Getryl 4Mg

DESCRIPTION

GETRYL (Glimepiride) is an oral blood glucose lowering drug of the sulfonylurea class. Chemically glimepiride is 1-[[p-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl] phenyl]-sulphonyl]-3-(trans-4-methylcyclohexyl) urea. 

THERAPEUTIC INDICATIONS

GETRYL (Glimepiride) is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with noninsulin-dependent (Type 2) diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled by diet and exercise alone. GETRYL (Glimepiride) may be used concomitantly with metformin when diet, exercise, and GETRYL (Glimepiride) or metformin alone do result in adequate glycemic control. GETRYL (Glimepiride) is also indicated for use in combination with insulin to lower blood glucose in patients whose hyperglycemia cannot be controlled by diet and exercise in conjunction with an oral hypoglycemic agent. 

ADVERSE REACTIONS

Glimepiride is generally well tolerated. However, following are the side effects reported during treatment with glimepiride. Hypoglycemia: Hypoglycemia is the greatest potential risk with all sulfonylureas. Visual reactions: There may be temporary visual impairment (e.g., changes in accommodation and/or blurred vision) due to the change in blood glucose levels, especially at the start of treatment. Gastrointestinal reactions: Occasionally gastrointestinal symptoms such as nausea, vomiting, sensations of pressure or fullness in the epigastrium, abdominal pain and diarrhea may occur. Hematologic reactions: Rarely, thrombocytopenia and in isolated cases, leucopenia may develop. In isolated instances, thrombocytopenic purpura, agranulocytosis, pancytopenia due to myelo suppression, eosinophilia, hemolytic anemia, aplastic anemia, erythron cytopenia and granule cytopenia may occur. Dermatologic reactions: Occasionally, allergic or pseudo-allergic skin reactions (e.g., pruritus, erythema, urticaria, erythematous and maculopapular and bullous skin eruptions or psoriasiform drug eruption) may occur in patients treated with sulfonylureas. Hepatic reactions: Increased liver enzymes (AST, ALT), abnormal liver function, cholestasis, cholestatic hepatitis, granulomatous hepatitis, bilirubinemia anemia and liver failure have been reported with sulfonylureas in isolated cases. Electrolyte disturbance: In isolated cases, hyponatremia has been reported in patients receiving glimepiride and other sulfonylureas, most often in patients who are on other medications or have medical conditions known to cause hyponatremia or to increase release of antidiuretic hormone. Other: Isolated cases of allergic vasculitis have been reported with sulfonylureas. 

CONTRAINDICATIONS

Glimepiride is contraindicated in: Patients with known hypersensitivity to the drug. Patients with diabetic ketoacidosis, with or without coma. This condition should be treated with insulin. Patients & lactating patients. Pediatric patients. Acute porphyria. 

PRECAUTIONS

The patient's fasting blood glucose and HbA1c must be measured periodically to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of adequate blood glucose lowering response. After an initial period of effectiveness glycosylated hemoglobin levels should be performed to monitor the patient's response to therapy. Hypoglycemia: All sulfonylurea drugs are capable of producing severe hypoglycemia. Proper patient selection, dosage, and instructions are important to avoid hypoglycemic episodes. Debilitated patients, malnourished patients and patients with adrenal, pituitary, renal or hepatic insufficiency are particularly susceptible to the hypoglycemic action of sulfonylureas and should therefore be carefully monitored. The dosage of glimepiride should be carefully adjusted in these patients. Hepatic insufficiency may cause increased serum concentrations of glimepiride and may diminish gluconeogenic capacity, both of which increase the risk of severe hypoglycemic reactions. Alcohol ingestion, severe or prolonged exercise, deficient caloric intake or use of more than one antidiabetic agent may predispose patients to the development of hypoglycemia. Loss of control of blood glucose: When a patient stabilized on any diabetic regimen is exposed to stress such as fever, trauma, infection, or surgery, a loss of control may occur. At such times, it may be necessary to add insulin in combination with glimepiride or even use insulin monotherapy. Pregnancy: Glimepiride should not be used during the whole pregnancy. In case of treatment by glimepiride, if the patient plans to become pregnant or if a pregnancy is discovered, the treatment should be switched as soon as possible to insulin therapy. Lactation: The excretion of glimepiride in human milk is unknown. As other sulfonylureas are excreted in human milk and because there is a risk of hypoglycemia in nursing infants, breast-feeding is advised against during treatment with glimepiride. 

DRUG INTERACTIONS

Glimepiride belongs to sulfonylureas (anti-diabetic) class of drugs and may have the following interactions: Hypoglycemic effect of anti-diabetics enhanced by alcohol. Hypoglycemic effect of anti-diabetics possibly enhanced by anabolic steroids, MAOIs & testosterone. Warning signs of hypoglycemia (such as tremor) with anti-diabetics may be masked when given with beta-blockers. Hypoglycemic effect of anti-diabetics possibly antagonized by corticosteroids, diazoxide, loop diuretics, thiazide diuretics, estrogens & progestogens. The hypoglycemic effect of sulfonylureas may be possibly potentiated by nonsteroidal anti-inflammatory drugs, coumarins, ACE inhibitors & tetracyclines. Effects of sulfonylureas enhanced by cimetidine, MAOIs & sulfinpyrazone. Effects of sulfonylureas rarely enhanced by trimethoprim & sulphonamide. Plasma concentration of sulfonylureas increased by fluconazole & miconazole. Requirements for sulfonylureas possibly reduced by octreotide. 

Getz Pharma (PVT) Ltd