LACTOLOGY FOUNDATION

Hydrocortisone enemas and rectal foams in ATC class A07EA02 are locally acting intestinal corticosteroids used in distal ulcerative colitis; they have partial systemic absorption but, when used in standard short‑term regimens, are generally compatible with breastfeeding with appropriate infant monitoring.ncbi.nlm.nih+2

ATC class and general pharmacology

ATC code A07EA forms part of the alimentary tract and metabolism group (A) and denotes “corticosteroids acting locally” within the broader category of antidiarrheals and intestinal anti‑inflammatory/anti‑infective agents. A07EA02 specifically identifies hydrocortisone formulations intended for rectal administration as enemas or rectal suspensions for the treatment of ulcerative colitis, particularly distal forms including proctitis, proctosigmoiditis and left‑sided colitis.who+3

Hydrocortisone is a naturally occurring glucocorticoid (cortisol) that exerts anti‑inflammatory and immunosuppressive effects via binding to intracellular glucocorticoid receptors and subsequent modulation of gene transcription, reducing pro‑inflammatory mediators and leukocyte trafficking. Rectal hydrocortisone enemas deliver high local concentrations to the distal colon and rectum; absorption studies in ulcerative colitis patients show that approximately up to 50% of the dose of a standard hydrocortisone retention enema and up to 30% of hydrocortisone acetate in a similar vehicle can be systemically absorbed, so the drug acts both topically and systemically.dailymed.nlm.nih+2

Clinically, hydrocortisone rectal suspensions are used as adjunctive therapy for active distal ulcerative colitis, typically administered once nightly for around 21 days or until clinical and endoscopic remission is achieved, with efforts made to retain the enema for at least one hour and preferably overnight to maximize local efficacy. Compared with systemic steroids, rectal hydrocortisone achieves relatively high luminal and mucosal exposure in the affected segment while limiting, but not eliminating, systemic exposure, which is central to both its therapeutic profile and its lactational risk assessment.clevelandclinic+3

Toxicological profile

The toxicological profile of hydrocortisone reflects that of glucocorticoids generally, with adverse effects strongly related to total systemic exposure and duration of therapy; rectal preparations have a lower incidence of systemic side effects than high‑dose oral regimens, but prolonged or high‑dose use can still produce typical steroid toxicities. Systemic reactions associated with hydrocortisone include hypothalamic‑pituitary‑adrenal axis suppression, Cushingoid features, hypertension, glucose intolerance, osteoporosis, muscle weakness, susceptibility to infection, and, in children, potential growth suppression, although these are rarely reported with standard short‑course rectal therapy.clevelandclinic+2

Product information for hydrocortisone retention enemas emphasizes that, despite their classification as locally acting corticosteroids, the drug is absorbed from the colon and acts both topically and systemically, and therefore prolonged use may cause systemic reactions similar to those seen with oral dosage forms. Local adverse effects can include rectal irritation, discomfort, and in rare cases local bleeding or increased infection risk, particularly in patients with severely inflamed mucosa; however, overall safety data suggest a relatively low incidence of serious local or systemic toxicities when used as recommended.dailymed.nlm.nih+2

From a toxicological standpoint, the partial systemic absorption documented in ulcerative colitis patients (up to about half the dose in some studies) indicates that hydrocortisone enemas cannot be regarded as purely topical, and cumulative steroid load should be considered, especially when combined with other systemic corticosteroid therapy. Nonetheless, compared with equivalent oral dosages needed to achieve similar distal colonic anti‑inflammatory effects, rectal hydrocortisone suspension tends to provide a more favorable risk‑benefit profile in adults because systemic exposure is reduced and disease control in the target segment is improved.patents.google+2

Lactation pharmacology and infant exposure

General principles of lactation pharmacology highlight that drug passage into breast milk is primarily determined by maternal plasma concentrations, protein binding, lipophilicity, molecular weight, and pKa, with lower systemic exposure usually translating into lower milk levels. Hydrocortisone, like other corticosteroids, has limited transfer into breast milk when maternal doses are modest, and corticosteroids overall are described as not entering breast milk well, with clinically relevant infant exposure more of a concern only at high systemic doses administered over weeks to months.infantrisk+3

Evidence and expert opinion indicate that topical hydrocortisone used on intact skin results in minimal systemic absorption and therefore negligible transfer into breast milk, and low‑dose topical preparations (for example 0.5–1% creams) are regarded as generally safe during breastfeeding when used away from the nipple area. For rectal administration, LactMed notes that maternal use of hydrocortisone rectally with a cream or by suppository poses little to no risk to the breastfed infant, implying that systemic exposure and subsequent milk transfer from standard rectal doses are low.ncbi.nlm.nih+2

Specific absorption data for rectal hydrocortisone enemas in ulcerative colitis patients show partial absorption, with up to 50% of the dose of some enema formulations entering systemic circulation, which would yield higher plasma levels than purely topical skin applications but still less than typical systemic oral regimens. In the infant, any hydrocortisone that appears in milk is taken orally and subject to first‑pass metabolism and incomplete gastrointestinal absorption, further reducing systemic exposure; older term infants with mature metabolic capacity are particularly likely to clear small amounts without clinical effect.accp+3

Lactological safety assessment and clinical recommendations

Risk assessment in lactation generally favors drugs with low systemic exposure, short half‑life, and poor oral bioavailability in the infant, and it gives preference to locally acting formulations over systemic ones where clinically appropriate. On this basis, hydrocortisone rectal enemas and suppositories in class A07EA02 are considered compatible with breastfeeding when used in usual therapeutic regimens for distal ulcerative colitis, especially given LactMed’s conclusion that maternal rectal use of hydrocortisone poses little to no risk to the breastfed infant.ncbi.nlm.nih+3

Corticosteroids as a group are not regarded as a major problem in breastfeeding women unless the oral or intravenous dose is very high and used over prolonged periods, and hydrocortisone is among the weaker systemic corticosteroids with relatively low potency; doses less than about 200 mg daily are often considered low from a lactation risk perspective. For standard rectal hydrocortisone enema regimens (for example 100 mg nightly for about 21 days), infant risk is generally low, and interruption of breastfeeding is usually unnecessary provided the lowest effective dose is used and therapy is not excessively prolonged.ncbi.nlm.nih+3

Clinical recommendations include continuing breastfeeding during rectal hydrocortisone treatment while monitoring the infant for non‑specific signs of steroid exposure such as poor weight gain, unusual lethargy, or signs of infection, particularly when maternal therapy is extended or combined with other systemic steroids. In high‑risk situations—such as very high total daily steroid dose, prolonged multi‑month therapy, or in preterm or medically fragile infants—closer clinical follow‑up and, in selected cases, laboratory monitoring (for example infant cortisol) may be considered, while still aiming to preserve breastfeeding whenever possible.ncbi.nlm.nih+3

Topical and rectal hydrocortisone should not be applied directly to the nipple or areola, and mothers should be advised to wash hands thoroughly after handling rectal or topical preparations to avoid direct infant dermal exposure or ingestion of residual cream. Overall, within a toxicological‑lactological framework, A07EA02 hydrocortisone rectal preparations are assessed as low‑risk in breastfeeding when used appropriately, and their benefits in controlling maternal distal colitis—which itself can compromise maternal health and breastfeeding capacity—strongly support their use under clinical supervision.ncbi.nlm.nih+3