Get your patient on Erythromycin - Erythromycin ointment (Erythromycin)

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 G should be given: a 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.

In the treatment of superficial ocular infections, erythromycin ophthalmic ointment approximately 1 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, a ribbon of ointment approximately 1 cm in length should be instilled into each lower conjunctival sac. The ointment should not be flushed from the eye following instillation. A new tube should be used for each infant.

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

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

To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 a strain of Streptomyces erythraeus . It is basic and readily forms a salt when combined with an acid. It has the following structural formula:

Chemical Name: ((3R ^● ,4S ^● ,5S ^● ,6R ^● ,7R ^● ,9R ^● ,11R ^● ,12R ^● ,13S ^● ,14R ^● )-4-[(2,6-dideoxy-3- C -methyl-3- 0 -methyl-α-L- ribo -hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)- β -D- xylo -hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione)

Each gram contains: Active: erythromycin USP, 5 mg (0.5%); Inactives: mineral oil and white petrolatum.

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 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 .

Erythromycin ophthalmic ointment USP, 0.5% is available in the following sizes:

3.5 g (1/8 oz) in a tamper-resistant tube – NDC 24208-910-55

• 1 g in a tamper-resistant tube (1 carton of 50 tubes) – NDC 24208-910-19

Storage: Store between 15°C to 25°C (59°F to 77°F).

Keep out of reach of children.

Distributed by:
Bausch & Lomb Americas Inc.
Bridgewater, NJ 08807 USA

Manufactured by :
Bausch & Lomb Incorporated
Tampa, FL 33637 USA

© 2025 Bausch & Lomb Incorporated or its affiliates

Revised: March 2025

9819800 (Folded)
9819900 (Flat)