ESTOMYCIN 250 Capsules; ESTOMYCIN 125S Suspension; ESTOMYCIN 250S Suspension

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

ESTOMYCIN 250 Capsules
ESTOMYCIN 125S Suspension
ESTOMYCIN 250S Suspension

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ESTOMYCIN 250 Capsules
ESTOMYCIN 125S Suspension
ESTOMYCIN 250S Suspension

APPROVED NAME:
Erythromycin Estolate.

COMPOSITION:

Estomycin 250	–	each capsule contains erythromycin estolate equivalent to 250 mg erythromycin base.
Estomycin 125S	–	each 5 mL of the suspension contains erythromycin estolate equivalent to 125 mg erythromycin base and as preservative 0,2% (m/v) sodium benzoate and 0,2% (m/v) potassium sorbate.
Estomycin 250S	–	each 5 mL of the suspension contains erythromycin estolate equivalent to 250 mg erythromycin base and as preservative 0,2% (m/v) sodium benzoate.

Both the suspensions contain TARTRAZINE.

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 Broad and medium spectrum antibiotics.

PHARMACOLOGICAL ACTION:
Estomycin 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 Estomycin is as follows (care must however be exercised when extrapolating this data to a clinical situation).

Estomycin is active against the following organisms:
Mycoplasma pneumoniae, Legionella pneumophilia and L. miodadei, Campylobacter jejuni, Streptococcus pyogenes and S. pneumoniae*, Neisseria gonorrhoeae, Bacillus anthracis*, Corynebacterium diphtheria (especially the carrier state), Listeria monocytogenes, Erysipelothrix rhusiopathiae, Ureaplasma urealyticum, Chlamydia trachomatis and Bordetella pertussis;

Estomycin may also have some activity against the following organisms:
Streptococcus agalactiae, streptococci of the viridans group* and anaerobic streptococci*, Clostridium perfringens* and Cl. tetani, Trepenoma pallidum, Bacteroides species:

* sensitivity tests must be performed.

The following organisms are resistant to Estomycin:
Staphylococcus epidermidis, Bacteroides fragilis, the majority of aerobic gram-negative bacilli, Mycobacterium fortuitum M. intracellulare, Staphylococcus aureus and Haemophilus influenzae.

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 non-specific 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 hypersensitive to penicillin): Rheumatic fever and bacterial endocarditis.

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

WARNINGS:
The safety of Estomycin during pregnancy has not been established, a second course should be given with caution.

ESTOMYCIN 125S and ESTOMYCIN 250S contain FD and C Yellow No 5 (TARTRAZINE). Tartrazine may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of tartrazine sensitivity in the general population is currently thought to be low it is frequently seen in patients who also have aspirin sensitivity.

DOSAGE AND DIRECTIONS FOR USE:
To be taken on an empty stomach.

Adults : 250 mg every six hours. In severe infections this dose should be doubled.
Children : 30 mg/kg body mass per day six hourly in divided doses.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS OF ITS TREATMENT:
Nausea, vomiting and diarrhoea may occur. Gram-negative bacteria, including Coliform bacilli, are unaffected in the intestines after oral administration. Superinfection by these bacteria or fungi may occur. Pseudomembranous colitis may also occur.

Sensitisation to erythromycin may occur. The hypersensitivity reactions include fever, eosinophilia, and skin eruptions, each of which may occur alone or in combination.

The most striking allergic reaction is cholestatic hepatitis. It is characterised by nausea, vomiting and abdominal cramps, often mimicking the pain of acute cholecystitis. These symptoms are shortly followed by jaundice, fever, leucocytosis, eosinophilia, and elevated plasma transaminase and bilirubin concentrations; the cholecystogram is negative. The syndrome resembles acute cholecystitis biliary obstruction pancreatitis, or viral hepatitis.

Anaphylaxis may also occur. Reversible loss of hearing may occur with high doses of estomycin, especially in patients with renal insufficiency.

Estomycin must be used with care in patients with impaired hepatic function.

It must not be given together with chloramphenical or thiamphenicol. The use of Estomycin in patients who are receiving theophylline may be associated with an increase in serum theophylline levels and potential theophylline toxicity.

Patients receiving Estomycin during treatment with coumarin-type anticoagulants must have their prothrombin times monitored (especially elderly patients).

Estomycin may potentiate the effects of carbamazepine, corticosteroids and digoxin.

False elevation of serum glutamicoxalacetic transaminase may appear in patients taking Estomycin.

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

IDENTIFICATION:

ESTOMYCIN 250	–	Yellow size 0 capsule with white powder.
ESTOMYCIN 125S	–	a green suspension with a lime taste.
ESTOMYCIN 250S	–	a green suspension with a lime taste.

PRESENTATION:

ESTOMYCIN 250	–	securitainers with 20 and 100 capsules.
ESTOMYCIN 125S	–	100 mL in amber glass bottles
ESTOMYCIN 250S	–	100 mL in amber glass bottles.

STORAGE INSTRUCTIONS:
Store in a dry place below 25°C. Keep out of reach of children.

REGISTRATION NUMBER:

ESTOMYCIN 250	–	Q/20.1.1/237
ESTOMYCIN 125S	–	Q/20.1.1/238
ESTOMYCIN 250S	–	X/20.1.1/15

NAME AND ADDRESS OF APPLICANT:
Columbia Pharmaceuticals (Pty) Limited
8 Aero Centre
Tempelhof South
Bonaero Park

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

07/04/92

Britepak