Isotroin (Isotretinoin (13-cis-retinoic acid))
Also sold as: Isotroin, Accutane, Sotret, Acutret, Tretiva
Pregnancy
Cat X
Lactation
Avoid
Schedule
H
Forms
Capsule 5mg, 10mg, 20mg, 30mg, 40mg
Indications
- Severe nodulocystic / conglobate acne (first-line — only drug with potential cure)
- Moderate acne resistant to ≥2 adequate courses of topical + oral antibiotic therapy
- Acne with significant scarring risk
- Gram-negative folliculitis
Adult Dosing
Severe/resistant acne
0.5–1 mg/kg/day PO in 2 divided doses with food (fat improves absorption)
Cumulative dose target: 120–150 mg/kg total course (determines duration — typically 4–6 months). Higher cumulative dose = lower relapse rate. Example: 70 kg patient: target 8,400–10,500 mg total. Daily dose 0.5 mg/kg × 5 months = 70 kg × 0.5 × 150 days = 5250 mg — adjust accordingly.
Pediatric Dosing
Paediatric use: dermatologist supervision mandatory. Must fulfil same pregnancy prevention requirements as adults.
Renal Dose Adjustment
| CrCl / eGFR | Dose Adjustment |
|---|---|
| Any CrCl | No dose adjustment — hepatically metabolised |
Hepatic Adjustment
CONTRAINDICATED in significant hepatic disease — hepatotoxicity risk; hepatic metabolism
Pregnancy & Lactation
Pregnancy: Category X
⚠️ ABSOLUTELY CONTRAINDICATED IN PREGNANCY — most teratogenic drug in clinical use. Causes major birth defects in virtually 100% of exposed pregnancies: craniofacial defects, CNS defects, cardiac defects, thymic hypoplasia, cleft palate. MANDATORY pregnancy prevention programme (iPLEDGE in USA; equivalent in India): negative pregnancy test BEFORE starting, effective contraception during and 1 MONTH after stopping, monthly pregnancy tests during treatment.
Lactation: Avoid
CONTRAINDICATED during breastfeeding — excreted in breast milk; teratogenic/toxic to infant.
Top Drug Interactions
| Interacting Drug | Effect | Severity |
|---|---|---|
| Vitamin A supplements | Additive vitamin A toxicity (hypervitaminosis A — headache, liver damage) — CONTRAINDICATED | Major |
| Tetracyclines (doxycycline, minocycline, tetracycline) | ABSOLUTELY CONTRAINDICATED — both cause benign intracranial hypertension (pseudotumour cerebri); combined risk of severe/permanent vision loss | Major |
| Methotrexate | Additive hepatotoxicity — avoid | Major |
| St John's Wort | Reduces contraceptive pill efficacy (important in pregnancy prevention) | Major |
| Carbamazepine | Isotretinoin may reduce carbamazepine levels | Moderate |
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Side Effects
Common
- Cheilitis (cracked dry lips — virtually universal; apply vaseline/lip balm constantly)
- Dry skin and mucous membranes (xerosis, epistaxis, conjunctivitis)
- Photosensitivity (sunscreen mandatory)
- Muscle and joint pain (myalgia, arthralgia)
- Hypertriglyceridaemia
- Elevated LFTs
- Night blindness (reduced dark adaptation)
- Dry eyes (contact lens intolerance)
Serious / Discontinue If
- Teratogenicity (category X — catastrophic fetal defects)
- Severe depression, mood changes, suicidality (controversial — association debated but FDA black box since 2002; monitor mental health closely)
- Pseudotumour cerebri / benign intracranial hypertension (headache, visual blurring — especially with tetracyclines; CONTRAINDICATED combination)
- Severe hypertriglyceridaemia (pancreatitis risk — check TG before and during)
- Inflammatory bowel disease (association not confirmed but report new bowel symptoms)
- Hepatotoxicity
- Corneal opacities (long-term)
Contraindications
- Pregnancy (absolute — most teratogenic drug in clinical use)
- Breastfeeding
- Concurrent vitamin A supplements (>5000 IU/day)
- Concurrent tetracyclines (intracranial hypertension)
- Concurrent methotrexate (hepatotoxicity)
- Severe hepatic or renal impairment
- Hypervitaminosis A
Available Indian Brands
| Brand | Manufacturer | Price (approx) |
|---|---|---|
| Isotroin 20mg | Cipla | 30 cap ₹425 |
| Sotret 20mg | Sun Pharma | 30 cap ₹395 |
| Acutret 20mg | Ranbaxy/Sun | 30 cap ₹375 |
| Tretiva 20mg | Intas | 30 cap ₹385 |
Monitoring Required
- Pregnancy test (before starting — 2 negative tests 1 month apart; monthly during treatment; 1 month after stopping)
- Fasting lipids (triglycerides, cholesterol — before and monthly; stop if TG > 800 mg/dL)
- LFTs (monthly)
- FBC
- Mental health assessment at every visit
- Visual symptoms (pseudotumour cerebri — headache, visual blurring)
- Cumulative dose calculation (to determine total treatment duration)
Patient Counseling Points
- ⚠️ WOMEN: You MUST use 2 forms of contraception during treatment and for 1 month after stopping — isotretinoin causes severe birth defects in virtually all exposed pregnancies
- Monthly pregnancy test is MANDATORY — treatment cannot continue without a negative result
- Lips will become very dry and cracked — apply petroleum jelly (Vaseline) frequently; this is almost universal
- ⚠️ Do NOT take vitamin A supplements, cod liver oil, or multivitamins with vitamin A — dangerous interaction
- ⚠️ Do NOT take doxycycline, minocycline, or other tetracycline antibiotics concurrently — severe headache and vision loss risk
- Use SPF50 sunscreen — you will burn much more easily
- Report severe headache, vision changes, or mood changes immediately
- Do not donate blood during treatment and for 1 month after — teratogenic to any recipient who is pregnant
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Clinically reviewed by: Dr. Padmavathi Rao, MD (Dermatology), Senior Consultant Dermatologist
Last reviewed: 2026-04-01
References
- AAD Acne Guidelines 2016 (updated 2024)
- BNF — Isotretinoin
- FDA iPLEDGE Programme
- Cochrane — Isotretinoin for Acne
- Indian Dermatology Online Journal — Isotretinoin Protocol India