COMPOSITION; Granules: When prepared as directed each medicine measureful (5 mL) contains erythromycin estolate equivalent to 125 mg of erythromycin base with sodium methylhydroxybenzoate 0,12% m/v and sodium propylhydroxybenzoate 0,04% m/v as preservative.
PHARMACOLOGICAL CLASSIFICATION: A 20.1.1 Broad and Medium Spectrum Antibiotics.
PHARMACOLOGICAL ACTION: ACU-ERYLATE S 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 concentration.
The in-vitro antibacterial spectrum of ACU-ERYLATE S is as follows (in-vitro sensitivity does not necessarily imply in-vivo efficacy):
ACU-ERYLATE S is effective in-vitro against the following organisms:
Mycoplasma pneumonia, Legionella pneumophilia and L. micdadei, Campylobacter jejuni, Streptococcus pyogenes and S. pneumoniae*, Neisseria gonorrhoea, Bacillus anthracis*, Corynebacterium diphtheria (especially the carrier state), Listeria monocytogenes, Erysipelothrix rhusiopathiae, Ureaplasma ureayticum, Chlamydia trachomatis and Bordetella pertussis.
ACU-ERYLATE S 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 specis.
* Sensitivity tests must be performed.
Many organisms including the following are resistant to ACU-ERYLATE S:
Staphylococcus epidermidis, Bacteroides fragilis, the majority of aerobic gram-negative bacilli, Mycobacterium fortuitum, M. intracellulare, Staphylococcus aureus and Haemophilus influenzae.
Respiratory Infections: Atypical and typical pneumonia, legionnaires disease, Chlamydial pneumonia in infants, diphtheria, pharyngitis, laryngotracheitis, otitis media and early cases of whooping cough. Urinary Tract Infections: Uncomplicated endocervical, rectal and epididymal 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 bacteraemia. 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:
250 mg to 500 mg every 6 hours before meals depending on the severity of the infections.
30 mg 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, eosinophilia and skin eruptions. Cholestatic hepatitis, characterised by nausea, vomiting, diarrhoea 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 a 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 time 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: Pink granules for reconstitution to 100 mL, with an odour of cherries.
PRESENTATION Clear 100 mL glass bottles containing 33 g granules.
STORAGE INSTRUCTIONS: Store below 25°C. Protect from moisture.
KEEP OUT OF REACH OF CHILDREN
REGISTRATION NUMBER: 27/20.1.1/0056
NAME AND BUSINESS ADDRESS OF THE APPLICANT: APOTEX S.A. PHARMACEUTICAL INNOVATION
Reg. Prop: Acupharm (Pty) Ltd
Cnr. Fleming & Watt Streets
Meadowdale Ext. 1
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 2 July 1992