INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ERYMYCIN ESTOLATE P
ERYMYCIN ESTOLATE PF
SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form)

ERYMYCIN ESTOLATE P
ERYMYCIN ESTOLATE PF
(Suspension)

COMPOSITION:
1. Each 5 mL of the ERYMYCIN ESTOLATE P suspension contains Erythromycin Estolate equivalent to 125 mg of erythromycin base
  Preservatives: 1.
2.
3.		 Methylparaben
Propylparaben
Butylparaben		 0,03% m/v
0,015% m/v
0,015% m/v
2 Each 5 mL of the ERYMYCIN ESTOLATE PF suspension contains Erythromycin Estolate equivalent to 250 mg of erythromycin base.
  Preservative: Nipastat 0,1% m/v 

PHARMACOLOGICAL CLASSIFICATION:
A.20.1.1 Antimicrobial Agents: Broad and Medium spectrum antibiotics.

PHARMACOLOGICAL ACTION:
Erythromycin is a macrolide antibiotic and inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit. It may be bactericidal or bacteriostatic depending on the organism and the concentration.
The in vitro antibacterial spectrum of erythromycin is as follows (in vitro sensitivity does not necessarily imply in vivo efficacy):
Erythromycin is active against the following organisms:
  Mycoplasma pneumoniae, Legionella pneumophilia and L. micadei, Campylobacter jejuni, Streptococcus pyogenes and S. pneumoniae*, Neisseria gonorrhoeae, Bacillus anthracis*, Corynebacterium diphtheriae (especially the carrier state), Listeria monocytogenes, Erysipelothrix rhusiopathiae, Ureaplasma urealyticum, Chlamydia trachomatis and Bordetella pertussis;
Erythromycin may also have some activity against the following organisms:
Streptococcus agalactiae, streptococci of the viridans group* and anaerobic streptococci*, Clostridium perfringens* and Cl. tetani, Treponema pallidum, Bacteroides species;* = sensitivity tests must be performed.
The following organisms are resistant to erythromycin:
Staphylococcus epidermidis, Bacteroides fragilis, the majority of aerobic gram-negative bacilli, Mycobacterium fortuitum, M. intracelulare, Staphylococcus aureus and Haemophilus influenzae.

INDICATIONS:
Respiratory infections:
Atypical and typical pneumonia, Legionaire's disease, diphtheria, pharyngitis, laryngotracheitis and otitis media.Urinary tract infections:
Uncomplicated endocervical, rectal and epydidymal infections and nonspecific urethritis.Gastro-intestinal infections:
Early bacterial gastro-enteritis.Skin and soft tissue infections:
Erysipelas, "malignant pustules" and erythrasma.Miscellaneous infections:
Scarlet fever, tetanus, early syphilis (in patients allergic to penicillin), gonococcal arthritis-dermatitis syndrome, meningitis and bacteremia.Prophylactic use (in patients hypersensitivity to penicillin):
Rheumatic fever and bacterial endocarditis.

CONTRA-INDICATIONS:
Patients with impaired liver function or patients who have developed jaundice or other symptoms of liver toxicity during previous treatment with an erythromycin. Known hypersensitivity to erythromycin.

WARNING:
The safety of erythromycin for use during pregnancy and lactation has not been established.
KEEP OUT OF REACH OF CHILDREN.

DOSAGE AND DIRECTIONS FOR USE:
Take the medicine at regular intervals. Complete the prescribed course unless otherwise directed.
Adults: 250 - 500 mg every 6 hours before meals.
Children: 30 - 50 mg/kg body-mass daily in divided doses before meals.
In severe infections these doses may be doubled.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal disturbances are fairly common. Nausea, vomiting and diarrhoea may occur. Super-infection following oral administration may occur due to resistant bacteria or fungi. Pseudomembranous colitis may also occur.
Among the allergic reactions observed are fever, eosinophylia and skin eruptions, which may occur alone or in combination. Cholestatic hepatitis is the most striking allergic reaction. The illness starts after about 10 to 20 days of treatment and is characterised initially by nausea, vomiting and abdominal cramps, often mimicking the symptoms of acute cholecystitis. These symptoms are followed shortly by jaundice, which may be accompanied by fever, leukocytosis, eosinophilia, and elevated activities of transaminases in plasma; the cholecystogram is usually negative.
Reversible deafness has occurred after high doses of erythromycin. The product should not be given to patients with impaired liver function or to patients who have developed jaundice or other symptoms of liver toxicity during previous treatment. A second course of treatment should be given with caution. The product should not be used in patients with a known history of allergy to erythromycin.
Erythromycin has been reported to potentiate the effects of carbamazepine, corticosteroids and digoxin, probably by interfering with their metabolism. In addition, high and potentially toxic concentrations of theophylline may result when erythromycin is administered concomitantly. The dose of theophylline should be reduced while the patients is receiving concomitant erythromycin therapy. Erythromycin may enhance the effect of warfarin, dose adjustment of warfarin may be necessary. Concurrent use of chloramphenicol and lincomycins together with erythromycin is to be avoided as antagonism occurs. False elevation of serum glutamic oxaloacetic trasaminase may appear in patients taking erythromycin. Erythromycin might interfere with fluorimetric estimations or urinary catecholamines.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and Special precautions". Treatment is symptomatic and supportive.

IDENTIFICATION:
1. ERYMYCIN ESTOLATE P is a sweet orange flavoured orange suspension with a slightly bitter aftertaste.
2. ERYMYCIN ESTOLATE PF is a sweet orange flavoured white suspension with a bitter aftertaste.

PRESENTATION:
Bottles of 100 mL

STORAGE INSTRUCTIONS:
Store below 25°C. Keep container tightly closed. Protect from light. Shake the bottle before use.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
ERYMYCIN ESTOLATE P –No. Y/20.1.1/183
ERYMYCIN ESTOLATE PF –No. Y/20.1.1/184

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
TRIOMED (Pty) Limited
6b Phumelela Park
Montague Drive
Montague gardens
7441

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
15/04/1991
        D254
        A&S PRINTERS

Updated on this site: February 2003
Source: Community Pharmacy

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