Abilify

[aripiprazole]

Drug Description
INDICATIONS and IMPORTANT SAFETY INFORMATION for ABILIFYŽ (aripiprazole)

INDICATIONS: ABILIFY is indicated for the treatment of:

• Schizophrenia, including maintaining stability in patients who had been symptomatically stable on other antipsychotic medications for periods of 3 months or longer and observed for relapse during a period of up to 26 weeks


• Acute manic and mixed episodes associated with Bipolar I Disorder


• Maintaining efficacy in patients with Bipolar I Disorder with a recent manic or mixed episode who had been stabilized and then maintained for at least 6 weeks

Elderly patients, diagnosed with psychosis as a result of dementia (for example, an inability to perform daily activities as a result of increased memory loss), and who are treated with atypical antipsychotic medicines including ABILIFY, are at an increased risk of death when compared to patients who are treated with a placebo (sugar pill). ABILIFY is not approved for the treatment of patients with dementia-related psychosis.

Serious side effects can occur with any antipsychotic medicine, including ABILIFY.

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Tell your healthcare provider right away if you have any conditions or side
effects, including the following:

• Very high fever, rigid muscles, shaking, confusion, sweating, or increased heart rate and blood pressure. These may be signs of a condition called neuroleptic malignant syndrome, a rare but serious side effect which could be fatal


• Abnormal or uncontrollable movements. These may be signs of a serious condition called tardive dyskinesia which may be permanent


• Elderly: An increased risk of stroke and ministroke has been reported in a clinical study of elderly patients with dementia-related psychosis


• Diabetes, risk factors for diabetes (for example, obesity, family history of diabetes), or unexpected increases in thirst, urination, or hunger. Increases in blood sugar levels (hyperglycemia), in some cases serious and associated with coma or death, have been reported in patients taking medicines like ABILIFY. Ask your healthcare provider about the need to monitor your blood sugar level before and during treatment.

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