Azilsartan medoxomil

Azilsartan medoxomil is indicated for the treatment of essential hypertension in adults.

The use of angiotensin II receptor antagonists is not recommended during the first trimester of pregnancy.

The use of angiotensin II receptor antagonists is contraindicated during the second and third trimester of pregnancy.

There are no data from the use of azilsartan medoxomil in pregnant women. Studies in animals have shown reproductive toxicity.

Epidemiological evidence regarding the risk of teratogenicity following exposure to angiotensin converting enzyme inhibitors during the first trimester of pregnancy has not been conclusive; however, a small increase in risk cannot be excluded. Whilst there are no controlled epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of medicinal products.

Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately and, if appropriate, alternative therapy should be started.

Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).

Should exposure to angiotensin II receptor antagonists have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.

Infants whose mothers have taken Angiotensin II receptor antagonists should be closely observed for hypotension.

The concomitant use of azilsartan medoxomil with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m²).