Janumet XR

Per 50/1,000 mg XR-FC tab Sitagliptin 50 mg, metformin HCl 1,000 mg. Per 100/1,000 mg XR-FC tab Sitagliptin 100 mg, metformin HCl 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 in combination w/ insulin; inadequately controlled on metformin or sitagliptin alone, or in patients already receiving sitagliptin & metformin combination; as part of triple combination therapy w/ sulfonylurea or PPARγ agonist (ie, thiazolidinediones).

Individualized dosage not exceeding max recommended daily dose of sitagliptin 100 mg. Patients w/ type 2 DM, whose hyperglycemia is inadequately controlled w/ diet & exercise alone Total daily starting dose: Sitagliptin 100 mg/metformin HCl 1,000 mg. May be titrated gradually up to max 2,000 mg metformin. Patients inadequately controlled on metformin monotherapy Total daily starting dose: Sitagliptin 100 mg & previously prescribed metformin dose. Patients inadequately controlled on sitagliptin monotherapy Initially sitagliptin 100 mg/metformin HCl 1,000 mg. Metformin dose may be titrated as needed. Switching from coadministration of sitagliptin & metformin May initiate at previously prescribed dose. Patients inadequately controlled on dual combination therapy w/ any 2 of these agents: Sitagliptin, metformin or sulfonylurea, or PPARγ agonist, or insulin Total daily starting dose: Sitagliptin 100 mg. Determine dose of metformin based on glycemic control level & current metformin dose. Renal impairment w/ estimated GFR <45 mL/min/1.73 m² Limit dose to 50 mg sitagliptin once daily.

Should be taken with food: Take w/ a meal, preferably in the evening.

Hypersensitivity. Acute or chronic metabolic acidosis including diabetic ketoacidosis w/ or w/o coma. Intravascular administration of iodinated contrast materials (discontinue treatment temporarily). Severe renal impairment (estimated GFR <30 mL/min/1.73 m²).

Discontinue if hypersensitivity reaction including anaphylaxis, angioedema & exfoliative skin conditions including SJS; bullous pemphigoid; pancreatitis is suspected; renal impairment is present; in patient w/ lactic acidosis taking metformin; if patient's estimated GFR falls <30 mL/min/1.73 m²; at the time of, or prior to iodinated contrast imaging procedure w/ eGFR ≥30 to <60 mL/min/1.73 m²; in patients w/ history of liver disease, alcoholism or heart failure; who will be administered intra-arterial iodinated contrast & withhold for 48 hr subsequent to the procedure. Promptly discontinue therapy if CV collapse, acute CHF & MI & other conditions characterized by hypoxemia occur. Temporarily suspend treatment for any surgical procedure (except minor procedures not associated w/ restricted intake of food & fluids). Withhold treatment in hypoxemia, dehydration or sepsis; & temporarily administer insulin if loss of glycemic control occurs. Not to be used in type 1 diabetes or diabetic ketoacidosis; severe infection or accident. Hypoglycemia in concomitant use w/ sulfonylurea, PPARγ agonist (eg, thiazolidinediones), insulin or ethanol. Increased risk of lactic acidosis in patients w/ CHF requiring pharmacologic management, particularly those w/ unstable or acute CHF at risk of hypoperfusion & hypoxemia, & in renal dysfunction. Excessive acute or chronic alcohol intake. Decreased vit B₁₂ levels. Debilitated or malnourished patients, & w/ adrenal or pituitary insufficiency or alcohol intoxication. Suspect lactic acidosis in any diabetic patient w/ metabolic acidosis lacking evidence of ketoacidosis (ketonuria & ketonemia). Assess renal function prior to initiation of therapy & at least annually thereafter. Evaluate serum electrolytes & ketones, blood glucose & pH, lactate, pyruvate, & metformin levels. Measure hematologic parameters annually; routine serum vit B₁₂ at 2-3 yr interval. Evaluate promptly for evidence of ketoacidosis or lactic acidosis in patients w/ lab abnormalities or clinical illness (especially vague & poorly defined illness). Concomitant use w/ drugs affecting renal function or metformin disposition eg, cationic drugs eliminated by renal tubular secretion. Avoid in patients w/ evidence of hepatic disease. Not recommended during pregnancy. Not to be used during lactation. Childn <10 yr. Elderly w/ renal impairment.

Diarrhea, nausea, dyspepsia, flatulence, vomiting, headache, hypoglycemia, abdominal pain, constipation, URTI, cough, fungal skin infection, peripheral edema. Pancreatitis; SJS.

Hyperglycemia & loss of glycemic control w/ thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OC, phenytoin, nicotinic acid, sympathomimetics, Ca channel blockers & INH. Metformin HCl: Decreased AUC & C_max of glyburide. Increased plasma & blood C_max, & AUC w/ furosemide & nifedipine. Decreased C_max & AUC of furosemide. Enhanced absorption w/ nifedipine. Increased systemic exposure & lactic acidosis w/ drugs that interfere w/ common renal tubular transport systems involved in renal elimination eg, organic cationic transporter-2 (OCT2)/multidrug & toxin extrusion inhibitors eg, ranolazine, vandetanib, dolutegravir & cimetidine.

Antidiabetic Agents

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

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