Reglus XR

Reglus XR

metformin

Manufacturer:

Landson
Concise Prescribing Info
Contents
Metformin HCl
Indications/Uses
Adjunct to diet & exercise to improve glycemic control in adults w/ type 2 DM.
Dosage/Direction for Use
Individualized dosage. Usual starting dose: 500 mg once daily. Max: 2,000 mg. Dose increase should be made in increments of 500 mg wkly.
Administration
Should be taken with food: Take w/ evening meal.
Contraindications
Hypersensitivity. Temporarily discontinue in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials. Acute or chronic metabolic acidosis including diabetic ketoacidosis w/ or w/o coma. Renal disease or dysfunction eg, serum creatinine level ≥1.5 mg/dL (male), ≥1.4 mg/dL (female) or abnormal CrCl which may also result from CV collapse (shock), acute MI & septicemia.
Special Precautions
Increased risk of lactic acidosis in patients w/ CHF requiring pharmacologic management. Excessive alcohol intake. Patients w/ serum creatinine level above ULN for their age should not receive metformin XR. Concomitant use w/ cationic drugs eliminated by renal tubular secretion. Temporarily discontinue at the time of or prior to radiologic studies involving use of intravascular iodinated contrast materials or any surgical procedure except minor procedures. Patient w/ previously well controlled type 2 DM who develop lab abnormalities or clinical illness should be evaluated promptly for evidence of ketoacidosis or lactic acidosis. Hypoglycemia can occur when caloric intake is deficient, strenuous exercise is not compensated by caloric supplementation, or during concomitant use w/ other glucose-lowering agents (eg, sulfonylureas & insulin) or ethanol. A temporary loss of glycemic control may occur during fever, trauma, infection, or surgery. Avoid in patients w/ clinical or lab evidence of hepatic disease. Monitor renal function before initiation of therapy & at least annually thereafter; regularly in elderly ≥80 yr. Not to be used during pregnancy unless clearly needed. Nursing mothers. Childn. Not to be initiated in patients ≥80 yr unless CrCl measurement demonstrates renal function is not reduced.
Adverse Reactions
Diarrhea, nausea/vomiting, abdominal pain, constipation, abdominal distension, dyspepsia/heartburn, flatulence, dizziness, headache, upper resp infection, taste disturbance.
Drug Interactions
Enhanced absorption w/ nifedipine. Cationic drugs. Hyperglycemia & may lead to loss of glycemic control w/ thiazide & 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
Reglus XR caplet 500 mg
Packing/Price
3 × 10's
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