Bal Pharma


ECE Pharma


Full Prescribing Info
Each uncoated modified release tablet contains: Gliclazide BP 30 mg.
Pharmacology: Pharmacodynamics: Gliclazide Modified-Release (Gliclazide MR) tablets are antidiabetic agent, which has a high tech formulation which releases the gliclazide in such a manner that the treatment taken once daily with breakfast controls high blood glucose over 24 hours, restores the early peak of insulin secretion and ensures glycemic control throughout 24 hours and combats microthrombosis by decreasing platelet hyperadhesiveness and hyperaggregation Increasing fibrinolytic activity, scavenging free-radicals.
Gliclazide reduces blood glucose levels by correcting both defective insulin secretion and peripheral insulin resistance. This occurs by closure of K+ channels In the β-cells of pancreas, subsequently calcium channels open, leading to increase in intracellular calcium and induction of insulin release.
Pharmacokinetics: Gliclazide MR was found to be 0.74 mg/L at a tmax of 7 hours and AUC was 16.2 mg/L.h. In patients with type 2 diabetes mellitus, the apparent clearance of gliclazide MR was 0.9 L/h and apparent volume of distribution (Vd) of 19 L. There was an exponential decline in plasma concentration with an elimination half-life (t1/2) of approximately 16 hours. The drug is highly bound to albumin (35%). It is extensively metabolised to at least seven metabolites; with no active circulating active metabolite. <1 % of unchanged gliclazide is excreted in urine.
TYPE II DIABETES in association with dietary measures when dietary measures alone are inadequate to control blood glucose.
Dosage/Direction for Use
The usual daily dose is 1-2 tablets per day as a single dosage. Once daily administration of Gliclazide MR 60 mg tablet must be taken whole with half a glass of water just before breakfast. Every administration of the tablet must be followed by a meal.
Moderate symptoms of hypoglycaemia without loss of consciousness or neurological signs should be corrected by carbohydrate intake, dose adjustment and/or modification of diet. Strict monitoring should be continued until the doctor is sure that the patient is out of danger. Severe hypoglycaemic reactions are possible (with coma, convulsions or other neurological disorders) end should be treated as a medical emergency, requiring immediate hospitalisation. If hypoglycaemic coma is diagnosed or suspected, the patient should be given a rapid I.V. injection of 50 mL of concentrated glucose solution (20 to 30%). This should be followed by continuous infusion of a more dilute glucose solution (10%) at a rate necessary to maintain blood glucose levels above 5 mmol/L. It is recommended that patients should be monitored closely for a 48 hour period at least.
Contraindicated in insulin-dependent diabetes mellitus, diabetic coma, precoma and extreme imbalance with tendency to acidosis, hepatic or renal failure, surgical stress or acute infection.
Contraindicated in pregnancy and lactation and if allergic to any of the constituents of the product.
Special Precautions
Hypoglycemia may occur if the patient's dietary intake is reduced or after accidental or deliberate overdose or after severe exercise, alcohol intake, trauma and stress. Adjust dose of gliclazide according to blood and urinary glucose levels during the first few months. Begin treatment with low doses in patients with renal and/or, hepatic impairment.
Severe renal or hepatic insufficiency may affect the distribution of gliclazide and hepatic insufficiency may also reduce the capacity for gluconeogenesis. These two effects increase the risk of severe hypoglycaemic reactions.
Use In Pregnancy & Lactation
Contraindicated in pregnancy and lactation.
Adverse Reactions
Gastrointestinal disturbances: Nausea. diarrhoea, gastric pain, constipation and vomiting.
Dermatological effects: Rash, pruritus, urticaria, erythema and flushing.
Miscellaneous: Headache and dizziness.
Drug Interactions
As with all hypoglycaemics, caution should be observed in administering thiazide diuretics, since these diuretics have been reported to aggravate the diabetic state.
Other drugs which may adversely affect blood sugar control with hypoglycaemic agents, include barbiturates, chlorpromazine, danazol, glucocorticoids. oestrogens and progestogens, salbutamol, terbutaline.
Certain drugs may potentiate the effect of gliclazide and thereby increase the risk or hypoglycaemia. These include insulin, biguanides, sulfonamides, oxyphenbutazone, phenylbutazone, clofibrate, salicylates (high doses). coumarin derivates, chloramphenicol, MAOI's, (blockers, cimetidine, ACE inhibitors, ethanol, fluconazole and miconazol).
Ingestion of alcohol may also cause a disulfiram-like reaction with characteristic flushing of the face, throbbing headache, giddiness, tachypnoea, tachycardia or angina pectoris. Chronic alcohol abuse may, as a result of liver enzyme induction, increase the metabolism of sulfonylurea drugs, shortening the plasma half- life and duration or action.
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
A10BB09 - gliclazide ; Belongs to the class of sulfonylureas. Used in the treatment of diabetes.
MR tab 30 mg x 30's.
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