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

Logo RUBIMYCIN®-250 TABLETS
RUBIMYCIN®-500 TABLETS

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

RUBIMYCIN®-250 TABLETS
and
RUBIMYCIN®-500 TABLETS

COMPOSITION:
Each tablet contains
Erythromycin Stearate equivalent to:
(i) 250 mg Erythromycin base
(ii) 500 mg Erythromycin base

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 Broad and medium spectrum antibiotics.

PHARMACOLOGICAL ACTION:
Erythromycin stearate is an antibiotic belonging to the macrolide group and acts by inhibition of protein synthesis of the micro organisms.
It produces peak plasma levels in one to four hours, depending on the rapidity of gastric emptying. The level declines after four to six hours.
The antibiotic is concentrated in the liver and excreted in active form in the bile. About 2 - 5% of the drug is excreted in the urine, also in the active form.
It diffuses readily in most body fluids, mainly in pleural and peritoneal fluids. Passage of the antibiotic across the bloodbrain barrier is increased in meningeal inflammation. It crosses the placental barrier but foetal plasma levels are low (5 - 20% of maternal plasma levels).

INDICATIONS:
Infections due to susceptible micro-organisms such as gram positive cocci and bacilli. When possible, cultures and sensitivity tests should be done.
(In vitro sensitivity does not necessarily imply in vivo efficacy).
Erythromycin stearate has been found to be effective in vitro against Gram-positive organisms such as Staphylococcus aureus*, Streptococcus pyogenes and Streptococcus viridans *, enterococci and pneumococci. It also inhibits some strains of Neisseriae, Haemophilus influenzae, Corynebacterium diphtheriae, Listeria, Pasteurella and Treponema.
Upper and lower respiratory tract infections due to Streptococcus pyogenes (Group AB-hemolytic streptococcus), Haemophilus influenzae* and Mycoplasma pneumoniae.
* = sensitivity tests must be performed.
Erythromycin stearate is an alternate treatment for Neisseria gonorrhoea and primary syphilis (T. pallidum) in patients allergic to the penicillins. Before treatment of gonorrhoea patients who are suspected of also having syphilis should have a microscopic examination for T. pallidum.

Miscellaneous infections
Erythromycin is successful as adjunctive therapy to the antitoxin in the treatment of tetanus. The drug has also proved to be successful in the treatment of infections due to Bordetella pertussis and Listeria monocytogenes.

Prophylactic use
Group AB-hemolytic streptococcus - prevention of streptococcal pharyngitis and long term prophylaxis of rheumatic fever.
Corynebacterium diphtheriae - as an adjunct to antitoxin, to prevent the establishment of carriers or eradicate the organism in carriers.

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.

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

DOSAGE AND DIRECTIONS FOR USE
In order to obtain optimal blood levels, Rubimycin should be given on an empty stomach.
For adults:
250 to 500 mg every 6 hours depending on the severity of the infection.
For children:
The basic recommendation ranges from 30 to 50 mg/kg/day or more, depending on the severity of the infections: these amounts are administered in four divided doses.

Dosage schedule for specific indications
In streptococcal infections, erythromycin stearate should be administered at therapeutic dosage for at least 10 days. For continuous prophylaxis of streptococcal infections or rheumatic fever recurrences in persons with a history of rheumatic heart disease, the dose is 250 mg twice a day. When used prior to surgery to prevent endocarditis (see hemolytic streptococcus) a recommended schedule for adults is 1 g before the procedure and 500 mg every 6 hours for 8 doses after the procedure.

Treatment of primary syphilis:
2 - 4 grams per day given in divided doses over a period of 10 to 15 days.
Treatment of gonorrhoea:
500 mg four times daily for 5 days.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Caution should be taken in administering erythromycin stearate to patients with impaired hepatic function.
Gastro-intestinal disturbances e.g. nausea, vomiting, abdominal cramps and diarrhoea may occur. Sensitisation to erythromycin and hypersensitivity reactions such as fever, eosinophilia and skin reactions may occur. Anaphylaxis has been reported.
Super-infection caused by resistant organisms.
Pseudo-membranous colitis may occur.
Reversible deafness has occurred after high doses of erythromycin.
Hepatotoxicity has been reported after administration of erythromycin, but most commonly as the estolate.
Erythromycin should not be given concomitantly with chloramphenicol or thiamphenicol. Erythromycin may potentiate the action of carbamazepine, cyclosporin, corticosteroids, digoxin, theophylline and warfarin, probably by inhibition of their hepatic metabolism.
Erythromycin may interfere with some diagnostic tests including measurements of urinary catecholamines, 17-hydroxycorticosteroids and 17-ketosteroids, and with the microbiological measurements of blood folate.
To avoid the ototoxicity of erythromycin in patients with renal failure, it is suggested that the daily dosage should not exceed 15 g in patients with serum creatinine above 180 micromol per litre; hearing acuity should be tested before and during treatment, especially in the elderly; and erythromycin should not be given with other potentially ototoxic medicines.
There have been reports of excessive prolongation of prothrombin times in patients receiving erythromycin concurrently with chronic coumarin-type anti-coagulant 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. Development of bacterial strains resistant to erythromycin is more common during prolonged treatment of infections more difficult to eradicate.

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

IDENTIFICATION:
250 mg Tablets - Pink, biconvex film-coated tablets.
500 mg Tablets - White, ovoid film-coated tablets.

PRESENTATION:
250 mg Tablets - Packs of 20, 100, 250 and 500 tablets.
500 mg Tablets - Packs of 15, 100 and 250 tablets.

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

REGISTRATION NUMBERS:
250 mg Tablets - M/20.1.1/68.
500 mg Tablets - M/20.1.1/69.

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
18/12/1978

        G883
        A&S PRINTERS

Updated on this site: April 2005
Source: Hospital Pharmacy

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