Isotretinoin 10 MG Oral Capsule Zenatane
INDICATIONS AND USAGE Severe Recalcitrant Nodular Acne Zenatane 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, Zenatane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Zenatane is indicated only for those patients who are not pregnant, because Zenatane can cause life threatening birth defects (see Boxed CONTRAINDICATIONS AND WARNING S ). 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 Zenatane. 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 ).
Dr. Reddy's Laboratories Limited
OVAL BLUE R135
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HOW SUPPLIED Zenatane (
ISOTRETINOIN capsules USP) 10 mg are opaque blue elliptical soft gelatin capsules imprinted with black ink, “R135” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blisters Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-135-81 Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-135-78 Zenatane (
ISOTRETINOIN capsules USP) 20 mg are opaque pink elliptical soft gelatin capsules imprinted with black ink, “R136” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blisters Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-136-81 Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-136-78 Zenatane (
ISOTRETINOIN capsules USP) 30 mg are reddish brown colored opaque, elliptical shaped soft gelatin capsule imprinted with “RI” in black colored ink along the length of body on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and in boxes of 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-113-81 Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-113-78 Zenatane (
ISOTRETINOIN capsules USP) 40 mg are opaque green elliptical soft gelatin capsules imprinted with black ink, “R137” on one side and are supplied in boxes of 30 containing 3 prescription packs of 10 capsules and 100 containing 10 prescription packs of 10 capsules, as unit dose blisters. Boxes of 30 (3 Prescription Packs of 10 capsules) NDC 55111-137-81 Boxes of 100 (10 Prescription Packs of 10 capsules) NDC 55111-137-78
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