Skip to content
ClinCalc Pro
Menu
Macrolide Antibiotic Pregnancy: There is a large amount of observational data (more than 7000 exposed pregnancies); most studies do not suggest an increased risk of adverse foetal effects such as major congenital or cardiovascular malformations, and epidemiological evidence on miscarriage after early-pregnancy exposure is inconclusive. Azithromycin should only be used during pregnancy if clinically needed. It is excreted in human milk to a substantial extent — decide whether to discontinue breast-feeding or to discontinue/abstain from therapy, weighing the benefit of breast-feeding for the child against the benefit of therapy for the woman.

Azithromycin

Brand names: Zithromax

Azithromycin is a macrolide antibiotic with a long tissue half-life, used for respiratory, skin and soft-tissue, and certain sexually transmitted and atypical infections, and prophylactically in some chronic respiratory conditions.

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: 500 mg once daily for 3 days, or 500 mg on day 1 followed by 250 mg once daily on days 2-5 (acute streptococcal tonsillitis and pharyngitis; acute bacterial sinusitis; acute bacterial otitis media; acute exacerbations of chronic bronchitis, adults only; community-acquired pneumonia; acute bacterial skin and skin structure infections). Urethritis and cervicitis caused by Chlamydia trachomatis: 1000 mg as a single dose
Route: Oral — powder for oral suspension after reconstitution, taken as a single daily dose with or without a meal; administration immediately before a meal may enhance gastrointestinal tolerability. Shake the bottle before each new dose
Frequency: Once daily (single dose for chlamydial urethritis and cervicitis)
PROVENANCE: the bundled eMC source is the SPC for Azithromycin 200mg/5ml Powder for Oral Suspension (bundle is byte-identical to the one supplied for id 'azithromycin_gm'), and its adult table is headed 'Adults and adolescents weighing at least 45 kg and unable to swallow solid pharmaceutical forms' — for patients who can swallow solids, confirm against the corresponding tablet/capsule SPC. This bundle contains no intravenous posology; for IV therapy refer to the SPC of the azithromycin IV formulations. NOT IN SOURCE: the 1000 mg single dose is licensed in this SPC only for 'Urethritis and cervicitis caused by Chlamydia trachomatis' — it must not be generalised to sexually transmitted infections as a class, and this source contains no gonorrhoea, chancroid or MAC-prophylaxis regimen. No absolute adult maximum dose is stated: the paediatric tables reference the adult ceiling with the footnote '# not to exceed the adult daily dose of 500 mg', but the licensed single 1000 mg dose exceeds that figure, so no maxDose has been recorded. Community-acquired pneumonia: in adults, oral treatment may also follow intravenous treatment if clinically indicated, to complete a 7- to 10-day total course. Acute exacerbations of chronic bronchitis is an adults-only indication. Consideration should be given to the treatment regimens, doses and duration of treatment recommended in updated treatment guidelines for each indication, and treatment should only be initiated after careful assessment of benefit and risk given the local prevalence of resistance and where preferred regimens are not indicated. Missed dose: if 12 hours or less have passed, take it as soon as possible and take the next dose at the regularly scheduled time; if more than 12 hours have passed, wait until the next scheduled dose. Elderly: no dose adjustment required, but particular caution is recommended because of the risk of cardiac arrhythmia and torsade de pointes. Hepatic impairment: no dose adjustment in mild (Child-Pugh A) or moderate (Child-Pugh B) impairment; no data in severe impairment (Child-Pugh C), so administer with caution. §4.5 was not included in this bundle and §4.8 is marked truncated at the source-fetch limit.

Paediatric dose

Route: Oral (powder for oral suspension)
Frequency: Single daily dose
Max: The daily dose should not exceed the adult daily dose of 500 mg, with the exception of the 1-day (single dose) treatment course for acute bacterial otitis media for which the maximum total dose of 1500 mg should not be exceeded. The maximum recommended total dose for any treatment in paediatric patients weighing less than 45 kg is 1500 mg, except for the 5-day regimen for acute streptococcal tonsillitis and pharyngitis
Paediatric patients aged 6 months and older weighing less than 45 kg, by indication (multiple per-kg regimens are stated, so no single per-kg figure is recorded here). Acute bacterial sinusitis, community-acquired pneumonia, acute bacterial skin and skin structure infections: 10 mg/kg/day for 3 days, or 10 mg/kg on day 1 followed by 5 mg/kg/day on days 2-5. Acute bacterial otitis media: a single dose of 30 mg/kg, or 10 mg/kg/day for 3 days, or 10 mg/kg on day 1 followed by 5 mg/kg/day on days 2-5. Acute streptococcal tonsillitis and pharyngitis: 20 mg/kg/day for 3 days, or 12 mg/kg/day for 5 days. Safety and efficacy have not been established in children under 6 months of age for any indication, and there is no relevant use for acute exacerbations of chronic bronchitis in paediatric patients. The SPC carries weight-banded maximum daily dose and volume tables for the 20 mg/mL and 40 mg/mL suspensions. Verify against a children's formulary.

Dose adjustments

Renal

No dose adjustment is required in patients with GFR 10 mL/min or greater. In patients with GFR below 10 mL/min azithromycin should be administered with caution.

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 the active substance, erythromycin, any macrolide or ketolide antibiotic, or to any of the excipients

Side effects

  • Diarrhoea, headache, vomiting, abdominal pain, nausea and abnormal laboratory test values (most commonly reported)
  • Anaphylactic reactions, hypersensitivity and angioedema
  • Torsade de pointes, arrhythmia including ventricular tachycardia, and ECG QT prolongation
  • Pseudomembranous colitis and pancreatitis
  • Hepatic failure; severe cutaneous adverse reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS and acute generalised exanthematous pustulosis

Interactions

  • Other active substances known to prolong the QT interval — increased risk of ventricular arrhythmias including torsade de pointes; use azithromycin with caution (stated in SPC §4.4, which cross-refers to §4.5; §4.5 itself was not retrieved in this bundle)

Clinical monograph

How it works

It binds the bacterial 50S ribosomal subunit and inhibits protein synthesis by blocking translocation, giving bacteriostatic and, at higher concentrations, bactericidal activity against susceptible organisms.

Prescribing in practice

  • Azithromycin can prolong the QT interval, so it should be used with caution in patients with cardiac risk factors, electrolyte disturbance, or concomitant QT-prolonging drugs.
  • It carries a recognised risk of hepatotoxicity and should be reviewed if signs of liver dysfunction develop.
  • Long courses for respiratory prophylaxis warrant consideration of macrolide resistance and hearing assessment.

Monitoring

Monitor liver function and, where there is cardiac risk or prolonged use, ECG, electrolytes and hearing as appropriate.

Counselling the patient

  • Complete the prescribed course even if you feel better.
  • Report palpitations, fainting, or yellowing of the skin or eyes.
  • Tell your clinician about any heart-rhythm problems or other medicines you take.

Evidence & guidelines

Azithromycin features in UK antimicrobial guidance for various infections, with the MHRA having highlighted its association with QT-interval prolongation.

Reference: BASHH STI Guidelines; RECOVERY Trial (Horby et al, NEJM 2021); 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.