Lamotrigine Tablets USP 50mg Technical Specification:
| Product Name: | Lamotrigine Tablets USP 50mg |
| Brand Name: | Generics |
| Strength: | 25mg, 50mg, 100mg, 150mg, 200mg |
| Dosage Form: | Tablets (Un-coated) |
| Route of Administration: | Via oral Route |
| Packing: | 30s, 90s, 100s |
| 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 |
| Indication: | Lamotrigine tablet use to treat epilepsy and bipolar disorder – NHS. |
| Storage: | Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Lamotrigine Tablets USP 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Lamotrigine Tablets USP 50mg
Each uncoated tablet contains:
Lamotrigine USP……………….50mg
Excipients………………………………q.s.
THERAPEUTIC INDICATIONS:
Lamotrigine is used alone or with other medications to prevent and control seizures. It may also be used to help prevent the extreme mood swings of bipolar disorder in adults. Lamotrigine is known as an anticonvulsant or antiepileptic drug.
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 at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
Dosage: As directed by the Physician.
| Attach dispensing label as per end country. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Lamotrigine Tablets USP 25mg
Lamotrigine Tablets USP 50mg
Lamotrigine Tablets USP 100mg
Lamotrigine Tablets USP 150mg Lamotrigine Tablets USP 200mg
Lamotrigine Tablets USP 50mg
Lamotrigine Tablets USP 100mg
Lamotrigine Tablets USP 150mg Lamotrigine Tablets USP 200mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Lamotrigine Tablets USP 25mg
Each uncoated tablet contains:
Lamotrigine USP……………….25mg
Excipients……………………………...q.s.
b) Lamotrigine Tablets USP 50mg
Each uncoated tablet contains:
Lamotrigine USP……………….50mg
Excipients……………………………...q.s.
c) Lamotrigine Tablets USP 100mg
Each uncoated tablet contains:
Lamotrigine USP……………….100mg
Excipients………………………………q.s.
d) Lamotrigine Tablets USP 150mg
Each uncoated tablet contains:
Lamotrigine USP……………….150mg
Excipients……………………………...q.s.
e) Lamotrigine Tablets USP 200mg
Each uncoated tablet contains:
Lamotrigine USP……………….200mg
Excipients……………………………...q.s.
Each uncoated tablet contains:
Lamotrigine USP……………….25mg
Excipients……………………………...q.s.
b) Lamotrigine Tablets USP 50mg
Each uncoated tablet contains:
Lamotrigine USP……………….50mg
Excipients……………………………...q.s.
c) Lamotrigine Tablets USP 100mg
Each uncoated tablet contains:
Lamotrigine USP……………….100mg
Excipients………………………………q.s.
d) Lamotrigine Tablets USP 150mg
Each uncoated tablet contains:
Lamotrigine USP……………….150mg
Excipients……………………………...q.s.
e) Lamotrigine Tablets USP 200mg
Each uncoated tablet contains:
Lamotrigine USP……………….200mg
Excipients……………………………...q.s.
THERAPEUTIC INDICATIONS:
Lamotrigine is used alone or with other medications to prevent and control seizures. It may also be used to help prevent the extreme mood swings of bipolar disorder in adults. Lamotrigine is known as an anticonvulsant or antiepileptic drug.
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.
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 at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
