Captopril
1. Pregnancy Evidence & Regulatory Labeling
FDA Pregnancy and Lactation Labeling Rule (PLLR 8.1) & EMA SmPC Section 4.6
Clinical Risk Summary
Pregnancy Female patients of childbearing age should be told about the consequences of second- and third-trimester exposure to ACE inhibitors, and they should also be told that these consequences do not appear to have resulted from intrauterine ACE-inhibitor exposure that has been limited to the first trimester. These patients should be asked to report pregnancies to their physicians as soon as possible.
Regulatory Warnings & Contraindications
FDA Boxed Warning: This medication carries an official Boxed Warning regarding embryo-fetal toxicity or pregnancy-related adverse outcomes.
CONTRAINDICATIONS Captopril : This product is contraindicated in patients who are hypersensitive to captopril or any other angiotensin-converting enzyme inhibitor (e.g., a patient who has experienced angioedema during therapy with any other ACE inhibitor). Hydrochlorothiazide : Hydrochlorothiazide is contraindicated in anuria. It is also contraindicated in patients who have previously demonstrated hypersensitivity to hydrochlorothiazide or other sulfonamide-derived drugs.
2. Lactation & Breastfeeding Safety
NIH / NLM LactMed® Database & FDA Labeling Section 8.2
Summary of Use during Lactation
Nursing Mothers Both captopril and hydrochlorothiazide are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from both drugs, a decision should be made whether to discontinue nursing or to discontinue therapy taking into account the importance of captopril and hydrochlorothiazide to the mother. (See PRECAUTIONS: Pediatric Use. )
Drug Levels in Breast Milk & Relative Infant Dose
Evaluated in human/animal pharmacokinetic models.
3. Females & Males of Reproductive Potential
FDA Labeling Section 8.3 — Pregnancy Testing, Contraception & Infertility
Standard pre-treatment clinical assessment as indicated.
Review contraception duration based on drug elimination half-life.
No significant drug-induced impairment reported in standard models.
4. Regulatory Source Provenance & Comparison
Direct attribution to official regulatory documents without synthesized consensus
| Regulatory Organization | Jurisdiction | Document / Framework | Effective Date | Official Source Link |
|---|---|---|---|---|
|
U.S. Food and Drug Administration (FDA)
FDA Prescribing Information (PLLR)
|
United States | regulatory_label | 2023-02-21 | Official Record |
|
European Medicines Agency (EMA)
EMA Summary of Product Characteristics (SmPC 4.6)
|
European Union | regulatory_label | Recent | Official Record |