Adult: As an adjunct to diet and exercise to improve glycaemic control: As conventional tab: Initially, 2.5-5 mg once daily, may be adjusted at intervals of several days in increments of 2.5-5 mg daily according to patient response. Doses >15 mg daily may be given in 2 divided doses. Max: 20 mg daily. As extended-release tab: Initially, 2.5-5 mg once daily, may be adjusted based on patient response. Max: 20 mg daily. Dosage recommendations may vary among individual products and between countries (refer to specific product guidelines). Elderly: As conventional or extended-release tab: Initially, 2.5 mg once daily. Maintenance dosing must be conservative.
Renal Impairment
Mild to moderate: As conventional or extended-release tab: Initially, 2.5 mg once daily. Maintenance dosing must be conservative. Severe: Contraindicated.
Hepatic Impairment
Mild to moderate: As conventional or extended-release tab: Initially, 2.5 mg once daily. Maintenance dosing must be conservative. Severe: Contraindicated.
Administration
immediate-release: Should be taken on an empty stomach. Take 30 min before meals. extended-release: Should be taken with food. Swallow whole, do not chew/crush/divide.
Contraindications
Hypersensitivity to glipizide, other sulfonylureas or sulfonamides. Type 1 diabetes mellitus, diabetic ketoacidosis (with or without coma), severe thyroid impairment. Severe renal and hepatic impairment.
Special Precautions
Patient with G6PD deficiency, adrenal or pituitary insufficiency, risk factors for hypoglycaemia (e.g. deficient caloric intake, following rigorous or prolonged exercise, alcohol intake); stress-related states (e.g. fever, trauma, surgery, infection); porphyria. Avoid administration of extended-release tab in patients who have severe gastrointestinal narrowing (pathologic or iatrogenic). Debilitated or malnourished patients. Concomitant use with miconazole. Mild to moderate renal and hepatic impairment. Elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Hypoglycaemia (may be severe); haemolytic anaemia (particularly in patients with G6PD deficiency). Blood and lymphatic system disorders: Leucopenia, aplastic anaemia, pancytopenia, agranulocytosis, thrombocytopenia. Eye disorders: Blurred vision. Gastrointestinal disorders: Nausea, abdominal pain, diarrhoea, vomiting, constipation, gastralgia. General disorders and administration site conditions: Malaise. Hepatobiliary disorders: Cholestatic jaundice, hepatic porphyria. Metabolism and nutrition disorders: Hyponatraemia, SIADH. Nervous system disorders: Dizziness, drowsiness, headache, tremor. Psychiatric disorders: Confusional state. Skin and subcutaneous tissue disorders: Eczema, erythema, morbilliform or maculopapular rash, pruritus, urticaria, photosensitivity reaction, porphyria cutanea tarda.
This drug may impair the ability to concentrate and react due to hypoglycaemia, if affected, do not drive or operate machinery.
Monitoring Parameters
Monitor blood and urine glucose levels periodically, HbA1c (at least twice yearly in patients with stable glycaemic control and are meeting treatment goals; quarterly for those who have not met the treatment goals or with change in treatment); hepatic and renal function; weight. Assess for signs and symptoms of hypoglycaemia.
Overdosage
Symptoms: Hypoglycaemia; severe hypoglycaemic reactions with seizure, coma or other neurological impairment may also occur infrequently. Management: Supportive treatment. Mild hypoglycaemic symptoms (without loss of consciousness or neurologic manifestations) may be treated with oral glucose and adjustments in glipizide dosage and/or meal schedule. In case of suspected or diagnosed hypoglycaemic coma, administer a rapid IV inj of 50% glucose solution, followed by continuous infusion of 10% glucose solution at a rate sufficient to maintain blood glucose levels >100 mg/dL. Subsequent administration of IV glucagon and/or corticosteroids may also be needed in some patients. Closely monitor the patient for at least 24-48 hours.
Drug Interactions
May increase the risk of severe hypoglycaemia possibly leading to coma with miconazole. Increased hypoglycaemic effect with other antidiabetic agents, NSAIDs (e.g. phenylbutazone), salicylates, ACE inhibitors, ARBs, MAOIs, quinolones, fibrates, sulfonamides, chloramphenicol, fluconazole, voriconazole, probenecid, disopyramide, fluoxetine, pentoxifylline, coumarins, histamine (H2) receptor antagonists (e.g. cimetidine), and β-blockers. Symptoms of hypoglycaemia (e.g. palpitations, tachycardia) may be masked by β-blockers. Decreased hypoglycaemic effect with danazol, phenothiazines (e.g. chlorpromazine at doses >100 mg daily), atypical antipsychotic agents (e.g. clozapine, olanzapine), corticosteroids, sympathomimetics (e.g. ritodrine, salbutamol, terbutaline), thiazides and other diuretics, glucagon, estrogens, progestogens, oral contraceptives, thyroid hormones, phenytoin, nicotinic acid, Ca channel blockers, and isoniazid. Colesevelam may decrease the serum concentration of glipizide (extended-release tab).
Food Interaction
May delay absorption with food (conventional tab). Increased hypoglycaemic response with alcohol.
Action
Description: Mechanism of Action: Glipizide, a sulfonylurea antidiabetic agent, decreases blood glucose concentrations by stimulating the insulin release from pancreatic β-cells and reduces glucose output from the liver. It also increases insulin sensitivity at peripheral target sites. Duration: Up to 24 hours. Pharmacokinetics: Absorption: Rapidly and completely absorbed from the gastrointestinal tract (conventional tab). May delay absorption with food (conventional tab). Bioavailability: 90-100%. Time to peak plasma concentration: 1-3 hours (conventional tab); 6-12 hours (extended-release tab). Distribution: Plasma protein binding: 98-99%, mainly to albumin. Metabolism: Extensively metabolised in the liver by CYP2C9 to form inactive metabolites. Excretion: Mainly via urine (80% as metabolites, <10% as unchanged drug); faeces (10%). Elimination half-life: 2-5 hours.
Chemical Structure
Glipizide Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 3478, Glipizide. https://pubchem.ncbi.nlm.nih.gov/compound/Glipizide. Accessed Mar. 22, 2024.
Storage
Conventional tab: Store below 30°C. Protect from light. Extended-release tab: Store between 20-25°C. Protect from moisture and humidity. Storage recommendations may vary among individual products and between countries (refer to specific product guidelines).
A10BB07 - glipizide ; Belongs to the class of sulfonylureas. Used in the treatment of diabetes.
References
Anon. Glipizide. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 29/02/2024.Anon. Glipizide. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 29/02/2024.Buckingham R (ed). Glipizide. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 29/02/2024.Glipizide 5 mg Tablets (Generics [UK] Ltd t/a Mylan). MHRA. https://products.mhra.gov.uk. Accessed 29/02/2024.Glipizide Tablet (Accord Healthcare Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 29/02/2024.Glucotrol XL Tablet, Extended Release (Roerig). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 29/02/2024.Joint Formulary Committee. Glipizide. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 29/02/2024.Minidiab Tablet (Pfizer [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 29/02/2024.Pfizer New Zealand Limited. Minidiab 5 mg Tablet data sheet 28 May 2019. Medsafe. http://www.medsafe.govt.nz. Accessed 29/02/2024.
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