Euglucon (Glyburide)

EUGLUCON®

Pharmascience

Glyburide

Oral Hypoglycemic

Indications And Clinical Uses: To control hyperglycemia in glyburide responsive diabetes mellitus of stable, mild, nonketosis prone, maturity-onset or adult type which cannot be controlled by proper dietary management and exercise, or when insulin therapy is not appropriate.

Contra-Indications: Known hypersensitivity or allergy to glyburide; unstable and/or insulin-dependent diabetes mellitus; ketoacidosis; coma; stress conditions such as severe infections, trauma or surgery; the presence of jaundice, liver disease, or renal disease or impairment; during pregnancy; the presence of important pre-existing complications peculiar to diabetes, such as retinopathy or neuropathy, for which no oral antidiabetic drugs should be given.

Precautions: The use of glyburide will not prevent the development of complications peculiar to diabetes mellitus.

Use of glyburide must be considered as treatment in addition to a proper dietary regimen, and not as a substitute for diet. Patients may, over a period of time, become progressively less responsive to oral hypoglycemic therapy because of a deterioration of their diabetic state. If a loss of adequate blood glucose lowering response to glyburide is detected, discontinue the drug.

Careful selection of patients is important. There must be rigid attention to diet, careful adjustment of dosage, patient instruction on hypoglycemic reactions and their control, as well as regular, thorough follow-up examinations.

Since the effects of oral hypoglycemic agents on the vascular changes and other long-term sequelae of diabetes mellitus are not fully known, patients receiving such drugs must be closely observed for both short- and long-term complications. Periodic assessment of cardiovascular, ophthalmic, renal and hepatic status is advisable.

In patients stabilized on glyburide therapy, loss of blood sugar control may occur in cases of acute intercurrent disease or in stressful situations such as trauma or surgery. Under these conditions, discontinuation of glyburide and insulin administration should be considered.

Hypoglycemic Reactions: Severe hypoglycemia can be induced by all sulfonylureas. Particularly susceptible are elderly subjects, patients with impaired hepatic or renal function, those who are debilitated or malnourished, and patients with primary or secondary adrenal insufficiency. Hypoglycemia is more likely to occur when the caloric intake is inadequate or after strenuous or prolonged exercise.

Drug Interactions: As a result of drug interaction, hypoglycemia may be potentiated when a sulfonylurea is used concurrently with agents such as: long-acting sulfonamides, tuberculostatics, phenylbutazone, clofibrate, MAO inhibitors, coumarin derivatives, salicylates, probenecid or propranolol and other b-adrenergic receptor blockers.

Certain drugs tend to produce hyperglycemia and may lead to loss of blood sugar control; these include diuretics (thiazides, furosemide), corticosteroids, oral contraceptives (estrogen plus progestogen), phenothiazines, calcium channel blocking drugs and nicotinic acid in pharmacological doses.

Barbiturates and other sedatives and hypnotics should be used cautiously in patients receiving an oral hypoglycemic agent, since their action may be prolonged.

Intolerance to alcohol (disulfiram-like reaction: flushing, sensation of warmth, giddiness, nausea, and occasionally tachycardia) may occur in patients treated with a sulfonylurea, including glyburide. This reaction can be prevented by avoiding alcohol.

Adverse Reactions: Hypoglycemia: Severe hypoglycemia which mimics acute CNS disorders may occur (see Precautions). Hepatic and/or renal disease, malnutrition, debility, advanced age, alcoholism, adrenal or pituitary insufficiency may be predisposing factors.

Gastrointestinal: Nausea, epigastric fullness, heartburn, are common reactions to sulfonylurea therapy, tend to be dose related and may disappear when dosage is reduced. Jaundice has been reported rarely in conjunction with some sulfonylureas.

Dermatological: Allergic skin reactions such as pruritus, erythema, urticaria, morbilliform or maculopapular eruptions have been observed following sulfonylurea therapy. These may subside on continued use of the drug, but if they persist, discontinue the drug. Porphyria cutanea tarda and photosensitivity reactions have also been reported. In 1 patient, a severe skin reaction occurred as a result of a generalized hypersensitivity to glyburide; hepatic, splanchnic and renal complications, followed by bronchopneumonia and renal failure, resulted in a fatal outcome.

