Isotretinoin
- Atc Codes:D10AD04#D10BA01
- CAS Codes:4759-48-2#127471-94-7
- PHARMGKB ID:4759-48-2#127471-94-7
Table of contents
- Brand Names
- Drug Combinations
- Chemistry
- Pharmacologic Category
- Mechanism of Action
- Therapeutic Use
- Unlabeled Use
- Pregnancy and Lactation Implications
- Contraindications
- Warnings and Precautions
- Adverse Reactions
- Genes that may be involved
- Substrate of
- Drug Interactions
- Nutrition/Nutraceutical Interactions
- Dosage
- Pharmacokinetics and Pharmacodynamics
- Special Considerations
Brand Names
Europe
Austria: Ciscumed, Ciscutan, Isotretinoin, Isotrex, Lurantal; Belgium: Isotretinoina, Isosupra, Isocural, Roaccutane; Bulgaria: Roaccutane; Cyprus: Isotroin, Roaccutane, Rotren, Stiefotrex; Czech Republic: Aknenormin, Curacné, Roaccutane, Stiefel; Denmark: Accutin, Isotretinoin, Isotrex; Estonia: Isotretinoin, Roaccutane; Finland: Isotretinoin, Roaccutan; France: Contracne, Curacne, Isotretinoine, Procuta, Roaccutane; Germany: Aknefug Iso, Aknenormin, Isocutan, Isoderm, IsoGalen, Isopel, Isotret, Isotretinoin, Isotrex, Raoccutan, Roaccutane; Greece: A-Cnotren, Accuran, Acnogen, Aknesil, Curacne, Flitrion, Inotrin, Isosgeril, Isoskin, Isotretinoin, Isotrexol, Isotroin, Noroseptan, Novacne, Reducar, Roaccutan, Scheritonin, Stiefotrex, Tretin; Hungary: Aknenormin, Isostinoin, Isotretinoin, Isotrex, Roaccutan, Sotret, Tretinak; Ireland: Isotretinoin, Isotrex, Roaccutane; Italy: Aisoskin, Isoriac, Isotretinoina, Isotrex, Roaccutan; Latvia: Roaccutane; Lithuania: Roaccutane; Luxembourg: Isotrex, Roaccutane; Malta: Decutan, Isotrex, Roaccutane; Netherlands: Curacne, Isotretinoïne, Roaccutane; Poland: Aknenormin, Axotret, Curacne, Isotrex, Isotrexol, Izotek, Izotziaja, Roaccutane, Tretinex; Portugal: Isdiben, Isoprotil, Isotretinoína, Isotrex; Romania: Roaccutane, Sotret; Slovakia: Aknenormin, Curacne, Roaccutane; Slovenia: Roaccutane; Spain: Acnemin, Dercutane, Farmacne, Flexresan, Isdiben, Isoacne, Isotretinoína, Isotrex, Mayesta; UK: Isotretinoin, Isotrex, Roaccutane.
North America
Canada: Accutane, Clarus; USA: Amnesteem, Claravis, Sotret.
Latin America
Argentina: Atlacne, Curacne, Isotretinoina, Roaccutan, Zonatian; Brazil: Acnil, Cecnoin, Isoface, Isotretinoína, Isotrex, Lurantal, Roacutan; Mexico: Isoface, Isotrex, Neotrex, Oratane, Roaccutan, Sotrexe.
Drug combinations
Isotretinoin and Erythromycin
Chemistry
Isotretinoin: C~20~H~28~O~2~. Mw: 300.44. (1) Retinoic acid, 13-cis-; (2) 3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)2-cis-4-trans-6-trans-8-trans-nonatetraenoic acid. CAS-4759-48-2 (1979).
Isotretinoin Anisatil: C~29~H~36~O~4~. Mw: 448.59. (1) Retinoic acid, 1-2-(4-methoxyphenyl)-2-oxoethyl ester, 13-cis-; (2) p-Methoxyphenacyl 13-cis-retinoate. CAS-127471-94-7 (1997).
Pharmacologic Category
Skin and Mucous Membrane Agents, Miscellaneous; Acne Products; Retinoic Acid Derivative. (ATC-Code: D10AD04; D10BA01).
Mechanism of action
Mechanism of action in treatment of nodulocystic acne appears to include inhibition of sebaceous gland function and follicular keratinization. Treatment of neoplasms may involve effects mediated via cytosol-binding proteins, inhibition of ornithine decarboxylase activity, and effects on immune system. Has teratogenic and abortifacient effects.
Therapeutic use
Treatment of severe recalcitrant nodular acne unresponsive to conventional therapy.
Pregnancy and lactiation implications
Risk of teratogenic effects. Contraindicated in women who are pregnant, or likely to become so while using the drug.
Unlabeled use
Treatment of children with metastatic neuroblastoma or leukemia which does not respond to conventional therapy.
Contraindications
Hypersensitivity to isotretinoin or any component of the formulation. Sensitivity to parabens, vitamin A, or other retinoids. Pregnancy.
Warnings and precautions
Hearing impairment possible. Might decrease bone mineral density (use caution in osteoporosis, osteomalacia and in disease states or concomitant medications which can induce bone disorders). Skeletal hyperostosis and premature epiphyseal closure also reported. Clinical hepatitis and elevated liver enzymes reported. Inflammatory bowel disease also reported. Ocular effects (vision impairment, corneal opacities, and decreased night vision) might occur. Retinoids associated with pseudotumor cerebri (benign intracranial hypertension), especially in children (avoid concurrent use of other drugs associated with this effect (e.g. tetracyclines)). Psychiatric effects might occur (depression, psychosis, aggressive or violent behavior, and changes in mood, suicidal thoughts and actions (rarely)). Use with extreme caution in history of psychiatric disorder. Use with caution in diabetes mellitus (impaired glucose control). Use with caution in hypertriglyceridemia (acute pancreatitis and fatal hemorrhagic pancreatitis (rare) reported). Pseudotumor cerebri (benign intracranial hypertension) reported with use of isotretinoin in combination with tetracyclines (concomitant use should be avoided). Long-term use not recommended.