REMS
Contraindicated in:
Use Cautiously in:
CV: edema.
Derm: pruritus, palmar desquamation, photosensitivity, skin infections, STEVENS-JOHNSON SYNDROME (SJS), thinning of hair, TOXIC EPIDERMAL NECROLYSIS (TEN).
EENT: conjunctivitis, epistaxis, ↓ night vision, blurred vision, contact lens intolerance, corneal opacities, dry eyes.
Endo: hyperglycemia.
F and E: ↑thirst.
GI: cheilitis, dry mouth, nausea, vomiting, abdominal pain, anorexia, hepatitis, pancreatitis.
Hemat: anemia.
Metab: ↓high-density lipoprotein cholesterol (HDL-C), hypercholesterolemia, hypertriglyceridemia, ↑ appetite, hyperuricemia.
MS: arthralgia, back pain, muscle/bone pain (↑ in adolescents), hyperostosis.
Neuro: behavior changes, depression, PSEUDOTUMOR CEREBRI, psychosis, SUICIDAL THOUGHTS/BEHAVIORS.
Drug-Drug:
Drug-Food:
(Generic available)
12 yr): 0.5–1 mg/kg/day (may use up to 2 mg/kg/day for very severe disease) in 2 divided doses for 15–20 wk. Once discontinued, if relapse occurs, therapy may be reinstituted after an 8-wk rest period. Absorica LD: 0.4–0.8 mg/kg/day (may use up to 1.6 mg/kg/day for very severe disease) in 2 divided doses for 15–20 wk. Once discontinued, if relapse occurs, therapy may be reinstituted after an 8-wk rest period.Absorption: Rapidly absorbed following (23–25%) oral administration (bioavailability of Absorica LD higher than that of Absorica); absorption ↑ when taken with a high-fat meal.
Distribution: Appears to be widely distributed.
Protein Binding: 99.9%.
Metabolism/Excretion: Metabolized by the liver and excreted in the urine and feces.
Half-life: 10–20 hr.
25 mIU/mL before receiving initial prescription. First test is obtained by prescriber when decision is made to prescribe isotretinoin. Second pregnancy test should be done after patient has used 2 forms of contraception for 1 mo and during first 5 days of menstrual period immediately preceding beginning of therapy. For patients with amenorrhea, second test should be done 11 days after last act of unprotected sexual intercourse. Each mo of therapy patient must have a negative result from a urine or serum pregnancy test. Pregnancy test must be repeated every mo prior to receiving prescription in patients who can become pregnant. Patient should discontinue medication and inform health care professional immediately if pregnancy is suspected during or 1 month after therapy. If pregnancy occurs, must be reported immediately to the FDA via the MedWatch telephone number 1-800-FDA-1088, and also to the iPLEDGE pregnancy registry at 1-866-495-0654 or via the internet (). Recommended consent form prepared by manufacturer stresses fetal risk. Parents of minors should also read and sign form. Yellow self-adhesive qualification stickers completed by prescriber must accompany prescription. Advise patient to avoid breastfeeding during and for at least 8 days after last dose.NDC Code*