RiteMED Metformin HCl

RiteMED Metformin HCl

metformin

Manufacturer:

RiteMED

Distributor:

United Lab
Concise Prescribing Info
Contents
Metformin HCl
Indications/Uses
Adjunct to diet & exercise to improve glycemic control in patients w/ type 2 DM. As monotherapy or in combination w/ other oral antidiabetic agents or w/ insulin.
Dosage/Direction for Use
Tab Initially 500 mg every 12 hr, dose may be gradually increased to a max of 2,250 mg daily. SR tab Adult ≥17 yr 500 mg once daily, may increase in increments of 500 mg wkly up to a max of 2,000 mg once daily. If glycemic control w/ 2,000 mg once daily remains unsatisfactory, a dose of 1,000 mg bid may be considered. Max dose: 2,000 mg/day.
Administration
Should be taken with food: SR tab: Swallow whole, do not chew/crush.
Contraindications
Tab: Renal impairment, CHF requiring pharmacologic treatment, acute or chronic metabolic acidosis. SR tab: Hypersensitivity. Unstable &/or type 1 IDDM. History of lactic acidosis irrespective of precipitating factors. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, w/ or w/o coma; disease which may cause tissue hypoxia (eg, cardiac/resp failure, recent MI, shock); alcoholism. 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 involves the use of iodinated contrast agents/media. Severe renal impairment (eGFR <30mL/min/1.73 m2) or severe liver disease. Pregnancy & lactation.
Special Precautions
Tab: Elderly, hepatic & renal impairment. SR tab: Lactic acidosis in diabetic patients w/ significant renal failure. Do not use in patients w/ CHF receiving drugs eg, digoxin & furosemide. Not recommended to initiate therapy in patients w/ eGFR 30-45 mL/min/1.73 m2; discontinue if eGFR later falls <30 mL/min/1.73 m2. Discontinue at the time of, or prior to, an iodinated contrast imaging procedure in patients w/ eGFR 30-60 mL/min/1.73 m2, history of liver disease, alcoholism, or heart failure, or those administered w/ intraarterial iodinated contrast; re-evaluate eGFR 48 hr after the imaging procedure & restart treatment if renal function is stable. Promptly discontinue if hypoxic states occur during therapy. Hypoglycemia especially in elderly, debilitated or malnourished patients, & those w/ adrenal or pituitary insufficiency or alcohol intoxication. Temporary discontinuation during periods of stress (eg, fever, trauma, infection, or surgery) to maintain adequate glucose control. Avoid excessive alcohol intake on an acute or chronic basis. Frequently assess renal function in patients at increased risk of developing renal impairment. Evaluate hematologic parameters prior to initiation of therapy & at least annually. Concomitant use w/ medications that may affect renal function or result in significant hemodynamic change or interfere w/ the disposition (ie, cationic drugs). Avoid in patients w/ hepatic disease. May affect the ability to drive & use machine. Childn. Elderly.
Adverse Reactions
Tab: Anorexia, nausea, vomiting, diarrhea, lactic acidosis, decreased vit B12 absorption. SR tab: Decreased vit B12 serum; hyperglycemia, hypoglycemia (concomitant use w/ sulfonylureas &/or alcohol), lactic acidosis, decreased wt; agitation, dizziness, headache, lightheadedness; chest discomfort, palpitations; flushing, hypertension; dyspnea, flu syndrome, pneumonitis w/ vasculitis, rhinitis, upper resp infection; abdominal discomfort (eg, bloating, abdominal cramps), abdominal distention, abnormal stools/loose stools, anorexia, constipation, dry mouth, dyspepsia/heartburn, epigastric discomfort, flatulence, gastric disorder, gastric ulcer, GI disorder, indigestion, taste disturbance (metallic taste in the mouth); abnormal liver function tests, autoimmune hepatitis, cholestasis, hepatic injury, hepatitis; erythema, nail disorder, pruritus, rash, skin lesion, urticaria; asthenia, chills, musculoskeletal pain, myalgia; UTI; fatigue, increased sweating.
Drug Interactions
Tab: Alcohol, ACE inhibitors, cimetidine, ketotifen, linezolid, MAOIs. SR tab: Increased peak plasma/whole blood conc & whole blood AUC w/ cationic drugs (eg, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, & vancomycin). Reduced urinary excretion & increased plasma conc w/ cimetidine. Hypoglycemia w/ other antidiabetics (eg, sulfonylureas, meglitinides, glitazones, or insulin). May exacerbate DM w/ thiazide diuretics. May increase absorption, Cmax, AUC & excretion w/ nifedipine. May impair glucose tolerance, mask the true frequency or severity of hypoglycemia, block hypoglycemia-induced tachycardia (but not hypoglycemic sweating), delayed rate of recovery of blood glucose conc following drug-induced hypoglycemia, & impair peripheral circulation 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 (acute or chronic intake). May increase ovulatory response w/ clomifene in premenopausal w/ polycystic ovary syndrome. May affect the pharmacokinetic properties of coumarin anticoagulants. May lead to renal failure & risk of lactic acidosis w/ iodinated contrast media. Decreased Cmax & blood AUC of glyburide. Hyperglycemia & may exacerbate loss of glycemic control w/ thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OCs, phenytoin, nicotinic acid, sympathomimetics, Ca channel blocking drugs, & INH.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BA02 - metformin ; Belongs to the class of biguanides. Used in the treatment of diabetes.
Presentation/Packing
Form
RiteMED Metformin HCl SR tab 500 mg
Packing/Price
100's (P625/box)
Form
RiteMED Metformin HCl tab 500 mg
Packing/Price
100's (P3.25/tab, P325/box)
Form
RiteMED Metformin HCl tab 850 mg
Packing/Price
100's (P6/tab, P600/box)
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