Bisoprolol / hydrochlorothiazide Pregnancy and Breastfeeding Warnings
Bisoprolol / hydrochlorothiazide is also known as: Ziac
Bisoprolol / hydrochlorothiazide Pregnancy Warnings
The Collaborative Perinatal Project monitored 50,282 mother-child pairs, of whom 233 were exposed to thiazide or related diuretics during the first trimester. An increased risk of malformations was found for thiazide diuretics. Use of thiazides after the first trimester does not seem to carry this risk. Thiazide diuretics may, however, pose metabolic risks to the mother and fetus (hyponatremia, hypokalemia, thrombocytopenia, hyperglycemia), and may have a direct effect on smooth muscle, resulting in inhibition of labor. Neonatal thrombocytopenia associated with antepartum administration of thiazide diuretics has been reported. Regarding the use of bisoprolol during pregnancy, most experts recommend monitoring neonates for signs and symptoms of beta-blockade, such as bradycardia and hypoglycemia.
Bisoprolol-hydrochlorothiazide (HCTZ) has been assigned to pregnancy category C by the FDA. Animal studies have failed to reveal evidence of teratogenicity. After dosages ranging from over 125 to 514 times the maximum recommended human dose (MRHD, on a per kg basis) were given to rats, an increased rate of fetal resorptions were observed. Materno- and fetotoxicity were observed after doses 14 and 57 times the MRHD of bisoprolol and HCTZ, respectively. Embryo deaths have been observed after doses 31 times the MRHD (on a per kg basis) were given to rabbits. Some retrospective reviews have shown an increased risk of malformations associated with thiazide diuretics, and some experts consider the use of diuretics during pregnancy in patients without cardiac disease to be contraindicated. There are no controlled data in human pregnancy. Bisoprolol-HCTZ should only be given during pregnancy when benefit outweighs risk, keeping in mind that some experts consider the routine use of diuretics during pregnancy to be contraindicated.
Bisoprolol / hydrochlorothiazide Breastfeeding Warnings
There are no data on the excretion of bisoprolol into human milk. In general, most experts recommend monitoring nursing infants for signs and symptoms of beta-blockade, such as bradycardia and hypoglycemia. Hydrochlorothiazide is secreted into human milk in low concentrations. Adverse effects in the nursing infant are unlikely. Hydrochlorothiazide is considered compatible with breast-feeding by the American Academy of Pediatrics. The manufacturer, however, 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.
In one case, peak HCTZ milk levels of 125 ng/mL were measured between 4 and 12 hours after a dose in a woman who was taking HCTZ 50 mg per day. A simultaneously measured maternal serum HCTZ level was approximately 275 ng per mL. There were no detectable drug levels or electrolyte abnormalities in the baby's blood. The authors calculated that, if a 1-month-old infant takes approximately 600 mL of milk per day, and the average milk HCTZ level is approximately 80 ng per mL, the infant would be exposed to approximately 0.05 mg HCTZ daily. This should represent an insignificant amount of HCTZ to the infant such that adverse effects in the nursing infant are unlikely.
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