Ilotycin

DESCRIPTION

ILOTYCIN™ErythromycinOphthalmicOintmentbelongs to themacrolidegroup 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 orchloroform. 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-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2, 10-dione) is anantibioticproduced from a strain ofStreptomyces 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.

INDICATIONS

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 toN. gonorrhoeaeorC. trachomatis.

The effectiveness of erythromycin in the prevention ofophthalmiacaused by penicillinase-producingN. gonorrhoeaeis not established.

For infants born to mothers with clinically apparentgonorrhea, intravenous orintramuscularinjections of aqueous crystallinepenicillinG should be given; a single dose of 50,000 units for term infants or 20,000 units for infants of low birth weight. Topicalprophylaxisalone is inadequate for these infants.

DOSAGE AND ADMINISTRATION

In the treatment of超级ficialocularinfections, 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 ofneonatalgonococcal or chlamydialconjunctivitis, a ribbon of ointment approximately 1 cm in length should be instilled into each lowerconjunctivalsac. The ointment should not be flushed from the eye following instillation. A new tube should be used for each infant.

HOW SUPPLIED

Sterile ILOTYCIN™ Ophthalmic Ointment USP, 5 mg/gas follows:

1 gtamper-evidenttubesNDC48102-016-11

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

Avoid excessive heat.

Protect from freezing.

Manufactured for: Fera Pharmaceuticals, LLC, Locust Valley, NY 11560. Rev. 06/10

SIDE EFFECTS

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-5pmESTor FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

No information provided.

警告

No information provided.

PRECAUTIONS

General

The use ofantimicrobialagents 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 Fertility

Two 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 B

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.

Nursing Mothers

Caution should be exercised when erythromycin is administered to a nursing woman.

Pediatric Use

SeeINDICATIONSandDOSAGE AND ADMINISTRATION.

OVERDOSE

No information provided.

CONTRAINDICATIONS

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

CLINICAL PHARMACOLOGY

Microbiology

Erythromycin inhibits protein synthesis without affectingnucleic acidsynthesis. Erythromycin is usually active against the following organismsin vitroand in clinical infections:

Streptococcus pyogenes(group A β-hemolytic)
Alpha-hemolytic streptococci (viridans group)
Staphylococcus aureus, including penicillinase-producing strains (甲氧西林-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

PATIENT INFORMATION

Avoid contaminating the applicator tip with material from the eye, fingers, or other source.