Bisoprolol / hydrochlorothiazide Pregnancy and Breastfeeding Warnings

Brand names: Ziac

Medically reviewed by Drugs.com. Last updated on Mar 20, 2024.

Bisoprolol / hydrochlorothiazide Pregnancy Warnings

Use is recommended only if clearly needed and the benefit outweighs the risk to the fetus.

US FDA pregnancy category: C

Animal models have revealed fetotoxicity at doses that produced maternal toxicity. Animal studies with bisoprolol have revealed evidence of embryolethality. There are no controlled data in human pregnancy.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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Bisoprolol / 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 (bisoprolol); Yes (hydrochlorothiazide)
Excreted into animal milk: Yes (bisoprolol)

Bisoprolol: This drug is expected to have a moderately high risk of accumulation in nursing infants due to 30% protein binding, 50% renal excretion, and a moderately long half-life. Beta blockers with similar excretion profiles have caused adverse events in breastfed newborns.
Hydrochlorothiazide: This drug was shown to be without apparent harmful effects at 50 mg or less per day.

See references

Further information

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