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ERYTHROMYCIN SXP, ERYTHROMYCIN HHH (Horizon Hospital Healthcare Pty Ltd)
Product name
ERYTHROMYCIN SXP, ERYTHROMYCIN HHH
Date registered
Evaluation commenced
Decision date
Approval time
157 working days (255)
Active ingredients
Erythromycin lactobionate
Registration type
New generic medicine
Indication
ERYTHROMYCIN SXP, ERYTHROMYCIN HHH (powder for injection) is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below when oral administration is not possible or when the severity of the infection requires immediate high serum levels of erythromycin. Oral erythromycin is not considered to be the antibiotic of choice in severely ill patients.
- Upper respiratory tract infections caused by Streptococcus pyogenes (Group A beta-haemolytic streptococci); Streptococcus pneumoniae (Diplococcus pneumoniae); Haemophilus influenzae (many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved).
- Lower respiratory tract infections caused by Streptococcus pyogenes (Group A beta-haemolytic streptococci); Streptococcus pneumoniae (Diplococcus pneumoniae).
- Respiratory tract infections due to Mycoplasma pneumoniae.
- Skin and skin structure infections caused by Streptococcus pyogenes and Staphylococcus aureus (resistant staphylococci may emerge during treatment).
- Diphtheria - As an adjunct to diphtheria antitoxin in infections due to Corynebacterium diphtheriae to prevent establishment of carriers and to eradicate the organism in carriers.
- Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythromycin powder for injection (sterile erythromycin lactobionate) followed by erythromycin stearate, base or ethyl succinate orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N.gonorrhoeae in female patients with a history of sensitivity to penicillin.
- Before treatment of gonorrhoea, patients who are suspected of also having syphilis should have microscopic examination for T. pallidum (by immunofluorescence or darkfield) before receiving erythromycin and monthly serologic tests for a minimum of 4 months thereafter.
- Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease.