RITEMED Glibenclamide 5mg Tablet 100's

Glibenclamide is used as an oral hypoglycemic drug that acts by eliciting the release of insulin from the pancreatic islet beta cells in patients with diabetes mellitus type II and by increasing the sensitivity of peripheral tissues to insulin.

 

Glibenclamide is initiated at 2.5 to 5 mg and is best given daily immediately before breakfast.
When necessary, the dose of the drug is adjusted at intervals with 2.5 mg increments, not to exceed 20 mg per day, although increasing it to 15 mg is unlikely to cause further benefit.
Doses more than 10 mg per day may be given in divided doses. The second dose is best given immediately before dinner.
Oral hypoglycemic drugs are given as adjuncts to diet modification in diabetic patients.

 

Overdosage

Should be taken with food: Take w/ breakfast or the 1st main meal of the day.

Glibenclamide is contraindicated to patients with insulin dependent diabetes mellitus or DM type I, to pregnant and lactating patients and to patients with significant hepatic and renal insufficiency.
In non-insulin dependent diabetes mellitus (NIDDM), glibenclamide is not recommended to be given to patients with hepatic or renal failure, ketoacidosis and those under stress, with severe infection, trauma or other severe conditions where the drug would unlikely control hyperglycemia. It is not safe to give glibenclamide to patients with porphyria.

Patients who are taking glibenclamide should take appropriate caution when driving, crossing the street, or operating machinery, in case hypoglycemia occurs. Intensive education and supervision is beneficial when prescribing glibenclamide and other oral hypoglycemic drugs to patients who may be fasting due to religious reasons (e.g. Ramadan).
Caution must be taken when giving glibenclamide to patients who are debilitated, malnourished and those with adrenal or pituitary insufficiency.
Use in patients with renal and hepatic impairment: Glibenclamide should be used with caution when given to patients with renal insufficiency and hepatic impairment. Risk of hypoglycemia is increased in the presence of severe hepatic impairment.
Use in patients with cardiovascular disease: Patients with cardiovascular disease must use glibenclamide with caution as this may cause hypoglycemia.
Use in Pregnancy: US FDA PREGNANCY CATEGORY C. (Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.)
Achieving normoglycemia is significant to pregnant women. If the patient is pregnant, treatment with glibenclamide or other oral hypoglycemic agents should be replaced by insulin, with the supervision of a physician.
Glibenclamide may enter fetal circulation which may cause neonatal hypoglycemia. Embryotoxicity and birth defects were seen after giving glibenclamide to animals.
Use in Lactation: Sulfonylureas, in general, are known to be excreted in breast milk. However, one study showed that glibenclamide was not found in breast milk.
Five women were given a daily dosage of 5 mg of glibenclamide starting on the first post partum day. No drug was detected in the breast milk of the mothers and hypoglycemia was not observed in the nursing infants.
Therefore, it is best to use glibenclamide with caution in lactating mothers.
Use in Elderly: Glibenclamide should be used with caution in elderly patients whom the incidence of hypoglycemia is at high risk.

 

Use In Pregnancy & Lactation

Among the adverse effects reported with the use of glibenclamide are headache, sleepiness, dizziness, nausea, vomiting, heartburn, diarrhea, constipation, abdominal pain, pruritus, rashes and photosensitivity. Also associated with the use of glibenclamide are cholestatic jaundice, eosinophilia, transient leucopenia, thrombocytopenia, aplastic anemia, agranulocytosis, haemolytic anemia, erythema multiforme, and exfoliative dermatitis.
The occurrence of hypoglycemia in patients taking glibenclamide is sometimes severe and prolonged. Lack of familiarity with the potent effects of the drug may lead to fatal outcomes. Hypoglycemic coma was also reported with glibenclamide use.
Increased appetite and weight gain may occur with the use of glibenclamide.
Glibenclamide is said to have mild diuretic action and may enhance water clearance.
In one study, a patient with diabetes mellitus type II developed myopia two days after initial treatment with glibenclamide. The visual difficulty, though, was resolved upon cessation of the use of the drug.

 

The effect of sulfonylureas may be reduced by epinephrine, chlorpromazine, corticosteroids, oral contraceptives thiazide diuretics and thyroid hormones.
Concomitant use with rifampicin reduces the hypoglycemic effect of glibenclamide.
In contrast, hypoglycemic effect may be heightened by ACE inhibitors, alcohol, allopurinol, selected analgesics such as phenylbutazone and salicylates, ketoconazole, fluconazole and miconazole, chloramphenicol, cimetidine, clofibrate coumarins fluoroquinolones, heparin, MAOIs, ranitidine, sulphonamides, tetracyclines and tricyclic antidepressants.
There were reports that beta-blockers may increase the hypoglycemic effect of glibenclamide and other sulfonylureas and may mask the typical sympathetic warning signs. However, a report that beta-blockers antagonize the hypoglycemic action of glibenclamide was also received. Beta-blockers are shown to have both hypoglycemic and intrinsic hyperglycemic activity of their own. Beta-blockers, when used in diabetic patients, might mask the early warning signs of hypoglycemia induced by the drug.
Reports on the effect of calcium channel blockers and sulfonylureas on glucose tolerance are contradictory. The effects, though, are clinically insignificant.

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Antidiabetic Agents