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

Logo ERYMYCIN AF (capsules)

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ERYMYCIN AF (capsules)

COMPOSITION:
Each capsule contains
Erythromycin stea, equivalent to 250 mg Erythromycin.

PHARMACOLOGICAL CLASSIFICATION:
A.20.1.1 Broad and Medium Spectrum Antibiotics.

PHARMACOLOGICAL ACTION:
Erythromycin has bacteriostatic and bactericidal activity depending on its concentration and the nature of the micro-organism. It is active (in vitro) against Gram-positive cocci, e.g. Staph. aureus, Group A streptococci, enterococci, pneumococci, many Gram-positive bacilli, Neisseria, Pasteurella multocida, Brucella, Rickettsias and Treponema. Mycobacteria have variable sensitivity to erythromycin.

INDICATIONS:
Infections caused by susceptible strains of the following organisms. Where possible cultures and sensitivity tests should be done. Staphylococcal infections of the skin and soft tissue of mild to moderate severity. Streptococcal infections, e.g. pharyngitis, scarlet fever and erysipelas.
Pneumococcal pneumonia
Diphtheria carrier state
Syphilis (in penicillin sensitive patients)
Infections due to Clostridium tetani and Mycoplasma pneumonia
Gonorrhoea (in penicillin sensitive patients)
Prophylaxis in rheumatic fever recurrence (in some patients allergic to penicillin).

CONTRA-INDICATIONS:
Contra-indicated in erythromycin sensitive patients.

DOSAGE AND DIRECTIONS FOR USE:
capsule to be taken every 6 hours or two capsules every 12 hours. For severe infections 2 to 4 g may be taken daily in two to four divided doses; for severe infections this may be increased up to 4 g daily in divided doses.
Twice-a-day dosing is not recommended when doses larger than 1 g daily are administered.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Caution should be observed when the drug is administered to patients with impaired liver function.
The most frequent side-effect after oral administration is epigastric distress with nausea, vomiting and diarrhoea.
Mild hypersensitivity reactions such as fever, eosinophylia and skin reactions may occur.
Jaundice may occur.
Superinfection may develop in rare cases. A variety of Gram-negative bacteria as well as yeasts and fungi, especially Candida may then be involved.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of overdosage are nausea, vomiting and diarrhoea. Treatment consists of symptomatic and supportive care.

IDENTIFICATION:
Opaque blue/white capsule overprinted “Erymycin’in black.

PRESENTATION:
Blister packs of 20’s and 100’s; containers of 1000’s capsules.

STORAGE INSTRUCTIONS:
Store in a cool (below 25°C), dry place.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
Q/20.1.1/307

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
TRIOMED (PTY) Ltd.
Montrose Place
2 Bella Rosa Street
Rosenpark
Belville
7530

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
28/03/1983        G203B
        Kohler C&P C.P.


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