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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use. CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. Accutane (isotretinoin) packaging 10 mg 10 amount of packaging.

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Clinical data
PronunciationSee note at tretinoin
Trade namesAccutane (originator), others [1]
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
Protein binding99.9%
Elimination half-life10–20 hours
ExcretionRenal and fecal

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