Amaryl M SR

Glimepiride 2 mg, metformin HCl 500 mg

Adjunct to diet & exercise in type 2 DM in case the monotherapy w/ glimepiride or metformin does not result in adequate glycemic control. Replacement of combination therapy of glimepiride & metformin.

Individualized dosage. Initially 1 tab once daily up to max glimepiride 8 mg & metformin 2,000 mg. Renal impairment Max daily dose: GFR 30-44 mL/min Metformin 1,000 mg, glimepiride 8 mg, 45-59 mL/min Metformin 2,000 mg, glimepiride 8 mg, 60-89 mL/min Metformin 3,000 mg, glimepiride 8 mg.

Should be taken with food: Take immediately before or during breakfast, or the 1st main meal of the day. Swallow whole, do not chew/crush.

Hypersensitivity. Acute metabolic acidosis eg, lactic acidosis, diabetic ketoacidosis & precoma; acute conditions w/ potential in altering renal function (eg, dehydration, severe infection, shock, intravascular administration of iodinated contrast agents); acute or chronic disease causing tissue hypoxia eg, cardiac/resp failure, recent MI, shock. Hepatic insufficiency, acute alcohol intoxication, alcoholism. Severe renal failure (GFR <30 mL/min). Lactation.

Continue the diet of all patients w/ regular distribution of carbohydrate intake during the day. Continue energy-restricted diet in overwt patients. Regularly perform usual lab tests for diabetes monitoring. Combination w/ insulin or sulfonylureas. Not to be used in women planning to become pregnant & during pregnancy. Discontinue lactation or treatment. Glimepiride: Adjust dose or entire therapy if risk factors for hypoglycemia are present eg, unwillingness or (more commonly in older patients) incapacity of patient to cooperate; undernourishment, irregular mealtimes or skipped meals; imbalance between physical exertion & carbohydrate intake; diet alterations; alcohol consumption, especially in combination w/ skipped meals; impaired renal function; severe impairment of liver function; overdosage; certain uncompensated disorders of endocrine system affecting carbohydrate metabolism or counterregulation of hypoglycaemia (as in certain disorders of thyroid function & anterior pituitary or corticoadrenal insufficiency); concurrent administration of certain other medicines; treatment w/ glimepiride in absence of any indication. Consider non-sulfonylurea alternative in patients w/ G6PD-deficiency. Metformin: Temporarily discontinue use in case of dehydration (severe diarrhoea or vomiting, fever, or reduced fluid intake); in presence of conditions altering renal function. Discontinue use in case of suspected symptoms of lactic acidosis; prior to, or at time of imaging procedure & not restarted until 48 hr after renal function has been re-evaluated & stable; at the time of surgery under general, spinal, or epidural anesth. Assess GFR before treatment initiation & regularly thereafter. Regularly monitor TSH levels in patients w/ hypothyroidism. Monitor vit B₁₂ level. Medicinal products that can acutely impair renal function (eg, antihypertensives, diuretics & NSAIDs). Decreased renal function in elderly when initiating antihypertensive or diuretic therapy & starting therapy w/ NSAID.

Nausea, vomiting, diarrhoea, abdominal pain, loss of appetite. Glimepiride: Hypoglycaemia, sweating, clammy skin, anxiety, tachycardia, HTN, palpitations, angina pectoris, cardiac arrhythmias; temporary visual impairment; changes in blood picture; allergic or pseudoallergic reactions. Metformin: Metallic taste.

Glimepiride: Potentiated blood-glucose lowering effect w/ insulin & other, oral antidiabetics; ACE inhibitors; anabolic steroids & male sex hormones; chloramphenicol; coumarin derivatives; cyclophosphamide; disopyramide; fenfluramine; fenyramidol; fibrates; fluoxetine; guanethidine; ifosfamide; MAOIs; miconazole; fluconazole; p-aminosalicylic acid; pentoxifylline (high dose parenteral); phenylbutazone; azapropazone; oxyphenbutazone; probenecid; quinolones; salicylates; sulfinpyrazone; clarithromycin; sulfonamide antibiotics; tetracyclines; tritoqualine; trofosfamide. Weakened blood-glucose lowering effect w/ acetazolamide; barbiturates; corticosteroids; diazoxide; diuretics; epinephrine (adrenaline) & other sympathomimetic agents; glucagon; laxatives (after protracted use); nicotinic acid (in high doses); oestrogens & progestogens; phenothiazines; phenytoin; rifampicin; thyroid hormones. Either potentiated or weakened blood-glucose-lowering effect w/ H₂-receptor antagonists, β-blockers, clonidine & reserpine; both acute & chronic alcohol intake. Potentiated or weakened effect of coumarin derivatives. Reduced absorption from GI tract w/ colesevelam. Metformin: Avoid consumption of alcohol & alcohol-containing medications. Iodinated contrast agents. Combination of NSAIDs including selective COX II inhibitors, ACE inhibitors, angiotensin II receptor antagonists & diuretics, especially loop diuretics; glucocorticoids (systemic & local routes), β₂-agonists (salbutamol, formoterol, & diuretics). Decreased anticoagulant effect of phenprocoumon. Reduced hypoglycemic effect w/ levothyroxine. Reduced efficacy w/ organic cation transporters (OCT) 1 inhibitors eg, verapamil. Increased GI absorption & efficacy w/ OCT 1 inhibitors eg, rifampicin. Increased plasma conc w/ OCT 2 inhibitors eg, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole. Altered efficacy & renal elimination w/ OCT 1 & 2 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.

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