详情
Manufacturer
MSD International GmbH (Puerto Rico Branch) LLC
Registraction Number
MAL14125081ARZ
Content
- Active Ingredients: Each tablet contains 100 mg of sitagliptin (as sitagliptin phosphate monohydrate) and 1,000 mg of metformin hydrochloride extended-release.
- Inactive Ingredients: The tablet includes cellulose, hypromellose, magnesium stearate, polyethylene glycol, and other components.
Indication
- Primary Use: Janumet XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
- Limitations of Use: Not for the treatment of type 1 diabetes. Has not been studied in patients with a history of pancreatitis.
Instructions
- Dosage: Take one tablet orally once daily with a meal, preferably in the evening.
- Administration: Swallow the tablet whole; do not split, crush, or chew.
- Renal Impairment: Assess renal function before initiation and periodically thereafter. Janumet XR is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m². Initiation is not recommended in patients with eGFR between 30–45 mL/min/1.73 m². Limit dose of sitagliptin to 50 mg once daily if eGFR falls below 45 mL/min/1.73 m².
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