Janumet

Janumet

metformin + sitagliptin

Manufacturer:

MSD

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per 50 mg/500 mg tab Sitagliptin 50 mg, metformin HCl 500 mg. Per 50 mg/850 mg tab Sitagliptin 50 mg, metformin HCl 850 mg. Per 50 mg/1,000 mg tab Sitagliptin 50 mg, metformin HCl 1,000 mg
Indications/Uses
Initial therapy in type 2 DM to improve glycemic control when diet & exercise do not provide adequate glycemic control. As an adjunct to diet & exercise to improve glycemic control in type 2 DM inadequately controlled on metformin or sitagliptin alone or in patients already being treated w/ the combination of sitagliptin & metformin. As part of triple combination therapy w/ a sulfonylurea or add-on to insulin, as an adjunct to diet & exercise in type 2 DM inadequately controlled w/ any 2 of the 3 agents: Metformin, sitagliptin or sulfonylurea.
Dosage/Direction for Use
Individualized dosage w/ a max daily dose of sitagliptin 100 mg & metformin 2 g. Patient inadequately controlled w/ diet & exercise alone 50 mg/500 mg bd. May be titrated up to 50 mg/1,000 mg bd. Patient inadequately controlled on metformin monotherapy Sitagliptin 50 mg bd + metformin already taken. Patient inadequately controlled on sitagliptin monotherapy 50 mg/500 mg bd. May be titrated up to 50 mg/1,000 mg bd. Switching from sitagliptin co-administered w/ metformin Initiate w/ dose of sitagliptin & metformin already being taken. Patient inadequately controlled on dual combination therapy w/ any 2 of the following antihyperglycemic agents: sitagliptin, metformin, sulfonylurea or w/ insulin & metformin Sitagliptin 50 mg bd + metformin dose based on glycemic control level. Patients currently on or initiating sulfonylurea may require lower sulfonylurea doses to reduce the risk of sulfonylurea-induced hypoglycemia. Gradual dose escalation to reduce GI effects associated w/ metformin.
Administration
Should be taken with food.
Contraindications
History of a serious hypersensitivity to Janumet or sitagliptin. Renal disease or dysfunction, abnormal CrCl which may result from CV collapse, acute MI & septicemia. Acute or chronic metabolic acidosis including diabetic ketoacidosis, w/ or w/o coma. Temporarily discontinue treatment in patients undergoing radiologic studies. Type 1 diabetes, diabetic ketoacidosis.
Special Precautions
History of pancreatitis. Regular monitoring of renal function. Unstable or acute CHF, CV collapse, acute MI at risk of hypoperfusion & hypoxemia. Lactic acidosis. Hypoglycemia. Avoid excessive alcohol intake. Suspend therapy prior to surgical procedure until resumption of oral intake & normal renal function. Discontinue use if pancreatitis is suspected. Impaired hepatic function. Monitor vit B12 level. Evaluate patients who develops laboratory abnormalities or clinical illness promptly.  Pregnancy & lactation. Childn <18 yr. Elderly ≥65 yr.
Adverse Reactions
Diarrhea, upper resp tract infection, nausea, vomiting, flatulence, abdominal pain, indigestion, asthenia & headache. Hypoglycemia.
Drug Interactions
Increased peak plasma & whole blood con w/ cationic drugs (eg, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim or vancomycin). Enhanced absorption w/ nifedipine. May produce hyperglycemia w/ thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OCs, phenytoin, nicotinic acid, sympathomimetics, Ca channel blockers & 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 50 mg/1000 mg FC tab
Packing/Price
56's
Form
Janumet 50 mg/500 mg FC tab
Packing/Price
56's
Form
Janumet 50 mg/850 mg FC tab
Packing/Price
56's
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