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Isotretinoin
Aka: Isotretinoin, Accutane
- Indications
- Severe Acne Vulgaris Management ( Cystic Acne)
- Treatment resistant Acne Vulgaris
- Mechanism
- Vitamin A derivative (Retinoid) that inhibits sebum production and comedolysis
- Dosing
- Course: 20 weeks
- Cummulative dose target: 120 mg/kg total over entire 20 week course
- Initial dosing
- Start 0.25 to 0.4 mg/kg/day (or 0.5 mg/kg/day if severe)
- Titrate to 1 mg/kg/day as tolerated after the first month
- May also maintain at lower dose for moderate Acne Vulgaris
- Moderate acne or flares
- Lower dosing: 0.3 to 0.5 mg/kg divided twice daily
- Facial Acne
- Standard dosing: 1 mg/kg divided bid)
- Truncal Acne
- Higher dosing: 2 mg/kg divided twice daily
- Consider repeat 4 month course after 2 month rest
- Indicated for severe, refractory truncal acne
- Adverse Effects
- Very Teratogenic (even 1 pill)
- See Precautions below
- Cheilitis (90%)
- Dry or chapped skin (90%)
- Dry nose and eyes (80%)
- Elevated Serum Triglycerides (25%)
- Arthralgias and Myalgias (15%)
- Elevated liver transaminases (15%)
- Hair shedding (10%)
- Peeling of palms and soles (5%)
- Intracranial Hypertension
- Night blindness
- Precautions
- Major Depression exacerbation
- Increased Suicidality was seen in early studies but have not been confirmed
- Teratogenicity
- Associated with anomalies of the head, CNS, Cardiovascular System, Thymus and pararthyroid glands
- Needs two forms Contraception while taking
- Counsel extensively before use
- Requires prescribers to to enter into the iPLEDGE program (see below)
- Monitoring
- Serum testing at baseline, 2 months and then as needed (if abnormal labs on initial testing)
- Liver transaminases
- Lipid panel (esp. Serum Triglycerides)
- iPLEDGE Program
- http://www.ipledgeprogram.com
- Only iPLEDGE registrants can administer Isotretinoin in the United States
- Replaces System Manage Accutane Related Teratogenicity (SMART)
- Required a Yellow Accutane Qualification Sticker
- Pregnancy prevention program per Roche and FDA
- Presciption limited to 30 days
- Mandates 2 forms of Birth Control
- Both forms started >1 month before Accutane
- Continue Contraception for 1 month after stopping
- One form must be primary Contraception
- Tubal Ligation or partner's Vasectomy
- Intrauterine Device
- Oral Contraceptive
- Depo Provera, Norplant or similar
- Mandates urine pregnancy timing
- Initial Urine Pregnancy Test
- Urine Pregnancy Test immediately before Accutane
- First five days of Menstrual Cycle
- 11 days after last intercourse if Amenorrhea
- Urine Pregnancy Test monthly at time of refill
- Other recommendations
- No supplemental Vitamin A intake while on Accutane
- Use Moisturizers, Lip balms, Artificial tears
- References
- Oge (2019) Am Fam Physician 100(8): 475-84 [PubMed]