Select a medication above to begin.
Claravis
isotretinoin
Black Box Warnings .
Appropriate Use
restricted distribution program, iPLEDGE, to minimize fetal exposure; prescribers/pharmacies must be registered and activated w/ program; only dispense to registered pts who meet all iPLEDGE requirements
Pregnancy Contraindicated
do not use in female pts who are or may become pregnant; extremely high risk of birth defects, incl. life-threatening, if pregnancy occurs while taking any isotretinoin even for short time periods; any fetus exposed during pregnancy may be affected; no accurate means exist for determining if exposed fetus has been affected; incr. spontaneous abortion risk; premature births reported; birth defects incl. abnormalities of face, eyes, ears, skull, CNS, cardiovascular system, thymus gland and parathyroid hormone deficiency; IQ scores <85 w/ or w/o other abnormalities reported; deaths occurred in some cases; if pregnancy occurs D/C isotretinoin immediately, refer pt to OB-GYN trained in reproductive toxicity for evaluation/counseling
Adult Dosing .
Dosage forms: CAP: 10 mg, 20 mg, 30 mg, 40 mg
Restricted Distribution in US
- [1-866-495-0654 or www.ipledgeprogram.com for more info]
Special Note
- [formulation clarification]
- Info: isotretinoin, isotretinoin lidose, isotretinoin micronized products not interchangeable; do not substitute on a mg to mg basis
acne, severe recalcitrant nodular
- [0.5-1 mg/kg/day PO divided bid x15-20wk]
- Info: may incr. dose to 2 mg/kg/day PO divided bid x15-20wk in very severe dz w/ scarring or acne primarily on trunk; give w/ food; may repeat course after off tx x2mo
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: CAP: 10 mg, 20 mg, 30 mg, 40 mg
Restricted Distribution in US
- [1-866-495-0654 or www.ipledgeprogram.com for more info]
Special Note
- [formulation clarification]
- Info: isotretinoin, isotretinoin lidose, isotretinoin micronized products not interchangeable; do not substitute on a mg to mg basis
acne, severe recalcitrant nodular
- [12 yo and older]
- Dose: 0.5-1 mg/kg/day PO divided bid x15-20wk; Info: give w/ food; may repeat course after off tx x2mo
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]