INDICATIONS
TREVIAMET (Sitagliptin+ Metformin HCl) is indicated as:
- Initial therapy in patients with type 2 diabetes mellitus to improve glycemic control when diet and exercise do not provide adequate glycemic control.
- As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus inadequately controlled on Metformin HCl or Sitagliptin alone or in patients already being treated with the combination of Sitagliptin and Metformin HCl.
- In triple combination with a sulphonylurea as an adjunct to diet and exercise in patients with type 2 diabetes mellitus inadequately controlled on their maximal tolerated dose of Metformin HCl and a sulphonylurea.
- In triple combination with a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of Metformin HCl and a PPARγ agonist.
- In patients with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control in combination with insulin.
Ingredient
- Sitagliptin 50mg
- Metformin HCl 500mg
DOSAGE AND ADMINISTRATION
The dosage of TREVIAMET (Sitagliptin + Metformin HCl) should be individualized on the basis of patient’s current regimen, effectiveness and tolerability while not exceeding the maximum recommended daily dose of 100mg Sitagliptin.
It should be given twice daily with meals, with gradual dose escalation, to reduce the gastrointestinal (GI) side effects associated with Metformin HCl.
As initial therapy
For patients with type 2 diabetes mellitus, whose hyperglycemic is inadequately controlled with diet and exercise alone, the recommended starting dose of TREVIAMET (Sitagliptin + Metformin HCl) is 50mg of Sitagliptin + 500mg of Metformin HCl twice daily. Patients may be titrated upto 50mg Sitagliptin + 1000mg of Metformin HCl twice daily.
For patients inadequately controlled on metfomrin monotherapy. The usual starting dose of TREVIAMET (Sitagliptin + Metformin HCl) should provide Sitagliptin dosed as 50mg twice daily (100mg total daily dose), plus Metformin HCl dose already being taken.
For patients inadequately controlled on Sitagliptin monotherapy. The usual starting dose of TREVIAMET (Sitagliptin + Metformin HCl) is 50mg Sitagliptin+500mg Metformin HCl twice daily. Patients may be titrated upto 50mg Sitagliptin+1000mg Metformin HCl twice daily
For patient switching from Sitagliptin co-administered with Metformin HCl. For patients switching from co-administration of Sitagliptin and Metformin HCl, TREVIAMET (Sitagliptin+Metformin HCl) may be initiated at the dose of Sitagliptin and Metformin HCl already being taken.
For patients inadequately controlled on dual combination therapy with any two of following three antihyperglycemic agents: Sitagliptin, Metformin HCl or PPARγ agonist (thiazolidinedione). The usual starting dose of TREVIAMET (Sitagliptin + Metformin HCl) should provide Sitagliptin dosed as 50mg twice daily (100mg total daily dose). In determining the starting dose of Metformin HCl component, the patients level of glycemic control and current dose (if any) of Metformin HCl should be considered.
For patients inadequately controlled on dual combination therapy with any two of following three antihyperglycemic agents: Sitagliptin, Metformin HCl or sulphonylurea. The usual starting dose of TREVIAMET (Sitagliptin + Metformin HCl) should provide Sitagliptin dosed as 50mg twice daily (100mg total daily dose). In determining the starting dose of Metformin HCl component, the patients level of glycemic control and current dose (if any) of Metformin HCl should be considered.
For patients inadequately controlled on dual combination therapy with any two of following three antihyperglycemic agents: Sitagliptin, Metformin HCl or insulin. The usual starting dose of TREVIAMET (Sitagliptin + Metformin HCl) should provide Sitagliptin dosed as 50mg twice daily (100mg total daily dose). In determining the starting dose of Metformin HCl component, the patients level of glycemic control and current dose (if any) of Metformin HCl should be considered.
ADVERSE REACTIONS
Sitagliptin with Metformin HCl
Common: nausea.
Uncommon: somnolence, diarrhea, upper abdominal pain and blood glucose decreased.
Sitagliptin with Metformin HCl and Sulphonylurea
Very common: hypoglycemia.
Common: constipation.
Sitagliptin with Metformin HCl and a PPAR agonist
Common: hypoglycemia, headache, diarrhea,vomiting and peripheral edema.
Sitagliptin with Metformin HCl and insulin
Very common: hypoglycemia.
Uncommon: headache and dry mouth.
Consult your doctor or pharmacist prior to starting or stopping a new medication
Consult your doctor or pharmacist prior to starting or stopping a new medication
