Glibenclamide + metformin


Generic Medicine Info
Administration
Should be taken with food.
Contraindications
Acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma; acute conditions that may alter renal function (e.g. severe infection, shock, dehydration); acute or chronic disease which may cause tissue hypoxia (e.g. unstable CHF, respiratory failure, recent MI, acute significant blood loss, sepsis, gangrene); elective major surgery (discontinue use 48 hours before surgery and until 48 hours afterwards), porphyria. Acute alcohol intoxication or alcoholism. Renal (CrCl <60 mL/min) or hepatic impairment. Concomitant use with bosentan, miconazole and intravascular iodinated contrast agents.
Special Precautions
Patient with thyroid insufficiency, impaired adrenal and/or pituitary function; stable heart failure, other risk factors for lactic acidosis (e.g. inadequately controlled diabetes, ketosis, prolonged fasting, concomitant use of drugs that may cause lactic acidosis). Avoid use in patients with G6PD deficiency. Malnourished or debilitated patients. Elderly. Pregnancy and lactation. Not indicated for use in patients with type 1 diabetes mellitus. Patient Counselling This drug may cause dizziness or impaired mental alertness and capacity to react, if affected, do not drive or operate machinery. Monitoring Parameters Monitor blood glucose, HbA1c twice yearly (in patients with stable glycaemic control and are meeting treatment goals) or quarterly (in patients not meeting treatment goals or with treatment change); renal function prior to initiation, annually during treatment and when clinically indicated; haematologic parameters (e.g. Hb/haematocrit, RBC indices) and hepatic function prior to initiation, periodically during treatment or at least annually once on maintenance therapy; vitamin B12 level periodically during prolonged use and folate (if megaloblastic anaemia is suspected). Monitor for signs and symptoms of hypoglycaemia.
Adverse Reactions
Significant: Hypoglycaemia (may be severe), vitamin B12 deficiency (long-term use), haemolytic anaemia. Very rarely, disulfiram-like reactions. Gastrointestinal disorders: Diarrhoea, nausea, vomiting, abdominal pain, taste disturbance, heartburn, dyspepsia. Hepatobiliary disorders: Hepatocellular, mixed hepatocellular, and cholestatic liver injury. Rarely, cholestatic jaundice and hepatitis which may progress to liver failure. Investigations: Liver function abnormalities (e.g. elevated transaminase). Metabolism and nutrition disorders: Loss of appetite. Nervous system disorders: Headache, dizziness. Skin and subcutaneous tissue disorders: Pruritus, erythema, urticaria, maculopapular or morbilliform eruptions.
Potentially Fatal: Lactic acidosis, increased risk for CV mortality.
Drug Interactions
May result in impaired glucose tolerance with thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, oral contraceptives, estrogen, phenytoin, nicotinic acid, sympathomimetics, Ca channel blockers, and isoniazid. Glibenclamide: May enhance hypoglycaemic effect with chloramphenicol, ciprofloxacin, sulfamethoxazole/trimethoprim combination, sulfonamides, tetracyclines, disopyramide, MAOIs, NSAIDs (e.g. phenylbutazone), salicylates, coumarin derivatives, clofibrate, probenecid, ACE inhibitors (e.g. captopril, enalapril), anabolic steroids. β-blockers may mask the symptoms of hypoglycaemia (e.g. palpitations, tachycardia); majority of the non-cardioselective β-blockers may increase the severity and incidence of hypoglycaemia. May reduce hypoglycaemic effect with rifampicin and diazoxide. Increased half-life with fluconazole. Reduced plasma concentration and exposure with bile acid sequestrants (e.g. colesevelam); administer glibenclamide + metformin at least 4 hours before bile acid sequestrants. Reduced antidiuretic effect of desmopressin. Metformin: May increase the risk of lactic acidosis with carbonic anhydrase inhibitors (e.g. acetazolamide, dichlorphenamide), NSAIDs, ACE inhibitors, angiotensin II receptor blockers, diuretics (particularly loop diuretics). May reduce efficacy with organic cationic transporter (OCT)-1 inhibitors (e.g. verapamil). Increased plasma concentration and reduced clearance with OCT2 inhibitors (e.g. cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole). May increase absorption and efficacy with OCT1 inducers (e.g. rifampicin). May decrease the anticoagulant effect of vitamin K antagonists.
CIMS Class
Antidiabetic Agents
ATC Classification
A10BA02 - metformin ; Belongs to the class of biguanides. Used in the treatment of diabetes.
A10BB01 - glibenclamide ; Belongs to the class of sulfonylureas. Used in the treatment of diabetes.
Disclaimer: This information is independently developed by CIMS based on glibenclamide + metformin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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