Ilotycin (Erythromycin) - Indications and Dosage

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 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.

DOSAGE AND ADMINISTRTION:

In the treatment of superficial ocular infections, a ribbon approximately 1 cm in length of ILOTYCIN^TM Ophthalmic 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.

HOW SUPPLIED:

Sterile ILOTYCIN^TM Ophthalmic Ointment USP, 5 mg/g as follows:

1 g tamper-evident tubes

NDC 48102-016-11

Store at 20^o to 25^oC (68^o to 77^oF) [See USP Controlled Room Temperature].

Avoid excessive heat.

Protect from freezing.

Manufactured for:

Fera Pharmaceuticals, LLC

Locust Valley, NY  11560

PF016

Rev. 06/10