Label: ERYTHROMYCIN ointment

Microbiology:Erythromycin inhibits protein synthesis without affecting nucleic acid synthesis. Erythromycin is usually active against the following organisms in vitroand in clinical infections:

Streptococcus pyogenes(group A β-hemolytic)

Alpha-hemolytic streptococci (viridans group)

Staphylococcus aureus, including penicillinase-producing strains (methicillin-resistant staphylococci are uniformly resistant to erythromycin)

Streptococcus pneumoniae

Mycoplasma pneumoniae(Eaton Agent, PPLO)

Haemophilus influenzae(not all strains of this organism are susceptible at the erythromycin concentrations ordinarily achieved)

Treponema pallidum

Corynebacterium diphtheriae

Neisseria gonorrhoeae

Chlamydia trachomatis

General:The use of antimicrobial agents may be associated with the overgrowth of nonsusceptible organisms including fungi; in such a case, antibiotic administration should be stopped and appropriate measures taken.

Information for Patients:Avoid contaminating the applicator tip with material from the eye, fingers, or other source.

Carcinogenesis, Mutagenesis, Impairment of Fertility:Two year oral studies conducted in rats with erythromycin did not provide evidence of tumorigenicity. Mutagenicity studies have not been conducted. No evidence of impaired fertility that appeared related to erythromycin was reported in animal studies.

Pregnancy:Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in rats, mice, and rabbits using erythromycin and its various salts and esters, at doses that were several multiples of the usual human dose. No evidence of harm to the fetus that appeared related to erythromycin was reported in these studies. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, the erythromycins should be used during pregnancy only if clearly needed.

Nursing Mothers:Caution should be exercised when erythromycin is administered to a nursing woman.

Pediatric Use -See INDICATIONS AND USAGEand DOSAGE AND ADMINISTRATION.

Geriatric Use:No overall differences in safety or effectiveness have been observed between elderly and younger patients.

STORAGE:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Avoid excessive heat.

Protect from freezing.

Distributed by:

Armas Pahrmaceuticals, Inc.

Freehold, NJ 07728 (USA)

Manufactured by:

Ophtapharm AG, Riethofstrasse 1, Hellingen,

8442, Switzerland (CHE) for Sentiss

Made in Switzerland

83008101 Rev. 07/23