Hyponorm MR Tablets / Modified Release
Gliclazide
30mg
Pharmax Pharmaceuticals FZ LLC
| Pack size | 30’s (15's blister x2) |
|---|---|
| Dispensing mode | POM |
| Source | UAE |
| Agent | AL ITTIHAD DRUG STORE |
| Retail Price | 17.50 AED |
Indications
Hyponorm MR Tablets / Modified Release is used for:
Type 2 DM
Adult Dose
Oral
Type 2 diabetes mellitus
Adult: Initially, 40-80 mg daily gradually increased to 320 mg daily if necessary. Doses >160 mg daily are given in 2 divided doses.
Modified-release tab: Initially, 30 mg once daily, may increase in increments of 30 mg up to max 120 mg daily. Interval between doses should be at least 1 mth.
For non-respondent patients, dose may be increased after 2 wk.
Child Dose
Renal Dose
Administration
Should be taken 30 mintues before meal or with meal.
Contra Indications
Type 1 DM, diabetes complicated with ketoacidosis; hypersensitivity; severe renal and hepatic impairment. Pregnancy and lactation.
Precautions
Monitor blood glucose concentration. May require insulin during metabolic stress. Care when transferring from combination therapy. Increased risk of severe hypoglycaemia in elderly, debilitated patients, patients with hepatic or renal impairment. Risk of hypogylcaemia when caloric intake is deficient, after strenuous exercise, when taken with ethanol or when >1 antidiabetic drug is used.
Pregnancy-Lactation
Pregnancy
Available data from a small number of published studies and postmarketing experience in pregnancy over decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal outcomes. However, sulfonylureas (including glimepiride) cross the placenta and have been associated with neonatal adverse reactions such as hypoglycemia; therefore, therapy should be discontinued at least two weeks before expected delivery; poorly controlled diabetes in pregnancy is also associated with risks to mother and fetus
Fetal neonatal adverse reactions
Neonates of women with gestational diabetes who are treated with sulfonylureas during pregnancy may be at increased risk for neonatal intensive care admission and may develop respiratory distress, hypoglycemia, birth injury, and be large for gestational age; prolonged severe hypoglycemia, lasting 4–10 days, reported in neonates born to mothers receiving a sulfonylurea at time of delivery and has been reported with use of agents with prolonged half-life; observe newborns for symptoms of hypoglycemia and respiratory distress and manage accordingly
Dose adjustments during pregnancy and postpartum period
Due to reports of prolonged severe hypoglycemia in neonates born to mothers receiving sulfonylurea at time of delivery, therapy should be discontinued at least two weeks before expected delivery
Lactation
Breastfed infants of lactating women in therapy should be monitored for symptoms of hypoglycemia; not known whether drug is excreted in human milk and there are no data on effects of drug on milk production; drug is present in rat milk; developmental and health benefits of breastfeeding should be considered along with mother's clinical need for drug and any potential adverse effects on breastfed child from drug or from underlying maternal condition
Monitor breastfed infants for signs of hypoglycemia (e.g., jitters, cyanosis, apnea, hypothermia, excessive sleepiness, poor feeding, seizures)
Interactions
May increase hypoglycaemic effect w/ phenylbutazone. Potentiation of blood glucose lowering effect w/ other antidiabetics (e.g. acarbose, insulins, metformin), beta-blockers, ACE inhibitors, H2-receptor antagonists, MAOIs, sulfonamides, clarithromycin and NSAIDs. Chlorpromazine, glucocorticoids, ritodrine, salbutamol and terbutaline may cause increases in blood glucose levels. May diminish hypoglycaemic effect w/ danazol. May increase anticoagulant effect of warfarin.
Potentially Fatal: Increased hypoglycaemic effect w/ miconazole
Adverse Effects
Side effects of Gliclazide :
GI disturbances, skin reaction, leucopenia, thrombocytopenia, agranulocytosis, haemolytic anaemia, cholestatic jaundice, vomiting, diarrhoea, gastritis, increased transaminases.
Mechanism of Action
Gliclazide stimulates insulin secretion from pancreatic beta-cells, reduces insulin uptake and glucose output by the liver, and increases insulin sensitivity at peripheral target sites. It decreases microthrombosis by partial inhibition of platelet aggregation and adhesion, and by restoring fibrinolysis w/ an increase in tissue plasminogen activator (t-PA) activity.
Note
Hyponorm MR 30mg Tablets / Modified Release manufactured by Pharmax Pharmaceuticals FZ LLC. Its generic name is Gliclazide. Hyponorm MR is availble in United Arab Emirates.
Farmaco UAE drug index information on Hyponorm MR Tablets / Modified Release is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.