High Cholesterol? Learn about treatments

Amlodipine / valsartan Pregnancy and Breastfeeding Warnings

Amlodipine / valsartan is also known as: Exforge

Amlodipine / valsartan Pregnancy Warnings

Amlodipine-valsartan has been assigned to pregnancy category D by the FDA. Animal data have revealed evidence of fetotoxicity, but have failed to reveal evidence to teratogenicity. There are no controlled data in human pregnancy. Spontaneous abortion, oligohydramnios and newborn renal dysfunction have been reported when pregnant women inadvertently took valsartan. Drugs acting directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women. Use of amlodipine-valsartan during pregnancy is considered contraindicated. When pregnancy is detected or expected, amlodipine-valsartan 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. Valsartan is similar to angiotensin converting enzyme (ACE) inhibitors, which are contraindicated during pregnancy. Because of the many reports of fetal deaths and malformations associated with the use of ACE inhibitors, a committee of the National Institutes of Health has recommended that these drugs be avoided during pregnancy. Drugs that act on the renin-angiotensin-aldosterone (RAA) system can cause fetal and neonatal morbidity and death when administered to pregnant women. Several dozen cases have been reported in the world literature in patients who were taking ACE inhibitors. When pregnancy is detected, valsartan should be discontinued as soon as possible. The use of drugs that act directly on the RAA 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 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 so informed. Nonetheless, when patients become pregnant, physicians should advise the patient to discontinue the use of valsartan as soon as possible. Rarely (probably less than once in every thousand pregnancies), no alternative to a drug acting on the RAA system will be found. In these rare cases, the mothers should be apprised of the potential hazards to their fetuses, and serial ultrasound examinations should be performed to assess the intra-amniotic environment. If oligohydramnios is observed, valsartan should be discontinued unless it is considered life-saving for the mother. Contraction stress testing (CST), a non-stress test (NST), or biophysical profiling (BPP) may be appropriate, depending upon the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury! Infants with histories of in utero exposure to an angiotensin II receptor antagonist should be closely observed for hypotension, oliguria, and hyperkalemia. If oliguria occurs, attention should be directed toward support of blood pressure and renal perfusion. Exchange transfusion or dialysis may be required as means of reversing hypotension and/or substituting for disordered renal function. Animal data have failed to reveal evidence of teratogenicity when valsartan was given to pregnant mice and rats at oral doses up to 600 mg/kg/day and to pregnant rabbits at oral doses up to 10 mg/kg/day. However, significant decreases in fetal weight, pup birth weight, pup survival rate, and slight delays in developmental milestones were observed in studies in which parental rats were treated with valsartan at oral, maternally toxic (reduction in body weight gain and food consumption) doses of 600 mg/kg/day during organogenesis or late gestation and lactation. In rabbits, fetotoxicity (resorptions, litter loss, abortions, and low body weight) associated with maternal toxicity (mortality) was observed at doses of 5 and 10 mg/kg/day. The doses that were not associated with adverse effects (600, 200, and 2 mg/kg/day) in mice, rats and rabbits, represent 9, 6, and 0.1 times, respectively, the maximum recommended human dose on a mg/m2 basis.

Amlodipine / valsartan Breastfeeding Warnings

Animal studies have shown that valsartan is excreted into the milk of lactating rats.

There are no data on the excretion of amlodipine-valsartan into human milk. 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.

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.

Hide
(web2)