Zeltine-MR

Zeltine-MR

gliclazide

Manufacturer:

Stallion Labs

Distributor:

MedChoice Endocrine Group
Concise Prescribing Info
Contents
Gliclazide
Indications/Uses
Non-insulin-dependent diabetes (type 2) in adults, in association w/ dietary measures & exercise, when these measures alone are not sufficient.
Dosage/Direction for Use
Initially 30 mg daily. May increase dose to 60, 90 or 120 mg daily in successive steps if blood glucose is not adequately controlled. Interval between each dose increments should be at least 1 mth except in patients whose blood glucose has not reduced after 2 wk of treatment. Max: 120 mg daily.
Administration
May be taken with or without food: Take at breakfast time. Swallow whole, do not crush/chew.
Contraindications
Hypersensitivity to gliclazide or to other sulfonylurea, sulfonamides. Type 1 diabetes, diabetic pre-coma & coma, diabetic keto-acidosis, severe renal or hepatic insufficiency; treatment w/ miconazole. Lactation.
Special Precautions
Risk of hypoglycemia if meal is taken late; low-calorie diets; prolonged or strenuous exercise, alcohol intake or in combination of hypoglycemic agents; patient refuses or (particularly in elderly) 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. Monitor blood glucose levels regularly. St. John's wort prep, fever, trauma, infection or surgical intervention. Concomitant w/ fluoroquinolones. Measure glycated Hb levels (or fasting venous plasma glucose). Patients w/ G6PD deficiency. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Severe renal & hepatic insufficiency. Pregnancy. Childn.
Adverse Reactions
Hypoglycemia; headache, intense hunger, nausea, vomiting, lassitude, sleep disorders, agitation, aggression, poor concentration, 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, possibly resulting in coma & lethal outcome; sweating, clammy skin, anxiety, tachycardia, HTN, palpitations, angina pectoris & cardiac arrhythmia.
Drug Interactions
Increased risk of hypoglycemia w/ miconazole & phenylbutazone. May lead to onset hypoglycemic coma w/ alcohol or medicinal products containing alcohol. Potentiation of blood glucose-lowering effect 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 & nonsteroidal anti-inflammatory agents. Enhances diabetogenic effect of danazol. Increased blood glucose w/ chlorpromazine; glucocorticoids, tetracosactrin; ritodrine, salbutamol, terbutaline. Decreased exposure w/ St. John's wort. Risk of dysglycemia w/ fluoroquinolones. May potentiate anticoagulation of 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
Zeltine-MR MR tab 30 mg
Packing/Price
60's (P5.75/modified-release tab)
Form
Zeltine-MR MR tab 60 mg
Packing/Price
60's (P11.5/modified-release tab)
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