에리드로마이신 스테아레이트

EYES: First check the victim for contact lenses and remove if present. Flush victim's eyes with water or normal saline solution for 20 to 30 minutes while simultaneously calling a hospital or poison control center. Do not put any ointments, oils, or medication in the victim's eyes without specific instructions from a physician. IMMEDIATELY transport the victim after flushing eyes to a hospital even if no symptoms (such as redness or irritation) develop.

SMALL SPILLS AND LEAKAGE: Should a spill occur while you are handling this chemical, FIRST REMOVE ALL SOURCES OF IGNITION, then you should dampen the solid spill material with 60-70% ethanol and transfer the dampened material to a suitable container. Use absorbent paper dampened with 60-70% ethanol to pick up any remaining material. Seal the absorbent paper, and any of your clothes, which may be contaminated, in a vapor-tight plastic bag for eventual disposal. Solvent wash all contaminated surfaces with 60-70% ethanol followed by washing with a soap and water solution. Do not reenter the contaminated area until the Safety Officer (or other responsible person) has verified that the area has been properly cleaned.

RECOMMENDED RESPIRATOR: Where the neat test chemical is weighed and diluted, wear a NIOSH-approved half face respirator equipped with a combination filter cartridge, i.e. organic vapor/acid gas/HEPA (specific for organic vapors, HCl, acid gas, SO2 and a high efficiency particulate filter). (NTP, 1992)

Erythromycin acts by penetrating the bacterial cell membrane and reversibly binding to the 50 S subunit of bacterial ribosomes or near the “P” or donor site so that binding of tRNA (transfer RNA) to the donor site is blocked. Translocation of peptides from the “A” or acceptor site to the “P” or donor site is prevented, and subsequent protein synthesis is inhibited. Erythromycin is effective only against actively dividing organisms. The exact mechanism by which erythmromycin reduces lesions of acne vulgaris is not fully known: however, the effect appears to be due in part to the antibacterial activity of the drug.

The following link will take the user to the National Toxicology Program (NTP) Test Agent Search Results page, which tabulates all of the "Standard Toxicology & Carcinogenesis Studies", "Developmental Studies", and "Genetic Toxicity Studies" performed with this chemical. Clicking on the "Testing Status" link will take the user to the status (i.e., in review, in progress, in preparation, on test, completed, etc.) and results of all the studies that the NTP has done on this chemical. [http://ntp-apps.niehs.nih.gov/ntp_tox/index.cfm?fuseaction=ntpsearch.searchresults&searchterm=643-22-1]

AMONG ALLERGIC REACTIONS ARE FEVER, EOSINOPHILIA, & SKIN ERUPTIONS, WHICH MAY OCCUR ALONE OR IN COMBINATION; EACH DISAPPEARS SHORTLY AFTER THERAPY IS STOPPED. ...OFTEN PRODUCES IRRITATIVE EFFECTS. ORAL ADMIN...FREQUENTLY ACCOMPANIED BY EPIGASTRIC DISTRESS, WHICH MAY BE QUITE SEVERE. /ERYTHROMCYIN/

IM INJECTION OF QUANTITIES LARGER THAN 100 MG PRODUCES EXTREMELY SEVERE PAIN THAT PERSISTS FOR HOURS. IV INFUSION OF 1-G DOSES...ALMOST REGULARLY IS FOLLOWED BY THROMBOPHLEBITIS. /ERYTHROMYCIN/

...MILD ELEVATIONS OF THE SGOT /SERUM GLUTAMIC-OXALOACETIC TRANSAMINASE/ WERE ALSO NOTED IN...3 OF 97 PT TREATED WITH ERYTHROMYCIN STEARATE...

SEVERE RESP DISTRESS DEVELOPED IN A 60-YR-OLD MAN AFTER INGESTION OF 2 TABLETS OF ERYTHROMYCIN STEARATE. AUTHORS SUGGEST AN ALLERGIC REACTION OF TYPE 1 & TYPE 3 PARTICIPATED IN COURSE OF CLINICAL PICTURE.

OTOTOXICITY DUE TO ORAL ERYTHROMYCIN STEARATE DEVELOPED IN 2 PT (17 & 50-YR-OLD) RECEIVING AT LEAST 4 G DAILY. UPON WITHDRAWAL OF THE DRUG, HEARING RETURNED IN BOTH PT.

