Topiramate Tablets USP 50mg Technical Specification:
| Product Name: | Topiramate Tablets USP 50mg |
| Brand Name: | Generics |
| Strength: | 15mg, 25mg, 50mg, 100mg, 200mg |
| 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: | Anti-Epileptic, Anticonvulsant, Central Nervous System |
| Indication: | Topiramate medicine is used to treat epilepsy and migraine – NHS. |
| 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:
- Topiramate Tablets USP 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Topiramate Tablets USP 50mg
Each film-coated tablet contains:
Topiramate USP……………………50mg
Excipients…………………………q.s.
Colour: Quinoline Yellow
THERAPEUTIC INDICATIONS:
Monotherapy in adults, adolescents and children over 6 years of age with partial seizures with or without secondary generalised seizures, and primary generalised tonic-clonic seizures.
Adjunctive therapy in children aged 2 years and above, adolescents and adults with partial onset seizures with or without secondary generalization or primary generalized tonic-clonic seizures and for the treatment of seizures associated with lennox-gastaut syndrome.
Topiramate is indicated in adults for the prophylaxis of migraine headache after careful evaluation of possible alternative treatment options. topiramate is not intended for acute treatment.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
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 from moisture.
Dosage: As directed by the Physician.
| Attach dispensing label as per end county. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
b) Topiramate Tablets USP 25mg
c) Topiramate Tablets USP 50mg
d) Topiramate Tablets USP 100mg
e) Topiramate Tablets USP 200mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film-coated tablet contains:
Topiramate USP……………………15mg
Excipients…………………………q.s.
Colour: Quinoline Yellow
b) Topiramate Tablets USP 25mg
Each film-coated tablet contains:
Topiramate USP……………………25mg
Excipients…………………………q.s.
Colour: Yellow Oxide of Iron
c) Topiramate Tablets USP 50mg
Each film-coated tablet contains:
Topiramate USP……………………50mg
Excipients…………………………q.s.
Colour: Sunset Yellow
d) Topiramate Tablets USP 100mg
Each film-coated tablet contains:
Topiramate USP……………………100mg
Excipients…………………………q.s.
Colour: Quinoline Yellow
e) Topiramate Tablets USP 200mg
Each film-coated tablet contains:
Topiramate USP……………………200mg
Excipients…………………………q.s.
Colour: Quinoline Yellow Lake
THERAPEUTIC INDICATIONS:
Adjunctive therapy in children aged 2 years and above, adolescents and adults with partial onset seizures with or without secondary generalization or primary generalized tonic-clonic seizures and for the treatment of seizures associated with lennox-gastaut syndrome.
Topiramate is indicated in adults for the prophylaxis of migraine headache after careful evaluation of possible alternative treatment options. topiramate is not intended for acute treatment.
CAUTION & WARNING:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Dosage: As directed by the Physician.
Attach dispensing label as per end county.
