Metformindrug info
metformin hydrochloride 1000 MG / sitagliptin phosphate 50 MG Oral Tablet
What it is used for
Sitagliptin and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Sitagliptin and metformin hydrochloride tablets should not be used in patients with type 1 diabetes mellitus. Sitagliptin and metformin hydrochloride tablets have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using sitagliptin and metformin hydrochloride tablets. Sitagliptin and metformin hydrochloride tablets is a combination of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use: Sitagliptin and metformin hydrochloride tablets should not be used in patients with type 1 diabetes. Sitagliptin and metformin hydrochloride has not been studied in patients with a history of pancreatitis.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective August 13, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Sitagliptin and metformin hydrochloride tablets for oral use contain two antihyperglycemic drugs: sitagliptin and metformin HCl. Sitagliptin Sitagliptin is an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin is present in sitagliptin and metformin hydrochloride tablets in the form of sitagliptin phosphate monohydrate. Sitagliptin phosphate monohydrate is described chemically as 7-[( R )-3-Amino-4-(2,4,5-trifluorophenyl)butanoyl]-3-(trifluoromethyl)-5,6,7,8-tetrahydro-1,2,4-triazolo[4,3- a ]pyrazine monophosphate monohydrate with a molecular formula of C 16 H 15 F 6 N 5 O
H 3 PO 4
H 2 O and a molecular weight of 523.32. The structural formula is: Sitagliptin phosphate monohydrate is a white or almost white, crystalline, non-hygroscopic powder. It is soluble in water, very slightly soluble in anhydrous ethanol and practically insoluble in heptane. Metformin HCl Metformin HCl (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. Metformin HCl is a white or almost white powder with a molecular formula of C 4 H 11 N 5
HCl and a molecular weight of 165.62. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone and methylene chloride. The pK a of metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is as shown: Sitagliptin and Metformin Hydrochloride Tablets Sitagliptin and metformin hydrochloride tablets are available as film-coated tablets containing: 64.25 mg sitagliptin monohydrate equivalent to 50 mg of sitagliptin and 500 mg metformin HCl (Sitagliptin and metformin hydrochloride tablets 50/500). 64.25 mg sitagliptin monohydrate equivalent to 50 mg of sitagliptin and 1,000 mg metformin HCl (Sitagliptin and metformin hydrochloride tablets 50/1,000). Each film-coated tablet of sitagliptin and metformin hydrochloride tablets contains the following inactive ingredients: croscarmellose sodium, ferric oxide red, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propyl gallate, and titanium dioxide. sitagliptinmetformin-01 sitagliptinmetformin-02
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective August 13, 2026. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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