isotretinoin 30 mg
1 INDICATIONS AND USAGE Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Isotretinoin capsules are retinoids indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. ( 1 ) Limitations of Use : If a second course of isotretinoin therapy is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of therapy. ( 1 ) Limitations of Use : If a second course of isotretinoin therapy is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of therapy [see Dosage and Administration (2.2) ] .
upsher-smith laboratories, llc
OVAL BROWN 573
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16 HOW SUPPLIED/STORAGE AND HANDLING 10 mg: yellow, oblong, opaque, soft gelatin capsule, containing a yellow/orange viscous liquid, imprinted "570" in black ink. Box of 30 capsules (3 × 10 Prescription Packs): NDC 0245-0570-01 20 mg: pink, oblong, opaque, soft gelatin capsule, containing a yellow/orange viscous liquid, imprinted "571" in black ink. Box of 30 capsules (3 × 10 Prescription Packs): NDC 0245-0571-01 30 mg: brown, oblong, opaque, soft gelatin capsule, containing a yellow/orange viscous liquid, imprinted "573" in black ink. Box of 30 capsules (3 × 10 Prescription Packs): NDC 0245-0573-01 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursion permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light.
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