Topiramate Tablets USP 25mg
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Topiramate Tablets USP 25mg Technical Specification: 

Product Name:                             Topiramate Tablets USP 15mg
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 25mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Topiramate Tablets USP 25mg
    Each film-coated tablet contains:
    Topiramate USP……………………25mg
    Excipients…………………………q.s.
    Colour: Yellow Oxide of Iron

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:

a) Topiramate Tablets USP 15mg
b) Topiramate Tablets USP 25mg
c) Topiramate Tablets USP 50mg
d) Topiramate Tablets USP 100mg
e) Topiramate Tablets USP 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Topiramate Tablets USP 15mg
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:

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.