Amlodipine / hydrochlorothiazide / valsartan Pregnancy and Breastfeeding Warnings

Amlodipine / hydrochlorothiazide / valsartan is also known as: Exforge HCT

Amlodipine / hydrochlorothiazide / valsartan Pregnancy Warnings

Amlodipine/hydrochlorothiazide/valsartan has been assigned to pregnancy category D by the FDA. Valsartan, like other drugs that act on the renin angiotensin system, can cause fetal and neonatal morbidity and death when taken during the second or third trimester of pregnancy. Angiotensin II receptor antagonists, like valsartan, and angiotensin converting enzyme (ACE) inhibitors exert similar effects on the renin-angiotensin system. In several published cases, ACE inhibitor use during the second and third trimesters of pregnancy was associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios was also reported, presumably from decreased fetal renal function. The oligohydramnios was associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus were also reported, although it is not clear whether these occurrences were due to exposure to the drug. In a clinical study, first trimester use of ACE inhibitors was associated with a potential risk of birth defects. When pregnancy occurs in a patient taking amlodipine/hydrochlorothiazide/valsartan, treatment should be discontinued as soon as possible. The patient should be informed of the potential risks to the fetus based on the time of gestational exposure to amlodipine/hydrochlorothiazide/valsartan. If exposure occurs beyond the first trimester, the intra-amniotic environment should be evaluated by serial ultrasound examinations. 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 non-stress examinations, biophysical profiles, and/or contraction stress tests may be appropriate based on gestational age and standards of care.

Amlodipine / hydrochlorothiazide / valsartan Breastfeeding Warnings

There are no data on the excretion of amlodipine or valsartan into human milk, but hydrochlorothiazide is excreted into human milk and valsartan is excreted in rat milk. Because of the potential for serious adverse effects in nursing infants, a decision should be made to discontinue nursing or discontinue administration of amlodipine/hydrochlorothiazide/valsartan, taking into account the importance of the drug to the mother.

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