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Glimicron Tablets (Gliclazide 80mg)
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Glimicron Tablets (Gliclazide 80mg)

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ACTION & PHARMACOLOGY:

Gliclazide, a sulphonylurea, acts by promoting release of insulin from the beta cells of pancreatic islet tissue by an unknown process. Insulin production is not increased. Hepatic glycogenolysis is decreased, Insulin sensitivity increased at peripheral target site.Therefore Sulfonylureas are effective only in patients whose pancreas are capable of producing insulin'

INDICATIONS:

Gliclazide is indicated in non-insulin dependent diabetes-mellitus (Type II)

CONTRAINDICATIONS:

Except under special circumstances, this medication should not be used when the following medical problems exists: Acidosis burns, diabetic coma, infection, ketoacidosis, surgery and trauma. Risk benefit should be considered when the following medical problems exists: Adrenal insufficiency, pituitary insufficiency, fever, nausea, vomiting, thyroid-function impairment, debilitated physical conditions, hepatic function Impairment, sensitivity to oral antidiabetic agents and patients with acute porphyria.

PRECAUTIONS:

Patients sensitivities to one of the oral antidiabetic agents may be sensitive to the other also. Oral antidiabetic agents must not be used during pregnancy. Abnormal blood glucose level have been associated with a higher incidence of congenital abnormalities during early pregnancy, and with increased perinatal morbidity and mortality later in pregnancy.

  • It should not be used in insulin-dependent diabetes mellitus (Type I).
  • It should not be given in severe impairment of renal and hepatic functions.
  • Its antidiuretic effects may cause problems in patients with conditions associated with fluid retention.

SIDE EFFECTS:

  • Gastro-intestinal disturbances such as nausea, vomiting, heart burn, anorexia and diarrhoea.
  • Skin rashes and pruritus.
  • Severe, prolonged and sometimes fatal hypoglycaemia.
  • Photosensitivity

DRUG INTERACTIONS:

  • Compounds that may diminish the hypoglycaemic effects and thus necessitate an increase in the dosage requirement of the Sulfonulurea include rifampicin and thiazide diuretics, corticosteroids and estrogens.
  • Compounds that may increase the hypoglycaemic effects of sulfonylureas and necessitate a reduction in their dosage requirement include anti infective agents such as chloramphenicol, guanetidine, monoamine oxidase inhibitors. salicylates, sulfonamides, trimethoprim, phenylbutazone, ketoconazole, miconazole, fluconazole, sulphinpyrazone and azapropazone.
  • A reversible decrease in thrombocyte count in patients receiving ketotifen concomitantly with oral anti diabetic agents has been observed in a few cases. Concurrent administration of ketotifen should therefore be avoided.
  • Beta blocker may mask some of the symptoms of hypoglycaemic. Also, beta-blockers may have hypoglycaemic or hyperglycaemic actions of their own.
  • The hypoglycaemic effects may be enhanced when administered concurrently with incline.

OVERDOSAGE:

Clinical Features:
  • Nausea and vomiting.
  • Abdominal pain, (rarely) and anemia.
  • Drowsiness, coma, twitching, convulsion.
  • Depressed limb reflexes with extensor planter responses.
  • Hyperapnea. acute pulmonary oedema.
  • Sinus tachycardia, hypotension, Circulatory failure.
  • Absence of sweating.
  • Hypogylcaemia, hyperkalaemia, metabolic (lactic) acidoses, leukocytosis.
  • Late complication cholestasis, jaundice.

Treatment of Overdosage:

  • Emesis or gastric lavage. If appropriate Administration of repeated doses of oral cathartic may also be used:
  • Supportive measure:
  • 50ml of 50% glucose IV repeated as necessary and/or glucagon 1-2 mg IV to correct hypoglycaemia, followed by an IV infusion of 5-10% dextrose for 24 to 72 hours as necessary.
  • Treat mild hypoglycaemia with immediate ingestion of a source of sugar.

DOSAGE & ADMINISTRATION:

ADULTS:
Oral, 40 to 80 mg daily, gradually increased, if necessary up to 320 mg daily. Doses of more than 160mg daily should be given in 2 divided doses.

PRESENTATION:

GLIMICRON (Gliclazide 80 mg Tablet) Blister Pack of 20 tablets.

PHARMACEUTICALS PRECAUTIONS & STORAGE:

Protect form direct Light, Heat and moisture. Store under controlled temperature (15-30¬įC).