Generic name: SITAGLIPTIN PHOSPHATE 50mg, METFORMIN HYDROCHLORIDE 500mg
Dosage form: tablet, film coated
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
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. Initial combination therapy or maintenance of combination therapy should be individualized and left to the discretion of the health care provider.
JANUMET should generally be given twice daily with meals, with gradual dose escalation, to reduce the gastrointestinal (GI) side effects due to metformin. JANUMET must not be split or divided before swallowing.
The starting dose of JANUMET should be based on the patient's current regimen. JANUMET should be given twice daily with meals. The following doses are available:
50 mg sitagliptin/500 mg metformin hydrochloride
50 mg sitagliptin/1000 mg metformin hydrochloride.
The recommended starting dose in patients not currently treated with metformin is 50 mg sitagliptin/500 mg metformin hydrochloride twice daily, with gradual dose escalation recommended to reduce gastrointestinal side effects associated with metformin.
The starting dose in patients already treated with metformin should provide sitagliptin dosed as 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 hydrochloride twice daily.
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.
Recommendations for Use in Renal Impairment
Assess renal function prior to initiation of JANUMET and periodically thereafter.
JANUMET is not recommended in patients with an eGFR between 30 and <45 mL/min/1.73 m2 because these patients require a lower dosage of sitagliptin than what is available in the fixed combination JANUMET product.
Discontinuation for Iodinated Contrast Imaging Procedures
Discontinue JANUMET at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 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 JANUMET if renal function is stable [see Warnings and Precautions (5.1)].
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