Janumet

Per 50 mg/500 mg tab Sitagliptin phosphate monohydrate 64.25 mg (equiv to sitagliptin 50 mg as free base), metformin HCl 500 mg. Per 50 mg/850 mg tab Sitagliptin phosphate monohydrate 64.25 mg (equiv to sitagliptin 50 mg as free base), metformin HCl 850 mg. Per 50 mg/1 g tab Sitagliptin phosphate monohydrate 64.25 mg (equiv to sitagliptin 50 mg as free base), metformin HCl 1,000 mg

Type 2 DM as initial therapy to improve glycemic control when diet & exercise alone do not provide adequate glycemic control. Type 2 DM as adjunct to diet & exercise to improve glycemic control in patients who cannot be controlled w/ metformin or sitagliptin alone or in patients already being treated w/ combination of sitagliptin & metformin. As part of triple combination therapy w/ a sulfonylurea or w/ a PPARγ agonist (ie, thiazolidinediones) as an adjunct to diet & exercise in patients w/ type 2 DM inadequately controlled w/ any 2 of 3 agents: Metformin, sitagliptin or a sulfonylurea alone or a PPARγ agonist alone. Type 2 DM as an adjunct to diet & exercise to improve glycemic control in combination w/ insulin; sitagliptin & metformin.

Individualized dosing. Initial therapy: Starting dose 50 mg/500 mg bid. May be titrated w/ sitagliptin 50 mg + metformin 1,000 mg bid. Patient inadequately controlled on metformin monotherapy Sitagliptin 50 mg bid + metformin already taken. Patient inadequately controlled on sitagliptin monotherapy 50 mg/500 mg tab bid. May be titrated up to 50 mg/1,000 mg tab bid. Patient inadequately controlled on dual combination therapy w/ any 2 of the following 3 antihyperglycemic agents: Sitagliptin, metformin or a PPARγ agonist (ie, thiazolidinediones) Usual starting dose: 50 mg bid (100 mg total daily dose). In determining the starting dose of the metformin component, the patient's level of glycemic control & current dose (if any) of metformin should be considered. Patient 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 3 antihyperglycemic agents: Sitagliptin, metformin or sulfonylurea Sitagliptin 50 mg bid + metformin dose based on glycemic control level. Patients currently on or initiating sulfonylurea may require lower doses of sulfonylurea doses to reduce the risk of sulfonylurea-induced hypoglycemia. Gradual dose escalation to reduce GI effects associated w/ metformin. Patient inadequately controlled on dual combination therapy w/ any 2 of the following 3 antihyperglycemic agents: Sitagliptin, metformin or insulin Sitagliptin 50 mg bid + metformin dose based on glycemic control level & current dose (if any) of metformin. Gradual dose escalation to reduce the GI side effects associated w/ metformin should be considered. Patients currently on or initiating insulin therapy may require lower doses of insulin to reduce the risk of hypoglycemia.

Should be taken with food.

Hypersensitivity. Severe renal impairment (eGFR <30 mL/min/1.73 m²). Acute or chronic metabolic acidosis including diabetic ketoacidosis, w/ or w/o coma. Temporarily discontinue treatment in patients undergoing radiologic studies involving IV administration of iodinated contrast materials.

Patients should be informed of the characteristic symptom of acute pancreatitis, fatal & non-fatal hemorrhagic or necrotizing pancreatitis which is persistent, severe abdominal pain. Risk of metformin accumulation & lactic acidosis increases w/ degree of impairment of renal function, renal function should be assessed & monitored regularly. Not recommended in patients w/ eGFR ≥30 to <45 mL/min/1.73 m². Hypoglycemia in combination w/ a sulfonylurea or w/ insulin. Discontinue if bullous pemphigoid or hypersensitivity reactions occur eg, anaphylaxis, angioedema, exfoliative skin conditions including SJS. Use min effective dose of metformin to reduce risk of lactic acidosis. Hypoglycemia, debilitated/malnourished patients. Concomitant use of cationic drugs that are eliminated by renal tubular secretion. Discontinue prior to & w/hold for 48 hr subsequent to an iodinated contrast imaging procedure in patients w/ eGFR ≥30 to <60 mL/min/1.73 m², history of liver disease, alcoholism or heart failure or in patients who will be administered intra-arterial iodinated contrast. Intravascular contrast studies w/ iodinated materials may lead to acute alteration of renal functions & have been associated w/ lactic acidosis in patients receiving metformin. Heart failure, unstable or acute CHF at risk of hypoperfusion & hypoxemia. Suspend therapy prior to surgical procedure until resumption of oral intake & renal function is acceptable. Avoid excessive alcohol intake. Impaired hepatic function. Monitor vit B₁₂ level. W/hold therapy if fever, trauma, infection or surgery, temporary loss of glycemic control may occur. Monitor renal function especially in elderly ≥65 yr. Pregnancy & lactation. Childn <18 yr.

Diarrhea, nausea, dyspepsia, flatulence, vomiting, headache, hypoglycemia, headache.

Sitagliptin: Increased conc w/ digoxin. Metformin HCl: Increased plasma conc w/ furosemide, nifedipine. Increased systemic exposure to metformin & risk for lactic acidosis in concomitant w/ drugs that interfere w/ common renal tubular transport systems involved in renal elimination of metformin (eg, OCT2/MATE inhibitors eg, ranolazine, vandetanib, dolutegravir & cimetidine). May lead to loss of glycemic control w/ drugs producing hyperglycemia eg, thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OCs, phenytoin, nicotinic acid, sympathomimetics, Ca channel blockers & INH.

Antidiabetic Agents

A10BD07 - metformin and sitagliptin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.

Rx