ilotycin

Generic Name: erythromycin
Dosage Form: ophthalmic ointment

ilotycin ERYTHROMYCIN OPHTHALMIC OINTMENT USP

DESCRIPTION:

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

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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.

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 β-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)

Haemophilus influenzae (not all strains of this organism are susceptible at the erythromycin concentrations ordinarily achieved)

Treponema pallidum

Corynebacterium diphtheriae

Neisseria gonorrhoeae

Chlamydia trachomatis

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.

CONTRAINDICATION:

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:

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.

DOSAGE AND ADMINISTRTION:

In the treatment of superficial ocular infections, a ribbon approximately 1 cm in length of ilotycinTM 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 ilotycinTM Ophthalmic Ointment USP, 5 mg/g as follows:

1 g tamper-evident tubes

NDC 48102-016-11



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

Avoid excessive heat.

Protect from freezing.



Manufactured for:

Fera Pharmaceuticals, LLC

Locust Valley, NY  11560


PF016

Rev. 06/10

PRINCIPAL DISPLAY PANEL - CARTON





NDC 48102-016-11

STERILE   Rx only


ilotycinTM

(ERYTHROMYCIN

OPHTHALMIC

OINTMENT USP)

0.5% (5mg/g)


Erythromycin USP
equivalent to 5 mg
erythromycin per gram.

NET WT 1 gram

WARNING:
Keep out of
reach of children.

See crimp of
tube for Lot No.
and Exp. Date.

Mfd. For:
Fera
Pharmaceuticals,
LLC
Locust Valley,
NY  11560

CF01611
R06/10

PRINCIPAL DISPLAY PANEL - TUBE




NDC 48102-016-11

STERILE     Rx only

ilotycinTM

ERYTHROMYCIN

OPHTHALMIC

OINTMENT, USP

0.5% (5mg/g)

NET WT 1 gram



Mfd. for:

Fera Pharmaceuticals, LLC

Locust Valley, NY  11560

TF01611   Rev. 06/10

ilotycin 
erythromycin ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:48102-016
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ERYTHROMYCIN (ERYTHROMYCIN) ERYTHROMYCIN 0.5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL  
PETROLATUM  
Packaging
# Item Code Package Description
1 NDC:48102-016-11 1 TUBE (TUBE) in 1 CARTON
1 1 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062447 10/12/2010
Labeler - Fera Pharmaceuticals, LLC (831023713)
Registrant - Fera Pharmaceuticals, LLC (831023713)
Revised: 10/2010
 
Fera Pharmaceuticals, LLC



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