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ilotycin Prescribing Information

Package insert / product label
Generic name: erythromycin
Dosage form: ophthalmic ointment
Drug class: Ophthalmic anti-infectives

Medically reviewed by Drugs.com. Last updated on Mar 25, 2024.

ilotycin Description

ILOTYCIN® 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-(dimethylamino)-ß-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione) is an antibiotic produced from a strain of Streptomyces erythraeus. It has the following structural formula:

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.

ilotycin - Clinical Pharmacology

Microbiology:

Erythromycin inhibits protein synthesis without affecting nucleic acid synthesis. Erythromycin is usually active against the following organisms in vitro and in clinical infections:

Streptococcus pyogenes(group A ß-hemolytic)
Alpha-hemolytic streptococci (viridans group)
Staphylococcus aureus, including penicillinase-producing strains (methicillin-resistant staphylococci are uniformly resistant to erythromycin)
Streptococcus pneumoniae
Mycoplasma pneumoniae(Eaton Agent, PPLO)
Haemophilusinfluenzae(not all strains of this organism are susceptible at the erythromycin concentrations ordinarily achieved)
Treponemapallidum
Corynebacteriumdiphtheriae
Neisseria gonorrhoeae
Chlamydia trachomatis

Indications and Usage for ilotycin

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. gonorrhoeaeor C. trachomatis. The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing N. gonorrhoeaeis 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.

Contraindications

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

Precautions

General:

The 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.

Information for Patients:

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

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:

See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION.

Adverse Reactions/Side Effects

The most frequently reported adverse reactions are minor ocular irritations, redness, and hypersensitivity reactions.

To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

ilotycin 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.

How is ilotycin supplied

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

1 g tamper-evident tubes

NDC 0574-4023-11

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

Avoid excessive heat.

Protect from freezing.

Manufactured For

Perrigo®

Minneapolis, MN 55427

1D500 RC J1 Rev 08-13 A

R0813

Ini 0813

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Rx Only

NDC 0574-4023-11

STERILE

ILOTYCIN®

(erythromycin)

Ophthalmic Ointment USP 0.5% (5 mg/g)

Erythromycin USP equivalent to 5 mg erythromycin per gram.

NET WT 1 g

Perrigo Ilotycin
ILOTYCIN
erythromycin ointment
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0574-4023
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ERYTHROMYCIN (UNII: 63937KV33D) (ERYTHROMYCIN - UNII:63937KV33D) ERYTHROMYCIN5 mg in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0574-4023-111 in 1 CARTON
11 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06244710/08/2014
Labeler - Paddock Laboratories, LLC (967694121)