
Tiapine XR50 mg
General Pharmaceuticals Ltd.
Established / FDA-Approved Uses Schizophrenia — treatment of schizophrenia in adults and adolescents (13–17 years).
Quetiapine Fumarate is not approved for the treatment of dementia-related psychosis in elderly patients (see Boxed Warning under Precautions and Warnings).
Low-dose Quetiapine Fumarate is sometimes used off-label (by physician judgment) for insomnia, generalized anxiety disorder, or agitation in certain settings; such use is not FDA-approved and should only be undertaken under close medical supervision.
| Indication | Starting Dose | Usual Target / Range |
|---|---|---|
| Schizophrenia | 25 mg twice daily (IR) | Titrate over ~4 days to 300–400 mg/day in divided doses (IR) or once daily (XR); usual range 150–750 mg/day |
| Bipolar Mania (mono or adjunct) | 100 mg on Day 1 | Titrate to 400 mg/day by Day 4; usual range 400–800 mg/day |
| Bipolar Depression | 50 mg at bedtime (Day 1) | Titrate to 300 mg/day at bedtime by Day 4 |
| Bipolar I Maintenance (adjunct) | Continue dose that controlled acute episode | Individualized, typically 400–800 mg/day |
| MDD, Adjunctive (XR only) | 50 mg once daily in the evening | Usual range 150–300 mg/day |
| Indication | Age | Dosing |
|---|---|---|
| Schizophrenia | 13–17 years | Start 25 mg twice daily; titrate to a target of 400–800 mg/day |
| Bipolar Mania | 10–17 years | Start 25 mg twice daily; titrate to a target of 400–600 mg/day |
Safety and efficacy of Quetiapine Fumarate have not been established in children below 10 years of age for any indication.
Immediate-release tablets may be taken with or without food, usually in divided doses. Extended-release tabletsshould be taken once daily, preferably in the evening, without food or with a light meal (a high-fat mealsignificantly increases absorption and should be avoided at the same time each day for consistency), and must beswallowed whole — not split, crushed, or chewed. Do not stop Quetiapine Fumarate abruptly; dose should betapered gradually under medical supervision when discontinuing.
See Precautions and Warnings for full detail on the boxed warnings and major risks associated with Quetiapine Fumarate.
Quetiapine Fumarate is contraindicated in patients with known hypersensitivity to quetiapine, quetiapine fumarate, or any component of the formulation.
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