PREGNANCY SECTION.

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.

SPL UNCLASSIFIED SECTION.

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.

TERATOGENIC EFFECTS SECTION.

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.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS:. The most frequently reported adverse reactions are minor ocular irritations, redness, and hypersensitivity reactions.To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

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.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY:. Microbiology:. Erythromycin inhibits protein synthesis without affecting nucleic acid synthesis. Erythromycin is usually active against the following organisms in vitro and in clinical infections:Streptococcus pyogenes (group ss-hemolytic)Alpha-hemolytic streptococci (viridans group)Staphylococcus aureus, including penicillinase-producing strains (methicillin-resistant staphylococci are uniformly resistant to erythromycin)Streptococcus pneumoniaMycoplasma pneumoniae (Eaton Agent, PPLO)Haemophilus influenzae (not all strains of this organism are susceptible at the erythromycin concentrations ordinarily achieved)Treponema pallidumCorynebacterium diphtheriaeNeisseria gonorrhoeaeChlamydia trachomatis.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS:. This drug is contraindicated in patients with history of hypersensitivity to erythromycin.

DESCRIPTION SECTION.

DESCRIPTION:. Erythromycin Ophthalmic Ointment belongs to the macrolide group of antibiotics. It is basic and readily forms salt when combined with an acid. The base, as crystals or powder, is slightly soluble in water, moderately soluble in ether, and readily soluble in alcohol or chloroform. Erythromycin ((3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4-[(2,6-dideoxy-3-C-methyl-3-0-methyl--L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-ss-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione) is antibiotic produced from strain of Streptomyces erythraeus. It has the following structural formula:Each gram contains Erythromycin USP mg in sterile ophthalmic base of mineral oil and white petrolatum.. Structure Image.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION:. In the treatment of superficial ocular infections, ribbon approximately cm in length of Erythromycin Ophthalmic Ointment should be applied directly to the infected structure up to times daily, depending on the severity of the infection. For prophylaxis of neonatal gonococcal or chlamydial conjunctivitis, ribbon of ointment approximately cm in length should be instilled into each lower conjunctival sac. The ointment should not be flushed from the eye following instillation. new tube should be used for each infant.

GENERAL PRECAUTIONS SECTION.

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

HOW SUPPLIED SECTION.

HOW SUPPLIED. Sterile Erythromycin Ophthalmic Ointment USP, mg/g as follows:3.5 (1/8 oz) tamper-evident tubes NDC 0574-4024-3524 3.5 (1/8 oz) Hospital-Pak (for hospital use only) NDC 0574-4024-39Carton of fifty (50) Unit Dose g tubes NDC 0574-4024-50Store at controlled room temperature 15-30C (59-86F). Avoid excessive heat.Protect from freezing.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE:. For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin.For prophylaxis of ophthalmia neonatorum due to N. gonorrhoeae or C. trachomatis. The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing N. gonorrheae is not established.For infants born to mothers with clinically apparent gonorrhea, intravenous or intramuscular injections of aqueous crystalline penicillin should be given; single dose of 50,000 units for term infants or 20,000 units for infants of low birth weight. Topical prophylaxis alone is inadequate for these infants.

INFORMATION FOR PATIENTS SECTION.

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

MICROBIOLOGY SECTION.

Microbiology:. Erythromycin inhibits protein synthesis without affecting nucleic acid synthesis. Erythromycin is usually active against the following organisms in vitro and in clinical infections:Streptococcus pyogenes (group ss-hemolytic)Alpha-hemolytic streptococci (viridans group)Staphylococcus aureus, including penicillinase-producing strains (methicillin-resistant staphylococci are uniformly resistant to erythromycin)Streptococcus pneumoniaMycoplasma pneumoniae (Eaton Agent, PPLO)Haemophilus influenzae (not all strains of this organism are susceptible at the erythromycin concentrations ordinarily achieved)Treponema pallidumCorynebacterium diphtheriaeNeisseria gonorrhoeaeChlamydia trachomatis.

NURSING MOTHERS SECTION.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Package/Label Display Panel Label. Rx OnlyNDC 0574-4024-35Erythromycin Ophthalmic Ointment USPNET WT 3.5 (1/8 OZ)STERILEThe following image is placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.. Erythromycin Ophthalmic Label.jpg. C:\Users\sbrown\Pictures\serialization-template.jpg.

PEDIATRIC USE SECTION.

Pediatric Use:. See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION.

PRECAUTIONS SECTION.

PRECAUTIONS:. General:. The use of antimicrobial agents may be associated with the overgrowth of nonsusceptible organisms including fungi; in such 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 nursing woman.. Pediatric Use:. See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION.