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Amlodipine / hydrochlorothiazide / olmesartan Pregnancy and Breastfeeding Warnings

Amlodipine / hydrochlorothiazide / olmesartan is also known as: Tribenzor

Amlodipine / hydrochlorothiazide / olmesartan Pregnancy Warnings

Amlodipine/hydrochlorothiazide/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 drugs that act directly on the renin-angiotensin system (such as olmesartan). Drugs acting directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women. If exposure occurs beyond the first trimester, the intra-amniotic environment should be evaluated by serial ultrasound examinations. When pregnancy is expected or detected, amlodipine/hydrochlorothiazide/olmesartan should be discontinued as soon as possible. In the rare instance when another antihypertensive agent cannot be used to treat the pregnant patient, routine serial ultrasound tests should be performed as well as fetal testing with nonstress examinations, biophysical profiles, and/or contraction stress tests may be appropriate based on gestational age and standards of care.

Drugs that act directly on the renin-angiotensin system (such as olmesartan) 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, amlodipine/hydrochlorothiazide/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 exposure. 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 amlodipine/hydrochlorothiazide/olmesartan as soon as possible.

Amlodipine / hydrochlorothiazide / olmesartan Breastfeeding Warnings

There are no data on the excretion of amlodipine or olmesartan into human milk, but olmesartan is excreted in low concentrations into the milk of lactating rats. Hydrochlorothiazide (HCTZ) is excreted into human milk in low concentrations; however the nursing infant is exposed to an amount of HCTZ that is considered to be insignificant. 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 amlodipine/hydrochlorothiazide/olmesartan, taking into account the importance of the drug to the mother.

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