Composition:
Orgic 80 tablet: Each tablet contains Gliclazide BP 80 mg.

Description:
Gliclazide is a second-generation sulfonylurea that has hypoglycemic and potentially useful hemobiological properties. It stimulates the influx of calcium ions into pancreatic β cells, and as a result, increases insulin secretion. Moreover, in-vivo studies have demonstrated changes in thrombin-induced platelet aggregation in NIDDM patients treated with gliclazide.

Indications:

• Non-insulin dependent diabetes mellitus (type-II) when dietary modification has failed.

Dosage and Administrations:

• Initially 40-80 mg daily, adjusted according to response; up to 160 mg as a single dose, with breakfast; higher doses divided; maximum 320 mg daily.

Adverse Reactions:

• Potentially life-threatening effects: All hypoglycemic agents have the potential to cause severe hypoglycemia and may cause severe brain damage or death. Gliclazide used in standard dose is less likely than glyburide to cause hypoglycemia. Hypoglycemia may be favored by concurrent conditions such as hepatic and renal disease, malnutrition, anorexia, senility, alcohol intoxication, or adrenal and pituitary insufficiency.
• Severe or irreversible adverse effects: Approximately 2% of patients have been withdrawn from therapy because of adverse reactions, namely hypoglycemia (overdose effect), gastrointestinal disturbances, and dermatological reactions.
• Symptomatic adverse effects: Side effects of Gliclazide treatment are similar to those of other sulfonylureas. Headache, gastrointestinal upsets, nausea, and dizziness have been reported and skin reactions, including rash, pruritus, erythema, and bullous eruptions may occur. Abnormalities of liver function are not uncommon.

Contraindications:

• Gliclazide should not be used in type-I diabetes, diabetic ketosis, and acidosis, diabetic coma, diabetic undergoing surgery, or patients known to have hypersensitivity to Gliclazide or other Sulphonylurea.

Precautions:

• Care should be taken when treating patients with hepatic or renal impairment. A reduced initial dose is recommended, along with careful monitoring of the patient’s condition.

Drug Interactions:

• The hypoglycemic action of sulfonylureas may be opposed by the induction of hepatic enzymes, which metabolize the drug causing lower plasma concentrations and less hypoglycemic effect. Common inducers include rifampicin, barbiturates, phenytoin, and alcohol, or by drugs that inhibit the release or action of insulin, e.g., thiazide diuretics, dizoxide, glucocorticoids, estrogens or sympathomimetic drugs. Early symptoms of hypoglycemia such as tremor, sweating, and tachycardia may be masked by beta-adrenoreceptor blocking drugs, such as propranolol, allowing severe hypoglycemic episodes without preceding warning symptoms.

Use in Specific Population:

• Neonates: The drug is not used in neonates.
• Nursing mothers: The drug should not be used in nursing mothers.
• Children: Gliclazide is contraindicated in children.
• Pregnant women: Gliclazide, as other sulfonylureas, is contraindicated for use in pregnant women. No teratological changes have been shown in animals or humans, but diabetes can be controlled more tightly in pregnancy by insulin than by oral hypoglycemic agents.
• Elderly: All sulfonylureas should be used with caution in the elderly because of the greater likelihood of their missing meals and the more severe outcome of significant hypoglycemia.
• Concurrent disease: Definite hepatic disease should contraindicate the use of Gliclazide, since it is almost completely metabolized in the liver. Renal disease does not appear significantly to alter the pharmacokinetics, although it may be wise to limit the maximum dose when the serum creatinine starts to rise.

Use in pregnancy and lactation:

• Gliclazide should not be used in pregnancy and nursing mothers.

Overdosage:

• Hypoglycemia may occur due to overdosage. Discontinue medication immediately and treat hypoglycemia by taking dextrose.

Storage:

• Do not store above 30°C. Keep in a dry place. Protect from light and keep out of the reach of children.

Packaging:

• Orgic 80 Tablet: Box containing 60 tablets in 6 x 10’s blister strips.