Velmetia

Velmetia Dosage/Direction for Use

metformin + sitagliptin

Manufacturer:

Merck Sharp & Dohme

Distributor:

Natrapharm
Full Prescribing Info
Dosage/Direction for Use
General: The dosage of antihyperglycemic therapy with SITAGLIPTIN PHOSPHATE + METFORMIN HCl (VELMETIA) 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.
SITAGLIPTIN PHOSPHATE + METFORMIN HCl (VELMETIA) should generally be given twice daily with meals, with gradual dose escalation, to reduce the gastrointestinal (GI) side effects associated with metformin.
Dosing Recommendations: The starting dose of SITAGLIPTIN PHOSPHATE + METFORMIN HCl (VELMETIA) should be based on the patient's current regimen. SITAGLIPTIN PHOSPHATE + METFORMIN HCl (VELMETIA) should be given twice daily with meals. The following doses are available: 50 mg sitagliptin/500 mg metformin hydrochloride; 50 mg sitagliptin/1 g metformin hydrochloride.
As initial therapy: For patients with type 2 diabetes mellitus, whose hyperglycemia is inadequately controlled with diet and exercise alone, the recommended starting dose of SITAGLIPTIN PHOSPHATE + METFORMIN HCl (VELMETIA) is 50 mg sitagliptin/500 mg metformin hydrochloride twice daily. Patients may be titrated up to 50 mg sitagliptin/1 g metformin hydrochloride twice daily.
For patients inadequately controlled on metformin monotherapy: For patients not adequately controlled on metformin alone, the usual starting dose of SITAGLIPTIN PHOSPHATE + METFORMIN HCl (VELMETIA) should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken.
For patients inadequately controlled on sitagliptin monotherapy: For patients inadequately controlled on sitagliptin alone, the usual starting dose of SITAGLIPTIN PHOSPHATE + METFORMIN HCl (VELMETIA) is 50 mg sitagliptin/500 mg metformin hydrochloride twice daily. Patients may be titrated up to 50 mg sitagliptin/1 g metformin hydrochloride twice daily. Patients taking sitagliptin monotherapy dose-adjusted for renal impairment should not be switched to SITAGLIPTIN PHOSPHATE + METFORMIN HCl (VELMETIA) (see CONTRAINDICATIONS).
For patients inadequately controlled on dual combination therapy with any two of the following three antihyperglycemic agents: sitagliptin, metformin or a PPARγ agonist (i.e. thiazolidinediones): The usual starting dose of SITAGLIPTIN PHOSPHATE + METFORMIN HCl (VELMETIA) should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose). In determining the starting dose of the metformin component, the patient's level of glycemic control and current dose (if any) of metformin should be considered. Gradual dose escalation to reduce the gastrointestinal (GI) side effects associated with metformin should be considered.
For patients switching from sitagliptin co-administered with metformin: For patients switching from co-administration of sitagliptin and metformin, SITAGLIPTIN PHOSPHATE + METFORMIN HCl (VELMETIA) may be initiated at the dose of sitagliptin and metformin already being taken.
For patients inadequately controlled on dual combination therapy with any two of the following three antihyperglycemic agents: sitagliptin, metformin or a sulfonylurea: The usual starting dose of SITAGLIPTIN PHOSPHATE + METFORMIN HCl (VELMETIA) should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose). In determining the starting dose of the metformin component, the patient's level of glycemic control and current dose (if any) of metformin should be considered. Gradual dose escalation to reduce the gastrointestinal (GI) side effects associated with metformin should be considered. Patients currently on or initiating a sulfonylurea may require lower sulfonylurea doses to reduce the risk of sulfonylurea-induced hypoglycemia (see PRECAUTIONS).
For patients inadequately controlled on dual combination therapy with any two of the following three antihyperglycemic agents: sitagliptin, metformin or insulin: The usual starting dose of SITAGLIPTIN PHOSPHATE + METFORMIN HCl (VELMETIA) should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose). In determining the starting dose of the metformin component, the patient's level of glycemic control and current dose (if any) of metformin should be considered. Gradual dose escalation to reduce the gastrointestinal (GI) side effects associated with metformin should be considered. Patients currently on or initiating insulin therapy may require lower doses of insulin to reduce the risk of hypoglycemia (see PRECAUTIONS).
No studies have been performed specifically examining the safety and efficacy of SITAGLIPTIN PHOSPHATE + METFORMIN HCl (VELMETIA) in patients previously treated with other oral antihyperglycemic agents and switched to SITAGLIPTIN PHOSPHATE + METFORMIN HCl (VELMETIA). Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.
Recommendations for use in renal impairment: Assess renal function prior to initiation of SITAGLIPTIN PHOSPHATE + METFORMIN HCl (VELMETIA) and periodically thereafter.
SITAGLIPTIN PHOSPHATE + METFORMIN HCl (VELMETIA) is contraindicated in patients with an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2.
SITAGLIPTIN PHOSPHATE + METFORMIN HCl (VELMETIA) SITAGLIPTIN PHOSPHATE + METFORMIN HCl (VELMETIA) is not recommended in patients with an eGFR ≥ 30 mL/min/1.73 m2 and < 45 mL/min/1.73 m2 because these patients require a lower dosage of sitagliptin than what is available in the fixed combination SITAGLIPTIN PHOSPHATE + METFORMIN HCl (VELMETIA) product.
Discontinuation for iodinated contrast imaging procedures: Discontinue SITAGLIPTIN PHOSPHATE + METFORMIN HCl (VELMETIA) at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR ≥ 30 to < 60 mL/min/1.73 m2; in patients with a history of liver disease, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart SITAGLIPTIN PHOSPHATE + METFORMIN HCl (VELMETIA) if renal function is acceptable (see PRECAUTIONS).
Mode of Administration: SITAGLIPTIN PHOSPHATE + METFORMIN HCl (VELMETIA) is available for oral administration as tablets. It should generally be given twice daily with meals.
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