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A flexible dosage regimen: 2 agents, 1 tablet

JANUMET provides powerful glucose control by providing 2 agents — a DPP-4 inhibitor and metformin — in a single tablet.

When dosing JANUMET, the sitagliptin dose remains constant.


See dosing information below for:


  • Patients not currently being treated with metformin
  • Patients currently being treated with metformin
  • Patients treated with an insulin secretagogue or insulin
dosing information for janumet® (sitagliptin/metformin HCl) tablets

Patients not currently being treated with metformin

Start: Initial combination therapy or maintenance of combination therapy should be individualized and left to discretion of the health care provider. For a patient with type 2 diabetes not currently being treated with metformin, the recommended starting dose is 50 mg sitagliptin/500 mg metformin twice daily, with gradual dose escalation to reduce the gastrointestinal side effects due to metformin.

Titrate: The dosage of JANUMET 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.

Meals: JANUMET should generally be given twice daily with meals, with gradual dose escalation, to reduce the gastrointestinal side effects due to metformin.

Patients currently being treated with metformin

Start: For a patient currently being treated with metformin, the starting dose of JANUMET should be sitagliptin 50 mg twice daily (100 mg total daily dose) and the dose of metformin already being taken. For patients taking metformin 850 mg twice daily, the recommended starting dose of JANUMET is
50 mg sitagliptin/1000 mg metformin twice daily.

Titrate: The dosage of JANUMET 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.

Meals: JANUMET should generally be given twice daily with meals, with gradual dose escalation, to reduce the gastrointestinal side effects due to metformin.

Patients treated with an insulin secretagogue or insulin

Start: Coadministration of JANUMET with an insulin secretagogue (eg, sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.

Titrate: The dosage of JANUMET 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.

Meals: JANUMET should generally be given twice daily with meals, with gradual dose escalation, to reduce the gastrointestinal side effects due to metformin.

 
Printable dosing card

[PDF: 340 KB, 3 pages]

Selected Important Risk Information
Patients with congestive heart failure requiring pharmacologic management, in particular those with unstable or acute congestive heart failure who are at risk of hypoperfusion and hypoxemia, are at increased risk of lactic acidosis. The risk of lactic acidosis increases with the degree of renal dysfunction and the patient’s age. The risk of lactic acidosis may, therefore, be significantly decreased by regular monitoring of renal function in patients taking metformin and by use of the minimum effective dose of metformin. In particular, treatment of the elderly should be accompanied by careful monitoring of renal function. Metformin treatment should not be initiated in patients >80 years of age unless measurement of creatinine clearance demonstrates that renal function is not reduced, as these patients are more susceptible to developing lactic acidosis. In addition, metformin should be promptly withheld in the presence of any condition associated with hypoxemia, dehydration, or sepsis.

There have been postmarketing reports of acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, in patients taking JANUMET. After initiating JANUMET, observe patients carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, promptly discontinue JANUMET and initiate appropriate management. It is unknown whether patients with a history of pancreatitis are at increased risk of developing pancreatitis while taking JANUMET.

Please read the Boxed Warning about lactic acidosis.