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Logo ADCO-ERYTHROMYCIN CAPSULES

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ADCO-ERYTHROMYCIN CAPSULES
Capsule

COMPOSITION:
Each ADCO-ERYTHROMYCIN CAPSULE contains
erythromycin estolate equivalent to 250 mg erythromycin base.

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 Broad and Medium Spectrum Antibiotics

PHARMACOLOGICAL ACTION:
Erythromycin is produced by a strain of Streptomyces erythreus and belongs to the macrolide group of antibiotics. It may be bactericidal or bacteriostatic, depending on the micro-organism and the concentration of the drug. Erythromycin inhibits protein synthesis by bonding to the 50S ribosomal subunits of sensitive micro-organisms. The bactericidal activity is markedly enhanced in an alkaline medium. Orally administered erythromycin is readily absorbed, especially when given on an empty stomach. Hereafter, erythromycin diffuses readily into intracellular fluids and antibacterial activity can be achieved at essentially all sites except the brain and the cerebrospinal fluid. Erythromycin penetrates into the prostatic fluid and in pregnancy, it crosses the placental barrier and results in foetal plasma concentrations of between 5% and 20% of that in the maternal circulation. Erythromycin binds to plasma proteins possibly in excess of 70%. Erythromycin is concentrated in the liver and excreted in the bile in the active form. Only 2 to 5% of orally administered erythromycin is excreted in the active form in the urine.
Erythromycin estolate is the lauryl sulphate salt of the propionyl ester of erythromycin and it is readily absorbed on oral administration. The serum levels thus obtained are comparable whether it is taken after food or in the fasting state, because of the acid stability of the compound.
After oral administration of erythromycin estolate, the antibiotic appears in the serum as erythromycin base and propionyl erythromycin ester, which is itself continuously hydrolysed to erythromycin base. Peak plasma levels are achieved after approximately 2 hours of an oral dose of erythromycin estolate.

INDICATIONS:
Indicated for infections caused by susceptible organisms, especially those affecting the respiratory system.
Mycoplasma pneumoniae Infections :
Erythromycin reduces the duration of fever caused by M. pneumoniae and accelerates the rate of clearing.
Legionnaires' Disease:
Erythromycin is currently recommended for the treatment of pneumonia caused by Legionella pneumophila or L. micdadei.
Chlamydia Infections:
Chlamydia infections can be treated effectively with erythromycin. It is specifically recommended as an alternative to tetracycline in patients with uncomplicated urethral, endocervical, rectal, or epididymal infections. During pregnancy, erythromycin becomes the drug of choice for chlamydial urogenital infections.
Diphtheria:
Erythromycin is very effective in eradicating the acute or chronic diphtheria bacillus carrier state. However, neither erythromycin nor any other antibiotic alters the course of an acute infection with the diphtheria bacillus or the risk of complications.
Pertussis:
If administered early in the course of whooping cough, erythromycin may shorten the duration of illness. It may prevent the disease in susceptible individuals who are exposed to the disease.
Streptococcal Infections:
Pharyngitis, scarlet fever and erysipelas produced by Strep. pyogenes respond to erythromycin. The oral administration of erythromycin cures these diseases, prevents the appearance of suppurative complications and suppresses the formation of antistreptococcal antibodies. Erythromycin is thus a valuable alternative for the treatment of streptococcal infections in patients who are allergic to penicillin.
Pneumococcal Pneumonia:
Responds promptly to oral therapy with erythromycin.
Staphylococcal Infections:
Erythromycin is an alternative agent for the treatment of relatively minor infections caused by either penicillin-sensitive or penicillin-resistant Staph. aureus. However, the emergence of appreciable numbers of strains that are resistant to erythromycin limits the use of the drug.
Campylobacter Infections:
The treatment of gastroenteritis caused by Campylobacter jejuni with erythromycin has been shown to hasten the eradication of the micro-organism from the stools: however, when therapy is initiated four of more days after the onset of symptoms, erythromycin does not alter the clinical course. Nevertheless, the drug is recommended in patients with protracted or severe illness.
Tetanus:
Erythromycin may be given to eradicate Cl. tetani in patients with tetanus who are allergic to penicillin. The mainstays of therapy are debridement, physiological support, tetanus antitoxin and drug control of convulsions.
Syphilis:
Erythromycin has been employed successfully in the treatment of early syphilis in the patient who is allergic to penicillin.
Gonorrhoea:
Erythromycin estolate has been used in the therapy of gonococcal urethritis. However, the relapse rate is nearly 25% after the oral administration of 9 g over a four day period; this is unacceptably high for routine use. Erythromycin may be useful for disseminated gonococcal disease in the pregnant patient who is allergic to penicillin (since tetracyclines should be avoided during pregnancy).
Prophylactic Uses:
Although penicillin is the drug of choice for the prophylaxis of recurrences of rheumatic fever, erythromycin is effective in patients allergic to this drug or to sulphonamides.
Erythromycin is recommended as an alternative to penicillin in allergic patients for prevention of bacterial endocarditis following dental or oropharyngeal procedures.

