Janumet

Per 50/500 mg tab Sitagliptin 50 mg, metformin HCl 500 mg. Per 50/1,000 mg tab Sitagliptin 50 mg, metformin HCl 1,000 mg

Adjunct to diet & exercise to improve glycemic control in adults w/ type 2 DM when treatment w/ both sitagliptin & metformin is appropriate.

Individualized dosage not exceeding max recommended daily dose of 100 mg sitagliptin & 2,000 mg metformin. Generally given bd w/ gradual dose escalation. Patient inadequately controlled w/ diet & exercise alone Starting dose: 50 mg sitagliptin/500 mg metformin HCl bd, may be titrated up to 50 mg sitagliptin/1,000 mg metformin HCl bd. Patient inadequately controlled on metformin monotherapy Usual starting dose: 50 mg sitagliptin bd + metformin dose already being taken. For patients taking 850 mg metformin bd, the recommended starting dose is 50 mg sitagliptin/1,000 mg metformin HCl bd. Patient inadequately controlled on sitagliptin monotherapy Starting dose: 50 mg sitagliptin/500 mg metformin HCl bd, may be titrated up to 50 mg sitagliptin/1,000 mg metformin HCl bd. Patient switching from co-administration of sitagliptin & metformin May be initiated at the dose of sitagliptin & metformin already being taken. Patient inadequately controlled on dual combination therapy w/ any 2 of the following: sitagliptin, metformin or a sulfonylurea Usual starting dose should provide sitagliptin dosed as 50 mg bd. To determine the starting dose of metformin component, consider patient's level of glycemic control & current dose (if any) of metformin. Patients currently on or initiating a sulfonylurea may require lower sulfonylurea doses. Patient inadequately controlled on dual combination therapy w/ any 2 of the following: sitagliptin, metformin or a PPAR agonist (ie, thiazolidinediones) Usual starting dose should provide sitagliptin dosed as 50 mg bd. To determine the starting dose of metformin component, consider patient's level of glycemic control & current dose (if any) of metformin. Patient inadequately controlled on dual combination therapy w/ any 2 of the following: sitagliptin, metformin or insulin Usual starting dose should provide sitagliptin dosed as 50 mg bd. To determine the starting dose of metformin component, consider patient's level of glycemic control & current dose (if any) of metformin. Patients currently on or initiating insulin therapy may require lower doses of insulin.

Should be taken with food.

Hypersensitivity. Acute conditions w/ potential to alter renal function eg, dehydration, severe infection, shock. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, w/ or w/o coma. Temporarily discontinue in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials. Severe renal failure (GFR <30 mL/min).

Not for patients w/ type 1 DM or for treatment of diabetic ketoacidosis. Monitor renal function prior to treatment initiation & at least annually thereafter. Not recommended in patients w/ GFR ≥30 mL/min & <45 mL/min. Pregnancy. Should not be used by a woman who is nursing. Elderly. Ped patients. Sitagliptin phosphate: Reports of acute pancreatitis; hypoglycemia in combination w/ a sulfonylurea or w/ insulin; hypersensitivity reactions. Metformin HCl: Risk of metformin accumulation & lactic acidosis in renally impaired patients; hypoglycemia when caloric intake is deficient, when strenuous exercise is not compensated by caloric supplementation, or during concomitant use w/ other glucose-lowering agents (eg, sulfonylureas & insulin) or ethanol; subnormal vit B₁₂ levels. Radiologic studies w/ intravascular iodinated contrast materials. Hypoxic states. Excessive alcohol intake. Temporarily suspend therapy in case of any surgical procedures (except minor procedures not associated w/ restricted intake of food & fluids) & do not restart until the patient's oral intake has resumed & renal function has been evaluated as acceptable. Changes in clinical status of patients w/ previously controlled type 2 DM. Temporary loss of glycemic control in case of stress exposure (eg, fever, trauma, infection, or surgery). Use of concomitant medications that may affect renal function or metformin disposition. Patients w/ hepatic impairment.

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

Loss of glycemic control w/ thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OCs, phenytoin, nicotinic acid, sympathomimetics, Ca channel blocking drugs, & INH. Metformin HCl: Increased C_max & AUC w/ nifedipine. Increased systemic exposure & risk for lactic acidosis w/ drugs that interfere w/ common renal tubular transport systems involved in the renal elimination of metformin [eg, organic cationic transporter-2 (OCT2)/multidrug & toxin extrusion (MATE) 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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