Janumet XR

Janumet XR

metformin + sitagliptin

Manufacturer:

Merck Sharp & Dohme
Concise Prescribing Info
Contents
Per 50/500 mg tab Sitagliptin 50 mg, metformin HCl extended-release 500 mg. Per 50/1,000 mg tab Sitagliptin 50 mg, metformin HCl extended-release 1,000 mg. Per 100/1,000 mg tab Sitagliptin 100 mg, metformin HCl extended-release 1,000 mg
Indications/Uses
As adjunct to diet & exercise to improve glycemic control in type 2 DM inadequately controlled on metformin or sitagliptin alone, or combination of sitagliptin & metformin, or triple combination w/ sulfonylurea.
Dosage/Direction for Use
Individualized dosage. Max daily dose: Sitagliptin 100 mg/metformin HCl extended-release 2,000 mg.
Administration
Should be taken with food: Preferably taken in the evening. Swallow whole, do not split/break/crush/chew.
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. 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 & lactation. Childn <18 yr. Elderly.
Adverse Reactions
Diarrhea, nausea, vomiting, abdominal pain, flatulence, indigestion, constipation. Upper resp tract infection, nasopharyngitis. Headache. Asthenia, arthralgia, myalgia, pain in extremity, back pain. Hypoglycaemia. Hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis & exfoliative skin condition including SJS. Hepatic enzyme elevations. Acute pancreatitis including fatal & non-fatal hemorrhagic & necrotizing pancreatitis. Pruritus, pemphigoid.
Drug Interactions
Increased peak metformin plasma & blood conc & AUC w/ cationic drugs (eg, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin) & furosemide. Nifedipine enhances metformin absorption. Thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OCs, phenytoin, nicotinic acid, sympathomimetics, Ca antagonists, INH may lead to loss of glycemic control.
MIMS Class
Antidiabetic Agents
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 50/500 mg tab
Packing/Price
28's
Form
Janumet XR 50/1,000 mg tab
Packing/Price
28's
Form
Janumet XR 100/1,000 mg tab
Packing/Price
28's
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