Glyzeric

Per 500 mg/80 mg FC tab Metformin HCl 500 mg, gliclazide 80 mg. Per 850 mg/80 mg FC tab Metformin HCl 850 mg, gliclazide 80 mg

Adjunct to diet & exercise to improve glycemic control in patients w/ type 2 DM who are already treated w/ gliclazide & metformin or whose diabetes is not adequately controlled w/ metformin alone, or for patients who have initially responded to gliclazide alone & require additional glycemic control.

1 tab bid.

Should be taken with food.

Hypersensitivity to gliclazide, metformin, other sulfonylureas & sulfonamides. Type 1 diabetes. Diabetic pre-coma, coma & ketoacidosis. Acute conditions w/ potential to alter renal function eg, dehydration, severe infection, shock. Disease which may cause tissue hypoxia (especially acute disease or worsening of chronic disease) eg, decompensated heart & resp failure, recent MI, shock. Avoid use in porphyria. Concomitant use w/ miconazole. Severe renal insufficiency. Hepatic insufficiency, acute alcohol intoxication, alcoholism. Lactation.

Ensure regular food intake, exercise & monitoring blood glucose levels during treatment. Gliclazide: Increased risk of hypoglycemia if meal is taken late, inadequate amount of food is consumed or food is low in carbohydrate; low-calorie diets, following prolonged or strenuous exercise, alcohol intake or in combination w/ hypoglycemic agents; w/ risk factors eg, patient refuses or (particularly in the elderly) is unable to cooperate, malnutrition, irregular mealtimes, skipping meals, periods of fasting or dietary change, imbalance between physical exercise & carbohydrate intake, renal insufficiency, overdose, severe hepatic insufficiency, endocrine & thyroid disorders, hypopituitarism & adrenal insufficiency, concomitant administration of certain other medicines. Blood glucose control may be affected by fever, trauma, infection or surgical intervention. Attenuated hypoglycaemic efficacy over time that may be due to progression in severity of diabetes or reduced response to treatment. Dysglycaemia. Patients w/ G6PD deficiency. Regularly monitor blood glucose levels. Measure glycated Hb levels (or fasting venous plasma glucose). Concomitant use w/ fluoroquinolones especially in the elderly. Patient's conc may be affected if diabetes is not satisfactorily controlled especially at beginning of treatment which may then affect ability to drive & use machines. Avoid use during pregnancy. Metformin: Discontinue use in case of dehydration (severe diarrhoea or vomiting, fever or reduced fluid intake); suspected symptoms of lactic acidosis; presence of conditions altering renal function. Contraindicated in patients w/ GFR <30 mL/min; acute & unstable heart failure. Increased risk of lactic acidosis due to accumulation. Risk factors for lactic acidosis eg, excessive alcohol intake, hepatic insufficiency, inadequately controlled diabetes, ketosis, prolonged fasting & any conditions associated w/ hypoxia, concomitant use of medicinal products that may cause lactic acidosis. Patients w/ heart failure. Concomitant use w/ medicinal products that can acutely impair renal function eg, antihypertensives, diuretics & NSAIDs. Discontinue use prior to or at time of the imaging procedure or surgery under general, spinal or epidural anaesth & should not be restarted until at least 48 hr after. Assess GFR prior to treatment initiation & regularly thereafter. Risk of hypoglycemia in combination w/ other antidiabetic agents (eg, sulfonylureas, insulin or meglitinides) which may affect ability to drive & use machines. Pregnancy.

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

Gliclazide: Increased hypoglycaemic effect w/ systemic oromucosal miconazole gel; systemic phenylbutazone. Hypoglycaemic effect may be enhanced w/ sulfonamides; allopurinol, sulfinpyrazone & probenecid; chloramphenicol; fluconazole; ACE inhibitors eg, captopril & enalapril; testosterone & anabolic steroids. Increased hypoglycaemic reaction w/ alcohol. Potentiated blood glucose-lowering effect & thus in some instances hypoglycaemia may occur w/ other antidiabetic agents (insulins, acarbose, metformin, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, GLP-1 receptor agonists), β-blockers, fluconazole, ACE inhibitors (captopril, enalapril), H₂-receptor antagonists, MAOIs, sulfonamides, clarithromycin & NSAIDs. Hypoglycaemic effects may be reduced & hypoglycaemia symptoms be masked w/ β-blockers. Possible increased hypoglycaemia w/ quinine & quinidine. Glucose tolerance may be improved & may have an additive effect w/ clofibrates. May cause hypo- or hyperglycaemia w/ octreotide. Diabetogenic effect of danazol. Increased blood glucose levels w/ chlorpromazine (>100 mg daily); systemic & local (IA, cutaneous & rectal prep) glucocorticoids & tetracosactrin; IV ritodrine, salbutamol, terbutaline; INH. Decreased exposure w/ St. John's wort. Hyperglycaemia may be induced w/ crisantaspase. Adjust dose in concomitant use w/ INH. Hypoglycaemic effect may be reduced w/ rifamycins; diazoxide; chlorpromazine in daily doses of ≥100 mg; loop & thiazide diuretics; oestrogens, progesterones, OCs & corticosteroids; thyroid hormones. Glucose tolerance may be occasionally impaired w/ lithium. May potentiate anticoagulation w/ anticoagulant therapy (warfarin). Metformin: Increased risk of lactic acidosis w/ alcohol intoxication. Discontinue use prior to or at time of imaging procedure w/ iodinated contrast agents & not restarted until at least 48 hr after. May increase risk of lactic acidosis w/ medicinal products that can adversely affect renal function eg, NSAIDs including selective COX II inhibitors, ACE inhibitors, AIIAs & diuretics especially loop diuretics. Concomitant use w/ medicinal products w/ intrinsic hyperglycaemic activity eg, glucocorticoids (systemic & local) & sympathomimetics. Efficacy may be reduced w/ OCT1 inhibitors eg, verapamil. GI absorption & efficacy may be increased w/ OCT1 inducers eg, rifampicin. Renal elimination may be decreased & thus lead to increased plasma conc w/ OCT2 inhibitors eg, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole. Efficacy & renal elimination may be altered w/ OCT1 & OCT2 inhibitors eg, crizotinib, olaparib.

Antidiabetic Agents

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

Rx