Janumet XR 50/500MG Tab (56’s)

Description

Contents
Sitagliptin phosphate/Metformin XR
Indications/Uses

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 or sitagliptin alone or in patients already being treated with the combination of sitagliptin and metformin.
As part of triple combination therapy with a sulfonylurea as an adjunct to diet and exercise in patients with type 2 diabetes mellitus inadequately controlled with any 2 of the 3 agents: Metformin, Sitagliptin, or a sulfonylurea.
As triple combination therapy with a PPARγ agonist (eg, a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARγ agonist.
As add-on to insulin (eg, triple combination therapy) as an adjunct to diet and exercise to improve glycemic control in patients when stable dosage of insulin and metformin alone do not provide adequate glycemic control.

Dosage/Direction for Use
For patients with type 2 diabetes mellitus, whose hyperglycemia is inadequately controlled with diet and exercise alone, the recommended total daily starting dose is 100/1000 mg. Patients with inadequate glycemic control on this dose can be titrated gradually to reduce gastrointestinal side effects associated with metformin, up to the maximum recommended daily metformin dose of 2000 mg.
Patients Inadequately Controlled on Metformin Monotherapy: The recommended total daily starting dose of Janumet XR is sitagliptin 100 mg and the previously prescribed dose of metformin.
Patients Inadequately Controlled on Sitagliptin Monotherapy: The recommended starting dose of Janumet XR is sitagliptin 100 mg and metformin HCl 1000 mg. The metformin dose can be titrated as needed to achieve glycemic control. Gradual dose escalation to reduce the gastrointestinal side effects associated with metformin should be considered. Patients taking sitagliptin monotherapy dose-adjusted for renal insufficiency should not be switched to Janumet XR (see Contraindications).
Patients Switching from Co-Administration of Sitagliptin and Metformin: For patients switching from co-administration of sitagliptin and metformin, Janumet XR may be initiated at the previously prescribed dose of sitagliptin and metformin.
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