TOXYLACT: a03 ac summary
The first professional lActological database in the word
The ATC A03AC group comprises synthetic antispasmodic drugs that are amide derivatives with tertiary amines, used mainly for functional gastrointestinal disorders and intestinal spasms, but with very limited lactation safety data and a precautionary approach in breastfeeding.medpedia.framar+2
Pharmacological class overview
Synthetic antispasmodics, amides with
tertiary amines (ATC
A03AC), are smooth‑muscle relaxants indicated for
functional bowel disorders
with cramping and abdominal pain.synapse.patsnap+1
They act predominantly on gastrointestinal smooth muscle
with minimal central
nervous system activity compared with classic
anticholinergics, aiming to
reduce spasm while limiting systemic side effects.apollopharmacy+1
Representatives and indications
According to the referenced ATC page, the
principal substances in
A03AC include dimethylaminopropionylphenothiazine
(A03AC02), nicofetamide
(A03AC04) and tiropramide (A03AC05).medbox.iiab+1
Tiropramide is marketed as an antispasmodic for
abdominal pain and cramping
associated with conditions such as irritable bowel
syndrome and other
gastrointestinal spasms.apollopharmacy+1
Toxicological profile
Typical adverse effects of A03AC
antispasmodics reflect their
smooth‑muscle relaxant and mild anticholinergic‑like
actions and may include
dry mouth, nausea, vomiting, constipation and rare
hypersensitivity reactions.synapse.patsnap+1
Serious toxicity is uncommon at therapeutic doses, but
caution is advised in
patients with gastrointestinal stenosis, megacolon,
severe circulatory failure
or other conditions in which inhibition of motility
could aggravate obstruction
or ischemia.mims+1
Use during pregnancy and lactation
For tiropramide, available prescribing
information advises
against use in pregnancy and in nursing mothers unless
clearly indicated and
supervised, reflecting the absence of human data and
theoretical risk to the infant.apollopharmacy+1
There is no robust published evidence on excretion of
A03AC drugs into breast
milk or on clinical outcomes in breastfed infants, so
they should be avoided
during breastfeeding whenever safer, better‑studied
antispasmodic alternatives are
available.sps+1
Lactation‑oriented recommendations
Given the paucity of lactation data and
precautionary labelling,
A03AC agents are generally not first‑line in
breastfeeding women and should be
reserved for situations where benefit clearly outweighs
potential and unknown
risks.infantrisk+3
If such treatment is considered unavoidable, it should
be used at the lowest
effective dose for the shortest possible duration, with
close monitoring of the
breastfed infant for sedation, feeding difficulties,
gastrointestinal symptoms
or allergic reactions, and with specialist
toxicology‑lactation consultation.sps+2