Hematological: Thrombocytopenia has occasionally been observed in patients receiving glyburide. Leukopenia, agranulocytosis, hemolytic anemia and aplastic anemia have been noted as a result of therapy with other sulfonylureas.

Metabolic: hepatic porphyria, disulfiram-like reactions.

Endocrinological: reduced RAI uptake by the thyroid gland.

Miscellaneous: Headache, tinnitus, fatigue, malaise, weakness and dizziness have been reported in a small number of patients.

Symptoms And Treatment Of Overdose: Sulfonylurea overdosage may result in hypoglycemia, but the dosage which causes hypoglycemia varies widely, and may be within the accepted therapeutic range in sensitive individuals.Symptoms: Manifestations of hypoglycemia include sweating, flushing or pallor, numbness, chilliness, hunger, trembling, headache, dizziness, increased pulse rate, palpitations, increased blood pressure and apprehensiveness in mild cases. In more severe cases, coma occurs. However, symptoms of hypoglycemia are not necessarily as typical as described above and sulfonylureas may cause insidious development of symptoms which mimic cerebrovascular insufficiency.

Treatment: Discontinue medication and treat the hypoglycemia by giving dextrose promptly and in sufficient quantity. Some sulfonylurea-induced hypoglycemias may be refractory to treatment and susceptible to relapse, and may be fatal, especially in elderly or malnourished patients. Continuous dextrose infusions for hours to days have been necessary.

Dosage And Administration: In diabetic subjects, there is no fixed dosage regimen for the management of blood glucose concentrations. Individual determination of the minimum dose that will lower the blood glucose adequately should be made.

In patients where, on initial trial, the maximal recommended dose fails to lower blood glucose adequately, the drug should be discontinued. During the course of therapy a loss of effectiveness may occur. The contribution of the drug in the control of blood glucose should be ascertained by discontinuing the medication semi-annually or at least annually with careful patient monitoring. If the need for the drug is not evident, do not resume therapy. In some diabetic subjects, short-term administration of the drug may be sufficient during periods of transient loss of blood sugar control.

Usual Starting Dose: In newly diagnosed diabetics, the initial dose is 5 mg daily (2.5 mg in patients over 60 years of age) for 5 to 7 days. Depending on the response, increase or decrease the dosage in steps of 2.5 mg. Maximum daily dosage is 20 mg.

Usual Maintenance Dose: Occasionally, control is maintained with 2.5 mg daily. The majority of cases can be controlled by 5 to 10 mg daily given as a single dose during or immediately after breakfast; patients who eat only a light breakfast should defer the first dose of the day until lunchtime. If more than 10 mg daily is required, take the excess with the evening meal.

Changeover from Other Oral Hypoglycemic Agents: Discontinue previous oral medication and start glyburide 5 mg daily (2.5 mg in patients over 60 years of age). Determine maintenance dosage as in newly diagnosed diabetics.

Changeover from Insulin: If a change from insulin to glyburide is contemplated in a patient with stable, mild, maturity onset diabetes, discontinue insulin treatment for a period of 2- or 3- test days, to determine whether any therapy other than dietary regulation and exercise is needed. During this insulin-free interval, test the patient’s urine at least 3 times daily for glucose and ketone bodies and monitored carefully by a physician. The appearance of significant ketonuria accompanied by glucosuria within 12 to 24 hours after the withdrawal of insulin, strongly suggests that the patient is ketosis prone, and precludes the change from insulin to sulfonylurea therapy.

Availability And Storage: 2.5 mg: Each white, cylindrical, biplane tablet with a “T” superimposed on a smaller “O” printed on one face, and single scored on the other with “A1” printed above and below the score line, contains: glyburide 2.5 mg. Nonmedicinal ingredients: lactose, magnesium stearate, maize starch, silicon dioxide and talc. Tartrazine-free. Blister packs of 30. Bottles of 100 and 500.

5 mg: Each white, oblong, scored tablet, coded BM/EU on both faces, contains: glyburide 5 mg. Nonmedicinal ingredients: lactose, magnesium stearate, maize starch, silicon dioxide and talc. Tartrazine-free. Blister packs of 30. Bottles of 100 and 500.

Store at room temperature.

EUGLUCON® Pharmascience Glyburide Oral Hypoglycemic

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