CONTRA-INDICATIONS:
ADCO-ERYTHROMYCIN CAPSULES are contra-indicated in 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.

DOSAGE AND DIRECTIONS FOR USE:
Children
: The usual dosage is 30 mg - 50 mg per kg body mass daily in divided doses, although it may be doubled in severe infections.

Adults: The usual dosage of ADCO-ERYTHROMYCIN CAPSULES is 250 mg (one capsule) six hourly, but this may be increased to 2 - 4 g (eight to sixteen capsules) in a 24 hour period, depending on the severity of the infection.
Mycoplasma pneumoniae Infections:
500 mg three to four times daily
Legionnaires' Disease:
500 mg to 1 g four times daily.
Chlamydia Infections:
500 mg every six hours for at least seven days.
Streptococcal Infections:
250 mg - 500 mg every six hours for ten days.
Pneumococcal pneumonia:
250 mg to 500 mg every six hours.
Staphylococcal Infections: (infections of the skin or wounds in patients who are allergic to penicillins and cephalosporins) :
500 mg every six hours for seven to ten days.
Campylobacter Infections:
250 mg four times a day.
Tetanus:
500 mg every six hours for ten days.
Syphilis: (in the treatment of early syphilis in the patient who is allergic to penicillin) :
2 g - 4 g per day for ten to fifteen days.
Gonorrhoea:
500 mg every six hours for five days.
Prophylaxis of bacterial endocarditis following dental or oropharyngeal procedures:
1 g one and a half to two hours before the procedure, followed by 500 mg every six hours for eight doses. Alternatively, 1 g may be given one hour before the procedure and a single 500 mg dose six hours later.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Anaphylaxis has been reported. Allergic reactions include fever, eosinophilia and skin eruptions which resolve quickly when therapy is withdrawn. Cholestatic hepatitis, characterised by nausea, vomiting and abdominal cramps followed by jaundice which may be accompanied by fever, leucocytosis, eosinophilia and elevated plasma transaminase activity has occurred as a hyper-sensitivity reaction. In such cases erythromycin therapy should be discontinued. Epigastric distress may follow oral administration of ADCO-ERYTHROMYCIN CAPSULES which may diminish with continued erythromycin therapy or necessitate withdrawal or reduction in dosage.
Therapy with erythromycin may give rise to superinfections caused by resistant bacteria or yeasts, which necessitate withdrawal of the therapy and the institution of suitable treatment. ADCO-ERYTHROMYCIN CAPSULES can cause pseudomembranous colitis.
Erythromycin should be administered with caution to patients with impaired hepatic function. Safety in pregnancy has not been established.
Erythromycin has been reported to potentiate the effects of carbamazepine, corticosteroids and digoxin, probably by interfering with their metabolism. High and potentially toxic levels of theophylline may result when erythromycin is administered concomitantly.
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 who generally exhibit slower coumarin-type anticoagulant clearance, 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.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
No specific symptoms but gastro-intestinal symptoms may be included. Treatment is symptomatic and supportive and may include gastric lavage.

IDENTIFICATION:
ADCO-ERYTHROMYCIN CAPSULES
are two-tone capsules with an orange-red cap and a beige body.

PRESENTATION:
Amber glass bottles and securitainers of 20, 50, 100 and 250 capsules.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light and moisture. Keep out of reach of children.

REGISTRATION NUMBER:
V/20.1.1/6

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston
Private Bag X69, Byranston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
16 August 1988

New addition to this site: April 2004
Source: Pharmaceutical Industry

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