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Logo PURMYCIN® CAPSULES

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

PURMYCIN® CAPSULES

COMPOSITION:
Each capsule contains erythromycin estolate equivalent to 250 mg
erythromycin base.

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 Broad and medium spectrum antibiotics.

PHARMACOLOGICAL ACTION:
Purmycin 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 Purmycin is as follows (care must however be exercised when extrapolating these data to the clinical situation):
Purmycin is active against the following organisms:Mycoplasma pneumoniae, Legionella pneumophilia and L. micdadei, Campylobacter jejuni, Streptococcus pyogenes and S. Pneumoniae*, Neisseria gonorrhoeae, Bacillus anthracis*, Corynebacterium (especially the carrier state), Listeria monocytogenes, Erysipelothrix rhusiopathiae, Ureaplasma urealyticum, Chlamydia trachomatis and Bordetella pertussis;
Purmycin may also have some activity against the following organisms:
Streptococcus agalactiae, streptococci of the viridans group* and anaerobic streptococci*, Clostridium perfringens* and Cl. tetani, Treponema pallidum, Bacteroides species;
*= sensitivity tests must be performed.
The following organisms are resistant to Purmycin:
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, Legionnaire’s disease, diphtheria, pharyngitis, laryngotracheitis and otitis media;
Urinary tract infections:
Uncomplicated endocervical, rectal and epydidymal infections and nonspecific urethritis;
Gastro-intestinal infections:
Early bacterial gastro-enteritis;
Skin and soft tissue infections:
Erysipelas, “malignant pustules”and erythrasma;
Miscellaneous infections:
Scarlet fever, tetanus, early syphillis (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 patients who have developed jaundice or other symptoms of liver toxicity during previous treatment with an erythromycin. Known hypersensitivity to erythromycin.
Erythromycin may be unsafe in patients with acute porphyria as it can be porphyrinogenic.

WARNING:
The safety of Purmycin for use during pregnancy and lactation has not been established.
KEEP OUT OF REACH OF CHILDREN.

DOSAGE AND DIRECTIONS FOR USE:
The usual oral dose for adults ranges from 1 to 2 g (base) per day, usually given every 6 hours, depending on the nature and severity of the infection. For severe infections 2 to 4 g (base) may be given daily. Twice-a-day dosing is not recommended when doses larger than 1 g daily are administered.
The medicine should be taken with a full glass of water (240 mL) on an empty stomach (either 1 hour before or 3 to 4 hours after meals).
Streptococcal Infections
250 mg to 500 mg every 6 hours for 10 days to prevent occurrence of rheumatic fever or glomerulonephritis in the treatment of those patients with group A beta-haemolytic streptococcal infections.
For prevention of bacterial endocarditis following dental or oropharyngeal procedures, the dose is 1 g orally 1,5 hours to 2 hours before the procedure followed by 500 mg every 6 hours for eight doses.
Primary Syphilis
Doses of 2 to 4 g per day for 10 to 15 days have been employed successfully in early syphilis.
Legionnaire's Disease
A dose of 0,5 to 1 g four times daily may be used.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal disturbances are fairly common. Nausea, vomiting and diarrhoea may occur. Super-infection following oral administration may occur due to resistant bacteria or fungi. Pseudomembranous colitis may also occur.
Among the allergic reactions observed are fever, eosinophilia and skin eruptions, which may occur alone or in combination. Cholestatic hepatitis is the most striking allergic reaction. The illness starts after about 10 to 20 days of treatment and is characterised initially by nausea, vomiting and abdominal cramps often mimicking the symptoms of acute cholecystitis. These symptoms are followed shortly by jaundice, which may be accompanied by fever, leukocytosis, eosinophilia, and elevated activities of transaminases in plasma; the cholecystogram is usually negative.
Reversible deafness has occurred after high doses of erythromycin. The product 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. A second course of treatment should be given with caution.
The product should not be used in patients with a known history of allergy to erythromycin.
Erythromycin has been reported to potentiate the effects of carbamazepine, corticosteroids and digoxin, probably by interfering with their metabolism. In addition high and potentially toxic concentrations of theophylline may result when erythromycin is administered concomitantly. The dose of theophylline should be reduced while the patient is receiving concomitant erythromycin therapy. Erythromycin may enhance the effect of warfarin, dose adjustment of warfarin may be necessary. Concurrent use of chloramphenicol and lincomycins together with erythromycin is to be avoided as antagonism occurs. False elevation of serum glutamic oxaloacetic transaminase may appear in patients taking erythromycin. Erythromycin might interfere with fluorimetric estimations or urinary catecholamines.

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

IDENTIFICATION:
A No. 0 capsule with an opaque cream body and opaque red cap, printed with a Lennon logo, "LENNON" and "PURMYCIN" in black ink.

PRESENTATION:
Packs of 20, 100 and 500 capsules.

STORAGE INSTRUCTIONS:
Protect from light.
Keep container tightly closed.
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:
L/20.1.1/145.

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
7 Fairclough Road
PORT ELIZABETH 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
6/2/1979
                        G957
        A&S PRINTERS

Updated on this site: February 2004
Source: Community Pharmacy

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