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Isotretinoin

Isotretinoin is one of 8,063 medications in the MedPlain dataset. Key details — Brand name: Isotretinoin; Generic name: ISOTRETINOIN; Drug class: Retinoid [EPC].

Brand nameIsotretinoin
Generic nameISOTRETINOIN
Drug classRetinoid [EPC]
ManufacturerMayne Pharma
Used forINDICATIONS AND USAGE Severe Recalcitrant Nodular Acne Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe," by definition, 2 means "many" as opposed to "few or several" nodules. Because of significant adverse effects associated with its use, isotretinoin capsules should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, isotretinoin capsules are indicated only for those patients who are not pregnant, because isotretinoin capsules can caus
DosageDOSAGE AND ADMINISTRATION Isotretinoin capsules should be administered with a meal (see PRECAUTIONS: Information for Patients ). The recommended dosage range for isotretinoin capsules are 0.5 to 1 mg/kg/day given in two divided doses with food for 15 to 20 weeks. In studies comparing 0.1, 0.5, and 1 mg/kg/day 8 , it was found that all dosages provided initial clearing of disease, but there was a greater need for retreatment with the lower dosages. During treatment, the dose may be adjusted accor
WarningsWARNINGS Psychiatric Disorders Isotretinoin capsules may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors. No mechanism of action has been established for these events (see ADVERSE REACTIONS: Psychiatric ). Prescribers should read the brochure, Recognizing Psychiatric Disorders in Adolescents and Young Adults: A Guide for Prescribers of Isotretinoin. Prescribers should be alert to the warning signs of psychiatric disor
Active ingredient(s)ISOTRETINOIN
RouteORAL
Official labelhttps://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0114567b-3bac-490d-b9eb-03a6c5d90935

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