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Last updated: January 2024
Therapeutic action
- Macrolide antibacterial
Indications
- Alternative to first-line antibiotic treatment of:
- Louse-borne relapsing fever, leptospirosis
- Acute otitis media, pharyngitis and sinusitis; diphtheria, pertussis, atypical pneumonia due to Mycoplasma pneumoniae or Chlamydophila pneumoniae
- Leg ulcer
- Cervicitis and urethritis due to Chlamydia trachomatis (in combination with a treatment for gonorrhoea), donovanosis, chancroid, lymphogranuloma venereum, syphilis
- Trachoma
- Neonatal conjunctivitis due to Chlamydia trachomatis
- Completion treatment following parenteral therapy with erythromycin
Forms and strengths
- 250 mg and 500 mg tablets
- 125 mg/5 ml powder for oral suspension:
,- to be reconstituted with filtered water
- to be administered using a measuring device (oral syringe, measuring spoon, or cup with graduations)
Dosage
Louse-borne relapsing fever
- Child under 5 years: 250 mg single dose
- Child 5 years and over and adult: 500 mg single dose
Diphtheria
- Child under 40 kg: 10 to 15 mg/kg (max. 500 mg) 4 times daily
- Child 40 kg and over and adult: 500 mg 4 times daily
Neonatal conjunctivitis due to C. trachomatis
- Neonate: 12.5 mg/kg 4 times daily
Other indications
- Child: 30 to 50 mg/kg daily in divided doses
|
Age |
Weight |
Daily dose |
125 mg/5 ml susp. |
250 mg tablet |
500 mg tablet |
|---|---|---|---|---|---|
|
1 to < 2 months |
4 to < 5 kg |
62.5 mg x 2 |
2.5 ml x 2 |
¼ tab x 2 |
− |
|
2 to < 12 months |
5 to < 10 kg |
125 mg x 2 |
5 ml x 2 |
½ tab x 2 |
¼ tab x 2 |
|
1 to < 3 years |
10 to < 15 kg |
250 mg x 2 |
10 ml x 2 |
1 tab x 2 |
½ tab x 2 |
|
3 to < 8 years |
15 to < 25 kg |
250 mg x 3 |
10 ml x 3 |
1 tab x 3 |
½ tab x 3 |
|
8 to < 11 years |
25 to < 35 kg |
500 mg x 2 |
− |
2 tab x 2 |
1 tab x 2 |
|
11 to < 13 years |
35 to < 45 kg |
500 mg x 3 |
− |
2 tab x 3 |
1 tab x 3 |
- Adult: 500 mg 4 times daily or 1 g 2 to 3 times daily
Duration
- Leptospirosis, pertussis, cervicitis and urethritis, chancroid, leg ulcer: 7 days
- Sinusitis: 7 to 10 days
- Pharyngitis, otitis: 10 days
- Atypical pneumonia: 10 to 14 days
- Diphtheria, early syphilis, lymphogranuloma venereum, donovanosis, conjunctivitis due to C. trachomatis, trachoma: 14 days
- Late latent syphilis: 30 days
Contra-indications, adverse effects, precautions
- Do not administer to patients with allergy to erythromycin or another macrolide.
- Avoid or administer with caution to children under 6 months and particularly to neonates under 2 weeks (risk of hypertrophic pyloric stenosis).
- Administer with caution to patients with hepatic or renal impairment (max. 1.5 g daily for adult with severe renal impairment), electrolyte disturbances or at increased risk of cardiovascular morbidity.
- May cause: gastrointestinal disturbances, reversible hearing disorders, heart rhythm disorders (QT prolongation); allergic reactions sometimes severe. In the event of allergic reaction, stop treatment immediately.
- Avoid combination with drugs that prolong the QT interval (amiodarone, chloroquine, co-artemether, fluconazole, haloperidol, mefloquine, moxifloxacin, ondansetron, pentamidine, quinine, etc.).
- Administer with caution and monitor use in patients taking carbamazepine, digoxin or warfarin (plasma concentrations of these drugs increased).
- Pregnancy and breast-feeding: no contra-indication
Remarks
- Take tablets preferably one hour before or 2 hours after a meal.
Storage
–
– Below 25 °C
For the oral suspension (powder or reconstituted suspension): follow manufacturer’s instructions.
For the oral suspension (powder or reconstituted suspension): follow manufacturer’s instructions.