EXTRAFORMIN PLUS
Tablets

Antidiabetic agents

  • Chemical Composition

    Glyburide(Glibenclamide) 5 mg - Metformin HCl 500 mg

  • Packing

    30Coated Tablets

  • Medical Id

    T108

  • License Number

    183/2016

  • License date

    26/5/2016

Excipients Cross carmellose sodium, Magnesium stearate, Microcrystalline cellulose, Povidone, Sorbic acid, Titanium dioxide, Polyethylene glycol 6000, Polydextrose, Ammonio methacrylate copolymer (type B ), HPMC, Triacetin, Sodium hydroxide, yellow iron oxide as colorant.
Mechanism Of Action Plus combines Glyburide and Metformin hydrochloride, two antihyperglycemic agents with complementary mechanisms of action, to improve glycemic control in patients with type 2 diabetes. Glyburide appears to lower blood glucose acutely by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells in the pancreatic islets. Metformin hydrochloride is an antihyperglycemic agent that improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Metformin hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
INDICATIONS Extraformin Plus tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
CONTRAINDICATIONS Extraformin Plus is contraindicated in patients with: • Renal disease or renal dysfunction, which may also result from conditions such as cardiovascular collapse (shock),acute myocardial infarction, and septicemia. • Known hypersensitivity to metformin hydrochloride or glyburide. • Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin. • Extraformin Plus 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.
Side EFFECTS The most common adverse events associated with treatment with Glyburide/Metformin HCl combination include upper respiratory infection, diarrhea, headache nausea/vomiting, abdominal pain, and dizziness. 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. Moreover, allergic reactions of varying intensity may occur.
WARNINGS Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with Extraformin Plus tablets; when it occurs, it is fatal in approximately 50% of cases. The risk of lactic acidosis increases with renal dysfunction and the increase in patient’s age. Treatment with Extraformin Plus should not be initiated in patients > 80 years of age unless measurement of creatinine clearance demonstrates that renal function is not reduced, as these patients are more susceptible to developing lactic acidosis. In addition, Extraformin Plus should be promptly withheld in the presence of any condition associated with hypoxemia, dehydration, or sepsis. Because impaired hepatic function may significantly limit the ability to clear lactate, Extraformin Plus should generally be avoided in patients with clinical or laboratory evidence of hepatic disease. Patients should be cautioned against excessive alcohol intake, either acute or chronic, when taking Extraformin Plus, since alcohol potentiates the effects of metformin hydrochloride on lactate metabolism. In addition, Extraformin Plus should be temporarily discontinued prior to any intravascular radiocontrast study and for any surgical procedure. The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. Treatment of patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency with sulfonylurea agents can lead to hemolytic anemia. Because Glyburide/Metformine Hydrochloride belongs to the class of sulfonylurea agents, caution should be used in patients with G6PD deficiency and a non-sulfonylurea alternative should be considered. 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. Renal Impairment: Metformin, when used in patients with renal insufficiency (based on an estimated creatinine clearance <80 ml/min), can precipitate lactic acidosis. Because of this potentially life-threatening metabolic effect, the use of metformin in patients with renal disease is not recommended.Because aging is associated with reduced renal function, Extraformin Plus (glyburide and metformin) should be used with caution as age increases. Care should be taken in dose selection and should be based on careful and regular monitoring of renal function. Generally, elderly patients should not be titrated to the maximum dose of Extraformin Plus Liver Impairement: Because metformin can precipitate lactic acidosis and because liver disease may decrease the elimination of lactate, the use of metformin in patients with liver disease is not recommended.
DRUG INTERACTIONS Extraformin Plus may interact withcertain drugs that tend to produce hyperglycemia and may lead to loss of blood glucose 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 Plus, the patient should be closely observed for loss of blood glucose control. When such drugs are withdrawn from a patient receiving Extraformin Plus, the patient should be observed closely for hypoglycemia. Metformin is negligibly bound to plasma proteins and is, therefore, less likely to interact with highly protein-bound drugs such as salicylates, sulfonamides, chloramphenicol, and probenecid as compared to sulfonylureas, which are extensively bound to serum proteins. The hypoglycemic action of sulfonylureas may be potentiated by certain drugs including nonsteroidal anti-inflammatory agents and other drugs that are highly protein bound, salicylates, sulfonamides, chloramphenicol, probenecid, coumarins, monoamine oxidase inhibitors, and beta adrenergic blocking agents. When such drugs are administered to a patient receiving Extraformin Plus, the patient should be observed closely for hypoglycemia. When such drugs are withdrawn from a patient receiving Extraformin Plus, the patient should be observed closely for loss of blood glucose control. A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported
Pregnancy And lactations Pregnancy (category B): Extraformin Plus 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 Extraformin Plus, taking into account the importance of the drug to the mother. If Extraformin Plus is discontinued, and if diet alone is inadequate for controlling blood glucose, insulin therapy should be considered
Dosage And Administration Dosage of Extraformin Plus must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended daily dose of 20 mg glyburide/2000 mg metformin. Extraformin Plus should be given with meals and should be initiated at a low dose, with gradual dose escalation.
OVERDOSE Overdosage of sulfonylureas, including glyburide, can produce hypoglycemia. Mild hypoglycemic symptoms, without loss of consciousness or neurological findings, should be treated aggressively with oral glucose and adjustments in drug dosage and/or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalization. If hypoglycemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dL. Patients should be closely monitored for a minimum of 24 to 48 hours, since hypoglycemia may recur after apparent clinical recovery. Overdose of metformin hydrochloride has occurred, including ingestion of amounts > 50 g. 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. Metformin is dialyzable with a clearance of up to 170 ml/min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected.
Storage Conditions Store at room temperature, up to 25° C” “Keep out of reach of children”