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Aliskiren / hydrochlorothiazide Pregnancy and Breastfeeding Warnings

Aliskiren / hydrochlorothiazide is also known as: Tekturna HCT

Aliskiren / hydrochlorothiazide Pregnancy Warnings

Aliskiren-hydrochlorothiazide contains aliskiren (a direct renin inhibitor). When administered during the second or third trimester of pregnancy, drugs that act directly on the renin-angiotensin-aldosterone system can cause fetal and neonatal morbidity and death. Thiazides can cross the placenta, and their use during pregnancy is associated with a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults. If the patient becomes pregnant while taking aliskiren-hydrochlorothiazide, the drug should be discontinued as soon as possible and the patient should be informed of the potential risks to the fetus based on the time of gestational exposure (first trimester only or later). If exposure occurs beyond the first trimester, an ultrasound examination should be performed. In rare cases when another antihypertensive agent cannot be used to treat the pregnant patient, serial ultrasound examinations should be used to assess the intra-amniotic environment. Routine fetal testing with nonstress tests, biophysical profiles, or contraction stress tests may be appropriate based on gestational age and standards of care in the community. If oligohydramnios occurs in these situations, individualized decisions about continuing treatment and about pregnancy management should be made. Oligohydramnios may not appear until after the fetus has sustained irreversible injury. Infants exposed to aliskiren-hydrochlorothiazide in utero should be closely observed for hypotension, oliguria, and hyperkalemia. If oliguria occurs, these infants may require blood pressure and renal perfusion support. Exchange transfusion or dialysis may be required to reverse hypotension or support decreased renal function. Maternal hypertension is associated with increased risks for preterm delivery, intrauterine growth restriction, placental abruption, preeclampsia, and perinatal mortality. Appropriate management of maternal hypertension during pregnancy is important. Renin inhibitors (like aliskiren), angiotensin II receptor antagonists, and angiotensin converting enzyme (ACE) inhibitors exert similar effects on the renin-angiotensin-aldosterone system. Based on several published cases, ACE inhibitor use during the second and third trimesters of pregnancy is associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Decreased fetal renal function may result in oligohydramnios and is associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus have been reported in women using these drugs, but it is not clear whether these occurrences were due to drug exposure. Limited data are conflicting about whether first trimester use of ACE inhibitors is associated with an increased risk of birth defects, but the mechanism of action of these drugs raises a theoretical concern. US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use is contraindicated. US FDA pregnancy category: D Comments: -Adequate methods of contraception should be encouraged. -This drug can harm a fetus. -If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Aliskiren / hydrochlorothiazide Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown (aliskiren); Yes (hydrochlorothiazide) Excreted into animal milk: Yes (aliskiren)

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