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Six-Week Investigational Study In Adults With Major Depressive,Disorder Evaluates The Effectiveness of Adjunctive Aripiprazole,Therapy With Antidepressants

emperature has been attributed to antipsychotics. Appropriate care is advised for patients who may exercise strenuously, be exposed to extreme heat, receive concomitant medication with anticholinergic activity, or be subject to dehydration.

As antipsychotics have been associated with esophageal dysmotility and aspiration, aripiprazole should be used cautiously in patients at risk for aspiration pneumonia.

As the possibility of a suicide attempt is inherent in psychotic illness and bipolar disorder, close supervision of high-risk patients should accompany drug therapy. Prescriptions for aripiprazole should be written for the smallest quantity consistent with good patient management to reduce the risk of overdose.

Physicians should determine if a patient is pregnant or intends to become pregnant while taking aripiprazole. Patients should be advised not to breast- feed while taking aripiprazole.

Physicians should advise patients to avoid alcohol while taking aripiprazole.

Both CYP3A4 and CYP2D6 are responsible for aripiprazole metabolism. Agents that induce CYP3A4 (eg, carbamazepine) could cause an increase in aripiprazole clearance and lower blood levels. Inhibitors of CYP3A4 (eg, ketoconazole) or CYP2D6 (eg, quinidine, fluoxetine, or paroxetine) can inhibit aripiprazole elimination and cause increased blood levels.

Commonly observed adverse events (greater than or equal to 5% incidence and at a rate at least twice the rate of placebo for aripiprazole vs placebo, respectively):

       Aripiprazole Oral

       In 3-week bipolar mania trials the following were reported: akathisia

       (15% vs 3%), constipation (13% vs 6%), sedation (8% vs 3%), tremor (7%

       vs 3%), restlessness (6% vs 3%), and extrapyramidal disorder (5% vs

       2%).


       In 4- to 6-week schizophrenia trials the following was reported:

       akathisia (8% vs 4%).


       A similar adverse event profile was observed in a 26-week trial
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