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Logo ADCO-ERYTHROMYCIN 125 mg/5 mL

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ADCO-ERYTHROMYCIN 125 mg/5 mL
Suspension

COMPOSITION:
When prepared as directed each medicine measureful (5 mL) contains
erythromycin estolate equivalent to 125 mg of erythromycin base with sodium methyl hydroxybenzoate 0,12% m/v and sodium propyl hydroxy- benzoate 0,04% m/v as preservatives.

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 Broad and Medium Spectrum Antibiotics

PHARMACOLOGICAL ACTION:
ADCO-ERYTHROMYCIN 125 mg/5 mL
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 ADCO-ERYTHROMYCIN 125 mg/5 mL is as follows (in vitro sensitivity does not necessarily imply in-vivo efficacy):
ADCO-ERYTHROMYCIN 125 mg/5 mL is effective in-vitro against the following organisms:
Mycoplasma pneumoniae, Legionella pneumophilia and L. micdadei, 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;
ADCO-ERYTHROMYCIN 125 mg/5 mL may also have some effect against the following organisms in-vitro:
Streptococcus agalactiae, streptococci of the viridans group* and anaerobic streptococci*, Clostridium perfringens* and Cl. tetani, Treponema pallidum, Bacteroides species;
Many organisms including the following are resistant to ADCO-ERYTHROMYCIN 125 mg/5 mL: Staphylococcus epidermidis, Bacteroides fragilis, the majority of aerobic gram-negative bacilli, Mycobacterium fortuitum, M. intracellulare, Staphylococcus aureus and Haemophilus influenzae. * = sensitivity tests must be performed.

INDICATIONS:
Respiratory infections:
Atypical and typical pneumonia, Legionaires disease, Chlamydial pneumonia in infants, diphtheria, pharyngitis, laryngotracheitis, otitis media and early cases of whooping cough;
Urinary tract infections:
Uncomplicated endocervical, rectal and epydidymal infections and nonspecific urethritis;
Gastro-intestinal infections:
Early 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 uses (in patients hypersensitive to penicillin):
Rheumatic fever and bacterial endocarditis.

CONTRA-INDICATIONS:
Patients with known hypersensitivity to erythromycin. Erythromycin estolate 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 with erythromycin.
Safety of use in pregnancy and lactation has not been established.

DOSAGE AND DIRECTIONS FOR USE:
Adults:
250 mg to 500 mg every six hours before meals depending on the severity of the infection.
Children:
30 mg to 50 mg/kg/day in divided doses every six hours before meals.
Directions for reconstituting the granules:
Add 80 mL of distilled water, and shake thoroughly. After reconstitution store below 20°C. USE WITHIN FOURTEEN DAYS.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Anaphylaxis has been reported. Allergic reactions include fever, eosinophilia and skin eruptions. Cholestatic hepatitis, characterised by nausea, vomiting and abdominal cramps followed by jaundice. Jaundice may be accompanied by fever, leucocytosis, eosinophilia and elevated plasma transaminase, which may occur as a hypersensitivity reaction. In such cases erythromycin should be discontinued. Abdominal discomfort or cramping may be encountered, nausea and vomiting may also occur.
Superinfection caused by resistant bacteria, as well as pseudomembranous colitis may occur.
Caution should be exercised in administering erythromycin to patients with impaired hepatic function.
Reversible deafness has occurred after high doses of erythromycin.
There have been reports of excessive prolongation of prothrombin times in patients receiving erythromycin concurrently with chronic coumarin-type anticoagulant therapy. Such patients, particularly the elderly, may be at risk for developing bleeding due to this interaction. In patients receiving erythromycin during chronic treatment with a coumarin-type anticoagulant, prothrombin times should be monitored closely and the coumarin-type anticoagulant dosage adjusted accordingly.
Erythromycin potentiates the effects of carbamazepine, corticosteroids and digoxin. High levels of theophylline may result when erythromycin is administered concommitantly.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Gastro-intestinal symptoms may occur. Treatment is symptomatic and supportive.

IDENTIFICATION:
Pink granules with odour of cherries.

PRESENTATION:
Granules for reconstitution of 100 mL of suspension.

STORAGE INSTRUCTIONS:
Store below 20°C. Protect from moisture. Keep out of reach of children.

REGISTRATION NUMBER:
J/20.1.1/115

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston
Private Bag X69, Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
23 April 1990

New addition to this site: April 2004
Source: Pharmaceutical Industry

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