Solosamet SR

Glimepiride 2 mg, metformin HCl 500 mg

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

Individualized dosage. Initiate the lowest effective dose & increase dose based on patient's blood glucose level. Titrate daily dose in increments of 1 tab only. Max: 8 mg glimepiride/2,000 mg metformin daily. Renal impairment GFR 60-89 mL/min Max: 3,000 mg, 45-59 mL/min Max: 2,000 mg, 30-44 mL/min Max: 1,000 mg.

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

Hypersensitivity to glimepiride, metformin, other sulfonylureas, other sulfonamides. Lactic acidosis, diabetic ketoacidosis, diabetic pre-coma; acute conditions w/ potential to alter renal function eg, dehydration, severe infection, shock, intravascular administration of iodinated contrast agent. Acute or chronic disease which may cause tissue hypoxia eg, cardiac or resp failure, recent MI. Acute alcohol intoxication, alcoholism. Any type of acute metabolic acidosis eg, lactic acidosis. Hepatic insufficiency; severe renal failure (GFR <30 mL/min). Pregnancy & lactation.

Glimepiride: Risk of hypoglycemia. Patients w/ G6PD deficiency. May deteriorate blood glucose in exceptional stress situations eg, trauma, surgery, febrile infections. Metformin: Caution in conditions where renal function may be impaired eg, initiating antihypertensive or diuretic therapy & when starting w/ an NSAID therapy. Administration of iodinated contrast agent; discontinue 48 hr before elective surgery w/ general, spinal, epidural anaesth or imaging procedure w/ intravascular administration of iodinated contrast agents & should not resume earlier than 48 hr afterwards. Regular monitoring of vit B₁₂ level & of TSH levels in patients w/ hypothyroidism. In combination w/ insulin or sulfonylureas. Discontinue in case of dehydration (severe diarrhea, vomiting, fever, or reduced fluid intake). May impair ability to drive & use machines. Impaired renal function. Pregnancy & lactation.

Hypoglycemia. GI symptoms eg, nausea, vomiting, abdominal pain, diarrhea. Glimepiride: Headache, ravenous hunger, lassitude, sleepiness, sleep disorder, restlessness, aggressiveness, impaired concentration, alertness & reactions, depression, confusion, speech disorders, aphasia, visual disorders, tremor, pareses, sensory disturbances, dizziness, helplessness, loss of self-control, delirium, cerebral convulsions, somnolence & loss of consciousness, coma, shallow resp & bradycardia. Temporary visual impairment; sensations of pressure or fullness in epigastrium; allergic or pseudoallergic reactions. Metformin: Loss of appetite; metallic taste; decrease of vit B₁₂ absorption w/ decrease of serum levels.

Glimepiride: May potentiate 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, para-aminosalicylic acid, pentoxifylline (high dose parenteral), phenylbutazone, azapropazone, oxyphenbutazone, probenecid, quinolones, salicylates, sulfinpyrazone, clarithromycin, sulfonamide antibiotics, tetracyclines, tritoqualine, trofosfamide. May reduce 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. May potentiate or reduce blood glucose-lowering effect w/ β-blockers, clonidine, reserpine & alcohol. May potentiate or weaken effect of coumarin derivatives. Metformin: Alcohol intoxication. Renal failure w/ intravascular administration of iodinated contrast agents. Caution use w/ glucocorticoids, β₂-agonists & diuretics for their intrinsic hyperglycaemic activity. Decreased blood glucose levels w/ ACE inhibitors. Decreased anticoagulant effect of phenprocoumon. Reduced hypoglycaemic effect w/ levothyroxine.

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