Lamotrigine Dispersible Tablets USP 100mg Technical Specification:
| Product Name: | Lamotrigine Dispersible Tablets USP 100mg |
| Brand Name: | Generic |
| Strength: | 25mg, 50mg, 100mg |
| Dosage Form: | Tablets (Uncoated) |
| 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: | Anti-Epileptic, Central Nervous System |
| Indication: | Lamotrigine tablet use to treat epilepsy and bipolar disorder – NHS. |
| Storage: | Store below 30°C. Protect from Light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Lamotrigine Dispersible Tablets USP 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Lamotrigine Dispersible Tablets USP 100mg
Each uncoated dispersible tablet contains:
Lamotrigine USP…………………100mg
Excipients…………………………q.s.
In a flavoured base.
Colours: Ponceau 4 R
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 below 30°C.
Protect from Light and moisture.
Dosage: As directed by the Physician.
Direction of use: Disperse the tablet in 10 ml of boiled and cooled water before administration.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Lamotrigine Dispersible Tablets USP 25mg
B) Lamotrigine Dispersible Tablets USP 50mg
C) Lamotrigine Dispersible Tablets USP 100mg
B) Lamotrigine Dispersible Tablets USP 50mg
C) Lamotrigine Dispersible Tablets USP 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Lamotrigine Dispersible Tablets USP 25mg
Each uncoated dispersible tablet contains:
Lamotrigine USP…………………25mg
Excipients…………………………q.s.
In a flavoured base.
Colours: Lake tartrazine
B) Lamotrigine Dispersible Tablets USP 50mg
Each uncoated dispersible tablet contains:
Lamotrigine USP…………………50mg
Excipients…………………………q.s.
In a flavoured base.
Colours: Ponceau 4 R
C) Lamotrigine Dispersible Tablets USP 100mg
Each uncoated dispersible tablet contains:
Lamotrigine USP…………………100mg
Excipients…………………………q.s.
In a flavoured base.
Colours: Lake Ponceau 4 R
Each uncoated dispersible tablet contains:
Lamotrigine USP…………………25mg
Excipients…………………………q.s.
In a flavoured base.
Colours: Lake tartrazine
B) Lamotrigine Dispersible Tablets USP 50mg
Each uncoated dispersible tablet contains:
Lamotrigine USP…………………50mg
Excipients…………………………q.s.
In a flavoured base.
Colours: Ponceau 4 R
C) Lamotrigine Dispersible Tablets USP 100mg
Each uncoated dispersible tablet contains:
Lamotrigine USP…………………100mg
Excipients…………………………q.s.
In a flavoured base.
Colours: Lake Ponceau 4 R
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 below 30°C.
Protect from Light and moisture.
Dosage: As directed by the Physician.
Direction of use: Disperse the tablet in 10 ml of boiled and cooled water before administration.
Protect from Light and moisture.
Dosage: As directed by the Physician.
Direction of use: Disperse the tablet in 10 ml of boiled and cooled water before administration.
