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Saphris Indications and Usage
Saphris is an atypical antipsychotic indicated for:
- Acute treatment of schizophrenia in adults
- Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults
Dosage and Administration
Schizophrenia: The recommended starting and target dose of Saphris is 5 mg sublingually twice daily.
Bipolar Disorder: The recommended starting dose of Saphris is 10 mg sublingually twice daily. The dose can be decreased to 5 mg twice daily if there are adverse effects.
Administration: Do not swallow tablet. Saphris sublingual tablets should be placed under the tongue and left to dissolve completely. The tablet will dissolve in saliva within seconds. Eating and drinking should be avoided for 10 minutes after administration.
Dosage Forms and Strengths
Sublingual tablets: 5 mg and 10 mg
Warnings and Precautions
- Cerebrovascular Adverse Events: An increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) has been seen in elderly patients with dementia-related psychoses treated with atypical antipsychotic drugs.
- Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring.
- Tardive Dyskinesia: Discontinue if clinically appropriate.
- Hyperglycemia and Diabetes Mellitus: Monitor glucose regularly in patients with, and at risk for, diabetes.
- Orthostatic Hypotension and Syncope: Dizziness, tachycardia or bradycardia, and syncope may occur, especially early in treatment. Use with caution in patients with known cardiovascular or cerebrovascular disease, and in antipsychotic-naïve patients.
- Leukopenia, Neutropenia, and Agranulocytosis have been reported with antipsychotics. Patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and Saphris should be discontinued at the first sign of a decline in WBC in the absence of other causative factors.
- QT Prolongation: Increases in QT interval; avoid use with drugs that also increase the QT interval and in patients with risk factors for prolonged QT interval.
- Seizures: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold.
- Potential for Cognitive and Motor Impairment: Use caution when operating machinery.
- Suicide: The possibility of a suicide attempt is inherent in schizophrenia and bipolar disorder. Closely supervise high-risk patients.
Saphris Side Effects
Commonly observed adverse reactions (incidence ≥5% 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 weight increased.