Amophage Extra 2.5/500 mg - 30 Tablet

Antidiabetic combination therapy consisting of an agent that belongs to Biguanide group (metformin) and an agent that belongs to Sulfonylurea group (Glyburide), used in the treatment of type 2 diabetes mellitus.

-All doses should be administered with a meal. -Twice-daily dosing should be administered with the morning and evening meals.

Side effects due to Glyburide: Epigastric fullness, heartburn, nausea, hypersensitivity reaction (including erythema, maculopapular rash, morbilliform rash, pruritus, urticaria), disulfiram-like reaction, hypoglycemia, hyponatremia, weight gain, diuresis, hemolytic anemia, cholestatic jaundice, hepatic failure, hepatitis, accommodation disturbance, angioedema, arthralgia, blurred vision, bullous rash, erythema multiforme, exfoliative dermatitis, increased serum transaminases, myalgia and vasculitis. Side effects due to Metformin: -Diarrhea, nausea, flatulence, dyspepsia, vomiting, and abdominal pain, lactic acidosis, vitamin B12 deficiency and subsequent anemia and neuropathy. -Chest discomfort, flushing, palpitations, diaphoresis, hypoglycemia, abdominal distention, abdominal distress, abdominal pain, abnormal stools, dyspepsia, heartburn, chills, dizziness, headache, asthenia, myalgia, dyspnea, flu-like symptoms, upper respiratory tract infection, hemolytic anemia, hepatic injury and encephalopathy.

-Should not be given to patients suffering from hypersensitivity to metformin or glyburide. -Should not be given to patients suffering from severe renal impairment (if the glomerular filtration rate is <30 mL/minute/1.73 m2). -Should not be given to patients suffering from acute or chronic metabolic acidosis, including diabetic ketoacidosis. -All sulfonylurea drugs are capable of producing severe hypoglycemia. Hypoglycemia is more likely to occur when caloric intake is deficient, after severe or prolonged exercise, when ethanol is ingested, or when more than one glucose-lowering drug is used. It is also more likely in elderly patients, malnourished or debilitated patients, and in patients with severe renal and hepatic impairment, adrenal and/or pituitary insufficiency. -Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency may be at an increased risk of sulfonylurea-induced hemolytic anemia. -Intensive glucose control (HbA1c <6.5%) has been linked to increased cardiovascular mortality. -Should not be given to patients suffering from severe hepatic dysfunction. -Use cautiously in patients with heart failure. -Not indicated for use in patients with type 1 diabetes mellitus or with diabetic ketoacidosis. -Administration of iodinated contrast agents has been associated with postcontrast acute kidney injury (AKI); acute decreases in renal function have been associated with an increased risk of lactic acidosis due to reduced metformin excretion. -Older adults are more likely to experience vitamin B12 deficiency with long-term use of metformin. -Metformin may cause lactic acidosis. -Use of glyburide is not recommended in patients ≥65 years of age due to an increased risk of severe prolonged hypoglycemia. -In case of over dose be ready to tell or show what was taken, how much and when it happened, and seek immediate medical attention. For additional information call us on 16676. Always tell your physician your detailed medical history.

-Store at room temperature. -Interactions due to Metformin: -Alcohol (Ethyl): May enhance the adverse/toxic effect of Metformin. -Alpha-Lipoic Acid: May enhance the hypoglycemic effect of antidiabetic agents. -Beta-blockers: May enhance the hypoglycemic effect of antidiabetic agents. Symptoms of hypoglycemia, particularly tachycardia, may be also be blunted. -Cephalexin: May increase the serum concentration of Metformin. -Direct Acting Antiviral Agents (HCV): May enhance the hypoglycemic effect of antidiabetic agents. -Iodinated Contrast Agents: May enhance the adverse/toxic effect of Metformin. -Lamotrigine: May increase the serum concentration of Metformin. -Levoketoconazole: May increase the serum concentration of Metformin. -Monoamine Oxidase Inhibitors: May enhance the hypoglycemic effect of agents with blood glucose lowering effects. -Nonsteroidal Anti-Inflammatory Agents: May enhance the adverse/toxic effect of Metformin. -Ondansetron: May increase the serum concentration of Metformin. -Quinolones: May enhance the hypoglycemic effect of agents with blood glucose lowering effects. -Salicylates: May enhance the hypoglycemic effect of agents with blood glucose lowering effects. -Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of agents with blood glucose lowering effects. -Thiazide diuretics: May diminish the therapeutic effect of antidiabetic agents. -Topiramate: May enhance the adverse/toxic effect of Metformin. -Trimethoprim: May increase the serum concentration of Metformin. -Verapamil: May diminish the therapeutic effect of Metformin. -Vitamin K antagonists (eg, warfarin): Metformin may diminish the anticoagulant effect of Vitamin K antagonists.

Interactions due to Glyburide: -Alcohol (Ethyl): Sulfonylureas may enhance the adverse/toxic effect of alcohol. -Alpha-Lipoic Acid: May enhance the hypoglycemic effect of antidiabetic agents. -Amiodarone: May enhance the hypoglycemic effect of Sulfonylureas. -Antidiabetic agents: May enhance the hypoglycemic effect of hypoglycemia-associated agents. -Beta-blockers: May enhance the hypoglycemic effect of Sulfonylureas. -Carbocisteine: Sulfonylureas may enhance the adverse/toxic effect of Carbocisteine. -Chloramphenicol: May increase the serum concentration of Sulfonylureas. -Clarithromycin: May enhance the hypoglycemic effect of Sulfonylureas. -Dipeptidyl Peptidase-IV Inhibitors: May enhance the hypoglycemic effect of Sulfonylureas. -Direct acting antiviral agents (HCV): May enhance the hypoglycemic effect of antidiabetic agents. -Miconazole (Oral): May enhance the hypoglycemic effect of Sulfonylureas. -Monoamine Oxidase Inhibitors: May enhance the hypoglycemic effect of agents with blood glucose lowering effects. -Quinolones: May enhance the hypoglycemic effect of agents with blood glucose lowering effects. -Salicylates: May enhance the hypoglycemic effect of agents with blood glucose lowering effects. -Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of agents with blood Glucose lowering effects. -Tetracyclines: May enhance the hypoglycemic effect of Sulfonylureas. -Thiazide diuretics: May diminish the therapeutic effect of antidiabetic agents. -Vitamin K Antagonists (eg, warfarin): Sulfonylureas may enhance the anticoagulant effect of Vitamin K antagonists. -Voriconazole: May increase the serum concentration of Sulfonylureas. -For the rest of interactions refer to Storage.

-Glyburide and metformin cross the placenta, severe hypoglycemia lasting 4 to 10 days has been noted in infants born to mothers taking a sulfonylurea at the time of delivery, long-term safety data are not available. Agents other than glyburide and metformin are currently recommended to treat diabetes mellitus in pregnancy. -Metformin and Glyburide may be present in breast milk, the relative infant dose (RID) of glyburide was calculated to be 0.08%, the relative infant dose (RID) of metformin is 1.08%, breastfeeding is considered acceptable when the RID is <10, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. -Ask your physician before taking any medication during pregnancy and lactation.

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