- SITAMET-SR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treated with both sitagliptin and metformin sustained release is appropriate.
- SITAMET-SR should not be used in patients with type I diabetes mellitus or for the treatment of diabetic ketoacidosis.
The dose of SITAMET-SR should be individualized on the basis of the patient’s current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin. Initial combination therapy or maintenance of combination therapy should be individualized and left to the discretion of the healthcare provider.
- In patients not currently treated with metformin, the recommended total daily starting dose of SITAMET-SR is 100 mg sitagliptin and 1000 mg metformin hydrochloride (HCl) extended release. Patients with inadequate glycemic control on this dose of metformin can be titrated gradually, to reduce gastrointestinal side effects associated with metformin, up to the maximum recommended daily dose.
- In patients already treated with metformin, the recommended total daily starting dose of SITAMET-SR is 100 mg sitagliptin and the previously prescribed dose of metformin.
- For patients taking metformin immediate-release 850 mg twice daily or 1000 mg twice daily, the recommended starting dose of SITAMET-SR is two 50 mg sitagliptin/1000 mg metformin hydrochloride extended-release tablets
SITAMET is contraindicated in the case of following events,
- Pancreatitis
- Renal impairments
- With medications known to cause hypoglycemia (Sulfonylureas or insulin)
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin
- Hypersensitivity reactions to Metformin or Sitagliptin and other drug components which may lead to events like anaphylaxis and angioedema
- Type I diabetes mellitus
- Pancreatitis
- Lactic acidosis
- Children and adolescents
- Alcohol
- Pregnancy and breast-feeding
- Driving and using machines
- Diarrhea
- URTI
- Headache
- Nasopharyngitis
- Hypoglycemia
- Pancreatitis
- Hypersensitivity reactions
- Severe and disabling arthralgia
- Rare: lactic acidosis (may be fatal).
- Do not store above 25°C (77°F). Protect from moisture.
- Store in a cool and dry place away from sunlight.
SITAMET-SR 500: 10×10’s
SITAMET-SR 850: 5×10’s
SITAMET-SR 1000: 10×10’s
