Glibenclamide

Registered South African indications:

• Diabetes mellitus

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to sulfonylureas
• Insulin-dependent diabetics
• Diabetes in young people
• Diabetes mellitus complicated by ketoacidosis and in those with severe infection, stress, trauma, and severe impairment of renal, hepatic, or thyroid function
• Chronic liver disease including that caused by uncompensated cardiac failure or alcoholism
• Patients with seriously impaired adrenal function
• Diabetes mellitus in patients with a history of metabolic decompensation e.g., acidosis, diabetic pre-coma, and coma
• Pregnancy
• Lactation

Cautions

• Mild to moderate renal impairment
• Mild to moderate hepatic impairment
• Galactose intolerance
• Lapp lactase deficiency
• Glucose galactose malabsorption
• Debilitated or malnourished patients
• Excessive exercise
• Adrenal insufficiency
• Pituatary insufficiency

Forms avail. in SA and covered in this monograph: tab

Non insulin-dependent diabetes mellitus

• Oral (tab): Initial: 5mg, Titrate by 2.5mg at intervals of 7 days; Maintenance: 5-15mg

Doses greater than 10mg/day can be given in two divided doses

Not established for use in children

Pregnancy

• Contraindicated
• Agents other than glibenclamide are currently recommended to treat diabetes in pregnant women

Breastfeeding:

• Contraindicated

Renal Impairment

• GFR ≥30-89 ml/min: Caution; dose adjustment recommended
  Type 2 diabetes mellitus (not on insulin); Max maintenance dose: 10mg/24hrs
  Type 2 diabetes mellitus (previously maintained on insulin): Max maintenance dose: 5mg/24hrs
• GFR ≤29 ml/min: Contraindicated

Hepatic Impairment

• Mild to moderate (Child-Pugh class A and B): Caution; dose adjustment recommended
  Maintenance dosage should not exceed 5mg/24hrs
• Severe (Child-Pugh class C): Contraindicated
  Includes patients with profound hepatic-biliary disease (hepatitis, cirrhosis, gallbladder disorders) or patients taking hepatotoxic therapy

Elderly

• > 70 years: Contraindicated

Porphyria Information

• Possibly porphyrinogenic (PSP)

Drugs in Sport

• Permitted - No warnings

Gastrointestinal Disorders

• Nausea and vomiting
• Heartburn
• Anorexia
• Metallic taste
• Epigastric discomfort
• Abdominal pain
• Diarrhoea

Hepatobiliary Disorders

• Elevated liver enzymes
• Cholestatic jaundice

Endocrine and Metabolic Disorders

• Hypoglycaemia
• Inappropriate secretion of antidiuretic hormone
• Hyponatraemia

Skin and Subcutaneous Tissue Disorders

• Pruritis
• Rash
• Photosensitivity
• Urticaria
• Steven-Johnson syndrome
• Erythema nodosum
• Exfoliative dermatitis
• Erythema multiforme

Immune, Blood and Lymphatic System Disorders

• Thrombocytopenia
• Leukopenia
• Agranulocytosis
• Pancytopenia
• Haemolytic anaemia
• Erythrocytopenia
• Granulocytopenia
• Hypersensitivity reactions

Sensory Disorders

• Temporary visual impairment

• Bosentan
• Warfarin
• Ciclosporin
• Immunosuppressants
• Rifampicin
• Thiazide diuretics
• Beta blockers
• Alcohol
• Heparin
• Lipid-regulating agents
• Antidepressants
• Angiotensin converting enzyme inhibitors
• Antihistamine
• Methyldopa
• Sulphinpyrazone
• Anti-infective agents
• Non-steroidal anti-inflammatory drugs
• Corticosteroids
• Oral contraceptives

None routine

Glibenclamide is a sulphonylurea which is an oral hypoglycaemic medicine. Sulphonylureas stimulate the pancreatic islet tissue to secrete insulin by causing degranulation of the β-cells.

Tablet 5mg 

• Bio-Glibenclamide (Biotech Laboratories)
• Diacare (Be-Tabs Pharma)
• Euglucon (Roche) originator
• Glycomin (Pharmacare)
• Sandoz Glibenclamide (Sandoz)
• Glibenclamide 5 Oethmaan (Oethmaan Biosims)

COMBINATION PREPARATIONS

Metformin/Glibenclamide

Tablet 250mg/1.25mg

• Glucovance (Merck) originator

Metformin/Glibenclamide

Tablet 500mg/2.5mg

• Glucovance (Merck) originator

Metformin/Glibenclamide

Tablet 500mg/5mg

• Glucovance (Merck) originator