Janumet XR

Per 100 mg/1 g ER tab Sitagliptin phosphate 100 mg, metformin HCl 1 g

Initial therapy in patients w/ type 2 DM to improve glycemic control when diet & exercise do not provide adequate glycemic control. Adjunct to diet & exercise to improve glycemic control in patients w/ 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 as an adjunct to diet & exercise in patients w/ type 2 DM inadequately controlled w/ any 2 of the 3 agents: Metformin, sitagliptin or a sulfonylurea. As part of triple combination therapy w/ a PPARγ agonist (ie, thiazolidinediones) as an adjunct to diet & exercise in patients w/ type 2 DM inadequately controlled w/ any 2 of the 3 agents: Metformin, sitagliptin or a PPARγ agonist. In combination w/ insulin as an adjunct to diet & exercise to improve glycemic control in patients w/ type 2 DM.

Individualized dosage. Total daily starting dose: 1 tab once daily. May be titrated gradually to reduce GI effects associated w/ metformin, up to max of metformin 2,000 mg daily. Patient inadequately controlled on metformin monotherapy Total daily starting dose: Sitagliptin 100 mg + previously prescribed dose of metformin. Patient inadequately controlled on sitagliptin monotherapy Initially 1 tab. Metformin dose may be titrated as needed. Consider gradual dose escalation to reduce GI effects associated w/ metformin. Patient switching from co-administration of sitagliptin & metformin May be initiated w/ previously prescribed dose of sitagliptin & metformin. Patient inadequately controlled on dual combination therapy w/ any 2 of the following 3 antihyperglycemic agents: Sitagliptin, metformin or sulfonylurea Initially sitagliptin 100 mg total daily dose + metformin dose based on glycemic control level & current dose (if any) of metformin. Consider gradual dose escalation to reduce GI effects associated w/ metformin. Patients currently on or initiating sulfonylurea therapy may require lower sulfonylurea doses to reduce the risk of sulfonylurea-induced hypoglycemia. Patient inadequately controlled on dual combination therapy w/ any 2 of the following 3 antihyperglycemic agents: Sitagliptin, metformin or a PPARγ agonist (ie, thiazolidinediones) Initially sitagliptin 100 mg total daily dose + metformin dose based on glycemic control level & current dose (if any) of metformin. Consider 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 Initially sitagliptin 100 mg total daily dose + metformin dose based on glycemic control level & current dose (if any) of metformin. Consider gradual dose escalation to reduce GI effects associated w/ metformin. Patients currently on or initiating insulin therapy may require lower insulin doses to reduce the risk of hypoglycemia.

Should be taken with food: Take w/ meals preferably in the evening. Swallow whole, do not split/break/crush/chew.

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 use in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials.

Not for patients w/ type 1 diabetes or for the treatment of diabetic ketoacidosis. Discontinue use if pancreatitis is suspected. Monitor renal function especially for elderly, before initiation & at least annually thereafter, discontinue use if renal impairment is present. Not recommended in patients w/ eGFR ≥30 to <45 mL/min/1.73 m². Sitagliptin: Hypoglycemia in combination w/ sulfonylurea or insulin. Discontinue use if bullous pemphigoid or hypersensitivity reaction including anaphylaxis, angioedema & exfoliative skin conditions eg, SJS is suspected. Metformin HCl: Discontinue immediately & institute general supportive measures promptly in patients w/ lactic acidosis. Prompt evaluation in patients w/ type 2 DM who develops lab abnormalities or clinical illness for evidence of ketoacidosis or lactic acidosis including serum electrolytes, ketones & blood glucose. Concomitant use w/ cationic drugs that are eliminated by renal tubular secretion. Temporarily 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 hepatic impairment, alcoholism or heart failure, or in patients who will be administered intra-arterial iodinated contrast. Use of intravascular contrast studies w/ iodinated materials may lead to acute alteration of renal function & have been associated w/ lactic acidosis. Suspend therapy for any surgical procedure & should not be restarted until resumption of oral intake & renal function is acceptable. Patients w/ hepatic disease, adrenal or pituitary insufficiency or alcohol intoxication. Avoid alcohol intake. Monitor vit B₁₂ level. W/hold therapy & temporarily administer insulin if temporary loss of glycemic control occur due to fever, trauma, infection or surgery. Pregnancy & lactation. Childn <18 yr. Elderly (≥65 yr).

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

Sitagliptin: May increase drug conc of digoxin. Metformin HCl: Increased plasma & blood conc w/ furosemide. Enhanced absorption w/ nifedipine. Concomitant use of 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 increase risk of lactic acidosis. May lead to loss of glycemic control w/ 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