How Supplied:
10 mg, 20 mg, and 40 mg tablets
Indications and Usage:
Amnesteem is indicated for treatment in severe recalcitrant nodular acne and is reserved for patients who are unresponsive to conventional therapy, including systemic antibiotics.
Prescribing Instructions:
Prescribing Information Instructions [PDF]
Side Effects and Contraindications:
Amnesteem must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Amnesteem in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected. There is an increased risk of spontaneous abortion, and premature births have been reported. If pregnancy does occur during treatment of a female patient who is taking Amnesteem, Amnesteem must be discontinued immediately and she should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for evaluation and counseling. Amnesteem may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors. Patients are to adhere to the iPledge guidelines. See Accutane for further side effects.
Company:
Mylan Pharmaceuticals Inc.
304-599-2595
www.mylanpharms.com
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