apexa™ Erythromycin Ophthalmic Ointment USP, 0.5% STERILE Rx Only

Erythromycin Ophthalmic Ointment belongs to the macrolide group of antibiotics. It is basic and readily forms a 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-α-L-ribo-hexopyranosyl)-oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethyl-amino)-β-D-xylo-hexo-pyranosyl]oxy]oxacyclotetradecane-2,10-dione)) is an antibiotic produced from a strain of Streptomyces erythraeus.

It has the following structural formula:

Molecular Formula: C₃₇H₆₇NO₁₃

Molecular Weight: 733.94

Each gram contains Erythromycin USP 5 mg in a sterile ophthalmic base of mineral oil and white petrolatum.

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, a ribbon approximately 1 cm in length of Erythromycin Opthalmic Ointment should be applied directly to the infected structure up to 6 times daily, depending on the severity of the infection.

For prophylaxis of neonatal gonococcal or chlamydial conjunctivitis, 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.

Sterile Erythromycin Ophthalmic Ointment USP, 0.5% is available as follows:

3.5 g (1/8 oz) sterile tamper-resistant tube

(NDC 13985-605-03)

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

Avoid excessive heat.

Protect from freezing.

apexa™
Manufactured by: Akorn Inc.
Lake Forest, IL 60045
Distributed by: MWI
Boise, ID 83705

MWER00N         Rev. 07/14

Principal Display Panel Text for Container Label:

NDC 13985-605-03

Erythromycin STERILE

Ophthalmic Ointment Rx Only

USP, 0.5%

Apexa logo

AP 704007 Net Weight: 3.5g (1/8 oz)

Principal Display Panel Text for Carton Label:

NDC 13985-605-03

Erythromycin

Ophthalmic

Ointment

USP, 0.5%

STERILE

Rx Only

Apexa logo

AP 704007

Net Weight: 3.5g (1/8 oz)