METFORMIN-Najo 500 F.C. TABLET                     

Category: Blood Glucose Lowering Drug

INDICATIONS: As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes, may be used concomitantly with a sulfonylurea or insulin to improve glycemic control.

DOSAGE AND ADMINISTRATION: The maximum recommended daily dose of Metformin HCl is 2000 mg in patients. Metformin HCl should be started at a low dose, with gradual dose escalation, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient. The usual starting dose of Metformin HCl tablets is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly, up to a total of 2000 mg per day, given in divided doses. If patients have not responded to four weeks of the maximum dose of Metformin HCl monotherapy, consideration should be given to gradual addition of an oral sulfonylurea while continuing Metformin HCl at the maximum dose, even if prior primary or secondary failure to a sulfonylurea has occurred.

Mechanism of Action: Metformin HCl is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Unlike sulfonylureas, Metformin does not produce hypoglycemia in either patients with type 2 diabetes or normal subjects (except in special circumstances, see PRECAUTIONS) and does not cause hyperinsulinemia. With Metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may actually decrease.

CONTRAINDICATIONS:

1. Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥ 1.5 mg/dL [males], ≥ 1.4 mg/dL [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia.

2. Known hypersensitivity to Metformin HCl.

3. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.

WARNINGS: Lactic acidosis is a rare, but serious, metabolic complication, The reported incidence of lactic acidosis in patients receiving Metformin HCl is very low (approximately 0.03 cases/1000 patient-years, with approximately 0.015 fatal cases/1000 patient-years).

PRECAUTIONS:

Patients with serum creatinine levels above the upper limit of normal for their age should not receive Metformin HCl.

Intravascular contrast studies with iodinated materials can lead to acute alteration of renal function and have been associated with lactic acidosis in patients receiving Metformin HCl.

Cardiovascular collapse (shock) has been associated with lactic acidosis and may also cause prerenal azotemia. When such events occur in patients on Metformin HCl therapy, the drug should be promptly discontinued.

Since impaired hepatic function has been associated with some cases of lactic acidosis, Metformin HCl should generally be avoided in patients with clinical or laboratory evidence of hepatic disease.

Measurement of hematologic parameters on an annual basis is advised in patients Metformin HCl. Certain individuals (those with inadequate vitamin B₁₂ or calcium intake or absorption) appear to be predisposed to developing subnormal vitamin B₁₂ levels.

Pregnancy: Pregnancy Category B, Metformin HCl should not be used during pregnancy unless clearly needed.

Nursing Mothers: Because the potential for hypoglycemia in nursing infants may exist, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: The safety and effectiveness of Metformin HCl for the treatment of type 2 diabetes have been established in pediatric patients' ages 10 to 16 years.

Geriatric Use: Because aging is associated with reduced renal function, Metformin HCl should be used with caution as age increases.

SIDE EFFECTS: following adverse reactions were reported in ≥ 1.0 - ≤ 5.0% of Metformin HCl patients and were more commonly reported with Metformin HCl than placebo: abnormal stools, hypoglycemia, myalgia, lightheaded, dyspnea, nail disorder, rash, sweating increased, taste disorder, chest discomfort, chills, flu syndrome, flushing, palpitation.

DRUG INTERACTION: Glyburide, Furosemide, Nifedipine, Cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin),

thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, isoniazid, salicylates, sulfonamides, chloramphenicol, and probenecid.

OVERDOSDE: Overdose of Metformin HCl has occurred, including ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with Metformin hydrochloride has been established. Lactic acidosis has been reported in approximately 32% of Metformin overdose cases. Hemodialysis may be useful for removal of accumulated drug from patients.

How Supplied: Each pack of Metformin-Najo 500 contains 10 blisters and 100 F.C. tablets.

storage: Store below 30°C, Dispense in light-resistant containers.

For more information please refer to:

USPDI for Professional Health Care 2007, 1937.

Martindale 35^th edition, 411.

IRAN NAJO PHARMACEUTICAL COMPANY

www.irannajo.com
Address: No. 9, West Hoveiseh, Sabounchi St., Sohrevardi Ave., Tehran 1533693317, Iran
Tel: +9821-88747363   Fax: +9821-88740644   info@irannajo.com