metformin + sitagliptin




Agencia Lei Va Hong
Concise Prescribing Info
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.
Dosage/Direction for Use
Individualized dosage not exceeding max recommended daily dose of 100 mg sitagliptin & 2,000 mg metformin. Generally given bd w/ gradual dose escalation. Patients 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. Patients 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. Patients 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. Switching from co-administration of sitagliptin & metformin May be initiated at the dose of sitagliptin & metformin already being taken.
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).
Special Precautions
Not for patients w/ type 1 DM or for treatment of diabetic ketoacidosis. Reports of acute pancreatitis; hypoglycemia. Monitor renal function prior to treatment initiation & at least annually thereafter. Pregnancy & lactation. Elderly. Childn <18 yr. Sitagliptin phosphate: Hypersensitivity reactions. Metformin HCl: Risk of metformin accumulation & lactic acidosis in renally impaired patients. Radiologic studies w/ intravascular iodinated contrast materials. Hypoxic states. Temporarily suspend therapy in case of any surgical procedures. Excessive alcohol intake. Subnormal vit B12 levels. 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. Hepatic impairment.
Adverse Reactions
Diarrhea, nausea, dyspepsia, flatulence, vomiting, headache, hypoglycaemia, abdominal pain.
Drug Interactions
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 Cmax & 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].
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.
Janumet 50/1000 mg film-coated tab
Janumet 50/500 mg film-coated tab
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