Isotretinoin 40 MG Oral Capsule Amnesteem
INDICATIONS AND USAGE Severe Recalcitrant Nodular Acne Amnesteem is 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, Amnesteem should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics . In addition, Amnesteem is indicated only for those patients who are not pregnant, because Amnesteem can cause life threatening birth defects (see Boxed CONTRAINDICATIONS AND WARNINGS ). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4 If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Amnesteem. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density , Hyperostosis , Premature Epiphyseal Closure ).
Mylan Pharmaceuticals Inc.
OVAL ORANGE I40
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HOW SUPPLIED Amnesteem (
ISOTRETINOIN capsules, USP) contains 10 mg, 20 mg or 40 mg of
ISOTRETINOIN, USP. The 10 mg capsules are reddish brown and imprinted with I10. They are available as follows: NDC 0378-6611-93 cartons of 30 containing 3 prescription packs of 10 capsules The 20 mg capsules are reddish brown and cream and imprinted with I20. They are available as follows: NDC 0378-6612-93 cartons of 30 containing 3 prescription packs of 10 capsules The 40 mg capsules are orange-brown and imprinted with I40. They are available as follows: NDC 0378-6614-93 cartons of 30 containing 3 prescription packs of 10 capsules Storage: Store at 68° to 77°F (20° to 25°C). [See USP Controlled Room Temperature.] Protect from light.
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