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A07AC01 designates miconazole as an intestinal imidazole derivative intended for locally acting treatment of gastrointestinal mycosis, with low systemic absorption and a favourable safety profile in breastfeeding. From a toxicological‑lactological perspective, maternal use of A07AC01 miconazole at therapeutic doses is expected to result in minimal transfer into breast milk and a very low risk of adverse effects in the breastfed infant.atcddd.fhi+4

ATC classification and substance identity

A07AC01 belongs to the ATC main group A “Alimentary tract and metabolism”, subgroup A07 “Antidiarrheals, intestinal anti‑inflammatory/anti‑infective agents”. Within A07, it is part of A07A “Intestinal antiinfectives” and the chemical subgroup A07AC “Imidazole derivatives”.atcddd.fhi+2

A07AC01 is assigned specifically to miconazole, an azole (imidazole) antifungal compound used for local intestinal treatment. The WHO Collaborating Centre ATC/DDD Index lists a Defined Daily Dose (DDD) of 1 g via oral administration (unit “g”, route “O”) for A07AC01, based on treatment of gastrointestinal mycosis.ebi+3

Pharmacodynamic properties

Miconazole exerts antifungal activity by inhibiting cytochrome P450‑dependent synthesis of ergosterol in fungal cell membranes, causing altered membrane permeability and fungal cell death. It has broad‑spectrum activity against yeasts such as Candida species and some filamentous fungi, with additional limited activity against certain Gram‑positive bacteria.ebi+1

In the A07AC01 intestinal context, the pharmacodynamic goal is local suppression of fungal overgrowth or infection within the digestive tract, rather than systemic antifungal therapy. This local mechanism aligns with the “locally acting antiinfectives” description in the ATC/DDD guidelines for A07A and A07AC.pubmed.ncbi.nlm.nih+3

Therapeutic indications and clinical use

A07AC01 miconazole is indicated for gastrointestinal candidiasis and related fungal infections, particularly when associated with predisposing factors such as broad‑spectrum antibiotic therapy, immunosuppression, or local mucosal disruption. Oral miconazole tablets or other local formulations have demonstrated clinical efficacy in candidiasis of the oral cavity and digestive tract, with improvement and mycological cure in small clinical series.pubmed.ncbi.nlm.nih+1

Use in practice is typically short‑ to medium‑term, tailored to the severity of gastrointestinal symptoms and underlying conditions. Because A07AC01 belongs to locally acting intestinal antiinfectives, it is not used for systemic mycoses, which require systemically absorbed antifungals classified elsewhere in the ATC system.who+3

Formulations, dosage and administration

The ATC/DDD Index specifies a DDD of 1 g miconazole by oral route for A07AC01, reflecting average adult maintenance needs for epidemiological and utilisation comparisons. Clinical dosing regimens may differ depending on the specific medicinal product (e.g., tablet strength, dosing frequency) and patient characteristics such as age, comorbidities and concomitant medications.atcddd.fhi+3

Formulations for A07AC01 are designed to deliver miconazole into the gastrointestinal lumen with limited systemic bioavailability, for example as coated tablets or local oral preparations that act predominantly within the mucosa and digestive tract. Administration is usually oral, with instructions to ensure adequate mucosal contact and adherence over the full prescribed course to prevent relapse.pubmed.ncbi.nlm.nih+1

Pharmacokinetics and milk transfer

Unlike some purely non‑absorbed agents, a fraction of miconazole can be absorbed from the intestinal tract, but this systemic absorption is still limited for local preparations compared with highly bioavailable systemic azoles. Topical and vaginal miconazole are known to have low systemic absorption, and similar pharmacokinetic principles apply to intestinally focused formulations, leading to relatively low maternal plasma concentrations at therapeutic doses.ncbi.nlm.nih+3

Breast milk transfer of miconazole has not been extensively quantified, but expert teratology and lactation sources note that only small amounts are expected to pass into breast milk when the drug is used in locally acting forms. Consequently, infant exposure via breastfeeding is expected to be minimal, well below doses used directly on infants’ skin or mucosa when miconazole cream or gel is prescribed to treat neonatal or infant candidiasis.ncbi.nlm.nih+1

