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Azilsartan oral

Updated 2 Feb 2023 | Angiotensin-II antagonists


Oral formulations of azilsartan medoxomil (as potassium)

Drugs List

  • azilsartan 20mg tablets
  • azilsartan 40mg tablets
  • azilsartan 80mg tablets
  • EDARBI 20mg tablets
  • EDARBI 40mg tablets
  • EDARBI 80mg tablets
  • Therapeutic Indications


    Treatment of essential hypertension



    The recommended starting dose is 40 mg once daily. The dose may be increased to a maximum of 80 mg once daily for patients whose blood pressure is not adequately controlled at the lower dose.

    The near-maximal antihypertensive effect is seen at 2 weeks, with maximal effects attained by 4 weeks after starting therapy.

    If blood pressure is not adequately controlled with azilsartan medoxomil alone, additional blood pressure reduction can be achieved when azilsartan medoxomil is coadministered with other antihypertensives, including diuretics (for example chlortalidone and hydrochlorothiazide) and calcium channel blockers.


    Patients up to 75 years:
    (See Dosage; Adult)

    Patients 75 years and over:
    A lower starting dose of 20 mg once daily should be considered.

    Patients with Hepatic Impairment

    Mild to moderate hepatic impairment
    A lower starting dose of 20 mg once daily should be considered under close monitoring.

    Additional Dosage Information

    Intravascular volume depletion
    Patients with possible depletion of intravascular volume or salt depletion (e.g. patients with vomiting, diarrhoea or taking high doses of diuretics), azilsartan medoxomil should be initiated under close medical supervision and consideration can be given to 20 mg as a starting dose.


    Children under 18 years
    Severe bilateral renal artery stenosis
    Severe hepatic impairment
    Severe unilateral stenosis of solitary functioning kidney

    Precautions and Warnings

    Patients over 75 years
    Aortic stenosis
    Bilateral renal artery stenosis
    End stage renal disease
    Hepatic impairment
    Hypertrophic obstructive cardiomyopathy
    Mitral stenosis
    Peripheral vascular disease
    Renovascular disorder
    Severe congestive cardiac failure
    Severe generalised atherosclerosis
    Severe renal impairment
    Unilateral stenosis of solitary functioning kidney

    Consider reducing initial dose in hepatic impairment
    Patients with primary aldosteronism may not benefit from this treatment
    Switch to more suitable alternative before planned pregnancy
    Advise ability to drive/operate machinery may be affected by side effects
    Advise patient that first dose hypotension may occur
    Afro-Caribbean or black patients may show reduced response
    Correct volume and/or salt depletion before initiating therapy
    Evaluate renal function before and during treatment
    Monitor serum electrolytes before and during treatment
    Monitor serum potassium regularly
    Increased risk of hyperkalaemia with K+ suppl. and K+ sparing diuretic
    Advise patient to seek advice at first indications of pregnancy
    Consider reducing initial dose in the elderly
    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

    In patients whose renal function may depend on the activity of the renin-angiotensin system (e.g. patients with severe congestive heart failure), treatment with ACE inhibitors has been associated with oliguria and/ or progressive azotaemia and in rare cases with acute renal failure and/ or death. As azilsartan medoxomil is an angiotensin II antagonist, it cannot be excluded that the use of this medication may be associated with impairment of the renal function.

    Pregnancy and Lactation


    Azilsartan medoxomil is contraindicated in pregnancy.

    Angiotensin II receptor antagonists may be associated with similar risks as ACE inhibitors. Angiotensin II receptor antagonist exposure during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).

    The MHRA states that the use of angiotensin II receptor antagonists in late pregnancy has been associated with adverse effects on the foetal kidney and other congenital anomalies, therefore angiotensin II receptor antagonists should not be used at any stage during of pregnancy unless absolutely necessary and only then after the potential risks and benefits have been discussed with the patient.

    Exposure to angiotensin II receptor antagonists during the first trimester has been inconclusive, however, a small increase in risk cannot be excluded and a detailed ultrasound is recommended.

    If pregnancy is detected during therapy, azilsartan medoxomil 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.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Azilsartan medoxomil is contraindicated in breastfeeding.

    Schaefer (2007) 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. The MHRA concludes that the use of angiotensin II receptor antagonists in breastfeeding mothers is not recommended. Alternative agents with more established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm baby.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Blood urea increased
    Creatine phosphokinase increased
    Decrease in haematocrit
    Haemoglobin decrease
    Muscle spasm
    Peripheral oedema
    Serum creatinine increased


    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 ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: June 2015

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press Accessed on 15 June 2015.

    Martindale: The Complete Drug Reference (online) London: Brayfield A (ed). Pharmaceutical Press Accessed on 15 June 2015.

    Summary of Product Characteristics: Edarbi tablets. Takeda UK Ltd. Revised September 2014.

    MHRA Drug Safety Update May 2009
    Available at:
    Last accessed: 15 June, 2015

    National Institute for Health and Clinical excellence (NICE) clinical guidance 107: Hypertension in pregnancy. Issue date August 2010
    Available at:
    Last accessed: 15 June, 2015

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Azilsartan Last revised: 10 March, 2015
    Last accessed: 15 June, 2015

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