Gliget MR

Gliget MR

gliclazide

Manufacturer:

Stallion Labs

Distributor:

Getz Pharma
Concise Prescribing Info
Contents
Gliclazide
Indications/Uses
Non-insulin-dependent diabetes (type 2) in adults, in association w/ dietary measures & w/ exercise, when these measures alone are not sufficient.
Dosage/Direction for Use
Initially 30 mg daily (½ tab); may be used for maintenance treatment if blood glucose is effectively controlled. May be increased to 60, 90 or 120 mg daily, in successive steps if blood glucose is not adequately controlled. Interval between each dose increment should be at least 1 mth except in patients whose blood glucose has not reduced after 2 wk of treatment. Dose may be increased at the end of the 2nd wk of treatment. Max daily dose: 120 mg. Switching from gliclazide 80 mg tab to gliclazide (Gliget MR) 60 mg MR tab 1 tab of gliclazide 80 mg tab is comparable to 30 mg of the MR formulation (ie, ½ tab of Gliget 60 mg); perform w/ careful blood monitoring consequently. Switching from another oral antidiabetic agent to gliclazide (Gliget MR) 60 mg Initially 30 mg & adjust to suit patient's blood glucose response. Patient at risk of hypoglycemia Min daily starting dose: 30 mg.
Administration
Should be taken with food: Take w/ breakfast. Swallow whole w/o crushing/chewing.
Contraindications
Hypersensitivity to gliclazide, other sulfonylurea, sulfonamides. Type 1 diabetes; diabetic pre-coma & coma, diabetic keto-acidosis. Severe renal or hepatic insufficiency. Concomitant use w/ miconazole. Lactation.
Special Precautions
Hypoglycemia. Increased risk of hypoglycemia in patient refuses or (particularly in elderly) is unable to cooperate; malnutrition, irregular mealtimes, skipping meals, periods of fasting or dietary changes; imbalance between physical exercise & carbohydrate intake; overdose; thyroid disorders, hypopituitarism & adrenal insufficiency; concomitant administration of certain medicinal products. Inform patient about importance of following dietary advice, of taking regular exercise, & of regular monitoring of blood glucose levels. Poor blood glucose control may be affected by St. John's wort (Hypericum perforatum) prep, fever, trauma, infection or surgical intervention. Consider adequate dose adjustment & dietary compliance before classifying patient as secondary failure. Dysglycemia in diabetics receiving concomitant treatment w/ fluoroquinolones, especially in elderly. Measurement of glycated Hb levels (or fasting venous plasma glucose) in assessing blood glucose control; blood glucose self-monitoring may be useful. Patients w/ G6PD-deficiency & consider non-sulfonylurea alternative. Not to be administered to patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Make patients aware of symptoms of hypoglycemia & be careful if driving or operating machinery, especially at beginning of treatment. Discontinue treatment if cholestatic jaundice appears. Renal & hepatic insufficiency. Avoid use during pregnancy. Childn & adolescents.
Adverse Reactions
Hypoglycemia. GI disturbances, including abdominal pain, nausea, vomiting, dyspepsia, diarrhea, & constipation.
Drug Interactions
Increased risk of hypoglycemia w/ miconazole (systemic route, oromucosal gel); phenylbutazone (systemic route) (displaces binding to plasma proteins &/or reduces elimination); alcohol (by inhibiting compensatory reactions). Potentiation of blood glucose lowering effect & hypoglycemia may occur w/ other antidiabetic agents (insulins, acarbose, metformin, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, GLP-1 receptor agonists), β-blockers, fluconazole, ACE inhibitors (captopril, enalapril), H2-receptor antagonists, MAOIs, sulfonamides, clarithromycin & NSAIDs. Diabetogenic effect of danazol. Increased blood glucose levels (reduced insulin release) w/ high doses (>100 mg/day) of chlorpromazine (neuroleptic agent). Increased blood glucose levels w/ possible ketosis (reduced tolerance to carbohydrates due to glucocorticoids) w/ glucocorticoids (systemic & local route: IA, cutaneous & rectal prep) & tetracosactrin. Increased blood glucose levels due to β-2 agonist effects of ritodrine, salbutamol, terbutaline (IV). Decreased exposure w/ St. John's wort (Hypericum perforatum) prep. May cause dysglycemia w/ fluoroquinolones. Potentiation of anticoagulation during concurrent anticoagulant therapy (eg, warfarin).
MIMS Class
Antidiabetic Agents
ATC Classification
A10BB09 - gliclazide ; Belongs to the class of sulfonylureas. Used in the treatment of diabetes.
Presentation/Packing
Form
Gliget MR MR tab 60 mg
Packing/Price
30's
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