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Isotretinoin
Clinical data
PronunciationSee note at tretinoin
Trade namesAccutane (originator), subsequently many generics [1]
AHFS/Drugs.comMonograph
MedlinePlusa681043
License dataUS   FDA: Isotretinoin
Pregnancy categoryAU: X (High risk) US: X (Contraindicated)
Routes of administrationBy mouth, topical
ATC codeD10AD04 ( WHO )
Legal status
Legal statusAU: S4 (Prescription only) CA : ℞-only UK: POM (Prescription only) US: ℞-only In general: ℞ (Prescription only)
Pharmacokinetic data
BioavailabilityVariable
Protein binding99.9%
MetabolismHepatic
Elimination half-life10–20 hours
ExcretionRenal and fecal
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