| Product Name: | Sitagliptin Phosphate Tablet USP |
| Brand Name: | Generics |
| Strength: | 25mg, 50mg, 100mg |
| Dosage Form: | Tablets (Film-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: | Antidiabetic, Diabetology |
| Indication: | Sitagliptin is used with a proper diet and exercise program and possibly with other medications to control high blood sugar. It is used in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. |
| Storage: | Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect it from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Sitagliptin Phosphate Tablet USP 25mg
- Sitagliptin Phosphate Tablet USP 50mg
- Sitagliptin Phosphate Tablet USP 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Sitagliptin Phosphate Tablet USP 25mg
Each film-coated tablet contains:
Sitagliptin Phosphate Monohydrate USP
Equivalent to Sitagliptin…………………… 25mg
Excipients……………………………………q.s.
Color: Iron oxide Yellow - Sitagliptin Phosphate Tablet USP 50mg
Each film-coated tablet contains:
Sitagliptin Phosphate Monohydrate USP
Equivalent to Sitagliptin…………………… 50mg
Excipients……………………………………q.s.
Color: Iron oxide Red - Sitagliptin Phosphate Tablet USP 100mg
Each film-coated tablet contains:
Sitagliptin Phosphate Monohydrate USP
Equivalent to Sitagliptin…………………… 100mg
Excipients……………………………………q.s.
Color: Quinoline Yellow
THERAPEUTIC INDICATIONS:
Sitagliptin is used along with diet and exercise and sometimes with other medications to lower blood sugar levels in adults with type 2 diabetes (a condition in which blood sugar is too high because the body does not produce or use insulin normally).
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep the 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 it from moisture.
Dosage: As directed by the Physician.