Usage And Safety
Side Effects
Gastro-intestinal: Abdominal pain, anal fissure, appetite increased, colitis, duodenal ulcer, epigastric fullness, faecal incontinence, flatulence, gastric irritation, gastroesophageal reflux, GI neoplasm benign, hemorrhoids, melena, dry mouth, oesophagitis, saliva increased, tooth ache, tooth disorder, vomiting. These reactions are generally dose-related and may disappear when the dose is reduced. Hearing and vestibular: hearing decreased, tinnitus. Liver and biliary: increased liver enzymes, hepatitis, hepatomegaly. Metabolic and nutritional: gout, glycosuria, hypercholesterolemia, hypertriglyceridemia, thirst. Cases of hepatic porphyria and disulfiram-like reactions have been described with sulfonylurea drugs. Clinical experience to date has shown that gliclazide 80 mg tablets has a low incidence of disulfiram type reactions. Musculo-skeletal: arthropathy, bursitis, hernia congenital, skeletal pain, spine malformation.
Drug Interactions
Long-acting sulfonamides, tuberculostatics, NSAIDs, fibrates, monoamine oxidase inhibitors, salicylates, probenecid, beta-blockers, azole antifungal agents (oral and parenteral preparations), H2 receptor antagonists and angiotensin converting enzyme inhibitors , other antidiabetic agents (insulin, alpha glucosidase inhibitors, biguanides) , diuretics (thiazides, furosemide), corticosteroids, oral contraceptives (estrogen plus progestogen), chlorpromazine, ritodrine, salbutamol, terbutaline and nicotinic acid , Miconazole , Phenylbutazone , MAOIs , Chlorpromazine (neuroleptic agent) .
Indication
It is used to control blood glucose (sugar) in patients with Type II diabetes mellitus.
When not to Use
Do not take if • You are allergic to: gliclazide, or any of the other ingredients • You have had an allergic reaction to any other sulphonylureas, or related medicines such as sulfa antibiotics or to thiazide diuretics (a type of fluid or water tablet).
Warnings
Warning 1
Use of gliclazide must be considered as treatment in addition to proper dietary regimen and not as substitute for diet.
Warning 2
All sulfonylurea drugs can induce severe hypoglycemia. Particularly susceptible are elderly subjects, patients with impaired hepatic or renal function, those who are debilitated or malnourished and patients with primary or secondary adrenal insufficiency. Some cases may be severe and prolonged.
Warning 3
The efficacy of gliclazide, in reducing glucose to the desired level decreases over a long period of time in many patients: this may be due to progression in the severity of the diabetes, or to a reduced response to treatment. This phenomenon is known as secondary failure and should be distinguished from primary failure, when the drug is ineffective when prescribed as first-line treatment. Adequate dose adjustment and compliance with dietary measures should be considered before classifying the patient as secondary failure. If a loss of adequate blood glucose-lowering response to GLICLAZIDE is detected, the drug should be discontinued.
