No information provided.
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 Fera Pharmaceuticals, LLC at (414) 434-6604 Monday-Friday 9am-5pm EST or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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.
Reproduction studies have been performed in rats, mice, and rabbits using erythromycin and its various salts and esters, at doses that were several multiples of the usual human dose. No evidence of harm to the fetus that appeared related to erythromycin was reported in these studies. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, the erythromycins should be used during pregnancy only if clearly needed.
Sterile ILOTYCIN™ Ophthalmic Ointment USP, 5 mg/g as follows:
1 g tamper-evident tubes NDC 48102-016-11
Store at 20° to 25°C (68° to 77°F).
Avoid excessive heat.
Protect from freezing.
Manufactured for: Fera Pharmaceuticals, LLC, Locust Valley, NY 11560. Rev. 06/10
No information provided.
PRECAUTIONS GeneralThe use of antimicrobial agents may be associated with the overgrowth of nonsusceptible organisms including fungi; in such a case, antibiotic administration should be stopped and appropriate measures taken.
Carcinogenesis, Mutagenesis, Impairment of FertilityTwo year oral studies conducted in rats with erythromycin did not provide evidence of tumorigenicity. Mutagenicity studies have not been conducted. No evidence of impaired fertility that appeared related to erythromycin was reported in animal studies.
Pregnancy Teratogenic effects -Pregnancy category BReproduction studies have been performed in rats, mice, and rabbits using erythromycin and its various salts and esters, at doses that were several multiples of the usual human dose. No evidence of harm to the fetus that appeared related to erythromycin was reported in these studies. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, the erythromycins should be used during pregnancy only if clearly needed.
Nursing MothersCaution should be exercised when erythromycin is administered to a nursing woman.
Pediatric UseSee INDICATIONS and DOSAGE AND ADMINISTRATION.
In the treatment of superficial ocular infections, a ribbon approximately 1 cm in length of ILOTYCIN™ 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.
The most frequently reported adverse reactions are minor ocular irritations, redness, and hypersensitivity reactions.
To report SUSPECTED ADVERSE REACTIONS, contact Fera Pharmaceuticals, LLC at (414) 434-6604 Monday-Friday 9am-5pm EST or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONSNo information provided.
