| Product Name: | Quetiapine fumarate Tablets USP |
| Brand Name: | Generics |
| Strength: | 25mg, 50mg, 100mg, 150mg, 200mg |
| Dosage Form: | Tablets (Film-coated) |
| Route of Administration: | Via oral Route |
| Packing: | 60s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antipsychotic, Antidementia, Antidepressant |
| Indication: | Quetiapine tablets may be used as part of a treatment program to treat bipolar disorder and schizophrenia in children and teenagers. |
| Storage: | Store below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect it from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Quetiapine fumarate Tablets USP 25mg
- Quetiapine fumarate Tablets USP 50mg
- Quetiapine fumarate Tablets USP 100mg
- Quetiapine fumarate Tablets USP 150mg
- Quetiapine fumarate Tablets USP 200mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Quetiapine fumarate Tablets USP 25mg
Each film-coated tablet contains:
Quetiapine fumarate USP
Equivalent to Quetiapine………….25mg
Excipients……………………………q.s.
Colours: Iron Oxide Red - Quetiapine fumarate Tablets USP 50mg
Each film-coated tablet contains:
Quetiapine fumarate USP
Equivalent to Quetiapine………….50mg
Excipients……………………………q.s.
Colours: Quinoline Yellow - Quetiapine fumarate Tablets USP 100mg
Each film-coated tablet contains:
Quetiapine fumarate USP
Equivalent to Quetiapine………….100mg
Excipients……………………………q.s.
Colours: D&C Orange 4 - Quetiapine fumarate Tablets USP 150mg
Each film-coated tablet contains:
Quetiapine fumarate USP
Equivalent to Quetiapine………….150mg
Excipients……………………………q.s.
Colours: Erythrosine Lake - Quetiapine fumarate Tablets USP 200mg
Each film-coated tablet contains:
Quetiapine fumarate USP
Equivalent to Quetiapine………….200mg
Excipients……………………………q.s.
Colours: Yellow Iron Oxide
THERAPEUTIC INDICATIONS:
Quetiapine oral tablet is used to treat the symptoms of schizophrenia, bipolar disorder, or depression. Quetiapine can be used to treat symptoms in adults who have depressive episodes or manic episodes caused by bipolar I disorder. For major depression, quetiapine is used as an add-on treatment for people already taking antidepressant drugs.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect it from moisture.
Dosage: As directed by the Physician.