Galvusmet

Type 2 DM in adults ≥18 yr as an adjunct to diet & exercise to improve glycemic control: Initial therapy when diabetes is not adequately controlled by diet & exercise alone; in patients inadequately controlled w/ metformin HCl or vildagliptin alone or who are already treated w/ the combination of vildagliptin & metformin HCl, as separate tab; as combination therapy w/ other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycemic control.

Patient inadequately controlled w/ vildagliptin monotherapy Initially 50 mg/500 mg bid & gradually titrated after assessing the adequacy of therapeutic response. Patient inadequately controlled w/ metformin HCl monotherapy Initiate at either 50 mg/500 mg or 50 mg/850 mg or 50 mg/1,000 mg bid (based on current dose of metformin HCl). Patient switching from combination therapy of vildagliptin + metformin HCl as separate tab Initiate at either 50 mg/500 mg or 50 mg/850 mg or 50 mg/1,000 mg (based on vildagliptin or metformin already being taken). Naïve patient Initially 50 mg/500 mg once daily, titrated gradually to a max of 50 mg/1,000 mg bid after assessing therapeutic response adequacy. In combination w/ sulfonylurea or insulin Should provide vildagliptin 50 mg bid (100 mg total daily dose) & a dose of metformin similar to the dose already being taken. Do not exceed max daily dose of 100 mg of vildagliptin. Patient w/ renal impairment Metformin max daily dose should be divided into 2-3 daily doses, GFR 60-89 mL/min Metformin max: 3,000 mg daily. Vildagliptin max: 100 mg daily, 45-59 mL/min Metformin starting dose should not be >1,000 mg w/ max 2,000 mg daily. Vildagliptin max: 50 mg daily, 30-44 mL/min Metformin starting dose should not be >500 mg w/ max 1,000 mg daily. Vildagliptin max: 50 mg daily.

Should be taken with food: Administer w/ meals to reduce GI side effects.

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

Not a substitute for insulin. Should not be used in patients w/ type 1 diabetes or for treatment of diabetic ketoacidosis. Risk of hypoglycemia especially in deficient caloric intake, strenuous exercise not compensated by caloric supplementation, ethanol use. W/hold treatment & temporarily administer insulin in case of loss of blood glucose control. Should not be used during pregnancy unless potential benefit justifies potential risk to fetus. Should not be administered to breast-feeding women. Not recommended for use in childn <18 yr. Ensure careful dose titration in elderly ≥65 yr to establish min dose for adequate glycemic effect & regularly monitor renal function. Vildagliptin: Not recommended in patients w/ hepatic impairment, including patients w/ pre-treatment ALT or AST >2.5 times ULN. Perform LFTs prior to treatment initiation & monitor at 3-mth interval during 1st yr then periodically thereafter. W/draw therapy if increase in AST or ALT ≥3 times ULN persist. Discontinue in patients who develop jaundice or other signs suggestive of liver dysfunction. Limited clinical experience & inconclusive results in patients w/ NYHA functional class III. Not recommended in patients w/ NYHA functional class IV. Metformin: Risk of lactic acidosis. Discontinue in case of dehydration (eg, due to severe diarrhea or vomiting, fever or reduced fluid intake); suspected metabolic acidosis; CV collapse (shock), acute CHF, acute MI & other conditions characterized by hypoxemia. Assess GFR prior treatment initiation & regularly thereafter; temporarily discontinue in the presence of conditions that alter renal function. Caution w/ concomitant medications that may affect renal function, result in significant hemodynamic change or inhibit renal transport & increase metformin systemic exposure. Contrast-induced nephropathy w/ intravascular administration of iodinated contrast agents may lead to metformin accumulation & increased risk of lactic acidosis. Discontinue use prior to or at the time of imaging procedure & do not restart until 48 hr after the procedure; reinstate only after renal function is stable. Discontinue use at the time of surgery under general, spinal or epidural anaesth (except minor procedures not associated w/ restricted food & fluid intake); treatment may be restarted no earlier than 48 hr following surgery or until patient's oral nutrition has resumed & renal function is stable. Associated w/ decreased vit B₁₂ serum levels. Avoid excessive alcohol intake. Promptly evaluate for ketoacidosis &/or lactic acidosis in case of change in clinical status of patients w/ previously controlled type 2 diabetes.

Tremor, dizziness, headache. Vildagliptin + insulin (w/ or w/o metformin): Headache; nausea, GERD; chills; decreased blood glucose. Vildagliptin + metformin + sulfonylurea: Dizziness, tremor; asthenia; hypoglycemia; hyperhidrosis. Vildagliptin: Dizziness. Metformin: Decreased appetite; flatulence, nausea, vomiting, diarrhea, abdominal pain. Dysgeusia.

Metformin: Decreased C_max & blood AUC of furosemide. Increased C_max & blood AUC of metformin w/ furosemide. Increased absorption, C_max, AUC & excretion in urine w/ nifedipine. Increased systemic exposure w/ drugs that interfere w/ common renal tubular transport systems (eg, organic cationic transporter-2 [OCT2]/multidrug & toxin extrusion [MATE] inhibitors eg, ranolazine, vandetanib, dolutegravir, & cimetidine). Risk of loss of glycemic control w/ thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OCs, phenytoin, nicotinic acid, sympathomimetics, Ca channel blocking drugs, INH. Increased risk of lactic acidosis in acute alcohol intoxication; concomitant use of drugs which adversely affects renal function eg, NSAIDs, COX-2 inhibitors, ACE inhibitors, AIIA & diuretics (loop diuretics).

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