Clamide Glibenclamide Tablet

CLAMIDE TABLET
Description

Oblong, white uncoated tablet bevel-edged, flat-faces, “HD” embossed and scored on the same face.

 
Composition

Each tablet contains Glibenclamide 5mg

 
Actions and Pharmacology

Glibenclamide reduces blood glucose concentration by increasing the secretion of insulin from the beta cells of islet tissue in functional pancreas. It also decreases hepatic glycogenolysis and gluconeogenesis as well as increases insulin sensitivity of extrapancreatic tissues.

Glibenclamide is widely distributed throughout the body and does not appear to accumulate.

It is extensively bound to plasma proteins and is excreted mainly via faeces.

 
Indications

For treatment of mild or moderately severe uncomplicated maturity-onset diabetes mellitus unresponsive to diet alone.

 

Contraindications

Not recommended for patients with burns, diabetic coma, severe infection, Type I diabetes mellitus, ketosis, ketoacidosis, major surgery, severe trauma, impaired renal, hepatic, thyroid or adrenal function, pregnancy and lactation.

 
Precautions

• Glucose urine tests and ketone tests should be monitored.

• To be taken in conjunction with meals.

• Obese patients should avoid sulphonylureas unless symptoms and diabetic control have not improved despite weight loss to within 1.5%.

• Clamide Tablet is not recommended for children

 
Main Side/Adverse Effects

• Nausea, vomiting, epigastric pain, dizziness, weakness, paraesthesia and sensitivity reactions.

• Prolonged hypoglycaemia has been reported following the ingestion of glibenclamide.

• Cross sensitivity to sulphonamides or their derivatives may occur. Transient visual disturbances may occur at the start of treatment. Reversible leucopenia and thrombocytopenia have been reported but are rare. Agranulocytosis, pancytopenia and haemolytic anaemia have been reported very rarely.

• Treatment with sulphonylureas has been associated with occasional disturbances of liver function and cholestatic jaundice. If hepatitis or cholestatic jaundice occurs, glibenclamide should be discontinued.

 

Drug Interactions and Incompatibilities

• Concurrent use with monoamine-oxidase inhibitors, oral anticoagulants, oxyphenbutazone, phenylbutazone and alcohol may increase glibenclamide activity.

• Blood glucose levels may be increased when used concurrently with corticosteroids, epinephrine, phenytoin, thiazide diuretics and thyroid hormones.

• Co-administration of beta-adrenergic blocking agents may mask symptoms of developing hypoglycaemia thus complicating patient monitoring.

• An increased hypoglycaemic effect has occurred or might be expected with ACE inhibitors, alcohol, allopurinol, some analgesics (notably azapropazone, phenylbutazone, and the salicylates), azole antifungals (fluconazole, ketoconazole, and miconazole), chloramphenicol, cimetidine, clofibrate and related compounds, coumarin anticoagulants, halofenate, heparin. MAOIs, octreotide (although this may also produce hyperglycaemia), ranitidine, sulphinpyrazone, sulphonamides (including co-trimoxazole), tetracyclines, tricyclic antidepressants, and thyroid hormones.

 
Overdosage

Clinical features: Nausea, vomiting, abdominal pain, drowsiness, coma, twitching, convulsions, hyperpnoea, sinus tachycardia, hypotension, hypoglycaemia and metabolic acidosis.

Treat overdosage by emesis or gastric lavage if appropriate and correct hypoglycaemia, if any, with 50ml of 50% glucose IV repeated as necessary and/or glucagon 1 – 2mg IV, followed by an IV infusion of 5 – 10% dextrose for 24 – 72
hours as necessary.

 
Dosage and administration

Oral, initially 5mg daily, the dosage then being adjusted as needed with maximum daily dose of 15mg if necessary.

The information given here is limited. For further information consult your doctor or pharmacist.

 
Storage

Store below 25°C. Protect from moisture.

 
Presentation/Packing

Tablet 5mg x 500’s, 1000’s, Blisters of l0 x 10’s.

 
Manufactured by

HOVID Bhd., 121, Jalan Tunku Abdul Rahman, 30010 Ipoh, Malaysia.
Revised date : September 2009

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