8, Akanbi-Onitiri Crescent, Off Eric Moore Road, Surulere, Lagos. Lagos.
Tel: 234-1-5875179, 5874082, 5877689; 90405798
Teva Pharm. Ind. Ltd, 5 Basel St. Petach, Isreal
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Tablets (NRN: 04-1520): Erythromycin (as stearate) 500 mg.
Erythromycin is a highly effective antibacterial agent which acts by the inhibition of protein synthesis. It is readily absorbed from the gastro-intestinal tract and following absorption, it diffuses readily into most body fluids.
Erythromycin is concentrated in the liver and excreted in the bile.
Erythromycin is virtually devoid of nephrotoxic, hepatotoxic, neurotoxic or photosensitivity reactions.
Erythromycin is particularly active against Gram-positive organisms. Consequently, the problem of over growth of non-susceptible organisms is of very low incidence.
Erythro-Teva is a suitable alternative to penicillins in the treatment and prophylaxis of infections due to Gram-positive cocci, especially streptococci, particularly in patients for whom penicillins are contraindicated.
Treatment of the following infections, when caused by susceptible organisms:
Upper and lower respiratory tract infections; Skin and soft tissue infections; Conjunctivitis of the nwborn caused by Chlamydia trachomatis; Urogenital infections caused by Chlamydia trachomatis; Enteric infections caused by Campylobacter jejuni; Venereal diseases (as an alternative regimen to penicillins and tetracyclines);
Intestinal amoebiasis; Legionnaires' disease; Long term prophylaxis in rheumatic fever; Short term prophylaxis against bacterial endocarditis in patients hypersensitive to penicillin who have congenital heart disease, or rheumatic or other acquired valvular heart diseases; when undergoing dental procedures and surgical procedures of the upper respiratory tract.
Known hypersensitivity to the drug; Patients receiving terfenadine, astemizole or cisapride; Breast-feeding (see "Precautions/Warnings").
Since erythromycin is excreted principally by the liver, caution should be exercised in administering the antibiotic to patients with impaired hepatic function. Liver function test should be performed when large doses of erythromycin are administered. Prolonged use may result in over growth of non-susceptible bacteria or fungi.
Should superinfection occur, the drug should be discontinued and/or appropriate therapy instituted. In the treatment of streptococcal infections, a therapeutic dose of erythromycin should be administered for at least 10 days. Erythro-Teva Suspension contains sucrose. Therefore, caution should be exercised when administering to diabetics.
Use in pregnancy:
Erythromycin crosses the placental barrier. Safety of use in pregnancy has not been established.
Use in breast-feeding:
Erythromycin is excreted in breast milk. Mothers using this medication should not nurse.
Concurrent use may increase the pharmacological effects of oral anticoagulants requiring a lower dose of anticoagulant.
Concurrent use may decrease theophylline hepatic clearance, resulting in increased serum theophylline levels and toxicity. Dosage adjustments may be necessary during and after therapy with erythromycin.
Since bacteriostatic drugs may interfere with the bactericidal effects of penicillins in the treatment of meningitis or other situations where a rapid bactericidal effect is necessary, it is best to avoid concurrent therapy.
Concurrent administration may increase serum levels of carbamazepine by inhibition of hepatic metabolism.
Concomitant administration of Digoxin and erythromycin may produce elevated digoxin levels via increased bioavailability in a small subset of patients (<10%) who metabolize significant amounts of digoxin in the gut. Therapeutic and toxic effects of digoxin may be increased.
Rhabdomyolysis, with or without renal impairment has been reported in seriously ill patients receiving erythromycin concomitantly with lovastatin. Therefore patients receiving concomitant lovastatin and erythromycin should be carefully monitored.
Concomitant administration may cause an increase in terfenadine plasma levels due to the inhibition of terfenadine metabolism by erythromycin (or other macrolide antibiotics). High plasma concentrations of terfenadine have been reported to prolong the QT interval and cause life-threatening cardiac arrhythmias. Therefore, such combination should be avoided (see "Contra-indications").
Erythromycin is known to impair the cytochrome p450 enzyme system which also influences astemizole metabolism. There have been two reports to date of syncope with torsade de pointes, requiring hospitalization in patients taking combinations of astemizole 10 mg daily with erythromycin. In each case, the QT interval were prolonged beyond 650 milliseconds at the time of the event. Therefore, concomitant administration of astemizole with erythromycin is contraindicated.
Initiation of erythromycin therapy in several patients receiving disopyramide reportedly has been associated with elevated serum disopyramide concentrations, QT interval prolongation, and polymorphic ventricular tachycardia.