Toxicological profile in the mother

Systemic adverse effects of imidazole antifungals may include gastrointestinal disturbances, hepatic enzyme elevations, skin reactions and, rarely, hypersensitivity reactions, particularly with more systemically absorbed agents. For A07AC01 miconazole intended as a locally acting intestinal antiinfective, clinical data and experience indicate that treatment is generally well tolerated, with occasional complaints such as unpleasant taste or mild gastrointestinal discomfort.ema.europa+3

Serious toxicity with A07AC01 at recommended doses is rare, but caution is advised in patients with significant liver disease, known hypersensitivity to imidazoles, or complex polypharmacy that might predispose to hepatic or allergic complications. Monitoring of symptoms and, when indicated, laboratory parameters may be appropriate in high‑risk patients receiving prolonged courses.ema.europa+1

Toxicological considerations in the breastfed infant

Given minimal expected systemic exposure, toxicological risk for breastfed infants during maternal A07AC01 use is very low. The main theoretical concerns would be subtle gastrointestinal effects (changes in stool pattern or mild mucosal irritation) or alteration of the infant’s gut microbiota, but there is no documented evidence of clinically significant harm from maternal miconazole therapy at standard doses.ncbi.nlm.nih+1

Miconazole creams and gels have been used directly on infants under medical supervision to treat candidiasis, further indicating a wide safety margin at low doses. When maternal therapy involves local oral or intestinal use, the quantity reaching the infant via breast milk is expected to be substantially smaller than the doses employed in direct paediatric treatment.ncbi.nlm.nih+1

Lactational risk assessment and recommendations

Available teratology and lactation resources report that miconazole, when used topically or vaginally, is not expected to cause side effects in nursing children, based on low systemic absorption and small milk passage. Extrapolating to A07AC01 intestinal use, the combination of limited bioavailability, low maternal plasma concentrations and small milk transfer supports classification of miconazole as compatible with breastfeeding under usual clinical conditions.ncbi.nlm.nih+2

In breastfeeding women prescribed A07AC01, continuation of nursing is generally appropriate, with standard clinical monitoring of the infant’s tolerance (feeding behaviour, stool pattern, general wellbeing). Routine interruption of breastfeeding or “pump‑and‑dump” is not indicated solely due to maternal use of A07AC01 at therapeutic doses, unless additional factors (severe prematurity, serious comorbidity, polypharmacy) necessitate individualised risk–benefit assessment.mothertobaby+1

Precautions and counselling in breastfeeding

Contraindications to A07AC01 in lactating women are the same as in non‑lactating adults, including known hypersensitivity to miconazole or other imidazoles and severe active hepatic disease. Clinicians should also consider overall maternal medication burden and hepatic function, especially in prolonged therapy, although risks remain low for locally acting intestinal preparations.ema.europa+1

Patient counselling should emphasise correct dosing, treatment duration and expectations of efficacy, along with reassurance that standard use of A07AC01 is compatible with breastfeeding and associated with minimal infant risk. If any unusual infant symptoms arise temporally with maternal treatment, clinicians should reassess therapy and breastfeeding plans, while avoiding unnecessary disruption of lactation whenever possible.mothertobaby+1

Educational summary for practice

A07AC01 is the ATC code for miconazole as an intestinal imidazole derivative within A07A “Intestinal antiinfectives”, used for local treatment of gastrointestinal mycosis. Its low systemic absorption and limited transfer into breast milk underpin a favourable toxicological‑lactological profile, with breastfeeding generally considered compatible during appropriately supervised therapy.atcddd.fhi+3

For healthcare professionals, integrating ATC classification, pharmacology, and lactation safety data supports evidence‑based counselling of breastfeeding patients who require antifungal treatment of the digestive tract. Emphasis on risk minimisation, accurate diagnosis, and maintenance of breastfeeding aligns with modern recommendations that avoid unnecessary interruption of lactation when maternal drug exposure poses low risk.who+2