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Video: Schering-Plough Announces FDA Approval of SAPHRIS(R) (asenapine) for Acute Treatment of Schizophrenia In Adults and Manic or Mixed Episodes of Bipolar I Disorder With or Without Psychotic Features In Adults
Date:8/14/2009

orrhea, gynecomastia and impotence have been reported in patients receiving prolactin-elevating compounds.

Seizures: SAPHRIS should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold, e.g., Alzheimer's dementia.

Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality in elderly patients, in particular those with advanced Alzheimer's dementia. SAPHRIS is not indicated for the treatment of dementia-related psychosis, and should not be used in patients at risk for aspiration pneumonia.

Potential for Cognitive and Motor Impairment: Somnolence was reported in patients treated with SAPHRIS. Patients should be cautioned about performing activities requiring mental alertness, such as operating hazardous machinery or operating a motor vehicle, until they are reasonably certain that SAPHRIS therapy does not affect them adversely.

Suicide: The possibility of suicide attempt is inherent in psychotic illnesses and bipolar disorder. Close supervision of high-risk patients should accompany drug therapy. Prescriptions for SAPHRIS should be written for the smallest quantity of tablets in order to reduce the risk of overdose.

SAPHRIS is not recommended in patients with severe hepatic impairment.

Co-administration of SAPHRIS with strong CYP1A2 inhibitors (fluvoxamine) or compounds which are both CYP2D6 substrates and inhibitors (paroxetine) should be done with caution.

Commonly observed adverse reactions (incidence equal to or greater than 5 percent and at least twice that for placebo) were: Patients with Schizophrenia: akathisia, oral hypoesthesia and somnolence. Patients with Bipolar Disorder: somnolence, dizziness, extrapyramidal symptoms other than akathisia and
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