Erythromycin Stearate

TR-338: Toxicology and Carcinogenesis Studies of Erythromycin Stearate (CASRN 643-22-1) in F344/N Rats and B6C3F1 Mice (Feed Studies) (1988 )

07/14/87

No Evidence

No Evidence

No Evidence

READILY PRODUCES DIARRHEA & DEATH IN RABBITS DUE TO OVERGROWTH OF GRAM-NEGATIVE BACTERIA. /ERYTHROMYCIN/

CELLULAR DAMAGE PARALLELED KNOWN HEPATOTOXIC POTENTIAL OF THESE AGENTS IN MAN, SUGGESTING POSSIBLE USEFULNESS OF THIS SYSTEM AS AN ADDNL METHOD OF EVALUATING CYTOTOXIC POTENTIAL OF CHEMICALLY RELATED DRUGS

Erythromycin stearate was found to be negative when tested for mutagenicity using the Salmonella/microsome preincubation assay, using the standard protocol approved by the National Toxicology Program (NTP). Erythromycin stearate was tested in as many as 5 Salmonella typhimurium strains (TA1535, TA1537, TA97, TA98, and TA100) in the presence and absence of rat and hamster liver S-9, at doses of 0.300, 1.000, 3.000, 10.000, and 33.000 ug/plate. The highest ineffective dose tested in any S. typhimurium strain was 33.000 ug/plate.

... Conclusions: Under the conditions of these 2 yr studies, there was no evidence of carcinogenic activity of erythromycin stearate for male or female F344/N rats administered erythromycin stearate in the diet at 5,000 or 10,000 ppm. There was no evidence of carcinogenic activity of erythromycin stearate for male or female B6C3F1 mice administered erythromycin stearate in the diet at 2,500 or 5,000 ppm. ... /Erythromycin stearate/

Toxicology and carcinogenesis studies of erythromycin stearate (USP grade, greater than 96% pure) were conducted by admin ... in feed to groups of F344/N rats and B6C3F1 mice for ... 2 yr studies of erythromycin stearate were conducted by feeding diets containing 0, 5,000 or 10,000 ppm erythromycin stearate to groups of 50 rats of each sex for 103 wk. Diets containing 0, 2,5000 or 5000 ppm were fed to groups of 50 mice of each sex for 103 wk. Conclusions: Under the conditions of these 2 yr studies, there was no evidence of carcinogenic activity of erythromycin stearate for male or female F344/N rats administered erythromycin stearate in the diet at 5,000 or 10,000 ppm. There was no evidence of carcinogenic activity of erythromycin stearate for male or female B6C3F1 mice administered erythromycin stearate in the diet at 2,500 or 5,000 ppm. ... /Erythromycin stearate/

For use in the treatment of infections caused by susceptible strains of microorganisms in the following diseases: respiratory tract infections (upper and lower) of mild to moderate degree, pertussis (whooping cough), as adjunct to antitoxin in infections due to <i>Corynebacterium diphtheriae</i>, in the treatment of infections due to <i>Corynebacterium minutissimum</i>, intestinal amebiasis caused by <i>Entamoeba histolytica</i>, acute pelvic inflammatory disease caused by <i>Neisseria gonorrhoeae</i>, skin and soft tissue infections of mild to moderate severity caused by <i>Streptococcus pyogenes</i> and <i>Staphylococcus aureus</i>, primary syphilis caused by <i>Treponema pallidum</i>, infections caused by <i>Chlamydia trachomatis</i>, nongonococcal urethritis caused by <i>Ureaplasma urealyticum</i>, and Legionnaires' disease caused by <i>Legionella pneumophila</i>.

PREPN OF ERYTHROMCYIN STEARATE (ESTER) IS DESCRIBED IN BOOTH, MURRAY, US PATENT 2,862,921 (1958 TO UPJOHN).

BY REACTING ERYTHROMYCIN WITH PROPER QUANT OF STEARIC ACID IN ACETONE SOLN & THEN DILUTING SOLN WITH WATER TO PPT SALT.

ERYTHROMYCIN STEARATE TABLETS, USP (BRISTAMYCIN, ERYTHROCIN STEARATE, ETHRIL), CONTAIN 125, 250, OR 500 MG EACH.

ERYTHROMYCIN STEARATE: ...STEARIC ACID SALT OF ERYTHROMYCIN, WITH EXCESS OF STEARIC ACID. IT CONTAINS NOT LESS THAN 55% OF ERYTHROMYCIN.