Gliclazide ............................................................................ 30 mg
Excipients q.s .................................................................... 1 tablet
Modified-release tablet.
Box of 5 blisters x 20 tablets.
Glumeron contains Gliclazide which is a sulfonylurea anti-diabetic agent. Gliclazide works by stimulating pancreatic beta cells to release insulin. Hence, the drug only gives its effects when patient's pancreas is still able to produce insulin. Besides, gliclazide reduces the hepatic insulin clearance, therefore increases the amount of serum hormone.
Gliclazide is readily absorbed from the gastrointestinal tract and the plasma peak concentration of gliclazide occurs between 2 and 4 hours after ingestion. It is extensively bound to plasma proteins. Gliclazide is extensively metabolized in the liver and excreted in the urine. The half-life is about 12 to 20 hours
The drug is used with caution in drivers, machine operators, because of possibility of headache
Use of Glumeron 30 MR must be considered as treatment in addition to proper dietary regimen. When used in combination with other drugs that increase or decrease the hypoglycemic effects, the dosage of gliclazide should be adjusted. In the case of kidney failure, liver failure, the dosage should be reduced.
Hypoglycaemia may occur in patients with malnutrition, irregular mealtimes, periods of fasting or dietary changes; imbalance between physical exercise and carbohydrate intake; use of alcohols (particularly enclosed with skipping meals), overdose of gliclazide; certain endocrine disorders (thyroid disorders, hypopituitarism and adrenal insufficiency); severe hepatic insufficiency or severe renal insufficiency.
Decreased hemoglobin level and red blood cell destruction have been reported in patients with a family history or known to G6PD-deficiency.
The drug is contraindicated to pregnant women and breast-feeding mothers.
Hypoglycemic action may be potentiated when gliclazide is used concurrently with agents including nonsteroidal anti-inflammatory drugs (particularly aspirin), antibacterial sulfamides, coumarin, anticoagulants, MAOIs, beta-blockers, diazepam, tetracycline, perhexiline maleate, chloramphenicol, clofibrate, miconazole tablet. Hypoglycemia is more likely to occur following alcohol intake.
Certain drugs tend to induce hypoglycemia. These include barbituric, corticosteroids, sodium-eliminated diuretics, oral contraceptives.
Common: CNS disorders: headache; Gastrointestinal disorders: nausea; Skin disorders: rash.
Uncommon: Blood disorders (general reversible): thrombocytopenia, agranulocytosis, neutropenia, anemia; Skin disorders: skin and mucosa reactions.
Rare: CNS disorders: drowsiness, sweating; Cardiovascular disorders: increased heart rate; Skin disorders: paleness; Gastrointestinal disorders: vomiting, ravenousness.
Overdosage leads to manifestations of hypoglycemia including sweating, skin paleness, polycardia. For mild cases, the patient should be immediately taken a glass of syrup or fruit juice with 2 or 3 sugar coffee-spoons. For severe cases with vague symptoms, the patient should be given a rapid I.V. injection of glucose solution (10% or 30%) and hospitalized.
Read the directions carefully before use.
This drug is for prescription only.
Store in dry places, not exceeding 30°C, protect from light.
Non insulin-dependent diabetes (type 2) when dietary measures alone are not sufficient to control blood glucose.
Particularly, gliclazide should be used in the diabetic elderly.
Insulin-dependent diabetes mellitus (type 1). Diabetic coma or pre-coma. Severe renal or hepatic insufficiency. Hypersensitivity to sulfonamides and other sulfonylureas. Treatment with miconazole. Serious infection, trauma, surgery.
Determination of the proper dosage for Glumeron 30 MR for each patient should be made on the basis of frequent determinations of blood glucose. It is recommended that the tablet(s) be swallowed whole without crushing or chewing.
The recommended starting dose is one tablet of Glumeron 30 MR daily, even in elderly patients (over 65 years old). Dose adjustment should be carried out in steps of 30 mg (one tablet of Glumeron 30 MR). The interval between each dose increment should be at least 1 month except in patients whose blood glucose has not reduced after two weeks of treatment. In such cases, the dose may be increased at the end of the second week of treatment.
A usual dose of Glumeron 30 MR may vary from 1 tablet to 4 tablets (The dose should not exceed 120 mg). It is recommended that it be taken at breakfast time. The dosage depends on therapeutic response.
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