INFORMATION FOR PATIENTS SECTION.

Information for patients. Avoid contaminating the tip of container with material from the eye, fingers or other source.

NURSING MOTHERS SECTION.

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

HOW SUPPLIED SECTION.

How Supplied. Erythromycin Ophthalmic Ointment USP, 0.5% is available in the following sizes:1/8 oz. (3.5 g) tamper-resistant tube 09234DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.DO NOT USE IF BOTTOM RIDGE OF TUBE CAP IS EXPOSED.

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. gonorrhoeae 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.

DOSAGE & ADMINISTRATION SECTION.

Dosage and Administration. In the treatment of superficial ocular infections, erythromycin ophthalmic ointment approximately cm in length should be applied directly to the infected eye(s) up to six times daily, depending on the severity of the infection.For prophylaxis of neonatal gonococcal or chlamydial ophthalmia, 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.

ADVERSE REACTIONS SECTION.

Adverse Reactions. The most frequently reported adverse reactions are minor ocular irritations, redness and hypersensitivity reactions.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

Carcinogenesis, mutagenesis, impairment of fertility. Avoid contaminating the tip of container with material from the eye, fingers or other source.

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 -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.

CONTRAINDICATIONS SECTION.

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

DESCRIPTION SECTION.

Description. Erythromycin Ophthalmic Ointment USP belongs to the macrolide group of antibiotics. The sterile ophthalmic ointment flows freely over the conjunctiva. Erythromycin base, as crystals or powder, is slightly soluble in water, moderately soluble in ether, and readily soluble in alcohol or chloroform. Erythromycin is an antibiotic produced from strain of Streptomyces erythraeus. It is basic and readily forms salt when combined with an acid. It has the following structural formula:C37H67NO13 Mol. Wt. 733.94Chemical Name: (3Ro, 4So, 5So, 6Ro, 7Ro, 9Ro, 11Ro, 12Ro, 13So, 14Ro)-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)--D-xylo-opyranosyl]oxy]oxacyclotetradecane-2, 10-dioneEach Gram Contains: ACTIVE: Erythromycin, USP mg (0.5%); INACTIVES: White Petrolatum, Mineral Oil.. Chemical Structure.

GENERAL PRECAUTIONS SECTION.

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

SPL UNCLASSIFIED 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 -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.

STORAGE AND HANDLING SECTION.

Storage. Store between 15-30C (59-86F).KEEP OUT OF REACH OF CHILDREN.Revised February 2007Rx only.