toxylact

The first professional lActological database in the word

A07EB: Intestinal Antiallergic Agents Excluding Corticosteroids

ATC class and general pharmacology

A07EB is classified within the ATC system as intestinal antiallergic agents, excluding corticosteroids, under intestinal anti-inflammatory agents. WHO ATC/DDD Indexatcddd.fhi

The current fifth-level substance listed in this group is A07EB01, cromoglicic acid, also known as cromolyn sodium. This monograph addresses the class-level pharmacological and lactological principles; individual-agent details should be assessed in dedicated monographs. WHO ATC/DDD Indexatcddd.fhi

The class is characterized by mast-cell-stabilizing, non-corticosteroid anti-inflammatory activity. Cromolyn inhibits the release of mediators, including histamine and leukotrienes, from sensitized mast cells and has no intrinsic antihistamine, vasoconstrictor, or glucocorticoid activity. FDA cromolyn sodium prescribing informationaccessdata.fda

Oral intestinal cromolyn is very poorly absorbed from the gastrointestinal tract, with no more than 1% of an administered dose absorbed systemically. Most of the oral dose remains within the gastrointestinal tract and is excreted in feces, supporting a predominantly local intestinal pharmacological effect. FDA cromolyn sodium prescribing informationaccessdata.fda

Toxicological profile

The systemic toxicological burden of orally administered A07EB therapy is generally low because of minimal gastrointestinal absorption. Nevertheless, hypersensitivity to the active substance is a contraindication, and rare severe anaphylactic reactions have been reported with cromolyn sodium. FDA cromolyn sodium prescribing informationaccessdata.fda

The most frequently reported adverse effects in clinical studies of oral cromolyn included headache and diarrhea. Other reported effects included nausea, abdominal pain, pruritus, myalgia, rash, irritability, and malaise, although gastrointestinal symptoms may overlap with manifestations of the underlying disease. FDA cromolyn sodium prescribing informationaccessdata.fda

Post-marketing reports have included gastrointestinal, cutaneous, neurological, psychiatric, cardiovascular, respiratory, hematological, and hepatic events. Causality cannot be assumed for all of these reports because the available post-marketing information is often incomplete and patients may have significant underlying illness. FDA cromolyn sodium prescribing informationaccessdata.fda

Dose reduction should be considered in patients with impaired renal or hepatic function because absorbed drug is eliminated through renal and biliary pathways. This precaution is primarily relevant to maternal clinical safety rather than expected infant exposure through breast milk. FDA cromolyn sodium prescribing informationaccessdata.fda

Lactation pharmacology and infant exposure

Published studies measuring cromolyn concentrations in human milk, infant serum concentrations, relative infant dose, or clinical effects in breastfed infants are not available. LactMed: Cromolynncbi.nlm.nih

Maternal milk concentrations are nevertheless expected to be very low because oral cromolyn has extremely limited systemic absorption. Since no more than 1% of an oral maternal dose is absorbed, only a very small fraction would be available for transfer from maternal plasma into milk. FDA cromolyn sodium prescribing informationaccessdata.fda

Any cromolyn reaching milk is also expected to have low systemic relevance for the infant because it is poorly absorbed from the infant gastrointestinal tract. LactMed therefore considers maternal milk transfer likely to be low and infant oral absorption unlikely to be clinically significant. LactMed: Cromolynncbi.nlm.nih

No published evidence has identified an effect of cromolyn on milk production. The absence of direct lactation studies should be acknowledged when counselling, particularly for newborn, preterm, or medically fragile infants. LactMed: Cromolynncbi.nlm.nih

Lactological safety assessment and clinical recommendations

A07EB therapy is expected to present a low lactological risk when used orally at usual therapeutic doses because of poor maternal absorption and poor oral bioavailability in the infant. An expert panel cited by LactMed considers cromolyn acceptable during breastfeeding. LactMed: Cromolynncbi.nlm.nih

Breastfeeding can generally continue during maternal treatment without routine interruption, milk discarding, or dose-timing measures. Clinical decisions should still consider the maternal indication, treatment response, dose, formulation, co-medication, and the clinical vulnerability of the infant. LactMed: Cromolynncbi.nlm.nih

For healthy full-term infants, no specific infant monitoring is usually required beyond ordinary observation of feeding, growth, and general well-being. A more individualized assessment is appropriate when the infant is preterm, unwell, exposed to multiple medicines through milk, or when the mother has renal or hepatic impairment that could increase systemic drug exposure. FDA cromolyn sodium prescribing information; LactMed: Cromolynncbi.nlm.nih+1

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