Antidiabetic agents

  • Chemical Composition

    Metformin HCL 850 mg

  • Packing

    20Coated Tablets-30Coated Tablets

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  • License date


Mechanism Of Action Extraformin (Metformin HCl) is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin is a biguanide that reduces glycaemia and improves insulin action. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization
INDICATIONS Extraformin (Metformin HCl) tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. Extraformin (Metformin HCl) may be used concomitantly with a sulfonylurea or insulin to improve glycemic control in adults (17 years of age and older).
CONTRAINDICATIONS Extraformin (Metformin HCl) tablets must not be used in the following cases: - Known hypersensitivity to Metformin hydrochloride or any of the product components - Ketoacidosis - Renal disease or renal dysfunction - Serious hepatic and renal problems - Serious respiratory problems - Chronic alcoholism - Serious cardiocirculatory problems - During the two days following X-ray examination involving the use of iodinated contrast media
Side EFFECTS : Symptoms of hypoglycemia may occur, although this is more frequent in elderly or weak patients, or those suffering from trauma. Although rare, lactic acidosis symptoms may appear in patients with a predisposition to renal insufficiency or serious cardiocirculatory problems. The patient may also suffer from gastroenteric disorders, such as nausea, loss of appetite, stomach pain, vomiting and diarrhea. Moreover, allergic reactions of varying intensity may occur.
WARNINGS Metformin is known to be substantially excreted by the kidney, and the risk of metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Renal function should be assessed more frequently and Extraformin discontinued if evidence of renal impairment is present. In the case of traumas, surgery and febrile and infectious illness it may be necessary to stop treatment, substituting it with the temporary administration of insulin in order to control the diabetes adequately. The patient must be taught by the physician to recognize the first signs of hypoglycemia (headache, excessive perspiration, irritability, trembling) and of lactic acidosis (loss of appetite, nausea, vomiting, fever, breathing difficulty, discomfort, abdominal pains, diarrhea, confusion or loss of consciousness) so that he may call a physician should the need arise.
DRUG INTERACTIONS : Plasma levels of Metformin may be reduced by guar gum and alpha-glucosidase inhibitors and increased by cimetidine. Some 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. When such drugs are administered to a patient receiving Extraformin (Metformin HCl tablets) the patient should be closely observed for loss of blood glucose control. When such drugs are withdrawn from a patient receiving Extraformin (Metformin HCl tablets) the patient should be observed closely for hypoglycemia
Pregnancy And lactations Pregnancy: Uncontrolled diabetes during pregnancy is associated with increased risk of congenital abnormalities and perinatal mortality. When the patient plans to become pregnant and during pregnancy, it is recommended that diabetes should not be treated with metformin but insulin should be used to maintain blood glucose levels as close to normal as possible in order to lower the risk of foetal malformations associated with abnormal blood glucose levels. Lactation: Metformin is excreted into human breast milk. No adverse effects were observed in breastfed newborns/infants. However, as only limited data are available, breastfeeding is not recommended during metformin treatment. A decision on whether to discontinue breast-feeding should be made, taken into account the benefit of breastfeeding and the potential risk to adverse effects on the child.
Dosage And Administration According to the physician´s instructions. The usual starting dose of Extraformin (metformin hydrochloride tablets) is 500 mg twice a day or 850 mg once a day. given with meals. Dosage increases should be made in increments of 850 mg every 2 weeks, up to a total of 2000 mg per day , given in divided doses( 1 tablet of Extraformin -1000 mg twice daily).For those patients requiring additional glycemic control ,Extraformin may be given to a maximum daily doses of 2550 mg per day(1 tablet of Extraformin -850 mg thrice daily).
OVERDOSE : Hypoglycaemia has not been seen with metformin hydrochloride doses of up to 85 g, although lactic acidosis has occurred in such circumstances. High overdose of metformin or concomitant risks may lead to lactic acidosis. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and metformin is haemodialysis.
Storage Conditions Store between 15- 30° C Keep out of reach of children