Diamicron/Diamicron MR 60

Diamicron/Diamicron MR 60

gliclazide

Manufacturer:

Servier

Distributor:

Zuellig
Concise Prescribing Info
Contents
Gliclazide
Indications/Uses
Type 2 diabetes (NIDDM) in adults, in association w/ dietary measures & w/ exercise when these measures alone are not sufficient.
Dosage/Direction for Use
Diamicron Patient <65 yr Initially 1 tab daily. Adjust dose depending on the blood glucose response & in steps of 1 tab at a time (at least 14 days should separate successive steps in the dose). Maintenance: 1-3 tab daily, or rarely 4 tab daily. Usual dose: 2 tab daily. Patient at particular risk (eg, >65 yr) Initially ½ tab once daily, can progressively increase until blood glucose is satisfactorily controlled, while keeping to steps of at least 14 days between successive levels, & w/ close monitoring of blood glucose. Diamicron MR 60 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 been reduced after 2 wk of treatment. Dose may be increased at the end of the 2nd wk of treatment in such cases. Max: 120 mg/day. 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 Min starting dose of 30 mg daily.
Administration
Diamicron Should be taken with food: Take w/ meals to minimize GI disturbances. Diamicron MR 60 May be taken with or without food..
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
Increased risk of hypoglycemia due to low-calorie diet, following major or prolonged exercises, following ingestion of alcohol or in combination w/ other hypoglycemic agents; patient refuses or is unable to cooperate (particularly in elderly); malnutrition, irregular mealtimes, skipping meals, periods of fasting or dietary changes; imbalance between physical exercise & carbohydrate intake; overdosage; thyroid disorders, hypopituitarism & adrenal insufficiency. St. John's wort prep, fever, injury, infection, or surgery may affect blood glucose control. Dysglycemia (concomitant use w/ fluoroquinolones, especially in elderly). Monitor blood glucose levels regularly. G6PD-deficiency. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive or operate machinery. Avoid use during pregnancy. Childn & adolescents. Elderly.
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 hypoglycemia w/ miconazole (systemic route, oromucosal gel); phenylbutazone (systemic route); alcoholic drinks & any medicinal products containing alcohol (antabuse effect). Potentiated 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) & tetracosactide; due to β2-agonist effects w/ ritodrine, salbutamol, terbutaline (IV route). Decreased exposure w/ St. John's wort (Hypericum perforatum). Dysglycemia w/ fluoroquinolones. Potentiation of anticoagulant therapy (warfarin).
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 MR tab 60 mg
Packing/Price
60's (P1,599.49/box)
Form
Diamicron tab 80 mg
Packing/Price
60's (P487.5/box)
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