Alzor CCB Use In Pregnancy & Lactation

Pregnancy: There are no data about the use of Olmesartan medoxomil plus Amlodipine combination in pregnant patients. Animal reproductive toxicity studies with Olmesartan medoxomil plus Amlodipine combination have not been performed.
Olmesartan medoxomil (active ingredient of Olmesartan medoxomil plus Amlodipine combination): The use of angiotensin II antagonists is not recommended during the first trimester of pregnancy. The use of angiotensin II antagonists is contraindicated during the 2nd and 3rd trimesters of pregnancy.
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 and hyperkalemia).
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.
Amlodipine (active ingredient of Olmesartan medoxomil plus Amlodipine combination): 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, Olmesartan medoxomil plus Amlodipine combination is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimesters of pregnancy.
Breastfeeding: Olmesartan is excreted into the milk of lactating rats. However, it is not known whether olmesartan passes into human milk. It is not known whether amlodipine is excreted in breast milk. Similar calcium channel blockers of the dihydropyridine type are excreted in breast milk.
Because no information is available regarding the use of olmesartan and amlodipine during breast-feeding, Olmesartan medoxomil plus Amlodipine combination is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.