Diabemin XR

Metformin HCl

As monotherapy or in combination w/ other oral antidiabetic agents, or w/ insulin for type 2 DM in adults, particularly overwt patients, when diet & exercise alone is inadequate. As 1st-line therapy for intensive glucose control after diet failure in overwt type 2 diabetic patients. Impaired glucose tolerance for patients in whom lifestyle interventions (diet & exercise) have failed.

Adult Initially 500 mg once daily in the evening. Adjust on basis of blood glucose measurements after 10-15 days. Max: 2 g once daily in the evening. If glycemic control is not achieved on maximal daily dose given once daily, consider the same dose but divided along the day ie, 1 g during breakfast & 1 g during evening meal. Combination w/ insulin Initially 500 mg, while insulin dosage is adjusted on basis of blood glucose measurements.

Should be taken with food: Swallow whole. Do not crush or chew.

Hypersensitivity. Diabetic coma & ketoacidosis; renal dysfunction; chronic hepatic disease, cardiac failure, ischemic heart disease (eg, acute MI), alcoholism, history of or states associated w/ lactic acidosis eg, shock or pulmonary insufficiency, & conditions associated w/ hypoxia. Not recommended in pregnancy & lactation.

Lactic acidosis. Assess associated risk factors eg, poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, hepatic insufficiency & any condition associated w/ hypoxia for lactic acidosis incidence reduction. Discontinue & hospitalize patient immediately if metabolic acidosis is suspected. Determine serum creatinine levels or CrCl before initiating treatment & regularly thereafter; at least annually in patients w/ normal renal function; & at least 2-4 times a yr in patients w/ creatinine at the LLN & in elderly. Situations where renal function may become impaired, eg, elderly when initiating antihypertensive therapy or diuretic therapy & when starting therapy w/ NSAID. Discontinue for 48 hr prior to or at the time of intravascular administration of iodinated contrast materials in radiologic studies eg, IV urography or angiography, & do not reinstitute until 48 hr afterwards, & only after renal function has been reevaluated & found to be normal. Discontinue for 48 hr before elective major surgery. Not to be reinstituted until 48 hr after surgery & only after ensuring that kidney function is normal. Not advised in conditions which may cause dehydration or in patients suffering from serious infections or trauma. Evaluate serum B₁₂ levels annually in long-term therapy. Combination w/ sulfonylurea & insulin. Continue following any dietary advice including some energy-restricted diet for overwt patients. Avoid consumption of alcoholic beverages. Perform usual lab tests for diabetes monitoring regularly. Do not drive or use machines when symptoms of hypoglycemia occurs. Not recommended in childn. Elderly.

GI discomfort eg, nausea, vomiting, diarrhea, abdominal pain & loss of appetite (especially at the beginning of treatment). Taste disturbance.

Increased risk of lactic acidosis in acute alcohol intoxication, particularly in case of fasting or malnutrition & hepatic insufficiency. Intrinsic hyperglycemic activity w/ glucocorticoids (systemic & local routes) & tetracosactides, β2-agonists (eg, salbutamol, terbutaline), danazol, chlorpromazine at high dosage (100 mg/day) & diuretics. Increased risk of lactic acidosis w/ diuretics especially loop diuretics. May decrease blood glucose levels w/ ACE inhibitors. Intravascular administration of iodinated contrast agents may lead to renal failure, resulting in metformin accumulation & risk of lactic acidosis. Decreased renal clearance w/ cimetidine. NSAIDs, anticoagulants.

Antidiabetic Agents

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

Rx