Levetiracetam tablets USP Technical Specification:
| Product Name: |
Levetiracetam tablets USP |
| Brand Name: | Generics |
| Strength: | 250mg, 500mg, 750mg, 1000mg |
| Dosage Form: | Tablets (Film-coated) |
| Route of Administration: | Via oral Route |
| Packing: | 30s, 60s, 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: | Anti-Epileptic, Central Nervous System. |
| Indication: | Levetiracetam is used alone and along with other medications to control partial-onset seizures (seizures that involve only one part of the brain) in adults, children, and infants 1 month of age or older. |
| Storage: | Store below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Levetiracetam tablets USP 250mg
- Levetiracetam tablets USP 500mg
- Levetiracetam tablets USP 750mg
- Levetiracetam tablets USP 1000mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Levetiracetam tablets USP 250mg
Each film-coated tablet contains:
Levetiracetam USP…………….….250mg
Excipients……………………………q.s.
Colours: Titanium oxide
b) Levetiracetam tablets USP 500mg
Each film-coated tablet contains:
Levetiracetam USP…………….….500mg
Excipients……………………………q.s.
Colours: Iron Oxide Red
c) Levetiracetam tablets USP 750mg
Each film-coated tablet contains:
Levetiracetam USP…………….….750mg
Excipients……………………………q.s.
Colours: Quinoline Yellow
d) Levetiracetam tablets USP 1000mg
Each film-coated tablet contains:
Levetiracetam USP…………….….1000mg
Excipients……………………………q.s.
Colours: Sunset Yellow
THERAPEUTIC INDICATIONS:
Levetiracetam is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalization in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Levetiracetam is indicated as adjunctive therapy
- in the treatment of partial onset seizures with or without secondary generalization in adults, adolescents, children and infants from 1 month of age with epilepsy.
