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Logo ERYTHROMYCIN ETHYLSUCCINATE 125 mg - LENNON Granules for Suspension
ERYTHROMYCIN ETHYLSUCCINATE 250 mg - LENNON Granules for Suspension

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ERYTHROMYCIN ETHYLSUCCINATE 125 mg - LENNON Granules for Suspension
ERYTHROMYCIN ETHYLSUCCINATE 250 mg - LENNON Granules for Suspension

COMPOSITION:
Each 5 mL of the reconstituted suspension contains:
(1) Erythromycin ethylsuccinate equivalent to 125 mg
erythromycin base
(2) Erythromycin ethylsuccinate equivalent to 250 mg erythromycin base
Preserved with: 0,03% m/v propylhydroxybenzoate sodium 0,06% m/v methyl hydroxybenzoate sodium

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 Broad and medium spectrum antibiotics.

PHARMACOLOGICAL ACTION:
Erythromycin has
bacteriostatic activities with a range of antimicrobial action which is similar to that of penicillin G. It is active against some Gram-positive bacteria, some Gram-negative bacteria (Neisseria and Haemophilus), spirochaetes, some rickettsias, Streptococcus pneumoniae, haemolytic streptococci, and corynebacteria. Staphylococci (including those resistant to penicillin) are rather less sensitive. During prolonged treatment of infections, the development of resistant strains is common.

INDICATIONS:
Erythromycin is an agent for use in individuals unable to take penicillin because of previous reactions. Pharyngitis, Scarlet Fever anderysipelas produced by group-A Streptococcus pyogenes respond to erythromycin. Erythromycin is useful in cases in which the presence of penicillinase-producing staphylococci may be responsible for relapse of streptococcal pharyngitis after adequate treatment with penicillin G, and other infections due to enterococci may also respond well to the drug. Erythromycin is effective in eradicating the acute or chronic diphtheria bacillus carrier state. Treatment is required for 2 weeks. It must be stressed that, in the acute disease, neither this nor any other antibiotic alters the course of the infection or the risk of complications; a proper dose of specific antitoxin must be administered. Erythromycin has been used with some degree of success in syphilis in penicillin-sensitive persons. Clostridium tetani is cured by the drug; however, antitoxin must be given simultaneously in cases of tetanus.

Erythromycin is effective in the therapy of Mycoplasma pneumonia; however, the micro-organism may persist in the respiratory tract despite adequate plasma concentrations of the antibiotic. In general erythromycin is less effective than tetracycline in eliminating the carrier state. In gonorrhoea, erythromycin is a suitable substitute for penicillin therapy.

CONTRA-INDICATIONS:
Erythromycin ethylsuccinate is contra-indicated in patients with impaired liver function or in patients who have developed jaundice or other symptoms of liver toxicity during previous treatment and in those with a known hypersensitivity to erythromycin.

DOSAGE AND DIRECTIONS FOR USE:
Adults:
250 mg every 6 hours before meals.
Children: 30 mg/kg body-mass in divided doses before meals.

In severe infections these doses may be doubled and continued for up to 10 days.
To reconstitute: Add 70 mL water and shake well until granules are dissolved.
NOTE: Treatment should be continued until the bottle is empty unless otherwise instructed by the physician.
Once reconstituted, the suspension remains stable for 5 days at room temperature and for 10 days in a refrigerator.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Large doses produce nausea, vomiting, and diarrhoea. Supra-infection following oral administration may occur. Hypersensitivity reactions include fever, eosinophilia and skin eruptions, each of which may occur alone or in combination; they disappear shortly after therapy is stopped.
Elevation of serum glutamic oxalacetic transaminase may appear in patients taking erythromycin.

The safety of this drug for use during pregnancy has not been established.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Gastro-intestinal disturbances which clears within a few days of stopping treatment.

IDENTIFICATION:
Pink-coloured granules, which, when reconstituted as directed become a palatable cherry-flavoured suspension.

PRESENTATION:
125 mg/5 mL - Packs in 100 mL bottles.
250 mg/5 mL - Packs in 100 mL bottles

STORAGE INSTRUCTIONS:
Keep container tightly closed and store below 25°C.

Once reconstituted the suspension remains stable for 5 days at room temperature (below 25°C) or for 10 days in a refrigerator. Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
125 mg/5 mL: P/20.1.1/139
250 mg/5 mL: P/20.1.1/140

NAME AND BUSINESS ADDRESS OF APPLICANT:
Lennon Limited
7 Fairclough Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
3.1.1986 M871

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