Irbesartan


Generic Medicine Info
Indications and Dosage
Oral
Hypertension
Adult: 150 mg once daily, may increase to 300 mg once daily if needed. Patient w/ intravascular volume depletion: Initially, 75 mg once daily.
Elderly: >75 yr Initially, 75 mg once daily.

Oral
Diabetic nephropathy in Type 2 diabetes mellitus
Adult: Initially, 150 mg once daily, may increase to 300 mg once daily if needed.
Renal Impairment
Hypertension: Haemodialysis: Initially, 75 mg once daily.
Administration
May be taken with or without food.
Contraindications
Concomitant use w/ aliskiren in patients w/ diabetes and renal impairment (GFR <60 mL/min). Pregnancy.
Special Precautions
Patients w/ unilateral or bilateral renal artery stenosis, depletion of intravascular volume, aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Renal impairment. Lactation.
Adverse Reactions
Diarrhoea, fatigue, dyspepsia or heartburn, dizziness, orthostatic hypotension, nausea, vomiting, musculoskeletal pain, thrombocytopaenia, hyperkalaemia, elevated serum creatinine.
Monitoring Parameters
Monitor renal function periodically; electrolytes and serum creatinine levels.
Overdosage
Symptoms: Hypotension, tachycardia, bradycardia. Management: Symptomatic and supportive treatment. Induction of emesis and/or gastric lavage. Activated charcoal may also be helpful.
Drug Interactions
May antagonise hypotensive effect and increase risk of nephrotoxicity w/ NSAIDs. May increase serum lithium levels and toxicity. Increased risk of hyperkalaemia w/ K-sparing diuretics (e.g. amiloride, triamterene, spironolactone), K supplements or K-containing salt substitutes.
Potentially Fatal: May increase nephrotoxic, hyperkalaemic and hypotensive effect w/ aliskiren in patients w/ diabetes and renal impairment (GFR <60 mL/min).
Action
Description: Irbesartan is an angiotensin II receptor antagonist. It blocks the vasoconstricting and aldosterone-secreting effects of angiotensin II by binding to AT1 receptors.
Onset: 1-2 hr.
Duration: >24 hr.
Pharmacokinetics:
Absorption: Rapidly absorbed from the GI tract. Bioavailability: 60-80%. Time to peak plasma concentration: 1.5-2 hr.
Distribution: Volume of distribution: 53-93 L. Plasma protein binding: Approx 96%.
Metabolism: Undergoes hepatic metabolism via CYP2C9 isoenzyme to inactive metabolites.
Excretion: Via bile and urine (as unchanged drug and metabolites); urine (approx 20%, <2% as unchanged drug). Terminal elimination half-life: Approx 11-15 hr.
Storage
Store between 15-30°C.
References
Anon. Irbesartan. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 12/12/2013.

Avapro (Sanofi Aventis). U.S. FDA. https://www.fda.gov/. Accessed 12/12/2013.

Avapro Tablet. U.S. FDA. https://www.fda.gov/. Accessed 12/12/2013.

Buckingham R (ed). Irbesartan. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 12/12/2013.

Drugs Affecting the Renin-Angiotensin System. U.S. FDA. https://www.fda.gov/. Accessed 12/12/2013.

Joint Formulary Committee. Irbesartan. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 12/12/2013.

McEvoy GK, Snow EK, Miller J et al (eds). Irbesartan. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 12/12/2013.

Disclaimer: This information is independently developed by MIMS based on Irbesartan from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS 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 MIMS. All rights reserved. Powered by MIMS.com
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