| Product Name: | Aripiprazole Tablets USP |
| Brand Name: | Generic |
| Strength: | 10mg, 15mg |
| Dosage Form: | Tablets (Film-coated) |
| Route of Administration: | Via oral Route |
| Packing: | 30s, 90s, 100s, 500s, 1000s |
| 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 (SGA) or atypical antipsychotic, Central nervous system |
| Indication: | Aripiprazole is a medication that works in the brain to treat schizophrenia and other mental/mood disorders (such as bipolar disorder, Tourette’s syndrome, and irritability associated with autistic disorder). |
| Storage: | Protect from moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect it from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Aripiprazole Tablets USP 10mg
- Aripiprazole Tablets USP 15mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Aripiprazole Tablets USP 10mg
Each film-coated tablet contains:
Aripiprazole….………….10mg
Excipients……………………q.s.
Colour: D&C Orange 4. - Aripiprazole Tablets USP 15mg
Each film-coated tablet contains:
Aripiprazole………………15mg
Excipients…………………………q.s.
Colour: Carmoisine Lake.
THERAPEUTIC INDICATIONS:
Aripiprazole is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.
CAUTION & WARNING:
CAUTION: Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
Swallow whole does not chew or crush.
ANY UNUSED MEDICINAL PRODUCT OR WASTE MATERIAL SHOULD BE DISPOSED OF IN ACCORDANCE WITH LOCAL REQUIREMENTS.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Protect from moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect it from moisture.
Dosage: As directed by the Physician.