pms-Quetiapine

pms-Quetiapine Indications/Uses

quetiapine

Manufacturer:

Pharmascience

Distributor:

T-BOMA
Full Prescribing Info
Indications/Uses
Adults: Schizophrenia: pms-QUETIAPINE (quetiapine fumarate immediate-release) is indicated for the management of the manifestations of schizophrenia. The antipsychotic efficacy of quetiapine was established in short-term (6-week) controlled inpatient trials (see Pharmacology: Pharmacodynamics: Clinical Trials under Actions). The efficacy of quetiapine in long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials of patients with manifestations of schizophrenia.
Bipolar Disorder: pms-QUETIAPINE is indicated as monotherapy for the: Acute management of manic episodes associated with bipolar disorder; Acute management of depressive episodes associated with bipolar I and bipolar II disorder.
The efficacy of quetiapine fumarate in bipolar mania was established in two 12-week clinical trials of bipolar patients (see Pharmacology: Pharmacodynamics: Clinical Trials under Actions). The safety and effectiveness of quetiapine fumarate for long-term use, and for prophylactic use in bipolar mania has not been evaluated.
The efficacy of quetiapine fumarate in bipolar depression was established in four 8-week clinical trials that included either bipolar I or bipolar II patients (see Pharmacology: Pharmacodynamics: Clinical Trials under Actions).
Geriatrics (> 65 years of age): Quetiapine fumarate is not indicated in elderly patients with dementia (see Increased Mortality in Elderly Patients with Dementia under Warnings; Use in the Elderly: Use in Geriatric Patients with Dementia under Precautions).
Pediatrics (< 18 years of age): The safety and efficacy of quetiapine fumarate in children under the age of 18 years have not been established and its use is not recommended (see Use in Children: Pediatrics (< 18 years of age) under Precautions).
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