Janumet XR Dosage/Direction for Use

General: The dosage of antihyperglycemic therapy with SITAGLIPTIN + METFORMIN HCl (JANUMET XR) 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 + METFORMIN HCl (JANUMET XR) should be given once daily with a meal preferably in the evening. The dose should be escalated gradually to reduce the gastrointestinal (GI) side effects due to metformin. Additionally, administration of SITAGLIPTIN + METFORMIN HCl (JANUMET XR) with food enhances plasma concentrations of metformin. To preserve the modified-release properties, the tablets must not be split, broken, crushed, or chewed before swallowing. There have been reports of incompletely dissolved SITAGLIPTIN + METFORMIN HCl (JANUMET XR) tablets being eliminated in the feces. It is not known whether this material seen in feces contains active drug. If a patient reports repeatedly seeing tablets in feces, the healthcare provider should assess adequacy of glycemic control.
Dosing Recommendations: The starting dose of SITAGLIPTIN + METFORMIN HCl (JANUMET XR) should be based on the patient's current regimen.
SITAGLIPTIN + METFORMIN HCl (JANUMET XR) should be given once daily with a meal preferably in the evening. SITAGLIPTIN + METFORMIN HCl (JANUMET XR) tablet is available in 100 mg sitagliptin/1 g extended-release metformin hydrochloride strength.
The 100 mg sitagliptin/1 g metformin hydrochloride extended-release tablet should be taken as a single tablet once daily.
As initial therapy: For patients with type 2 diabetes mellitus, whose hyperglycemia is inadequately controlled with diet and exercise alone, the recommended total daily starting dose of SITAGLIPTIN + METFORMIN HCl (JANUMET XR) is 100 mg sitagliptin and 1 g metformin hydrochloride. 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.
For patients inadequately controlled on metformin monotherapy: For patients inadequately controlled on metformin alone, the recommended total daily starting dose of SITAGLIPTIN + METFORMIN HCl (JANUMET XR) is 100 mg sitagliptin and the previously prescribed dose of metformin.
For patients inadequately controlled on sitagliptin monotherapy: For patients inadequately controlled on sitagliptin alone, the recommended starting dose of SITAGLIPTIN + METFORMIN HCl (JANUMET XR) is 100 mg sitagliptin and 1 g metformin hydrochloride. The metformin dose can be titrated as needed to achieve glycemic control. Gradual dose escalation to reduce the gastrointestinal (GI) side effects associated with metformin should be considered. Patients taking sitagliptin monotherapy dose-adjusted for renal impairment should not be switched to SITAGLIPTIN + METFORMIN HCl (JANUMET XR) (see Contraindications).
For patients switching from coadministration of sitagliptin and metformin: For patients switching from coadministration of sitagliptin and metformin, SITAGLIPTIN + METFORMIN HCl (JANUMET XR) may be initiated at the previously prescribed dose of sitagliptin and metformin.
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 + METFORMIN HCl (JANUMET XR) should provide 100 mg total daily dose of sitagliptin. 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 a PPARγ agonist (i.e. thiazolidinediones): The usual starting dose of SITAGLIPTIN + METFORMIN HCl (JANUMET XR) should provide 100 mg total daily dose of sitagliptin. 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 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 + METFORMIN HCl (JANUMET XR) should provide 100 mg total daily dose of sitagliptin. 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 + METFORMIN HCl (JANUMET XR) in patients previously treated with other oral antihyperglycemic agents and switched to SITAGLIPTIN + METFORMIN HCl (JANUMET XR). 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 + METFORMIN HCl (JANUMET XR) and periodically thereafter.
SITAGLIPTIN + METFORMIN HCl (JANUMET XR) is contraindicated in patients with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m². Discontinue SITAGLIPTIN + METFORMIN HCl (JANUMET XR) if the patient's eGFR later falls below 30 mL/min/1.73 m² (see Contraindications and Precautions).
SITAGLIPTIN + METFORMIN HCl (JANUMET XR): Initiation of SITAGLIPTIN + METFORMIN HCl (JANUMET XR) in patients with an eGFR ≥30 mL/min/1.73 m² and <45 mL/min/1.73 m² is not recommended. In patients taking SITAGLIPTIN + METFORMIN HCl (JANUMET XR) whose eGFR later falls below 45 mL/min/1.73 m², assess the benefit and risk of continuing therapy and limit dose of the sitagliptin component to 50 mg once day.
Discontinuation for iodinated contrast imaging procedures: Discontinue SITAGLIPTIN + METFORMIN HCl (JANUMET XR) 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 + METFORMIN HCl (JANUMET XR) if renal function is acceptable (see Precautions).