Per 50/500 mg FC tab Sitagliptin 50 mg, metformin HCl ER 500 mg. Per 50/1,000 mg FC tab Sitagliptin 50 mg, metformin HCl ER 1,000 mg. Per 100/1,000 mg FC tab Sitagliptin 100 mg, metformin HCl ER 1,000 mg
Indications/Uses
Adjunct to diet & exercise to improve glycemic control in adults w/ type 2 DM when treatment w/ both sitagliptin & metformin ER is appropriate.
Individualize dosage not exceeding max recommended daily dose of 100 mg sitagliptin & 2,000 mg metformin HCl ER. Patient not currently treated w/ metformin Starting dose: 100 mg sitagliptin/1,000 mg metformin HCl ER daily, may be titrated to reduce GI side effects. Patient already treated w/ metformin Starting dose: 100 mg sitagliptin daily w/ previously prescribed metformin dose. Patient taking metformin IR 850 mg bd or 1,000 mg bd Starting dose: 2 tab of 50 mg sitagliptin/1,000 mg metformin HCl ER taken together once daily.
Should be taken with food: Swallow whole, do not split/crush/chew tab.
Contraindications
History of serious hypersensitivity (eg, anaphylaxis or angioedema). Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Severe renal impairment (eGFR <30 mL/min/1.73 m2).
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. Bullous pemphigoid. Metformin HCl: Risk of lactic acidosis. 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). Hepatic impairment.
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