Tablets containing 80mg Gliclazide.
Gliclazide is 1-(3-azabicyclo (3,3,0) oct-3-yl)-3-(p-tolylsulphonyl) urea.
Pharmacology: Mode of action: Gliclazide is a hypoglycaemic sulfonylurea differing from other related compounds by the addition of an azabicyclo octane ring. The drug is well absorbed and its half-life in man is approximately 10-12 hours. Gliclazide is metabolised in the liver; less than 5% of the dose is excreted unchanged in the urine.
In man, apart from having similar hypoglycaemic effect to the other sulphonylureas, gliclazide has been shown to reduce platelet adhesiveness and aggregation and increase fibrinolytic activity. These factors are thought to be implicated in the pathogenesis of long term complications of diabetes mellitus.
Gliclazide primarily enhances the first phase of insulin secretion, but also to a lesser degree its second phase.
Both phases are diminished in non-insulin dependent diabetes mellitus.
For the treatment of maturity onset diabetes mellitus.
Adults: The total daily dose may vary from 40 to 320mg taken orally. The dose should be adjusted according to the individual patient's response, commencing with 40-80mg daily (1/2 - 1 tablet) and increasing until adequate control is achieved. A single dose should not exceed 160mg (2 tablets). When higher doses are required, MEDOCLAZIDE should be taken twice daily and according to the main meals of the day.
In obese patients or those not showing adequate response to MEDOCLAZIDE alone, additional therapy may be required.
Elderly: Plasma clearance of gliclazide is not altered in the elderly and steady state plasma levels can therefore be expected to be similar to those in adults under 65 years. Clinical experience in the elderly to date shows that MEDOCLAZIDE is effective and well tolerated. Care should be exercised, however, when prescribing sulphonylureas in the elderly due to a possible age-related increased risk of hypoglycaemia.
Children: MEDOCLAZIDE, as with other sulphonylureas, is not indicated for the treatment of juvenile onset diabetes mellitus.
Route of administration: Oral.
The symptom to be expected with an overdose would be hypoglycaemia. The treatment is gastric lavage and correction of the hypoglycaemia by appropriate means with continued monitoring of the patient's blood sugar until the effect of the drug has ceased.
MEDOCLAZIDE should not be used in: Juvenile onset diabetes.
Diabetes complicated by ketosis and acidosis.
Diabetics undergoing surgery, after severe trauma or during infections.
Patients known to have hypersensitivity to other sulphonylureas and related drugs.
Diabetic pre-coma and coma.
Severe renal or hepatic insufficiency.
Care should be exercised in patients with hepatic and/or renal impairment and a small starting dose should be used with careful patient monitoring. As with other sulphonylureas, hypoglycaemia will occur if the patients' dietary intake is reduced or if they are receiving a larger dose of MEDOCLAZIDE than required.
Other special warnings and precautions: Hypoglycaemia: all sulphonylureas drugs are capable of producing moderate or severe hypoglycaemia, particularly in the following conditions: In patients controlled by diet alone; in cases of accidental overdose; when calorie or glucose intake is deficient; in patients with hepatic and/or renal impairment, however, in long-terrn clinical trials, patients with renal insufficiency have been treated satisfactorily, using MEDOCLAZIDE at reduced doses.
In order to reduce the risk of hypoglycaemia it is therefore recommended: To initiate treatment for non-insulin dependent diabetics by diet alone, if this is possible; to take into account the age of the patient: blood sugar levels not strictly controlled by diet alone might be acceptable in the elderly; to adjust the dose of MEDOCLAZIDE according to the blood glucose response and to the 24 hour urinary glucose during the first days of treatment.
Dosage adjustments may be necessary: On the occurrence of mild symptoms of hypoglycaemia (sweating, pallor, hunger pangs, tachycardia, sensation of malaise. Such findings should be treated with oral glucose and adjustments made in drug dosage and/or meal patterns; on the occurrence of severe hypoglycaemic reactions (coma or neurological impairment, see Overdosage); loss of control of blood glucose (hyperglycaemia).
When a patient stabilised on any diabetic regimen is exposed to stress such as fever, trauma, infection or surgery, a loss of control may occur. At such times, it may be necessary to progressively increase the dosage of MEDOCLAZIDE and if this is insufficient to discontinue the treatment with MEDOCLAZIDE and to administer insulin.
Effects on ability to drive and use machines: Patients should be informed that their concentration may be affected if their diabetes is not satisfactorily controlled, especially at the beginning of treatment (see Other special warnings and precautions as previously mentioned).
Pregnancy: See Contraindications.
Nursing mothers: It has not yet been established whether gliclazide is transferred to human milk. However, other sulphonylureas have been found in milk and there is no evidence to suggest that gliclazide differs from the group in this respect.
Hypoglycaemia (see Other special warnings and precautions under Precautions).
Abnormalities of hepatic function are not uncommon during gliclazide therapy. There are rare reports of hepatic failure, hepatitis, and jaundice following treatment with gliclazide. Mild gastro-intestinal disturbances including nausea, dyspepsia, diarrhoea and constipation have been reported, but this type of adverse reaction can be avoided if MEDOCLAZIDE is taken during a meal.
Skin reactions including rash, pruritus, erythema, bullous eruption; blood dyscrasia including anaemia, leucopaenia, thrombocytopaenia and granulocytopaenia have been observed during treatment with MEDOCLAZIDE but are not known to be directly attributable to the drug.
Care should be taken when giving MEDOCLAZIDE with drugs which are known to alter the diabetic state or potentiate the drug's action. The hypoglycaemic effect of MEDOCLAZIDE may be potentiated by phenylbutazone, salicylates, sulphonamides, coumarin derivatives, MAOIs, beta adrenergic blocking agents, tetracycline compounds, chloramphenicol, clofibrate, disopyramide, miconazole (oral forms) and cimetidine.
It may be diminished by corticosteroids, oral contraceptives, thiazide diuretics, phenothiazine derivatives, thyroid hormones and abuse of laxatives.
Incompatibilities (major): Non stated.
Store in a dry place at a temperature not exceeding 25°C away from light.
A10BB09 - gliclazide ; Belongs to the class of sulfonylureas. Used in the treatment of diabetes.