Quetiapine Fumarate ER
Quetiapine Fumarate ER is one of 8,063 medications in the MedPlain dataset. Key details — Brand name: Quetiapine Fumarate ER; Generic name: QUETIAPINE FUMARATE ER; Manufacturer: Direct_Rx.
| Brand name | Quetiapine Fumarate ER |
|---|---|
| Generic name | QUETIAPINE FUMARATE ER |
| Manufacturer | Direct_Rx |
| Used for | 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. Efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13 to 17 years) treated with quetiapine tablets [see CLINICAL STUDIES (14.1)]. 1.2 Bipolar Disorder Quetiapine extended-release tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. The effic |
| Dosage | 2.1 Important Administration Instructions Quetiapine extended-release tablets should be swallowed whole and not split, chewed or crushed. It is recommended that quetiapine extended-release tablets be taken without food or with a light meal (approximately 300 calories) [see CLINICAL PHARMACOLOGY (12.3)]. Quetiapine extended-release tablets should be administered once daily, preferably in the evening. 2.2 Recommended Dosing The recommended initial dose, titration, dose range and maximum quetiapine |
| Warnings | WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death [see WARNINGS AND PRECAUTIONS (5.1)] . Quetiapine extended-release tablets are not approved for the treatment of patients with dementia-related psychosis [see WARNINGS AND PRECAUTIONS (5.1)] . S |
| Active ingredient(s) | QUETIAPINE FUMARATE |
| Route | ORAL |
| Official label | https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0917ef53-2647-b54b-e063-6294a90a4211 |