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Macrolide Antibiotic — STI Treatment Pregnancy: UK SPC §4.6: animal reproduction studies showed no evidence of teratogenic effects, but there are no adequate and well-controlled studies in pregnant women. Observational data on more than 7,000 exposed pregnancies mostly do not suggest an increased risk of major congenital or cardiovascular malformations; epidemiological evidence on miscarriage risk after early-pregnancy exposure is inconclusive. Azithromycin should only be used during pregnancy if clinically needed. Breast-feeding: azithromycin is excreted in human milk to a substantial extent — decide whether to discontinue breast-feeding or the medicine, taking the benefits of each into account.

Azithromycin (Chlamydia / STI in Pregnancy)

Brand names: Zithromax

This page concerns azithromycin, a macrolide antibiotic, used to treat genital chlamydia and certain other sexually transmitted infections in pregnancy, where it is a preferred option.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Non-gonococcal urethritis and cervicitis: one single 1 gram dose
Route: Oral
Frequency: Single dose
DOSE SOURCE IS THE US LABEL. The UK SPC fetched in the bundle is Azithromycin 200 mg/5 mL powder for oral suspension, whose §4.2 extract covers ONLY paediatric patients aged 6 months and older weighing less than 45 kg (acute bacterial sinusitis, community-acquired pneumonia, skin and skin structure infections, acute otitis media, streptococcal tonsillitis/pharyngitis) — it carries no adult posology and no chlamydia/STI regimen, so the US prescribing information was used for the dose. OTHER US-LABELLED STI REGIMENS: gonococcal urethritis and cervicitis — one single 2 gram dose; genital ulcer disease (chancroid) — one single 1 gram dose. Azithromycin can be taken with or without food. This page's indication is treatment in pregnancy: the UK SPC §4.6 states there is a large amount of observational data (more than 7,000 exposed pregnancies) that mostly does not suggest an increased risk of major congenital or cardiovascular malformations, that epidemiological evidence on miscarriage risk in early pregnancy is inconclusive, and that azithromycin should only be used during pregnancy if clinically needed. Verify the regimen against the current national STI treatment guideline before use — the UK SPC advises that treatment should only be initiated after careful assessment of benefit and risk, considering local resistance prevalence, and when preferred treatment regimens are not indicated. PAEDIATRIC: per-kg regimens exist in both labels but ONLY for non-STI indications (otitis media 30 mg/kg single dose or 10 mg/kg daily for 3 days or 10 mg/kg day 1 then 5 mg/kg/day days 2–5; sinusitis and community-acquired pneumonia 10 mg/kg-based regimens; streptococcal pharyngitis/tonsillitis 12 mg/kg/day for 5 days or 20 mg/kg/day for 3 days). Those are NOT applicable to this page's STI indication, so paedDose is deliberately null; the paediatric daily dose must not exceed the adult daily dose of 500 mg except for the single-dose otitis media course (maximum total 1500 mg). Verify any paediatric use against a children's formulary. Ancillary sections below combine the UK SPC (contraindications, adverse reactions, pregnancy) with the US label (drug interactions, one additional contraindication) — the UK SPC §4.5 was not captured in the source bundle.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic, or to any of the excipients (UK SPC §4.3)
  • History of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin (US label §4.2)

Side effects

  • Diarrhoea (5 to 14%), nausea (3 to 18%), vomiting (2 to 7%) and abdominal pain (3 to 7%)
  • Headache and dizziness
  • QT interval prolongation, torsades de pointes and arrhythmia including ventricular tachycardia
  • Severe cutaneous adverse reactions — Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, acute generalised exanthematous pustulosis; angioedema and anaphylaxis (rarely fatal)
  • Hepatotoxicity — hepatitis, cholestatic jaundice, hepatic necrosis and hepatic failure, some fatal
  • Pseudomembranous colitis (Clostridioides difficile-associated diarrhoea); candida/vaginal infection

Interactions

  • Medicines known to prolong the QT interval — increased risk of ventricular arrhythmia including torsade de pointes; also use caution in congenital/documented QT prolongation, electrolyte disturbance (hypokalaemia, hypomagnesaemia), clinically relevant bradycardia, arrhythmia or severe cardiac insufficiency, and in the elderly (UK SPC §4.4)
  • Warfarin and other oral anticoagulants — may potentiate the anticoagulant effect; monitor prothrombin time carefully (US label §7.2)
  • Nelfinavir — increases azithromycin serum concentrations; no dose adjustment recommended, but monitor closely for liver enzyme abnormalities and hearing impairment (US label §7.1)

Clinical monograph

How it works

It binds the bacterial 50S ribosomal subunit and inhibits protein synthesis, giving a bacteriostatic effect against susceptible organisms including Chlamydia trachomatis.

Prescribing in practice

  • It is regarded as a suitable choice in pregnancy for chlamydia where tetracyclines are contraindicated, making it a key option for treating infection safely in this population.
  • It can prolong the QT interval, so caution is needed with other QT-prolonging drugs or relevant cardiac risk factors.
  • Test of cure and partner notification and treatment are important parts of management, and re-testing is advised in pregnancy.

Monitoring

Monitor for resolution with test of cure where indicated and for gastrointestinal tolerance rather than routine laboratory monitoring.

Counselling the patient

  • Complete the prescribed course and avoid sexual contact until you and your partner have completed treatment and follow-up advice.
  • Ensure partners are tested and treated to prevent reinfection.
  • Report severe or persistent diarrhoea or palpitations.

Evidence & guidelines

National sexual health and antenatal guidance support azithromycin as an effective treatment for chlamydia in pregnancy, with recommended test of cure.

Reference: BASHH Chlamydia Guidelines 2018; BASHH Gonorrhoea Guidelines 2019; MHRA QT alert 2013; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.