Janumet

Janumet Dosage/Direction for Use

metformin + sitagliptin

Manufacturer:

Merck Sharp & Dohme

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
General: The dosage of antihyperglycemic therapy with 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 sitagliptin 100 mg and metformin 2000 mg. Initial combination therapy or maintenance of combination therapy should be individualized and left to the discretion of the healthcare provider.
Janumet should generally be given twice daily with meals, with gradual dose escalation, to reduce the gastrointestinal (GI) side effects associated with metformin.
The starting dose of Janumet should be based on the patient's current regimen. Janumet should be given twice daily with meals.
Patients Inadequately Controlled with Diet and Exercise Alone: If therapy with a combination tablet containing sitagliptin and metformin is considered appropriate for a patient with type 2 diabetes mellitus inadequately controlled with diet and exercise alone, the recommended starting dose is sitagliptin 50 mg/metformin hydrochloride 500 mg twice daily. Patients with inadequate glycemic control on this dose can be titrated up to sitagliptin 50 mg/metformin hydrochloride 1000 mg twice daily.
Patients Inadequately Controlled on Metformin Monotherapy: If therapy with a combination tablet containing sitagliptin and metformin is considered appropriate for a patient inadequately controlled on metformin alone, the recommended starting dose of Janumet should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose), and the dose of metformin already being taken.
Patients Inadequately Controlled on Sitagliptin Monotherapy: If therapy with a combination tablet containing sitagliptin and metformin is considered appropriate for a patient inadequately controlled on sitagliptin alone, the recommended starting dose of Janumet is sitagliptin 50 mg/metformin hydrochloride 500 mg twice daily. Patients with inadequate control on this dose can be titrated up to sitagliptin 50 mg/metformin hydrochloride 1000 mg twice daily. Patients taking sitagliptin monotherapy dose-adjusted for renal insufficiency should not be switched to Janumet.
Patients Switching from Co-Administration of Sitagliptin and Metformin: For patients switching from sitagliptin co-administered with metformin, Janumet may be initiated at the dose of sitagliptin and metformin already being taken.
Patients Inadequately Controlled on Dual Combination Therapy with Any 2 of the Following 3 Antihyperglycemic Agents: Sitagliptin, Metformin or a Sulfonylurea: If therapy with a combination tablet containing sitagliptin and metformin is considered appropriate in this setting, the usual starting dose of Janumet 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 GI side effect associated with metformin should be considered. Patients currently on or initiating a sulfonylurea may require lower sulfonylurea doses to reduce the risk of hypoglycemia.
Patients Inadequately Controlled on Dual Combination Therapy with the Maximal Tolerated Dose of Metformin and a PPARγ Agonist: The dose of Janumet should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
Patients Inadequately Controlled on Dual Combination Therapy with Insulin and the Maximal Tolerated Dose of Metformin: The dose of Janumet should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken. When Janumet is used in combination with insulin, a lower dose of insulin may be required to reduce the risk of hypoglycemia (see Precautions).
No studies have been performed specifically examining the safety and efficacy of Janumet in patients previously treated with other oral antihyperglycemic agents and switched to Janumet. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.
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