ERYTHROPED SF Granules Ref.[49998] Active ingredients: Erythromycin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Amdipharm UK Limited, Capital House, 85 King William Street, London EC4N 7BL, UK

4.1. Therapeutic indications

For the prophylaxis and treatment of infections caused by erythromycin-sensitive organisms.

Erythromycin is highly effective in the treatment of a great variety of clinical infections such as:

1. Upper Respiratory Tract infections: tonsillitis, peritonsillar abscess, pharyngitis, laryngitis, sinusitis, secondary infections in influenza and common colds

2. Lower Respiratory Tract infections: tracheitis, acute and chronic bronchitis, pneumonia (lobar pneumonia, bronchopneumonia, primary atypical pneumonia), bronchiectasis, Legionnaire’s disease

3. Ear infection: otitis media and otitis externa, mastoiditis

4. Oral infections: gingivitis, Vincent’s angina

5. Eye infections: blepharitis

6. Skin and soft tissue infections: boils and carbuncles, paronychia, abscesses, pustular acne, impetigo, cellulitis, erysipelas

7. Gastrointestinal infections: cholecystitis, staphylococcal enterocolitis

8. Prophylaxis: pre- and post- operative trauma, burns, rheumatic fever

9. Other infections: osteomyelitis, urethritis, gonorrhoea, syphilis, lymphogranuloma venereum, diphtheria, prostatitis, scarlet fever

Note: Erythromycin has also proved to be of value in endocarditis and septicaemia, but in these conditions initial administration of erythromycin lactobionate by the intravenous route is advisable.

4.2. Posology and method of administration

Posology

Adults and children over 8 years

2g/day in divided doses. For severe infections up to 4g/day in divided doses.

Paediatric population

Children 2-8 years

30 mg/kg/day in divided doses. For severe infections up to 50 mg/kg/day in divided doses.

Normal dose: 250mg four times a day or 500mg twice daily.

Children up to 2 years

30mg/kg/day in divided doses. For severe infections up to 50mg/kg/day in divided doses.

Normal dose: 125mg four times a day or 250mg twice daily.

Presentations are available for adults and children over 8 years, children aged 2-8 years, and for children under 2 years.

Method of administration

For oral administrations.

4.9. Overdose

Symptoms: hearing loss, severe nausea, vomiting and diarrhoea.

Management: gastric lavage, general supportive measures.

6.3. Shelf life

Bottles: 24 months. Once reconstituted Erythroped SF should be used within 7 days.

Sachets: 24 months.

6.4. Special precautions for storage

None.

6.5. Nature and contents of container

High density polyethylene bottles, 100ml or 140ml, with polypropylene cap which may be a child resistant cap.

Sachets; 44GSM Paper / 12 GSM LDPE / 9Ξm A1 foil / 34 GSM LDPE

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

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