Concomitant administration of erythromycin and cyclosporin has been reported to increase the risk of cyclosporin plasma concentrations and may increase the risk of nephrotoxicity
Chloramphenicol or lincomycin may be displaced from or prevented from binding to 50S subunits of bacterial ribosome by erythromycin, thus antagonizing the effects of chloramphenicol and lincomycin. Concurrent use, therefore is not recommended.
Concomitant use of erythromycin with hepatotoxic medications may increase the potential for hepatotoxicity of these medications.
Erythromycin is known to impair the cytochrome p450 enzyme system which also influences cisapride metabolism.
This may lead to elevated plasma levels of cisapride. Prolongation of the QT-interval on the ECG has been reported as a result of elevated cisapride levels. Therefore, cisapride treatments should be discontinued in patients receiving erythromycin.
GI discomfort and abdominal cramps may occur, and is dose-related. Infrequently, nausea, vomiting and diarrhoea may occur. Allergic reactions such as urticaria and mild skin eruptions, cholestatic jaundice, oral candidiasis (following prolonged treatment) and anaphylaxis have occurred. There have been isolated reports of reversible hearing loss, occurring mainly in patients with renal insufficiency or receiving high doses of erythromycin.
Dosage & Administration
Erythro-Teva tablets should be taken on an empty stomach, Erythro-Teva suspension may be taken without regard to meals. In the treatment of streptococcal infections, a therapeutic dosage should be administered for at least 10 days.
Treatment of infections:
The following are the recommended usual dosages. In more severe infections, the dosage may be doubled. All doses are expressed in terms of erythromycin base.
The usual adult dosage is 250 mg (as stearate) or 400 mg (as ethylsuccinate) every 6 hours. This may be increased up to 4 g/day, according to the severity of infection.
If a twice daily dosage is desired, ½ of the total daily dose may be given every 12 hours. However, twice daily dosage is not recommended when doses higher than 1 g daily are administered. Doses may also be given 3 times daily, by administering 1/3 of the total daily dose every 8 hours.
Age, weight and severity of the infection are important factors in determining the proper dosage. In mild to moderate infections, the usual dosage of erythromycin (as ethylsuccinate) for children is 30 - 50 mg/kg body weight/day, in equally divided doses every 6 hours. For more severe infections, this dosage may be doubled.
If a twice daily dosage is desired, ½ of the total daily dose may be given every 12 hours. Doses may also be given 3 times daily, by administering 1/3 of the total daily dose every 8 hours.
The following are dosage recommendations for specific indications:
Chlamydia trachomatis infections:
- Neonatal Conjunctivitis: 50 mg/kg body weight/day (as ethylsuccinate) in 4 divided doses, for at least 2 weeks.
- Infant Pneumonia: 50 mg/kg body weight/day (as ethylsuccinate) in 4 divided doses, for at least 3 weeks.
- Urogenital infections during pregnancy (see "Precautions/Warnings"): 500 mg (as stearate) 4 times a day on an empty stomach, for at least 7 days. For women who cannot tolerate this regimen, a decreased dose of 250 mg ( as stearate) 4 times a day, should be used for at least 14 days.
Other Chlamydia trachomatis infections:
For the treatment of adults with uncomplicated urethral, endocervical, or rectal infections caused by Chlamydia trachomatis, in whom tetracyclines are contraindicated or not tolerated, the recommended dosage is 500 mg (as stearate) 4 times a day for at least 7 days.
1 - 4 g/day (as stearate) in divided doses.
40 - 50 mg/kg body weight/day (as ethylsuccinate) in divided doses for 5 - 14 days.
The standard dosage should be administered for a period of 10 - 14 days.
Prophylaxis of infections:
Long term prophylaxis: In continuous prophylaxis against recurrences of streptococcal infections in persons with a history of rheumatic heart disease, the usual dosage is 250 mg (as stearate), or 400 mg (as ethylsuccinate), twice daily.
Short term prophylaxis:
For prophylaxis against bacterial endocarditis in patients with congenital heart disease, or rheumatic or other acquired valvular heart disease when undergoing dental procedures or surgical procedures of the upper respiratory tract, 1 g as stearate, or 1.6 g as ethylsuccinate (20 mg/kg body weight for children, as ethylsuccinate) should be administered orally, 1½ - 2 hours before the procedure.
This should be followed by 500 mg as stearate, or 800 mg as ethylsuccinate (10 mg/kg body weight for children, as ethylsuccinate) administered orally, every 6 hours for 8 doses.
Reconstituted Erythro-Teva suspensions are stable for 10 days when kept in a refrigerator.