ProglinMet

To improve glycemic control in adults w/ type 2 DM as initial therapy when diabetes is not adequately controlled by diet & exercise alone; patients inadequately controlled w/ metformin HCl or vildagliptin alone or who are already w/ the combination of vildagliptin & metformin HCl, as sep tab. As combination therapy w/ other medicinal products for the treatment of diabetes including insulin, when these do not provide adequate glycemic control.

Type 2 DM Max daily dose: Not to exceed vildagliptin 100 mg. Patient inadequately controlled on vildagliptin monotherapy Initially 50 mg/500 mg tab bid. Patient inadequately controlled on metformin HCl monotherapy, patient switching from combination therapy of vildagliptin + metformin HCl as separate tab Strength based on the dose of vildagliptin or metformin already being taken. Naïve patient Initially 50 mg/500 mg once daily & gradually titrated to a max dose of 50 mg/1,000 mg bid. Combination w/ sulfonylurea or w/ insulin Vildagliptin 50 mg bid & dose of metformin already being taken. Renal impairment w/ GFR 60-89 mL/min Max daily dose: Metformin 3,000 mg, vildagliptin 100 mg, 45-59 mL/min Metformin starting dose should not be >1,000 mg. Max daily dose: Metformin 2,000 mg, vildagliptin 50 mg, 30-44 mL/min Metformin starting dose should not be >500 mg. Max daily dose: 1,000 mg.

Should be taken with food: Take w/ or immediately after meals to reduce GI discomfort.

Hypersensitivity. CHF, acute or chronic metabolic acidosis including lactic acidosis or diabetic ketoacidosis w/ or w/o coma. Severe renal impairment (<30 mL/min).

Not a substitute for insulin in patients requiring insulin; including pre-treatment ALT or AST >2.5x ULN. Not to be used in patients w/ type 1 diabetes or for diabetic ketoacidosis. Discontinue use if jaundice, other signs suggestive of liver dysfunction develop or AST/ALT of >/3x ULN persist. Not recommended in patients w/ NYHA functional class IV; hepatic impairment including patients w/ pre-treatment ALT or AST >2.5x ULN. Perform LFTs prior to initiation of treatment, & 3 mth interval during the 1st yr & periodically thereafter. Pregnancy. Should not be used during lactation. Elderly. Not recommended in childn <18 yr. Metformin: Lactic acidosis. Monitor GFR before treatment initiation & regularly thereafter. Intravascular administration of iodinated contrast agents; discontinue prior to or at the time of imaging procedures & not restart until 48 hr subsequent to the procedure & reinstitute only after renal function has been re-evaluated & stable. Hypoxic states. Discontinue at the time of surgery under general, spinal or epidural anesth & restart no earlier than 48 hr following surgery or until patient's oral nutrition has resumed & renal function is stable. Medicinal products that can acutely impair renal function (eg, antihypertensive, diuretics & NSAIDs). Excessive alcohol intake. Hypoglycemia. Loss of control of blood glucose due to exposure to stress (eg, fever, trauma, infection, surgery).

Angioedema, hepatic dysfunction (including hepatitis); diarrhea, nausea; tremor, dizziness, headache; constipation, peripheral edema; decreased appetite, lactic acidosis, dysgeusia, flatulence, vomiting, abdominal pain, skin reactions eg, erythema, pruritus, urticaria, decreased vit B₁₂ absorption; bullous & exfoliative skin lesions including bullous pemphigoid, pancreatitis, arthralgia.

Metformin: Furosemide, nifedipine, glyburide, iodinated contrast agents. Drugs that interfere w/ common renal tubular transport systems involved in the renal elimination eg, OCT2/MATE inhibitors (eg, ranolazine, vandetanib, dolutegravir, cimetidine), drugs that can adversely affect renal function which may increase the risk of lactic acidosis (eg, NSAIDs including selective COX-II inhibitors, ACE inhibitors, angiotensin receptor blockers, diuretics especially loop diuretics, drugs that may lead to loss of glycemic control (eg, thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OC, phenytoin, nicotinic acid, sympathomimetics, Ca channel blockers & INH. Increased risk of lactic acidosis in acute alcohol intoxication.

Antidiabetic Agents

A10BD08 - metformin and vildagliptin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.

Rx