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Logo ERYSTAT (granules)

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ERYSTAT (granules)

COMPOSITION:
Granules:
Each 5 mL of the reconstituted suspension contains:
Erythromycin estolate equivalent to 125 mg erythromycin base.
Preservatives: Sodium methylhydroxybenzoate 0,12% m/v
  Sodium propylhydroxybenzoate 0,04% m/v.
PHARMACOLOGICAL CLASSIFICATION:
A.20.1.1 Broad and Medium Spectrum Antibiotics.

PHARMACOLOGICAL ACTION:
ERYSTAT
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 activity spectrum of ERYSTAT is as follows (in vitro sensitivity does not necessarily imply in vivo efficacy):

ERYSTAT is effective in vitro 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.

ERYSTAT may also have some activity 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.

* = sensitivity tests must be performed.

Many organisms including the following are resistant to ERYSTAT:
Staphylococcus epidermis, 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 stages of whooping cough.

Urinary tract infections:
Uncomplicated endocervical, rectal and epydidymal infections and non-specific 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 use (in patients hypersensitivity to penicillin):
Rheumatic fever and bacterial endocarditis.

CONTRA-INDICATIONS:
Patients with known sensitivity 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 to 500 mg every 6 hours before meals depending on the severity of the infection.

Children:
30 to 50 mg/kg/day in divided doses every 6 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, eosinophylia 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 transaminases, 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 concomitantly.

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

IDENTIFICATION:
Granules for suspension: Free flowing light pink granules.
Reconstitution produces a pink suspension with a sweet, cherry flavour.

PRESENTATION:
Granules: Granules for reconstitution to 100 mL

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
28/20.1.1/0118

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Medpro Pharmaceutica (Pty) Ltd
Unit 9 Rosen Heights
Pasita Street
ROSENPARK 7530

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
NOVEMBER 1994

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