GliXa

GliXa

gliclazide

Manufacturer:

Stallion Labs

Distributor:

InnoGen Pharmaceuticals

Marketer:

Aldril
Concise Prescribing Info
Contents
Gliclazide
Indications/Uses
NIDDM 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 increased to 60, 90 or 120 mg daily, in successive steps. 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 in such cases. Max daily dose: 120 mg. Switching from gliclazide tab 80 mg to gliclazide MR tab 60 mg 1 tab of gliclazide 80 mg tab is comparable to 30 mg MR formulation (ie, ½ tab of GliXa 60 mg). Consequently, the switch can be performed w/ careful blood monitoring. Switching from another oral antidiabetic agent to gliclazide MR tab 60 mg Initially 30 mg/day, followed by a stepwise increase in dose, depending on the metabolic response. Patient at risk of hypoglycemia Min starting dose of 30 mg daily.
Administration
Should be taken with food: Take at breakfast. Swallow whole, do not crush or chew.
Contraindications
Hypersensitivity to gliclazide, other sulfonylureas or sulfonamides. Type 1 diabetes; diabetic pre-coma & coma, diabetic ketoacidosis. Concomitant use w/ miconazole. Severe renal or hepatic insufficiency. Lactation.
Special Precautions
Risk of hypoglycemia especially during low-calorie diets following prolonged or strenuous exercise, alcohol intake or if in combination w/ hypoglycemic agents. Malnutrition, irregular mealtimes, skipping meals, periods of fasting or dietary changes; imbalance between physical exercise & carbohydrate intake. Thyroid disorders, hypopituitarism & adrenal insufficiency. St. John's wort prep, fever, trauma, infection or surgery may affect blood glucose control. Dysglycemia in diabetic patients receiving concomitant use w/ fluoroquinolones, especially in elderly. Monitor blood glucose regularly. G6PD-deficiency. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Renal & hepatic insufficiency. May impair ability to drive or operate machinery. Pregnancy. Childn & adolescents.
Adverse Reactions
Hypoglycemia, headache, intense hunger, nausea, vomiting, lassitude, sleep disorders, agitation, aggression, poor conc, reduced awareness & slowed reactions, depression, confusion, visual & speech disorders, aphasia, tremor, paresis, sensory disorders, dizziness, feeling of powerlessness, loss of self-control, delirium, convulsions, shallow respiration, bradycardia, drowsiness & loss of consciousness; sweating, clammy skin, anxiety, tachycardia, HTN, palpitations, angina pectoris & cardiac arrhythmia. Abdominal pain, dyspepsia, diarrhea, constipation.
Drug Interactions
Increased risk of hypoglycemia w/ miconazole (systemic route, oromucosal gel); phenylbutazone (systemic route); alcohol & any medicinal products containing alcohol. Potentiate blood glucose lowering effect w/ other antidiabetic agents (insulin, 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/ chlorpromazine (>100 mg/day); w/ possible ketosis (reduced carbohydrates tolerance) w/ glucocorticoids (systemic & local route, IA, cutaneous & rectal prep) & tetracosactrin. Increased blood glucose levels w/ ritodrine, salbutamol, terbutaline (IV). Decreased exposure w/ St. John's wort (Hypericum perforatum). Dysglycemia w/ fluoroquinolones. May potentiate anticoagulation w/ 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
GliXa MR tab 60 mg
Packing/Price
60's
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