Isotretinoin
ACCUTANE
What it isOral retinoid reducing sebaceous gland size and keratinization; severe nodular acne.
Why this oneIt is the only agent that produces durable remission of acne rather than suppression.
What limits it⚑ Powerfully teratogenic under iPLEDGE with strict pregnancy prevention and testing. Dryness, hyperlipidemia and transaminitis are expected.
FDA-approved for
- severe nodular acne (1982)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Severe recalcitrant nodular acne (ABSORICA) | ≥12 yr | 0.5 mg/kg/day | 0.5-1 mg/kg/day BID x15-20 wk | 2 mg/kg/day (very severe/scarring/trunk) |
| Severe recalcitrant nodular acne (ABSORICA LD) | ≥12 yr | 0.4 mg/kg/day | 0.4-0.8 mg/kg/day BID x15-20 wk | 1.6 mg/kg/day (very severe/scarring/trunk) |
Renal Undefined
Hepatic Undefined
Instructions
- Give in two divided doses (BID); once-daily dosing is not recommended
- Swallow capsules whole with a full glass of liquid; do not split, crush, chew or suck
- Course of 15-20 weeks; if a dose is missed, skip it (do not double up)
- Before starting: verify not pregnant, obtain fasting lipid profile and liver function tests
- ABSORICA and ABSORICA LD are not substitutable (different bioavailability/dosing)
Contraindications
- Pregnancy
Cautions
- Psychiatric: depression, psychosis, rarely suicidal ideation/behavior
- Intracranial hypertension/pseudotumor cerebri (avoid concomitant tetracyclines)
- Pancreatitis and marked hypertriglyceridemia
- Hepatotoxicity
- Inflammatory bowel disease
- Serious skin reactions (erythema multiforme, SJS/TEN)
- Skeletal/bone mineral density effects; ocular (decreased night vision); hearing impairment
Adverse reactions
- Cheilitis, dry skin/lips
- Hypertriglyceridemia
- Dry eyes, conjunctivitis
- Epistaxis
- Musculoskeletal pain/back pain
- Headache, fatigue
Pregnancy Contraindicated; causes major congenital malformations, spontaneous abortion and premature birth.
Lactation Not recommended during treatment and for at least 8 days after the last dose.
⚠ BOXED WARNING
- Embryo-fetal toxicity; pregnancy must be excluded
Cost, est. cash$200–$1,500/month
Generic entry2002
Classes and tags
Clinical profile
Legacy pregnancy categoryX
Defining liabilityGenerally tolerated at therapeutic doses; clinically important risks are agent-specific and increase with interactions or organ impairment.
Active metabolites
Mechanism of action: Isotretinoin ballicule
