ERYTHROMYCIN OPHTHALMIC OINTMENT USP STERILE

ERYTHROMYCIN  - erythromycin ointment 
E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.

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DESCRIPTION:

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-ɑ-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.

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)

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.

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:

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

DOSAGE AND ADMINISTRATION:

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

3.5 g (1/8 oz) tamper-evident tubes
NDC 0168-0070-38

24 x 3.5 g (1/8 oz) Hospital-Pak (for hospital use only)
NDC 0168-0070-39

Carton of fifty (50) Unit Dose 1 g tubes
NDC 0168-0070-11

Store at controlled room temperature 15°-30°C (59°-86°F). Avoid excessive heat.
Protect from freezing.

E. FOUGERA & CO.

A division of Nycomed US Inc.

Melville, New York 11747

IF270B/I27038J

R10/07

#217

PRINCIPAL DISPLAY PANEL - CARTON LABEL 3.5 g (1/8 Oz)

NDC 0168-0070-38

Fougera®

Rx only

ERYTHROMYCIN

OPHTHALMIC OINTMENT USP

STERILE

CONTAINS: Erythromycin USP 5 mg per gram in a sterile ophthalmic based of Mineral Oil and White Petrolatum.

NET WT 3.5g (1/8 Oz)

Carton Label

PRINCIPAL DISPLAY PANEL - CONTAINER LABEL 3.5 g (1/8 Oz)

NDC 0168-0070-38

Fougera®

ERYTHROMYCIN

OPHTHALMIC OINTMENT USP

STERILE Rx only

CONTAINS: Erythromycin USP 5 mg per gram in a sterile ophthalmic based of Mineral Oil and White Petrolatum.

NET WT 3.5g (1/8 Oz)

Container Label


ERYTHROMYCIN 
erythromycin ointment
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0168-0070
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ERYTHROMYCIN (ERYTHROMYCIN) ERYTHROMYCIN5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 
PETROLATUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:0168-0070-381 TUBE in 1 CARTONcontains a TUBE
13.5 g in 1 TUBEThis package is contained within the CARTON (0168-0070-38)
2NDC:0168-0070-3924 TUBE in 1 CARTONcontains a TUBE
23.5 g in 1 TUBEThis package is contained within the CARTON (0168-0070-39)
3NDC:0168-0070-1150 TUBE in 1 CARTONcontains a TUBE
31 g in 1 TUBEThis package is contained within the CARTON (0168-0070-11)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06244709/26/198307/31/2009

Labeler - E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. (043838424)

Revised: 01/2013 E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.