Diamicron MR 60 mg

Diamicron MR 60 mg

gliclazide

Manufacturer:

Servier

Distributor:

Zuellig
Concise Prescribing Info
Contents
Gliclazide
Indications/Uses
NIDDM, 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. Max: 120 mg daily. Switching from Gliclazide 80 mg tab to Gliclazide 60 mg MR tab: 1 tab Gliclazide (Diamicron) 80 mg tab is comparable to 30 mg MR formulation (eg, ½ tab of Diamicron MR 60 mg). Consequently, the switch can be performed w/ careful blood monitoring. Switching from another oral antidiabetic agent to Gliclazide 60 mg MR tab: Initially 30 mg/day, followed by a stepwise increase in dose, depending on the metabolic response. Patients at risk of hypoglycemia Initially min of 30 mg daily.
Administration
May be taken with or without food: Swallow whole & divided halves, do not chew/crush.
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
Hypoglycemia. 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 (concomitant use w/ fluoroquinolones, especially in elderly). Monitor blood glucose regularly. G6PD-deficiency. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May impair ability to drive or operate machinery. Avoid use during pregnancy.
Adverse Reactions
Hypoglycemia, sweating, clammy skin, anxiety, tachycardia, HTN, palpitations, angina pectoris & cardiac arrhythmia. Abdominal pain, nausea, vomiting, dyspepsia, diarrhea & constipation. Rash, pruritus, urticaria, angioedema, erythema, maculopapular rashes, bullous reactions (eg, Stevens-Johnson syndrome & toxic epidermal necrolysis), & exceptionally, drug rash w/ eosinophilia & systemic symptoms (DRESS); raised hepatic enzyme levels (AST, ALT, alkaline phosphatase), hepatitis; transient visual disturbances.
Drug Interactions
Increased hypoglycemia w/ miconazole (systemic route, oromucosal gel); phenylbutazone (systemic route); alcoholic drinks & any medicinal products containing alcohol (antabuse effect). Potentiate blood glucose lowering effect w/ other antidiabetic agents (insulin, acarbose, metformin, thiazolidinediones, dipeptidylpeptidase-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 due to β-2 agonist effects w/ ritodrine, salbutamol, terbutaline (IV route). Decreased exposure w/ St. John's wort (H. perforatum). Dysglycemia w/ fluoroquinolones. Potentiation of anticoagulant therapy (warfarin).
MIMS Class
ATC Classification
A10BB09 - gliclazide ; Belongs to the class of sulfonylureas. Used in the treatment of diabetes.
Presentation/Packing
Form
Diamicron MR 60 mg MR tab 60 mg
Packing/Price
60's (P1,599.49/box)
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