Anti diabetic agents

  • Chemical Composition

    Metformin Hydrochloride 500 mg / 5 ml

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Excipients Glycerin , Saccharin Sodium , Citric acid , Sodium citrate , Nipagen sodium , Nipazole sodium , Cherry flavour , Purified water .
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) oral solution 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). It is also used in women with a certain disease of the ovaries (polycystic ovarian syndrome). Metformin may make menstrual cycles more regular and increase fertility.
CONTRAINDICATIONS Extraformin (Metformin HCl) 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 cardio circulatory problems • Pregnancy and lactation • 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) the patient should be closely observed for loss of blood glucose control. When such drugs are withdrawn from a patient receiving Extraformin (Metformin HCl) the patient should be observed closely for hypoglycemia.
Pregnancy And lactations You should consult a doctor if this drug is prescribed to pregnant or breastfeeding women
Dosage And Administration According to the physician’s instructions. Adults: 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 Extraformin (Metformin hydrochloride oral solution) is 500 mg (5 ml of Extraformin oral solution) twice a day or 850 mg (8.5 ml of Extraformin oral solution) once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg (20 ml of Extraformin oral solution) per day, given in divided doses. Patients can also be titrated from 500 mg twice a day to 850 mg twice a day after 2 weeks. For those patients requiring additional glycemic control, Extraformin may be given to a maximum daily dose of 2550 mg (25.5 ml of Extraformin oral solution) per day. Pediatrics: The usual starting dose of Extraformin oral solution is 500 mg (5 ml) twice a day, given with meals. Dosage increases should be made in increments of 500 mg (5 ml) weekly up to a maximum of 2000 mg (20 ml) per day, given in divided doses. Monitoring of renal function is necessary to aid in prevention of lactic acidosis, particularly in the elderly.
OVERDOSE Overdose of Metformin hydrochloride has occurred, including ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no casual association with Metformin hydrochloride has been established. Lactic acidosis has been reported in approximately 32% of metformin overdose cases. Metformin is dialyzable, therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom Metformin overdosage is suspected.
Storage Conditions Store at room temperature, between 15 - 30° C " " Keep out of reach of children " " Prescription only medicine "