Azoren Use In Pregnancy & Lactation

Pregnancy (see Contraindications): There are no data about the use of Azoren in pregnant patients. Animal reproductive toxicity studies with Azoren have not been performed.
Olmesartan medoxomil (active ingredient of Azoren): The use of angiotensin II antagonists is not recommended during the first trimester of pregnancy (see Precautions). The use of angiotensin II antagonists is contraindicated during the second and third trimester of pregnancy (see Contraindications and Precautions).
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however, a small increase in risk cannot be excluded. Whilst there is no controlled epidemiological data on the risk with angiotensin II antagonists, similar risks may exist for this class of drugs. Unless continued angiotensin II antagonists 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 antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started.
Exposure to angiotensin II antagonists 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) (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Should exposure to angiotensin II antagonists have occurred from the second trimester on, ultrasound check of renal function and skull is recommended. Infants whose mothers have taken angiotensin II antagonists should be closely observed for hypotension (see Contraindications and Precautions).
Amlodipine (active ingredient of Azoren): Data on a limited number of exposed pregnancies do not indicate that amlodipine or other calcium receptor antagonists have a harmful effect on the health of the fetus. However, there may be a risk of prolonged delivery.
As a consequence, Azoren is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimesters of pregnancy (see Contraindications and Precautions).
Lactation: Olmesartan is excreted into the milk of lactating rats. However, it is not known whether olmesartan medoxomil passes into human milk. Limited available data from a published clinical lactation study report that amlodipine is present in human milk at an estimated median relative infant dose of 4.2%. No adverse effects of amlodipine on the breast-fed infant have been observed. There is no available information on the effects of amlodipine on milk production.
During breast-feeding, Azoren is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or pre-term infant.
Fertility: Reversible biochemical changes in the head of spermatozoa have been reported in some patients treated by calcium channel blockers. Clinical data are insufficient regarding the potential effect of amlodipine on fertility. In one rat study, adverse effects were found on male fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).