Forbetes Plus 500/5

2nd-line therapy when diet, exercise, & initial treatment w/ a sulfonylurea or metformin do not result in adequate glycemic control in patients w/ type 2 diabetes w/ HbA1c >8%.

Recommended starting dose: 500 mg/5 mg twice daily, up to a max daily dose of 2,000 mg metformin/20 mg glibenclamide.

Should be taken with food.

Hypersensitivity to metformin HCl, glibenclamide or other sulfonylureas & sulfonamides. Diabetic pre-coma. Metabolic acidosis (eg, lactic acidosis, diabetic ketoacidosis). Conditions causing tissue hypoxia (eg, decompensated HF, resp failure, recent MI, shock). Acute alcohol intoxication, alcoholism. Porphyria. Concomitant use w/ miconazole. Renal disease/dysfunction. Hepatic insufficiency. Lactation.

Risk of lactic acidosis which may occur at acute worsening of renal function, cardioresp illness, or sepsis; CV collapse (shock), acute CHF & MI & other conditions characterized by hypoxemia; discontinue use if symptoms occur. Temporarily discontinue in case of dehydration; prior to any intravascular radio-contrast study & surgical procedure. Avoid use in patients w/ hepatic disease. Evaluate serum electrolytes, ketones, blood glucose, pH, lactate, pyruvate & metformin levels of type 2 diabetes patients on metformin who develop lab abnormalities or clinical illness for ketoacidosis or lactic acidosis; discontinue if acidosis occurs & initiate corrective measures. Risk of hypoglycemia in elderly, debilitated, malnourished patients & those w/ adrenal or pituitary insufficiency or alcohol intoxication. Assess renal function prior to therapy & at least annually. Concomitant medications that may affect renal function or result in significant hemodynamic change or may interfere w/ the disposition of metformin (eg, cationic drugs). Excessive alcohol intake; individuals w/ inadequate vit B12 or Ca intake or absorption. Caution in patients w/ G6PD-deficiency; not recommended in patients w/ rare hereditary problems of galactose-intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Impaired hepatic function. Not to be used during pregnancy. Lactation. Ped. Elderly ≥80 yr.

GI disorders eg, nausea, vomiting, diarrhoea, abdominal pain & loss of appetite. Taste disturbance.

Glibenclamide: Increased hypoglycaemic effect w/ miconazole. Masked hypoglycaemic symptoms w/ β-blockers. Decreased blood glucose levels w/ ACE inhbitors (eg, captopril, enalapril). Increased t_1/2 of sulfonylurea w/ possible onset of hypoglycaemia w/ fluconazole. Increased risk of hypoglycaemic effect & liver enzyme elevations w/ bosentan. Reduced hypoglycaemic effect w/ bile acid sequestrants. Metformin: Increased risk of lactic acidosis w/ alcohol; NSAIDs, selective COX-II inhibitors, ACE inhibitors, AIIA, diuretics (especially loop diuretics). Reduced efficacy w/ OCT1 inhibitors (eg, verapamil). Increased GI absorption & efficacy w/ OCT1 inducers (eg, rifampicin). Increased plasma conc w/ OCT2 inhibitors (eg, cimetidine, dolutegravir, ranolazine, trimethoprim, daclatasvir, vandetanib, isavuconazole). May alter efficacy & renal elimination w/ OCT1 & OCT2 inhibitors (eg, crizotinib, olaparib). Concomitant use w/ iodinated contrast agents. Sulfonylurea: Increased hypoglycaemic reaction w/ alcohol. All antidiabetic agents: Concomitant use w/ danazol. Elevated blood glucose w/ high dose chlorpromazine; corticosteroids (glucocorticoids & tetracosactides); β-agonists. May produce hyperglycaemia w/ thiazides, other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OCs, phenytoin, nicotinic acid, sympathomimetics, Ca-channel blockers, INH. May potentiate hypoglycaemic action of sulfonylurea by NSAIDs & other protein-bound drugs, salicylates, sulfonamides, chloramphenicol, probenecid, coumarins, MAOI, β-adrenergic blocking agents, ciprofloxacin.

Antidiabetic Agents

A10BD02 - metformin and sulfonylureas ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.

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