Gliclashin
Gliclazide
Indication
It is used in the treatment of type 2 or non-insulin-dependent diabetes mellitus; type II diabetic mellitus in adults when diet, exercise and weight loss alone do not have adequate effect on keeping blood sugar at the correct level; diabetes with or without obesity in adults and diabetes with vascul...
Dosage and Administration
Adult:
Initial dose: 40 – 80 mg daily, adjusted according to response, increased up to 160 mg as single dose.
Dose to be taken with breakfast and preferably at the same time each day.
Doses higher than 160 mg to be given in divided doses. Maximum dose: 320 mg/day.
In obese patients or those not showing adequate response to gliclazide alone, additional therapy may be required.
Composition
Each film-coated tablet contains:
Gliclazide B.P ... 80 mg.
Description
Gliclazide is a short-acting relatively high-potency, second generation sulfonylurea oral hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus. Chemically, it is 1-(Hexahydrocyclopenta[c]pyrrol-2(1H) -yl)-3-[(4-methylphenyl)sulfonyl] urea. The molecular formula is C15H...
Clinical Pharmacology
Gliclazide belongs to the sulfonylurea class of insulin secretagogues, which act by binding the specific receptor on β cells, leading to increase secretion of insulin and increase the sensitivity of the β cells to glucose. At the tissue, gliclazide restores the peripheral insulin sensitivity by decr...
Pharmacokinetics
Gliclazide is readily absorbed from the gastrointestinal tract. Food intake does not affect the rate or degree of absorption. It is extensively bound to plasma proteins (85 - 97%). Peak plasma concentrations occur within 4 - 6 hours of oral administration. The volume of distribution is around 19 lit...
Contraindication
It is contraindicated in patients with hypersensitivity to gliclazide or to other sulfonylureas or sulfonamides; insulin-dependent diabetes (type I diabetes); diabetic pre-coma and coma; diabetes ketoacidosis; diabetes undergoing surgery after severe trauma or during infections; severe renal or hepa...
Precaution
During the gliclazide treatment, regular monitoring of blood (and possibly urine) sugar level and also HbA1c is necessary. In the first few weeks of treatment, the risk of having reduced blood sugar levels (hypoglycemia) may be increased. Particular close medical monitoring is necessary. Hypoglycemi...
Treatment of patients with G6PD-deficiency with sulfonylurea agents can lead to haemolytic anaemia. Since gliclazide be-longs to the class of sulfonylurea agents, caution should be used in patients with G6PD deficiency and a non-sulfonylurea alternative should be considered.
Gliclazide is not suitable, insulin is the drug of first choice for treatment of diabetes during pregnancy. It is recommended that oral hypoglycemic therapy is changed to insulin before a pregnancy is attempted, or as soon as pregnancy is discovered.
Adverse Effects
The most frequent adverse reaction with gliclazide is hypoglycemia. Symptoms of low blood sugar are headache, intense hunger, nausea, vomiting, lassitude, sleep disorders, rest-lessness, aggressiveness, poor concentration, confusion, speech or visual disorders, tremor, sensory disturbances, dizzines...
Skin reactions such as rash, redness, itching, hives, blisters, angioedema; blood disorders that decrease in number of cells in blood (e.g. platelets, red and white blood cells) which may cause paleness, prolonged bleeding, bruising, sore throat, fever; digestive disorders such as abdominal pain, na...
Drug Interaction
Miconazole: increases the hypoglycemic effect with possible onset of hypoglycemic symptoms or even coma. Fluoroquinolones: may cause dysglycemia. Phenylbutazone: increase the hypoglycemic effect of sulfonylureas (displaces their binding to plasma proteins and/or reduces their elimination).
Other antidiabetic agents (such as insulin, acarbose, metformin or GLP-I receptor agonist biguanides): increase hypoglycemia. Enalapril or losartan: increase hypoglycemic effects. Alcohol: increase the hypoglycemic reaction (by inhibiting compensatory reactions) that can lead to the onset to hypogly...
Chlorpromazine: high doses (> 100 mg per day of chlorpromazine) increase blood glucose levels (reduced insulin release). It may be necessary to adjust the dose of the anti-diabetic active substance during and after treatment with the neuroleptic agent.
Glucocorticoids and tetracosactrin: increase in blood glucose levels with possible ketosis.
Anticoagulant therapy (e.g. warfarin): Sulfonylureas may lead to potentiation of anticoagulation during concurrent treatment. Adjustment of the anticoagulant may be necessary.
Storage
Store below 30°C in cool, dry place. Protect from light and moisture. Keep out of reach and sight of children.
Presentation
10 x 10’s Blisters.