Action And Clinical Pharmacology: Gliclazide is an hypoglycemic agent of the sulfonylurea group. Its hypoglycemic action is related to an improvement in insulin secretion from the functioning beta cells of the pancreas. It potentiates the insulin release and improves the dynamics of insulin.
Clinical Uses: Control of hyperglycemia in gliclazide responsive diabetes mellitus of stable, mild, non-ketosis prone, maturity onset or adult type which cannot be controlled by proper dietary management and exercise, or when insulin therapy is not appropriate.
Manufacturers' Warnings In Clinical States: The use of gliclazide will not prevent the development of complications peculiar to diabetes mellitus.
Use of gliclazide must be considered as treatment in addition to proper dietary regimen and not as substitute for diet.
Patients over a period of time, may become progressively less responsive to therapy with oral hypoglycemic agents because of worsening of their diabetic state. If a loss of adequate blood glucose-lowering response to gliclazide is detected, the drug should be discontinued.
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, propranolol, miconazole, cimetidine, disopyramide and angiotensin converting enzyme inhibitors.
Certain drugs tend to induce hyperglycemia and may lead to loss of control of blood sugar control. These include diuretics (thiazides, furosemide), corticosteroids, oral contraceptives (estrogen plus progestogen) and nicotinic acid in pharmacologic doses.
Intolerance to alcohol (disulfiram-like reaction: flushing, sensation of warmth, giddiness, nausea and occasionally tachycardia) may occur in patients treated with a sulfonylurea. This reaction can be prevented by avoiding the use of alcohol.
Adverse Reactions: As with other sulfonylurea drugs, manifestations of hypoglycemia including dizziness, lack of energy, drowsiness, headache and sweating have been observed. Nausea, vomiting, diarrhea, epigastric fullness and gastric irritation can be observed. These reactions are generally dose-related and may disappear when the dose is reduced. Allergic reactions such as pruritus, erythema, urticaria and morbiliform or maculopapular rash have been reported. These reactions may persist during treatment, which must then be interrupted.
Laboratory Tests: The pattern of laboratory tests abnormalities observed with gliclazide was similar to that for other sulfonylureas. Occasional mild to moderate elevations of AST, LDH and creatinine and decrease in natremia have been observed. These abnormalities frequently encountered with treated or untreated diabetic patients are rarely associated with clinical symptoms and generally not considered to be drug related.
Symptoms And Treatment Of Overdose: Symptoms: Overdosage with sulfonylureas may result in hypoglycemia but it should be noted that the dosage which causes such hypoglycemia varies widely and may be within the accepted therapeutic range in sensitive individuals.
The 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 appears.
Treatment: Discontinue medication and treat hypoglycemia by giving dextrose promptly and in sufficient quantity.
Dosage And Administration: There is no fixed dosage regimen for the management of diabetes mellitus with gliclazide or any other hypoglycemic agent. Determination of the proper dosage for gliclazide for each patient should be made on the basis of frequent determinations of blood glucose during dose titration and throughout maintenance.
In patients in whom 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.
It is advisable to ascertain the contribution of the drug in control of the blood glucose by discontinuing the medication semi-annually or at least annually with careful monitoring of the patient. If the need for the drug is not evident, the drug should not be resumed. In some diabetic subjects, short-term administration periods of the drug may be sufficient during periods of transient loss of blood sugar controls. MISSED DOSE: If you miss a dose, take as soon as remembered; do not take if it is almost time for the next dose, instead, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. STORAGE: Store at room temperature between 59 and 86 degrees F (between 15 and 30 degrees C) away from moisture and sunlight. Do not store in the bathroom. |
