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ABILIFY is indicated for the treatment of schizophrenia.
The recommended starting and maintenance dose for ABILIFY is 15 mg/day administered on a once-a-day schedule without regard to meals.
ABILIFY is effective in a dose range of 15 to 30 mg/day. Enhanced efficacy at doses higher than the recommended daily dose of 15 mg has not been demonstrated although individual patients may benefit from a higher dose. The maximum daily dose should not exceed 30 mg.
Children and adolescents: ABILIFY has not been studied in subjects under 18 years of age.
Patients with hepatic impairment: no dosage adjustment is required for patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the data available are insufficient to establish recommendations. In these patients dosing should be managed cautiously. However, the maximum daily dose of 30 mg should be used with caution in patients with severe hepatic impairment.
Patients with renal impairment: no dosage adjustment is required in patients with renal impairment.
Elderly: the effectiveness of ABILIFY in the treatment of schizophrenia in patients 65 years of age or older has not been established. Owing to the greater sensitivity of this population, a lower starting dose should be considered when clinical factors warrant.
Gender: no dosage adjustment is required for female patients as compared to male patients.
Smoking status: according to the metabolic pathway of ABILIFY no dosage adjustment is required for smokers.
When concomitant administration of potent CYP3A4 or CYP2D6 inhibitors with aripiprazole occurs, the aripiprazole dose should be reduced. When the CYP3A4 or CYP2D6 inhibitor is withdrawn from the combination therapy, aripiprazole dose should then be increased.
When concomitant administration of potent CYP3A4 inducers with aripiprazole occurs, the aripiprazole dose should be increased. When the CYP3A4 inducer is withdrawn from the combination therapy, the aripiprazole dose should then be reduced to the recommended dose.
Abilify side effects include lightheadedness, insomnia, akathisia, somnolence, tremor, blurred vision, headache, asthenia, nausea, vomiting, dyspepsia, constipation, orthostatic hypotension, and tachycardia (increased heart rate. ABILIFY is contraindicated in patients with hypersensitivity to aripiprazole or to any of the excipients.
Undesirable effects known to be associated with antipsychotic therapy and also reported during treatment with aripiprazole include neuroleptic malignant syndrome, tardive dyskinesia and seizure.
Extrapyramidal symptoms (EPS): in a long term 52-week controlled study, aripiprazole-treated patients had an overall-lower incidence (27.1%) of EPS including parkinsonism, akathisia, and dystonia compared with those treated with haloperidol (59.2%). In a long term 26-week placebo-controlled study, the incidence of EPS was 20.3% for aripiprazole-treated patients and 13.1% for placebo-treated patients. In another long-term 26-week controlled study, the incidence of EPS was 16.8% for aripiprazole-treated patients and 15.7% for olanzapine-treated patients.
Comparisons between aripiprazole and placebo in the proportions of patients experiencing potentially clinically significant changes in routine laboratory parameters revealed no medically important differences. Elevations of CPK (Creatine Phosphokinase), generally transient and asymptomatic, were observed in 3.9% of aripiprazole treated patients as compared to 3.6% of patients who received placebo.
During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks. Patients should be closely monitored throughout this period.
Tardive Dyskinesia: in premarketing studies of one year or less duration, there were uncommon reports of treatment emergent dyskinesia during treatment with aripiprazole. If signs and symptoms of tardive dyskinesia appear in a patient on ABILIFY, dose reduction or discontinuation should be considered. These symptoms can temporarily deteriorate or can even arise after discontinuation of treatment.
Neuroleptic Malignant Syndrome (NMS): NMS is a potentially fatal symptom complex associated with antipsychotic medicinal products. In premarketing studies, rare cases of NMS were reported during treatment with aripiprazole. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, all antipsychotic drugs, including ABILIFY, must be discontinued.
Seizure: in premarketing studies, uncommon cases of seizure were reported during treatment with aripiprazole. Therefore, aripiprazole should be used with caution in patients who have a history of seizure disorder or have conditions associated with seizures.