Quetiapine — 150MG, Extended-release tablet, bottle of 60 tablets

Quetiapine — 150MG, Extended-release tablet, bottle of 60 tablets

Quetiapine is a extended-release tablet for oral use. Quetiapine is an atypical antipsychotic indicated for the treatment of: Schizophrenia ( 1.1 ) Bipolar I disorder, manic, or mixed episodes ( 1.2 ) Bipolar disorder, depressive episodes ( 1.2 ) Major depressive disorder, adjunctive therapy with antidepressants ( 1.3 ) 1.1 Schizophrenia Quetiapine extended-release tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine extended-release tablets in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia.

• Active ingredient or product type: QUETIAPINE FUMARATE
• Strength/concentration: 150MG
• Dosage form and route: Extended-release tablet, Oral
• Exact package presentation: bottle of 60 tablets
• NDC/item number: 29300-309-16
• Manufacturer: UNICHEM PHARMA, INC.
• Storage/handling: Store quetiapine extended-release tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
• Status: Rx only

Important safety information: Cerebrovascular Adverse Reactions: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack) has been seen in elderly patients with dementia-related psychoses treated with atypical antipsychotic drugs ( 5.3 ) Neuroleptic Malignant Syndrome (NMS): Manage with immediate discontinuation and close monitoring ( 5.4 ) Metabolic Changes: Atypical antipsychotics have been associated with metabolic changes.

Refer to the current product labeling for complete indications, preparation or administration instructions, contraindications, warnings, precautions, and storage requirements.