Glimepiride Tablet USP 2mg Technical Specification:

Product Name:                                                                Glimepiride Tablet USP
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 2mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Glimepiride Tablet USP 2mg
    Each uncoated Tablets contains:
    Glimepiride tablets USP………….2mg
    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

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.

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.