Euglim 2Mg

COMPOSITION

EUGLIM 1 Each uncoated tablet contains Glimepiride USP 1mg. EUGLIM 2 Each uncoated tablet contains: Glimepiride USP 2mg. EUGLIM 3 Each uncoated tablet contains Glimepiride USP 3mg. EUGLIM 4 Each uncoated tablet contains Glimepiride USP 4mg. Colour Lake of indigo carmine. 

DESCRIPTION

EUGLIM tablets contain glimepiride which is an oral blood glucose lowering drug of the sulfonylurea class. Chemically, glimepiride is identified as 1- [[p-2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl] phenyl]-sulfonyl]-3-(trans-4-methylcyclohexyl) urea. Its molecular formula is C24 H34 N4 O5 S, and its molecular weight is 490.62. 

INDICATIONS

EUGLIM is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with non-insulin dependent (Type II) diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled by diet and exercise alone. 

CONTRAINDICATIONS

EUGLIM is contraindicated in patients with: Known hypersensitivity to the drug. Diabetic ketoacidosis, with or without coma. This condition should be treated with insulin. 

PRECAUTIONS AND WARNINGS

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. The patient should be informed of the potential risks and advantages of EUGLIM and of alternative modes of therapy. All sulfonylurea drugs are capable of producing severe hypoglycemia. Proper patient selection, dosage and instructions are important to avoid hypoglycemic episodes. A starting dose of 1 mg once daily followed by appropriate dose titration is recommended in those patients. Debilitated or malnourished patients, and those with adrenal, pituitary, or hepatic insufficiency are particularly susceptible to the hypoglycemic action of glucose-lowering drugs. Combined use of EUGLIM with insulin or metformin may increase the potential for hypoglycemia. At such times, it may be necessary to add insulin in combination with EUGLIM or even use insulin monotherapy. The phenomenon is known as secondary failure, to distinguish it from primary failure in which the drug is ineffective in an individual patient when first given. Should secondary failure occur with EUGLIM or metformin monotherapy, combined therapy with EUGLIM and metformin or EUGLIM and insulin may result in a response. Should secondary failure occur with combined glimepiride / metformin therapy, it may be necessary to initiate insulin therapy.

ADVERSE REACTIONS

The incidence of hypoglycemia with glimepiride, as documented by blood glucose values <60 mg/dL, has ranged from 0.9-1.7% in most of the clinical trials carried out with the drug. Adverse events, other than hypoglycemia, considered to be possible or probably related to study drug that occurred in more than 1% of patients treated with glimepiride are: dizziness, asthenia, headache and nausea. Vomiting, gastrointestinal pain and diarrhea have been reported but the incidence in placebo-controlled trials was less than 1%. In rare cases, there may be an elevation of liver enzyme levels. In isolated instance, impairment of liver function (e.g. with cholestasis and jaundice), as well as hepatitis, which may also lead to liver failure have been reported with sulfonylureas, including glimepiride.  Allergic skin reactions e.g., pruritus, erythema, urticaria and morbilliform or maculipapular eruptions, occur in less than 1% of treated patients. These may be transient and may disappear despite continued use of glimepiride. If these hypersensitivity reactions persist, the drug should be discontinued. Porphyria cutanea tarda, photosensitivity reactions and allergic vasculitis have been reported with sulfonylureas, including glimepiride. 

DRUG INTERACTIONS

The hypoglycemic action of sulfonylureas may be potentiated by certain drugs, including nonsteroidal anti-inflammatory drugs and other drugs that are highly protein bound, such as salicylates, sulfonamides, chloramphenicol, coumarins, probenecid, monoamine oxidase inhibitors and beta-adrenergic blocking agents. When these drugs are administered to a patient receiving EUGLIM, the patient should be observed closely for hypoglycemia. When these drugs are withdrawn from a patient receiving EUGLIM, the patient should be observed closely for loss of glycemic control. Certain drugs tend to produce hyperglycemia and may lead to loss of control. These drugs include the thiazide and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics and isoniazid. When these drugs are withdrawn from a patient receiving EUGLIM, the patient should be observed closely for hypoglycemia. 

OVERDOSAGE

Overdosage of sulfonylureas, including EUGLIM, can produce hypoglycemia. Mild hypoglycemic symptoms without loss of consciousness or neurologic 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, because hypoglycemia may recur after apparent clinical recovery.