Buy Janumet (Metformin HCl with Sitagliptin Phosphate) anti-diabetic medication
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JANUMET (METFORMIN, SITAGLIPTIN): PRESCRIBING INFORMATION
Janumet (Sitagliptin Phosphate, Metformin HCl) tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes: sitagliptin and metformin hydrochloride.
Sitagliptin is an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin is present in Janumet tablets in the form of sitagliptin phosphate monohydrate. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate with an empirical formula of C16H15F6N5OxH3PO4xH2O and a molecular weight of 523.32.
Sitagliptin Phosphate Monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate.
Metformin Hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. Metformin Hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5xHCl and a molecular weight of 165.63. Metformin Hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68.
Janumet is available for oral administration as tablets containing 64.25 mg sitagliptin phosphate monohydrate and metformin hydrochloride equivalent to: 50 mg sitagliptin as free base and 500 mg metformin hydrochloride (Janumet 50 mg / 500 mg) or 1000 mg metformin hydrochloride (Janumet 50 mg / 1000 mg). Each film-coated tablet of Janumet contains the following inactive ingredients: polyvinylpyrrolidone, microcrystalline cellulose, sodium lauryl sulfate, and sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, red iron oxide, titanium dioxide, and black iron oxide.
INDICATIONS AND USAGE
Janumet (Sitagliptin Phosphate, Metformin Hydrochloride) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.
Important Limitations of Use
Janumet (Sitagliptin Phosphate, Metformin HCl) should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.
This medication has 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 Janumet.
DOSAGE AND ADMINISTRATION
Janumet dosage and administration
DOSAGE FORMS AND STRENGTHS
50 mg / 500 mg tablets are light pink, capsule-shaped, film-coated tablets with "575" debossed on one side.
50 mg / 1000 mg tablets are red, capsule-shaped, film-coated tablets with "577" debossed on one side.
Janumet (Sitagliptin, Metformin) is contraindicated in patients with:
Renal disease or renal dysfunction, e.g., as suggested by serum creatinine levels >= 1.5 mg / dl (males), >= 1.4 mg / dl (females) or abnormal creatinine clearance which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia.
Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
History of a serious hypersensitivity reaction to Janumet or sitagliptin (one of the components of this medication), such as anaphylaxis or angioedema.
Janumet (Sitagliptin Phosphate, Metformin Hydrochloride) should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function.
WARNINGS AND PRECAUTIONS
Janumet warnings and precautions
Janumet adverse reactions
Janumet drug interactions
USE IN SPECIFIC POPULATIONS
Janumet use in specific populations
Janumet clinical pharmacology
Janumet nonclinical toxicology
Janumet clinical studies
HOW SUPPLIED / STORAGE AND HANDLING
Tablets Janumet, 50 mg / 500 mg, are light pink, capsule-shaped, film-coated tablets with "575" debossed on one side. They are supplied as follows: unit-of-use bottles of 60, 180; unit dose blister packages of 50; bulk bottles of 1000.
Tablets Janumet, 50 mg / 1000 mg, are red, capsule-shaped, film-coated tablets with "577" debossed on one side. They are supplied as follows: unit-of-use bottles of 60, 180; unit dose blister packages of 50; bulk bottles of 1000.
Store at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F).
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