Glumet/Glumet-XR

Adjunct to diet & exercise to improve glycemic control in type 2 DM. Monotherapy or in combination w/ other oral antidiabetic agents or w/ insulin.

Glumet tab Adult ≥17 yr Initially 500 mg bid. May be increased in increments of 500 mg wkly. Max: 2,000 mg daily in divided doses. Childn 10-16 yr 500 mg bid. May be increased by 500 mg wkly. Max: 2,000 mg daily in divided doses. Doses >2,000 mg should be given in 3 divided doses. Concomitant use w/ insulin Initially 500 mg once daily. May be increased by 500 mg after approx 1 wk & by 500 mg every wk thereafter until adequate glycemic control is achieved. Max: 2,500 mg daily. Glumet 850-mg tab Adult ≥17 yr Initially 500 bid or 850 once daily. May be increased in increments of 500 mg wkly or 850 mg every 2 wk up to 2,000 mg/day in divided doses. Can also be titrated from 500 mg bid to 850 mg bid after 2 wk. Max daily dose: 2,550 mg in divided doses. Doses >2,000 mg may be better tolerated if given in 3 divided doses. Childn 10-16 yr Initially 500 mg bid or 850 mg once daily. May be increased by 500 mg wkly. Max daily dose: 2,000 mg in divided doses. Concomitant use w/ insulin Initially 500 mg or 850 mg once daily. May be increased by 500 mg after approx 1 wk & by 500 mg every wk thereafter until adequate glycemic control is achieved. Max daily dose: 2,550 mg. Reduce insulin dose by 10-25% when fasting plasma glucose conc decrease <120 mg/dL. Glumet-XR Adult ≥17 yr Initially 500 mg once daily. May be increased in increments of 500 mg wkly. Max: 2,000 mg once daily. If glycemic control w/ 2,000 mg once daily remains unsatisfactory, 1,000 mg bid may be considered. Patient w/ moderate renal impairment: eGFR 45-<60 mL/min/1.73 m² Initially 500 mg once daily, up to max dose of 1,000 mg daily in 2 divided doses, 30-45 mL/min/1.73 m² Initiation of therapy: Use not recommended. Continuation of existing therapy: May continue at a reduced dose, up to max dose of 1,000 mg daily in 2 divided doses. Concomitant use w/ insulin Initially 500 mg once daily. May be increased by 500 mg after approx 1 wk & by 500 mg every wk thereafter until adequate glycemic control is achieved. Max: 2,000 mg daily (for 1 g PR tab) or 2,500 mg daily (for 500 mg XR tab).

Should be taken with food: Glumet-XR PR tab Swallow whole, do not chew/crush.

Hypersensitivity. Unstable &/or type 1 (insulin-dependent) DM. History of lactic acidosis irrespective of precipitating factors. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, w/ or w/o coma. Acute conditions w/ potential to alter renal function eg, dehydration due to persistent or severe diarrhea, recurrent vomiting; severe infection; diagnostic exam (eg, IV urography, angiography) that involve use of iodinated contrast agents/media. Cardiac or resp failure, recent MI, shock. Acute or chronic alcoholism. Severe renal impairment (eGFR <30 mL/min/1.73 m²). Severe liver disease. Pregnancy & lactation.

Lactic acidosis. Not to be used in patients w/ CHF receiving digoxin & furosemide. Monitor renal function. Discontinue use at the time of, or prior to, an iodinated contrast imaging procedure. Reevaluate eGFR 48 hr after the imaging procedure & restart if renal function is stable. Discontinue use when hypoxic states occur. Temporarily discontinue in patients undergoing surgery w/ restricted food or fluid intake; in periods of stress eg, fever, trauma, infection, or surgery. Avoid excessive alcohol intake. Evaluate hematologic parameters prior to initiation of therapy & at least annually. Hypoglycemia may occur especially in debilitated or malnourished patients, & those w/ adrenal or pituitary insufficiency or alcohol intoxication. May affect ability to drive & use machines. Not recommended in patients w/ eGFR 30-45 mL/min/1.73 m². Avoid in patients w/ clinical or lab evidence of hepatic disease. Elderly. Glumet-XR XR tab/Glumet-XR PR tab Childn. Glumet-XR PR tab Perform periodic measurements of serum vit B₁₂ levels on long-term treatment particularly in patients w/ anemia or neuropathy. Regularly monitor TSH levels in patients w/ hypothyroidism.

Nausea, vomiting, diarrhea, abdominal pain & loss of appetite. Decrease in serum vit B₁₂, megaloblastic anemia (rare); hyperglycemia, hypoglycemia, lactic acidosis, decreased wt; agitation, dizziness, headache, lightheadedness; chest discomfort, palpitations; flushing, HTN; dyspnea, flu syndrome, pneumonitis w/ vasculitis, rhinitis, upper resp infection; abdominal discomfort & distention, abnormal stools/loose stools, anorexia; constipation, dry mouth, dyspepsia/heartburn, epigastric discomfort, flatulence, gastric disorder & ulcer, GI disorder, indigestion, taste disturbance specifically metallic taste in the mouth; abnormal LFT, autoimmune hepatitis, cholestasis, hepatic injury, hepatitis; erythema, nail disorder, pruritus, rash, skin lesion, urticaria; asthenia, chills, musculoskeletal pain, myalgia; UTI; fatigue, increased sweating. Glumet-XR PR tab Hemolytic anemia (rare); hypomagnesemia; encephalopathy, peripheral neuropathy; cholestatic, hepatocellular, & mixed hepatocellular liver injury, pancreatitis; dermatitis, photosensitivity; increased blood lactic acid, decreased thyrotropin level.

May increase in peak plasma & whole blood conc, & whole blood AUC w/ cationic drugs eg, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim & vancomycin; furosemide. Reduced urinary excretion & increased plasma conc w/ cimetidine. Hypoglycemia may occur w/ other antidiabetic agents eg, sulfonylureas, meglitinides, glitazones, or insulin. May exacerbate DM & result in increased requirements of oral antidiabetic agents w/ thiazide diuretics. Increased absorption, C_max & AUC, & excretion in urine w/ nifedipine. May impair glucose tolerance & mask true frequency or severity of hypoglycemia w/ β-adrenergic blocking agents (eg, propranolol, nadolol). May reduce fasting blood glucose conc w/ ACE inhibitors (eg, captopril, enalapril). Increased risk of hypoglycemia & lactic acidosis w/ alcohol. Increased ovulatory response w/ clomifene in premenopausal patients w/ PCOS. May affect pharmacokinetic properties of coumarin anticoagulants. May lead to renal failure w/ iodinated contrast media. May cause hyperglycemia & exacerbate loss of glycemic control include other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OCs, phenytoin, nicotinic acid, sympathomimetics, Ca channel blocking drugs & INH. Glumet-XR PR tab May increase risk of lactic acidosis w/ carbonic anhydrase inhibitors eg, topiramate, zonisamide, acetazolamide or dichlorphenamide; NSAIDs, selective COX II inhibitors, ACE inhibitors, AIIA & diuretics. Systemic exposure & risk of lactic acidosis may be increased w/ OCT2/MATE inhibitors. 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/ inhibitors of both OCT1 & OCT2 eg, crizotinib, olaparib. Hypoglycemic effect may be reduced w/ levothyroxine.

Antidiabetic Agents

A10BA02 - metformin ; Belongs to the class of biguanides. Used in the treatment of diabetes.

Rx