Sitagliptin/Metformin Extended-Release Tablets (Janumet XR) is a novel fixed-dose combination antihyperglycemic medication. It integrates two hypoglycemic ingredients with distinct mechanisms of action, offering a more convenient and effective treatment option for patients with type 2 diabetes mellitus.
What are the Indications for Sitagliptin/Metformin Extended-Release Tablets (Janumet XR)?
Primary Indications
Sitagliptin/Metformin Extended-Release Tablets are specifically indicated for glycemic control in adult patients with type 2 diabetes mellitus.
As an adjunct to diet and exercise, this medication exerts a synergistic effect through dual mechanisms, which can significantly reduce patients' glycated hemoglobin levels and effectively control blood glucose fluctuations.
Usage Restrictions
It is important to note that this medication must not be used in patients with type 1 diabetes mellitus.
Currently, there are no relevant study data to support the safety of its use in patients with a history of pancreatitis.
Extreme caution should be exercised when considering the administration of this medication to patients with a history of pancreatitis.
Dosage Forms and Characteristics of Sitagliptin/Metformin Extended-Release Tablets (Janumet XR)
Dosage Form Compositions
50 mg sitagliptin and 500 mg metformin extended-release tablets: Pale blue, biconvex oval film-coated tablets, engraved with "78" on one side.
50 mg sitagliptin and 1000 mg metformin extended-release tablets: Pale green, biconvex oval film-coated tablets, marked with "80" on one side.
100 mg sitagliptin and 1000 mg metformin extended-release tablets: Blue, biconvex oval film-coated tablets, labeled with "81" on one side.
Active Ingredient Compositions
The medication contains two active ingredients: sitagliptin and metformin.
The chemical name of sitagliptin phosphate monohydrate is 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate.
Sitagliptin phosphate monohydrate is a white to off-white crystalline powder with non-hygroscopic properties.
Excipient Compositions
Tablets of all dosage strengths contain the following inactive ingredients: polyvinylpyrrolidone, hypromellose, colloidal silicon dioxide, sodium stearyl fumarate, propyl gallate, polyethylene glycol, and kaolin.
The film coating also contains hypromellose, hydroxypropyl cellulose, titanium dioxide, FD&C Blue No. 2/indigo carmine aluminum lake, and carnauba wax.
Storage Methods for Sitagliptin/Metformin Extended-Release Tablets (Janumet XR)
Storage Environment Requirements
The medication must be stored at a temperature of 20-25°C (68-77°F), with a permissible excursion range of 15-30°C (59-86°F).
The storage environment must be kept dry, and the bottle cap should be tightly closed to prevent moisture from entering and affecting the quality of the medication.
