PORPHYROCIN Film-coated tablet Ref.[28314] Active ingredients: Erythromycin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

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, cellulites, 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.

4.2. Posology and method of administration

Method of administration

Tablets for oral administration. Tablets should be swallowed whole and taken before or with meals.

Posology

Adults and children over 8 years old

For mild to moderate infections, 1 g to 2 g a day, in divided doses. Up to 4g daily in severe infections.

Elderly

No modified dosage recommendations.

Paediatric population

Note: For younger children, infants and babies, Porphyrocin, erythromycin ethylsuccinate suspensions, are normally recommended. The recommended dose for children age 2-8 years, for mild to moderate infections, is 1 gram daily in divided doses. The recommended dose for infants and babies, for mild to moderate infections, is 500 mg daily in divided doses. For severe infections doses may be doubled.

4.9. Overdose

Symptoms

Typical symptoms of overdose include severe nausea, diarrhea, vomiting and hearing loss.

Treatment

Treatment should be by gastric lavage and general supportive measures.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store below 25°C in the original package to be protected from light.

6.5. Nature and contents of container

Tablets are supplied in aluminium foil-polyvinylchloride film blisters of ten tablets. Packs of 20 and 100 tablets, with a patient information leaflet, in a card carton are available. Dispensing packs of 100, 250, 500 or 1000 tablets are also available.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

None.

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