Information about UNI METFORAL XR

Composition:
Each Extended-Release Tablet contains:
- 500 mg Metformin Hydrochloride equivalent to 390 mg Metformin Base.
Or;
- 750 Metformin Hydrochloride equivalent to 585 mg Metformin Base.
Or;
- 1000 mg Metformin Hydrochloride equivalent to 780 mg Metformin Base.
Mechanism of Action:
Metformin is an antihyperglycemic agent which decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Indications:
Metformin Hydrochloride extended-release is indicated to improve glycemic control in adults with type 2 diabetes mellitus.
Contraindications:
Metformin Hydrochloride extended - release is contraindicated in patients with:
- 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.
- Known hypersensitivity to Metformin Hydrochloride.
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma. Diabetic ketoacidosis should be treated with insulin.
- Metformin XR should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials because use of such products may result in acute alteration of renal function.
Dosage and Administration:
- Metformin XR should generally be given once daily with the evening meal.
- The therapeutic goal should be to decrease both fasting plasma glucose and
glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of metformin XR, either when used as monotherapy or in combination with sulfonylurea or insulin.
- Metformin XR tablets must be swallowed whole and never crushed or chewed.
- In general, clinically significant responses are not seen at doses below 1500 mg per day. However, a lower recommended starting dose and gradually increased dosage is advised to minimize gastrointestinal symptoms.
- The usual starting dose of metformin hydrochloride extended-release tablets is 500 mg once daily with the evening meal. Dosage increases should be made in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal.
- Safety and effectiveness of metformin XR in pediatric patients have not been
established.
- When transferring patients from chlorpropamide, care should be exercised during
the first two weeks because of the prolonged retention of chlorpropamide in the body, leading to overlapping drug effects and possible hypoglycemia.
- If patients have not satisfactorily responded to one to three months of concomitant therapy with the maximum dose of metformin XR and the maximum dose of an oral sulfonylurea, consider therapeutic alternatives including switching to insulin with or without metformin XR.
- Metformin XR therapy should be initiated at 500 mg once daily in patients on insulin therapy. For patients not responding adequately, the dose metformin XR should be increased by 500 mg after approximately 1 week and by 500 mg every week thereafter until adequate glycemic control is achieved. The maximum recommended daily dose is 2000 mg for metformin XR. It is recommended that the insulin dose be decreased by 10% to 25% when fasting plasma glucose concentrations decrease to less than 120 mg/dL in patients receiving concomitant insulin and metformin XR.
Drug Interaction:
- Glyburide: Coadministration of metformin and glyburide did not result in any changes in either metformin pharmacokinetics or pharmacodynamics.
- Furosemide: Furosemide increased the metformin Cmax by 22% and AUC by 15%,
without any significant change in metformin renal clearance.
- Nifedipine: Coadministration of nifedipine increased plasma metformin Cmax and
AUC by 20% and 9%, respectively, and increased the amount excreted in the urine.
- Cationic drugs: Cationic drugs (e.g., amiloride, digoxin, morphine, procainamide,
quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin) that are
eliminated by renal tubular secretion have the potential for interaction with metformin by competing for renal tubular transport systems.
- Other: Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid.
Packaging:
- Carton pack of 30 Extended-Release Tab. for 500 & 750 mg strengths.
- Carton pack of 28 Extended-Release Tab. for 1000 mg strength.