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These highlights do not include all the information needed to use AMNESTEEM® safely and effectively. See full prescribing information for AMNESTEEM® . AMNESTEEM® (Isotretinoin Capsules), for oral use Initial U.S. Approval: 1982
Medication labelWhy this: Advisory · dailymed-prescription
Amnesteem is 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, Amnesteem is reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use:If a second course of Amnesteem treatment 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 treatment [see Dosage and Administration (2.2) ].
- generic_name
- isotretinoin
- product_names
- isotretinoin
- ndc
- 0378-6611, 0378-6611-85, 0378-6611-93, 0378-6612, 0378-6612-85, 0378-6612-93, 0378-6613, 0378-6613-85, 0378-6613-93, 0378-6614, 0378-6614-85, 0378-6614-93
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en