![]() Weight Gain: Weight gain has been observed with atypical antipsychotic use.Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients with diabetes mellitus should be regularly monitored for worsening of glucose control those with risk factors for diabetes (e.g., obesity, family history of diabetes), should undergo baseline and periodic fasting blood glucose testing. Hyperglycemia/Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma, or death, has been reported in patients treated with atypical antipsychotics including aripiprazole.Metabolic Changes: Atypical antipsychotic drugs have caused metabolic changes including: If antipsychotic treatment is withdrawn, TD may remit, partially or completely. Prescribing should be consistent with the need to minimize TD. TD can develop after a relatively brief treatment period, even at low doses, or after discontinuation of treatment. Tardive Dyskinesia (TD): Risk of TD, and the potential to become irreversible, are believed to increase with duration of treatment and total cumulative dose of antipsychotic drugs. Manage NMS with immediate discontinuation of ABILIFY MAINTENA, intensive symptomatic treatment, and monitoring. Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Clinical signs of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability. Neuroleptic Malignant Syndrome (NMS): NMS is a potentially fatal symptom complex reported in association with administration of antipsychotic drugs including ABILIFY MAINTENA. Reactions have ranged from pruritus/urticaria to anaphylaxis.Ĭerebrovascular Adverse Events, Including Stroke: Increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, have been reported in clinical trials of elderly patients with dementia-related psychosis treated with oral aripiprazole. ABILIFY MAINTENA is not approved for the treatment of patients with dementia-related psychosis.Ĭontraindication: Known hypersensitivity reaction to aripiprazole. IMPORTANT SAFETY INFORMATION WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSISĮlderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death (1.6 to 1.7 times) compared to placebo-treated patients. ![]() Maintenance monotherapy treatment of bipolar I disorder in adults.If patients are not responding to these medications, they may go through a washout period of at least one week under the supervision of a study doctor before entering into this study.INDICATIONS and IMPORTANT SAFETY INFORMATION for ABILIFY MAINTENA ® (aripiprazole) INDICATIONSĪBILIFY MAINTENA ® (aripiprazole) is an atypical antipsychotic indicated for: Patients who are currently taking an antidepressant, antipsychotic, or mood stabilizing drug and who are responding to one or all of these medications.Patients meeting criteria for the following DSM-IV diagnoses: organic mental disorders substance use disorders, including alcohol, active within the last 6 months bipolar disorder schizoaffective disorder or antisocial personality disorder.Patients with a history of seizure disorder unstable physical disorders (cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic) or any physical disorder judged to significantly affect central nervous system function.Patients meeting DSM-IV criteria for major depression without psychotic features, or psychosis without major depression at the screen visit. ![]()
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