Ampicillin
1. Pregnancy Evidence & Regulatory Labeling
FDA Pregnancy and Lactation Labeling Rule (PLLR 8.1) & EMA SmPC Section 4.6
Clinical Risk Summary
Pregnancy: Reproduction studies have been performed in mice, rats, and rabbits at doses up to ten (10) times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to ampicillin and sulbactam for injection. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed (see PRECAUTIONS-Drug/ Laboratory Test Interactions section).
2. Lactation & Breastfeeding Safety
NIH / NLM LactMed® Database & FDA Labeling Section 8.2
Summary of Use during Lactation
Nursing Mothers: Low concentrations of ampicillin and sulbactam are excreted in the milk; therefore, caution should be exercised when ampicillin and sulbactam for injection is administered to a nursing woman.
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 | 2026-07-22 | Official Record |
|
European Medicines Agency (EMA)
EMA Summary of Product Characteristics (SmPC 4.6)
|
European Union | regulatory_label | Recent | Official Record |