Erythromycin Ophthalmic Ointment USP, 0.5% (Sterile)

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:

C₃₇H₆₇NO₁₃

Mol. Wt. 733.94

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-opyranosyl]oxy]oxacyclotetradecane-2, 10-dione

Each Gram Contains: ACTIVE: Erythromycin, USP 5 mg (0.5%); INACTIVES: White Petrolatum, Mineral Oil.

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.

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.

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.

Erythromycin Ophthalmic Ointment USP, 0.5% is available in the following sizes:

1/8 oz. (3.5 g) tamper-resistant tube – 09234

DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.

DO NOT USE IF BOTTOM RIDGE OF TUBE CAP IS EXPOSED.

Store between 15°-30°C (59°-86°F).

KEEP OUT OF REACH OF CHILDREN.

Revised February 2007

Rx only

Bausch & Lomb Incorporated
Tampa, FL 33637
©Bausch & Lomb Incorporated

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Erythromycin Ophthalmic