose reduction, dosing interruption or re-initiation may be required according to individual safety and tolerability (refer to detailed product guideline). Topical Acne vulgaris As 0.01-0.05% gel/cream/lotion: Apply enough to the entire affected area once daily at night or before bedtime. Therapeutic effects may be observed after 2-3 weeks but may require >6 weeks of treatment to see consistent beneficial effects. Mottled hyperpigmentation, roughness and fine wrinkling of photodamaged skin As 0.02% or 0.05% cream: Apply a pea-sized amount onto the face once daily at night or before bedtime, to cover the entire affected area lightly. Therapeutic effects may be observed after 6 months.
Administration
Should be taken with food.
Contraindications
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
ROUTE(S) : PO: D
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.
ATC Classification
D10AD01 - tretinoin ; Belongs to the class of topical retinoid preparations used in the treatment of acne.
L01XX14 - tretinoin ; Belongs to the class of other antineoplastic agents. Used in the treatment of cancer.
Disclaimer: This information is independently developed by CIMS based on tretinoin 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 CIMSAsia.com
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