Pregabalin Sustained Release & Methylcobalamin Tablets (75mg+1500mcg) Technical Specification:
| Product Name: | Pregabalin Sustained Release & Methylcobalamin Tablets |
| Brand Name: | Generic |
| Strength: | (75mg+1500mcg), (150mg+1500mcg) |
| Dosage Form: | Uncoated Bilayer Tablet |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 15S, 50S, 100s, 150s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Anticonvulsant, Vitamin B complex |
| Indication: | To treat pain caused by nerve damage due to diabetes, infection or spinal cord injury |
| Storage: | Store between 10°C to 25°C |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Pregabalin Sustained Release & Methylcobalamin Tablets (75mg+1500mcg)
Pregabalin Sustained Release & Methylcobalamin Tablets (150mg+1500mcg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Pregabalin Sustained Release & Methylcobalamin Tablets
Each Uncoated Bilayer Tablet Contains:
Pregabalin IP……………………….75 mg
(In sustained release form)
Methylcobalamin IP…………….1500 mcg
Excipients……………………………. Q.S.
Colour: Ferric Oxide Red USP-NF and Titanium Dioxide IP
Appropriate overages of Vitamin are added to compensate the loss on storage.
THERAPEUTIC INDICATIONS:
It is used for the treatment of Nerve Damage Pain, Seizures, Anxiety Disorder in Adults, Anemia, Nerve Damage, Numbness and Tingling and other conditions.
CAUTION & SCHEDULE:
CAUTION:
Keep out of reach of children.
Do not crush or chew the tablet. Take whole tablet with water.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG: WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
STORAGE & DOSAGE:
STORAGE: Store between 10°C to 25°C at a dry and dark place.
DOSAGE: As directed by the Physician.