toxylact

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Cromoglicic Acid / Cromolyn Sodium (ATC A07EB01): Toxicological-Lactological Monograph

ATC class and general pharmacology

A07EB01 designates cromoglicic acid, also known as cromolyn sodium, within the ATC group A07EB: intestinal antiallergic agents excluding corticosteroids. WHO ATC/DDD Index

Cromolyn sodium is a non-corticosteroid mast-cell stabilizer with antiallergic and anti-inflammatory activity. It inhibits mediator release from sensitized mast cells, including histamine and leukotrienes, but has no intrinsic glucocorticoid, antihistamine, or vasoconstrictor activity. FDA cromolyn sodium prescribing information

Oral cromolyn sodium is used in the management of mastocytosis and may improve gastrointestinal and systemic mediator-related symptoms, including diarrhea, flushing, abdominal pain, nausea, vomiting, urticaria, pruritus, and headache. FDA cromolyn sodium prescribing information

Systemic availability after oral administration is extremely low. No more than 1% of an oral dose is absorbed from the gastrointestinal tract, while most of the dose remains within the intestinal lumen and is excreted in feces. FDA cromolyn sodium prescribing information

In pharmacokinetic observations after a 500 mg oral dose, approximately 0.28–0.50% of the dose was recovered in urine within 24 hours in some subjects, and the mean urinary recovery was 0.45% in the remaining participants. FDA cromolyn sodium prescribing information

Toxicological profile

The toxicological profile of orally administered cromolyn is generally favorable because of its minimal gastrointestinal absorption and predominantly local action. However, hypersensitivity to cromolyn sodium is a contraindication, and rare severe anaphylactic reactions have been reported. FDA cromolyn sodium prescribing information

In mastocytosis studies, the most frequently reported adverse reactions were headache and diarrhea. Other reported reactions included pruritus, nausea, myalgia, abdominal pain, rash, irritability, and malaise, although some symptoms may also reflect the underlying mast-cell disease. FDA cromolyn sodium prescribing information

Post-marketing reports have described gastrointestinal complaints, skin reactions, headache, dizziness, paresthesia, anxiety, sleep disturbance, palpitations, dyspnea, hematological abnormalities, and altered hepatic function tests. These reports do not establish causality in every case because information on concomitant illness and treatment is often incomplete. FDA cromolyn sodium prescribing information

Dose reduction should be considered in patients with renal or hepatic impairment because the small absorbed fraction is eliminated through renal and biliary routes. This precaution is particularly relevant to maternal treatment safety and may also reduce the already low potential for systemic transfer into breast milk. FDA cromolyn sodium prescribing information

Lactation pharmacology and infant exposure

No published studies have measured cromolyn concentrations in human milk, infant plasma concentrations, relative infant dose, or clinical outcomes in breastfed infants. LactMed: Cromolynncbi.nlm.nih

Maternal milk concentrations are expected to be very low because oral cromolyn has no more than 1% gastrointestinal absorption and consequently produces very limited maternal systemic exposure. FDA cromolyn sodium prescribing information

If a small amount of cromolyn enters breast milk, systemic infant exposure is expected to remain negligible because cromolyn is poorly absorbed from the gastrointestinal tract. This conclusion is pharmacokinetically plausible but should be distinguished from direct human milk and infant-serum evidence, which is unavailable. LactMed: Cromolynncbi.nlm.nih

No published evidence has identified adverse effects in breastfed infants or an effect on maternal milk production. The absence of such reports does not replace direct lactation studies. LactMed: Cromolynncbi.nlm.nih

Lactological safety assessment and clinical recommendations

Cromolyn sodium is considered acceptable during breastfeeding by the expert panel cited in LactMed. Its extremely low maternal oral absorption and poor infant oral absorption support a low expected lactological risk. LactMed: Cromolynncbi.nlm.nih

For healthy, full-term infants, maternal oral cromolyn treatment can generally continue without interruption of breastfeeding, routine milk discarding, or dose-timing measures. LactMed: Cromolynncbi.nlm.nih

Routine infant laboratory monitoring is not required during usual maternal treatment. Ordinary clinical observation of feeding, growth, weight gain, and general well-being is appropriate, particularly in the absence of direct infant exposure studies. LactMed: Cromolynncbi.nlm.nih

An individualized benefit-risk assessment is prudent when the infant is preterm, medically unstable, or receiving multiple medicines, or when the mother has clinically significant renal or hepatic impairment. Maternal mast-cell disease should be adequately controlled, as therapeutic interruption may expose the mother to recurrent gastrointestinal and systemic mediator-related symptoms.

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