INDICATIONS AND USAGE
Severe Recalcitrant NodularAcne
Accutane is indicated for the treatment of severerecalcitrant nodular acne. Nodules are inflammatory lesions with adiameter of 5 mm or greater. The nodules may become suppurative orhemorrhagic. "Severe," by definition,[ 2 ] means "many" as opposed to "few or several" nodules. Because of significant adverse effects associatedwith its use, Accutane should be reserved for patients with severenodular acne who are unresponsive to conventional therapy, includingsystemic antibiotics. In addition, Accutane is indicatedonly for those female patients who are not pregnant, because Accutanecan cause severe birth defects (see Boxed CONTRAINDICATIONS AND WARNINGS).
A single course of therapy for 15 to 20weeks has been shown to result in complete and prolonged remissionof disease in many patients.[ 1, 3, 4 ] Ifa second course of therapy is needed, it should not be initiated untilat least 8 weeks after completion of the first course, because experiencehas shown that patients may continue to improve while off Accutane.The optimal interval before retreatment has not been defined for patientswho have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, and Premature Epiphyseal Closure).
Soft gelatin capsules, 10 mg (light pink), imprintedACCUTANE 10 ROCHE. Boxes of 100 containing 10 Prescription Paks of10 capsules (NDC 0004-0155-49).
Soft gelatincapsules, 20 mg (maroon), imprinted ACCUTANE 20 ROCHE. Boxes of 100containing 10 Prescription Paks of 10 capsules (NDC 0004-0169-49).
Soft gelatin capsules, 40 mg (yellow), imprinted ACCUTANE40 ROCHE. Boxes of 100 containing 10 Prescription Paks of 10 capsules(NDC 0004-0156-49).
Store at controlled room temperature (59° to86°F, 15° to 30°C). Protect from light.