Janumet XR

Janumet XR

metformin + sitagliptin


Merck Sharp & Dohme


Zuellig Pharma
Concise Prescribing Info
Per 50/500 mg FC tab Sitagliptin 50 mg, metformin HCl extended-release 500 mg. Per 50/1,000 mg FC tab Sitagliptin 50 mg, metformin HCl extended-release 1,000 mg. Per 100/1,000 mg FC tab Sitagliptin 100 mg, metformin HCl extended-release 1,000 mg
Initial therapy in type 2 DM when diet & exercise do not provide adequate glycemic control. Adjunct to diet & exercise to improve glycemic control in type 2 DM inadequately controlled on metformin or sitagliptin alone, or combination sitagliptin & metformin, or triple combination w/ sulfonylurea, or max tolerated dose of metformin & PPARγ agonist, or insulin & metformin alone.
Dosage/Direction for Use
Individualized dosage. Total daily starting dose: Sitagliptin 100 mg/metformin HCl extended-release 1,000 mg. Max daily dose: Sitagliptin 100 mg/metformin HCl extended-release 2 g.
Should be taken with food: Take preferably in the evening. Do not split/break/crush/chew tab.
Hypersensitivity. Acute or chronic metabolic acidosis including diabetic ketoacidosis w/ or w/o coma, intravascular administration of iodinated contrast materials. Renal disease or dysfunction. Lactation.
Special Precautions
Not for use in type 1 DM or treatment of ketoacidosis. Discontinue use if pancreatitis is suspected. Sulfonylurea- or insulin-induced hypoglycemia, risk of lactic acidosis, hypoxic states, surgical procedures, alcohol intake, decreased vit B12 absorption, loss of glycemic control. Renal & hepatic impairment. Pregnancy. Childn <18 yr. Elderly.
Adverse Reactions
Diarrhea, nausea, dyspepsia, flatulence, vomiting, headache, hypoglycaemia; abdominal pain, cough, fungal skin infection, peripheral edema, loss of appetite, metallic taste, upper resp tract infection, hypersensitivity reactions.
Drug Interactions
Metformin HCl: Furosemide increases metformin plasma & blood Cmax & AUC. Nifedipine enhances metformin absorption. Cationic drugs (eg, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin). Thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OCs, phenytoin, nicotinic acid, sympathomimetics, Ca antagonists, INH.
MIMS Class
ATC Classification
A10BD07 - metformin and sitagliptin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.
Janumet XR 100/1,000 mg FC tab
Janumet XR 50/1,000 mg FC tab
Janumet XR 50/500 mg FC tab
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