Irbesartan oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of irbesartan.
Drugs List
Therapeutic Indications
Uses
Renal disease in hypertensive type 2 diabetic patients
Treatment of essential hypertension
Dosage
Adults
Treatment of essential hypertension
Initial dose: 150mg once daily with or without food.
The dose can be increased to 300mg once daily if necessary, or other antihypertensive agents may be added.
Treatment of renal disease in hypertensive type 2 diabetic patients
Initial dose: 150mg once daily.
Maintenance dose: 300mg once daily.
Elderly
A lower initial dose of 75mg once daily should be considered for patients over 75 years.
The dose can be gradually increased to 300mg once daily if necessary, or other antihypertensive agents may be added.
Patients with Renal Impairment
A lower initial dose of 75mg once daily should be considered for patients undergoing haemodialysis.
The dose can be gradually increased to 300mg once daily if necessary, or other antihypertensive agents may be added.
There is no experience regarding administration in patients with a recent kidney transplantation.
Contraindications
Children under 18 years
Breastfeeding
Pregnancy
Precautions and Warnings
Patients over 75 years
Vascular tone dependent on renin-angiotensin system
Aortic stenosis
Bilateral renal artery stenosis
Diabetes mellitus
Electrolyte depletion
Galactosaemia
Glucose-galactose malabsorption syndrome
Haemodialysis
Hyperkalaemia
Hypertrophic obstructive cardiomyopathy
Hyponatraemia
Hypovolaemia
Ischaemic heart disease
Kidney transplantation
Lactose intolerance
Mitral stenosis
Renal impairment
Renovascular disorder
Severe congestive cardiac failure
Unilateral stenosis of solitary functioning kidney
Patients with primary aldosteronism may not benefit from this treatment
Advise ability to drive/operate machinery may be affected by side effects
Afro-Caribbean or black patients may show reduced response
Correct volume and/or salt depletion before initiating therapy
Reduce initial dose in the elderly
Some formulations contain lactose
Evaluate renal function before and during treatment
Monitor serum electrolytes before and during treatment
Diabetic control may need adjustment
Monitor blood glucose closely in patients with diabetes mellitus
Monitor blood pressure
Monitor serum potassium regularly
Increased risk of hyperkalaemia with K+ suppl. and K+ sparing diuretic
Increased risk of hypoglycaemia
Advise patient to seek advice at first indications of pregnancy
Advise patient not to take NSAIDs unless advised by clinician
Advise on problems of salt substitutes/high intake of potassium-rich food
Female: Ensure adequate contraception during treatment
Dual blockade of the renin angiotensin aldosterone system through combined use of angiotensin II receptor antagonists, ACE inhibitors or aliskiren is not recommended. It should only occur under specialist supervision. Angiotensin II receptor antagonists and ACE inhibitors should not be used concomitantly in patients with diabetic nephropathy.
In patients whose vascular tone and renal function may depend on the activity of the renin angiotensin aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease), treatment with angiotensin II receptor antagonists has been associated with acute hypotension, oliguria and/ or progressive azotaemia and in rare cases with acute renal failure. As with any antihypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in myocardial infarction or stroke.
Pregnancy and Lactation
Pregnancy
Irbesartan is contraindicated during pregnancy.
The manufacturer does not recommend using irbesartan during pregnancy. Angiotensin II receptor antagonists are not recommended in the first trimester of pregnancy and are contraindicated in the second and third trimesters. If pregnancy is detected during therapy, irbesartan should be discontinued as soon as possible and alternative treatment should be offered. Guidelines advise that women who are taking angiotensin II receptor blockers are told that there is an increased risk of congenital abnormalities if these drugs are taken during pregnancy and other antihypertensive treatments should be discussed and offered. It is not known whether irbesartan crosses the placenta in humans, but due to the low molecular weight it is expected. Animal studies have shown teratogenic effects, and as such a potential risk to humans cannot be excluded. A detailed ultrasound is recommended following exposure during the first trimester and in cases of long term prenatal therapy in the second or third trimester to monitor and assess the foetus. Newborn renal function and blood pressure should be closely monitored.
Lactation
Irbesartan is contraindicated during breastfeeding.
The manufacturer does not recommend using irbesartan while breastfeeding. Animal studies report irbesartan in breast milk, however presence in human breast milk is unknown. The safety of irbesartan has not been established during breastfeeding. The low molecular weight indicates that excretion into breast milk should be expected. However, most angiotensin II receptor antagonists are highly protein bound, which can substantially limit their transfer into breast milk. Schaefer (2015) suggests that accidental administration of a single dose does not require weaning, however, therapy should be changed to an antihypertensive which has been better studied in breastfeeding.
Side Effects
Abnormal liver function
Anaphylactic reaction
Anaphylactic shock
Angioedema
Arthralgia
Chest pain
Cough
Creatine kinase increased
Decrease in haemoglobin
Diarrhoea
Dizziness
Dysgeusia
Dyspepsia
Fatigue
Flushing
Headache
Heartburn
Hepatitis
Hyperkalaemia
Hypersensitivity reactions
Hypoglycaemia
Hypotension
Impaired renal function
Jaundice
Leukocytoclastic vasculitis
Muscular cramps
Musculoskeletal pain
Myalgia
Nausea
Orthostatic hypotension
Postural dizziness
Rash
Renal failure
Sexual dysfunction
Tachycardia
Thrombocytopenia
Tinnitus
Urticaria
Vertigo
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site (www.toxbasebackup.org ).
Further Information
Last Full Review Date: April 2019
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.
Summary of Product Characteristics: Aprovel 75mg Film-Coated Tablets. Sanofi. Revised July 2018.
Summary of Product Characteristics: Aprovel 150mg Film-Coated Tablets. Sanofi. Revised July 2021.
Summary of Product Characteristics: Aprovel 300mg Film-Coated Tablets. Sanofi. Revised July 2021.
Summary of Product Characteristics: Ifirmasta 75mg Film-Coated Tablets. Consilient Health Ltd. Revised October 2016.
Summary of Product Characteristics: Ifirmasta 150mg Film-Coated Tablets. Consilient Health Ltd. Revised October 2016.
Summary of Product Characteristics: Ifirmasta 300mg Film-Coated Tablets. Consilient Health Ltd. Revised October 2016.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 10 April 2019.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Irbesartan , Last revised: 28 February 2019.
Last accessed: 10 April 2019.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.