Neoform 500

Metformin HCl

Type 2 DM in adults, as monotherapy or in combination w/ other oral antidiabetic agents, or w/ insulin. As 1st line therapy for intensive glucose control in overwt type 2 diabetic patients. Impaired glucose tolerance for patients in whom lifestyle interventions (diet & exercise) have failed. Type 2 DM in childn & adolescents ≥10 yr.

Adult Monotherapy & in combination w/ other oral antidiabetic agents Initially 500 mg bid-tid. May be slowly increased by increment of 500 mg after 10-15 days depending on blood glucose measurements. Max: 3 g daily in 3 divided doses. In combination w/ insulin Initially 500 mg bid-tid, while insulin dosage is adjusted on basis of blood glucose measurements. Childn & adolescent ≥10 yr Monotherapy & combination w/ insulin Initially 500 mg bid. May be slowly increased by increment of 500 mg after 10-15 days depending on the basis of blood glucose measurements. Max: 2 g daily in 2-3 divided doses.

Should be taken with food: Take w/ or after meals.

Hypersensitivity. Diabetic coma or ketoacidosis, renal insufficiency, acute or chronic disease which may cause tissue hypoxia (eg, cardiac failure, MI, resp insufficiency, shock), impaired liver function & acute alcohol intoxication.

Lactic acidosis; primarily in diabetic patients w/ significant renal failure. 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. Determine 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/ CrCl at the LLN & in elderly. Discontinue for 48 hr before elective major surgery. May restart no earlier than 48 hr following surgery or resumption of oral nutrition & only if normal renal function has been established. Avoid consumption of alcoholic beverages. Patients w/ any other treatment being received & any infectious diseases eg, flu, resp tract infection or UTI. Continue diet w/ regular distribution of carbohydrate intake during the day for all patients; & energy restricted diet for overwt patients. Perform usual lab tests for diabetes monitoring regularly. Hypoglycemia. Concomitant use w/ insulin or other oral antidiabetics (eg, sulfonylureas or meglitinides). Pregnancy. Not recommended during breastfeeding. Confirm diagnosis of type 2 DM before initiating treatment in childn.

GI disorders eg, nausea, vomiting, diarrhea, abdominal pain & loss of appetite. Metallic taste & wt loss. Skin reaction eg, erythema, pruritus & urticaria. Lactic acidosis. Impaired absorption of various substances including vit B₁₂.

Increased risk of hypoglycemia w/ drugs that lower blood glucose conc. May reduce effect w/ drugs that increase blood glucose. May increase risk of lactic acidosis & hypoglycemia w/ alcohol. Concomitant use w/ drugs that may impair renal function.

Antidiabetic Agents

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

Rx