5 Interactions found for:

The following applies to the ingredients: Lisinopril

Professional Content

AU: Use is contraindicated.
UK: Use is not recommended during the first trimester and use is contraindicated during the second and third trimesters.
US: This drug should not be used during pregnancy unless there are no alternatives and the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Risk Summary: Use of drugs that act on the renin angiotensin system (RAS) during the second and third trimesters of pregnancy increases fetal and neonatal morbidity and death.

Comments:
-Adequate methods of contraception should be encouraged.
-Advise pregnant women and females of reproductive potential of the potential risk to a fetus.

Animal studies have revealed evidence of fetotoxicity. In humans, exposure to angiotensin-converting enzyme (ACE) inhibitors during the second and third trimesters has revealed evidence of fetal and neonatal toxicity and fetolethality. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

The following applies to the ingredients: Ezetimibe (found in Zetia)

Professional Content

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Risk summary: There are insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-According to some authorities: Concomitant therapy with a statin is contraindicated during pregnancy.
-Refer to the manufacturer product information for any statin, fenofibrate, or other LDL-C lowering therapy used in combination with this drug for additional recommendations on use during pregnancy.

Animal studies have failed to reveal evidence of direct or indirect harmful effects on pregnancy, embryofetal development, or on birth/postnatal development. Administration of this drug to pregnant animals during the period of organogenesis at doses ranging from 10 to 150 times the human exposure at the maximum recommended human dose (MRHD) resulted in an increased incidence of common fetal skeletal findings (e.g., extra thoracic ribs). Placental drug transfer was demonstrated in animal studies.

Administration of this drug in combination with a statin during animal studies resulted in higher exposures to this drug and/or the statin as compared to monotherapy; fetal abnormalities were observed. There were no adverse fetal effects observed when this drug was given concomitantly with fenofibrate at doses corresponding to 5 times (total ezetimibe) and 38 times (fenofibric acid) the anticipated MRHD. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

The following applies to the ingredients: Lisinopril

Professional Content

A decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-ACE inhibitors have the potential to adversely affect a nursing infant.

The following applies to the ingredients: Ezetimibe (found in Zetia)

Professional Content

Use is considered acceptable; benefit to mother should outweigh risk to the infant.
-According to some authorities: Use is not recommended during lactation.

Excreted into human milk: Yes (in very low amounts)

Comments:
-If this drug is used in combination with a statin, treatment should be avoided (or may be contraindicated) in patients who are breastfeeding; consult the manufacturer product information.
-There are no data on the effects of this drug on the breastfed infant or on milk production.
-Case reports and pharmacokinetic models predict that serum levels in infants exposed to this drug during breastfeeding are considerably lower than in adults.