Levetiracetam Tablets USP 500mg Technical Specification:
| Product Name: | Levetiracetam Tablets USP |
| Brand Name: | Generic |
| Strength: | 250mg, 500mg, 750mg, 1000mg |
| Dosage Form: | Tablets (Film coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 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: | Anticonvulsant, Anti-Epileptic |
| Indication: | Levetiracetam is used with other medications to treat seizures (epilepsy). It belongs to a class of drugs known as anticonvulsants. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Levetiracetam Tablets USP 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Levetiracetam Tablets USP 500mg
Each film coated tablet contains:
Levetiracetam USP 500mg
Excipients q.s
Colour: Iron Oxide RED
THERAPEUTIC INDICATIONS:
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.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep 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 at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dosage: As directed by the Physician
Attach dispensing label as per end county.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Levetiracetam Tablets USP 250mg
B) Levetiracetam Tablets USP 500mg
C) Levetiracetam Tablets USP 750mg
D) Levetiracetam Tablets USP 1000mg
B) Levetiracetam Tablets USP 500mg
C) Levetiracetam Tablets USP 750mg
D) Levetiracetam Tablets USP 1000mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Levetiracetam Tablets USP 250mg
Each film coated tablet contains:
Levetiracetam USP 250mg
Excipients q.s
Colour: Ferric Oxide Red USP-NF
B) Levetiracetam Tablets USP 500mg
Each film coated tablet contains:
Levetiracetam USP 500mg
Excipients q.s
Colour: Iron Oxide RED
C) Levetiracetam Tablets USP 750mg
Each film coated tablet contains:
Levetiracetam USP 750mg
Excipients q.s
Colour: Ferric Oxide Red USP-NF
D) Levetiracetam Tablets USP 1000mg
Each film coated tablet contains:
Levetiracetam USP 1000mg
Excipients q.s
Colour: Iron Oxide Yellow
Each film coated tablet contains:
Levetiracetam USP 250mg
Excipients q.s
Colour: Ferric Oxide Red USP-NF
B) Levetiracetam Tablets USP 500mg
Each film coated tablet contains:
Levetiracetam USP 500mg
Excipients q.s
Colour: Iron Oxide RED
C) Levetiracetam Tablets USP 750mg
Each film coated tablet contains:
Levetiracetam USP 750mg
Excipients q.s
Colour: Ferric Oxide Red USP-NF
D) Levetiracetam Tablets USP 1000mg
Each film coated tablet contains:
Levetiracetam USP 1000mg
Excipients q.s
Colour: Iron Oxide Yellow
THERAPEUTIC INDICATIONS:
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.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
KEEP 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.
Read enclosed leaflet before use.
KEEP 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 at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dosage: As directed by the Physician
Attach dispensing label as per end county.
Dosage: As directed by the Physician
Attach dispensing label as per end county.
