Diamicron MR 60

Diamicron MR 60

gliclazide

Manufacturer:

Servier
Concise Prescribing Info
Contents
Gliclazide
Indications/Uses
Non insulin-dependent diabetes (type 2) in adults when dietary measures, physical exercise & wt loss alone are not sufficient to control blood glucose.
Dosage/Direction for Use
½-2 tab daily ie, from 30-120 mg taken orally as a single intake, including in elderly & those w/ mild to moderate renal insufficiency w/ careful patient monitoring. One tab of Diamicron 60 mg MR is equiv to 2 tab of Diamicron 30 mg MR. Patients at risk of hypoglycemia Daily starting dose: 30 mg. Combination w/ other antidiabetics: Diamicron 60 mg MR can be given in combination w/ biguanides, α glucosidase inhibitors or insulin (under close medical supervision).
Administration
Should be taken with food: Take w/ breakfast. Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity to gliclazide, other sulfonylurea or sulphonamides. Type 1 diabetes, diabetic pre-coma & coma, diabetic ketoacidosis. Treatment w/ miconazole. Severe renal or hepatic insufficiency (in these cases the use of insulin is recommended). Lactation.
Special Precautions
Discontinue treatment in case of cholestatic jaundice. Hypoglycemia may occur w/ all sulfonylureas, in cases of accidental overdose, when calorie or glucose intake is deficient, following prolonged or strenuous exercise. Hospitalization & glucose administration for several days may be necessary. Inform patient of the importance of following dietary advice, of taking regular exercise & regular monitoring of blood glucose levels. To be prescribed only in patients w/ regular food intake. Patients w/ G6PD deficiency. Case of acute porphyria w/ some other sulphonylurea drugs. Contains lactose. Severe hepatic or renal impairment.
Adverse Reactions
Hypoglycemia, abdominal pain, nausea, vomiting, dyspepsia, diarrhea, constipation. Rash, pruritus, urticaria, angioedema, erythema, maculopapular rashes, bullous reactions eg, SJS & TEN & autoimmune bullous disorders, & exceptionally, DRESS. Changes in haematology generally reversible (anaemia, leucopenia, thrombocytopenia, granulocytopenia). Raised hepatic enzymes levels (AST, ALT, alkaline phosphatase), hepatitis (isolated reports). If cholestatic jaundice: discontinuation of treatment. Transient visual disturbances at start of treatment. As for other sulfonylureas: observed cases of erythrocytopenia, agranulocytosis, haemolytic anaemia, pancytopenia, allergic vasculitis, hyponatraemia, elevated liver enzymes, impairment of liver function (cholestasis, jaundice) & hepatitis which led to life-threatening liver failure in isolated cases.
Drug Interactions
Risk of hypoglycemia - contraindicated: Miconazole. Not recommended: Phenylbutazone; alcohol. Use w/ caution: Other antidiabetic agents, β-blockers, fluconazole, ACE inhibitors (captopril, enalapril), H2-receptor antagonists, MAOIs, sulfonamides, clarithromycin, NSAIDs. Risk of hyperglycaemia - Not recommended: Danazol. Use w/ caution: Chlorpromazine at high doses; glucocorticoids; ritodrine; salbutamol; terbutaline, St. John’s wort (Hypericum perforatum) prep. Risk of dysglycaemia - use w/ caution: Fluoroquinolones. Potentiation of anticoagulant therapy (eg, warfarin), adjustment of the anticoagulant may be necessary.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BB09 - gliclazide ; Belongs to the class of sulfonylureas. Used in the treatment of diabetes.
Presentation/Packing
Form
Diamicron MR 60 modified-release tab 60 mg
Packing/Price
30's (Rp288,138/pak)
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in