Janumet XR

Janumet XR

metformin + sitagliptin

Manufacturer:

MSD

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per 50/500 mg tab Sitagliptin 50 mg, metformin HCl 500 mg extended-release. Per 50/1,000 mg tab Sitagliptin 50 mg, metformin HCl 1,000 mg extended-release. Per 100/1,000 mg tab Sitagliptin 100 mg, metformin HCl 1,000 mg extended-release
Indications/Uses
As initial therapy in type 2 DM when diet & exercise do not provide adequate glycemic control. As 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 & a PPARγ agonist, or insulin & metformin alone.
Dosage/Direction for Use
Individualized dosage. Total daily starting dose: Sitagliptin 100 mg/metformin HCl 1,000 mg. Max daily dose: Sitagliptin 100 mg/metformin HCl 2 g.
Administration
Should be taken with food: Take w/ meals preferably in the evening. Do not split/break/crush/chew tab before swallowing.
Contraindications
Hypersensitivity. Renal disease or dysfunction, acute or chronic metabolic acidosis including diabetic ketoacidosis w/ or w/o coma, intravascular administration of iodinated contrast materials.
Special Precautions
Not for use in type 1 DM or treatment of ketoacidosis. Discontinue use if pancreatitis is suspected. Renal & hepatic impairment. Sulfonylurea- or insulin-induced hypoglycemia, risk of lactic acidosis, hypoxic states, surgical procedures, IV contrast studies w/ iodinated materials, alcohol intake, decreased vit B12 absorption, loss of glycemic control. Pregnancy & lactation. Elderly. Childn <18 yr.
Adverse Reactions
Diarrhea, upper resp tract infection, headache; nausea, vomiting, abdominal pain; hypoglycemia.
Drug Interactions
Sitagliptin: Has minimal effect on the plasma AUC & plasma Cmax of digoxin. Metfomin 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.
Presentation/Packing
Form
Janumet XR 100 mg/1000 mg FC tab
Packing/Price
28's;7's
Form
Janumet XR 50 mg/500 mg FC tab
Packing/Price
14's;56's
Form
Janumet XR 50 mg/1000 mg FC tab
Packing/Price
14's;56's
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