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Amlodipine / olmesartan Pregnancy and Breastfeeding Warnings

Amlodipine / olmesartan is also known as: Azor

Amlodipine / olmesartan Pregnancy Warnings

Amlodipine-olmesartan has been assigned to pregnancy category D by the FDA. Animal data have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy. Spontaneous abortion, oligohydramnios and newborn renal dysfunction have been reported when pregnant women inadvertently took angiotensin II receptor blockers. Drugs acting directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women. Use of amlodipine-olmesartan during pregnancy is considered contraindicated. When pregnancy is detected or expected, amlodipine-olmesartan should be discontinued as soon as possible.

No evidence of teratogenicity or embryo/fetal toxicity was reported when pregnant rats and rabbits were treated with amlodipine (doses 10 to 20 times the maximum recommended human dose) during periods of major organogenesis. However, in rats receiving amlodipine, litter size was significantly decreased and intrauterine deaths were significantly increased. Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered during pregnancy. Several dozen cases have been reported in the world literature in patients who were taking angiotensin converting enzyme (ACE) inhibitors. A committee of the National Institutes of Health has recommended that these drugs be avoided during pregnancy. When pregnancy is detected or expected, olmesartan should be discontinued as soon as possible. The use of drugs that act directly on the renin-angiotensin system during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function; oligohydramnios in this setting has been associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus have also been reported, although it is not clear whether these occurrences were due to exposure to the drug. These adverse effects do not appear to have resulted from intrauterine drug exposure that has been limited to the first trimester. Mothers whose embryos and fetuses are exposed to an angiotensin II receptor antagonist only during the first trimester should be informed. Nonetheless, when patients become pregnant, physicians should have the patient discontinue the use of olmesartan as soon as possible. Animal data have failed to reveal evidence of teratogenicity when olmesartan was given to pregnant rats at oral doses up to 1000 mg/kg/day and to pregnant rabbits at oral doses up to 1 mg/kg/day. However, significant decreases in fetal weight, pup birth weight, delays in developmental milestones, and dose-dependent increases in the incident of dilation of the renal pelvis were observed in studies in which parental rats were treated with olmesartan at doses of greater than 8 mg/kg/day.

Amlodipine / olmesartan Breastfeeding Warnings

There are no data on the excretion of amlodipine-olmesartan into human milk. Olmesartan is secreted at low concentration in the milk of lactating rats. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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