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 under40 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
125mg x 2
5 ml x 2
½ tab x 2
¼ tab x 2
1 to < 3 years
10to < 15 kg
250mg x 2
10 ml x 2
1 tab x 2
½ tab x 2
3 to < 8 years
15to < 25 kg
250mg x 3
10 ml x 3
1 tab x 3
½ tab x 3
8 to < 11 years
25to < 35 kg
500mg x 2
−
2 tab x 2
1 tab x 2
11 to < 13 years
35to < 45 kg
500mg 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
Atypicalpneumonia: 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.