Glimepiride Tablet USP 4mg Technical Specification:
Product Name: | Glimepiride Tablet USP 4mg |
Brand Name: | Generics |
Strength: | 1mg, 2mg, 3mg, 4mg |
Dosage Form: | Tablets (Uncoated) |
Route of Administration: | Via oral Route |
Packing: | 40s, 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: | Antidiabetic, Diabetology |
Indication: | Glimepiride is indicated for the treatment of type 2 diabetes mellitus, when diet, physical exercise and weight reduction alone are not adequate. |
Storage: | Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Glimepiride Tablet USP 4mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Glimepiride Tablet USP 4mg
Each uncoated Tablets contains:
Glimepiride tablets USP………….4mg
Excipients…………………….…. q.s.
THERAPEUTIC INDICATIONS:
Glimepiride is used to treat high blood sugar levels caused by type 2 diabetes. It may be used alone, or in combination with insulin or another oral medicine such as metformin. In type 2 diabetes, insulin produced by the pancreas is not able to get sugar into the cells of the body where it can work properly.
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: Protect form moisture at a temperature not exceeding 30˚C. 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 country. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Glimepiride Tablet USP 1mg
B. Glimepiride Tablet USP 2mg
C. Glimepiride Tablet USP 3mg
D. Glimepiride Tablet USP 4mg
B. Glimepiride Tablet USP 2mg
C. Glimepiride Tablet USP 3mg
D. Glimepiride Tablet USP 4mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Glimepiride Tablet USP 1mg
Each uncoated Tablets contains:
Glimepiride tablets USP………….1mg
Excipients…………………….…. q.s.
B. Glimepiride Tablet USP 2mg
Each uncoated Tablets contains:
Glimepiride tablets USP……………....2mg
Excipients………………………………. q.s.
C. Glimepiride Tablet USP 3mg
Each uncoated Tablets contains:
Glimepiride tablets USP……………...3mg
Excipients……………………………. q.s.
D. Glimepiride Tablet USP 4mg
Each uncoated Tablets contains:
Glimepiride tablets USP…………….4mg
Excipients……………………………. q.s.
Each uncoated Tablets contains:
Glimepiride tablets USP………….1mg
Excipients…………………….…. q.s.
B. Glimepiride Tablet USP 2mg
Each uncoated Tablets contains:
Glimepiride tablets USP……………....2mg
Excipients………………………………. q.s.
C. Glimepiride Tablet USP 3mg
Each uncoated Tablets contains:
Glimepiride tablets USP……………...3mg
Excipients……………………………. q.s.
D. Glimepiride Tablet USP 4mg
Each uncoated Tablets contains:
Glimepiride tablets USP…………….4mg
Excipients……………………………. q.s.
THERAPEUTIC INDICATIONS:
Glimepiride is used to treat high blood sugar levels caused by type 2 diabetes. It may be used alone, or in combination with insulin or another oral medicine such as metformin. In type 2 diabetes, insulin produced by the pancreas is not able to get sugar into the cells of the body where it can work properly.
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: Protect form moisture at a temperature not exceeding 30˚C. 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 country.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.