REGION:
Products
ERYTHROMYCIN STEARATE
Molecular formula: |
C55H103N1O15 |
Molecular weigh: |
1018 |
CAS registry No: |
643-22-1 |
Presentation: |
Crystalline powder |
Category: |
Macrolide antibiotic |
Application: |
For human use only. |
Quality: |
Ph. Eur., USP |
Contents:
Sum of Erythromycin A, Erythromycin B, and Erythromycin C (on the anhydrous substance) – Not less than 60.5%
Most commonly used drug forms:
tablets
Packing:
25 kg in a fiber drum.
Storage:
In a dry place, protected from light, at a temperature below 25°C
Re-test period:
2 years from manufacturing date.
Pharmacological action:
Erythromycin is produced by a strain of Saccharopolyspora erythraea and can be considered the prototype of macrolide group of antibiotics. It is basic and readily forms salts with acids but it is the base, which is microbiologically active.
Erythromycin acts by inhibition of protein synthesis by binding 50S ribosomal subunits of susceptible organisms and thus exerts bacteriostatic and bactericidal effect. It does not affect nucleic acid synthesis.
Erythromycin has a similar action spectrum as penicillin and includes in particular many Gram-positive bacteria (including Staphylococcus aureus, Streptococcus pyogenes, corynebacteria and clostridia) and some gram-negative organisms (Bordetella pertussis, Legionella pneumophila and Neisseria gonorrhoeae). It is also active against bacteria-like organisms (Chlamydia trachomatis, Mycoplasma pneumoniae, Ureaplasma urealyticum). Erythromycin is an antibiotic used to treat a wide variety of bacterial infections, such as respiratory tract infections, middle ear infections, and skin infections. Erythromycin can be used for the treatment of pneumonias. It is the drug of choice for Legionella pneumonia and a good alternative to tetracyclines for chlamydial infections and mycoplasmas. Pneumococcal pneumonias normally also respond well to erythromycin. Erythromycin can be considered as an alternative to penicillin for streptococcal pharyngitis. It serves in the prophylaxis and treatment of diphtheria carriers. Erythromycin is also suitable for the treatment of skin infections (eryspela, impetigo); it is the drug of choice for erythrasma. Erythromycin has a similar effect as tetracyclines against acne; it can be used systemically and topically. Erythromycin has good efficacy against chlamydial infections in the genito-urinary tract as well as in the eyes (conjunctivitis). Erythromycin is also suitable for the treatment of anaerobic infections like antrax and tetanus.
Orally administered Erythromycin base and its salts are readily absorbed in the microbiologically active form. After absorption, Erythromycin diffuses readily into most body fluids. Low concentrations are normally achieved in the spinal fluid. The drug crosses the placental barrier, but fetal plasma levels are low. Erythromycin is not removed by peritoneal dialysis or hemodialysis. In the presence of normal hepatic function erythromycin is concentrated in the liver and is excreted in the bile; the effect of hepatic dysfunction on biliary excretion of erythromycin is not known. After oral administration, less than 5% of the administered dose can be recovered in the active form in the urine. Erythromycin is generally well tolerated. It is thought that it can be used safely in pregnancy and during breast-feeding. It is particularly useful in individuals allergic to penicillin.