Erythromycin Ophthalmic Ointment

Pronunciation

Dosage Form: ophthalmic ointment

Erythromycin Ophthalmic Ointment USP
STERILE
RX ONLY

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-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 antibiotic produced from a strain of Streptomyces erythraeus. It has the following structural formula:

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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 pneumonia

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 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. gonorrheaeis 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.

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

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 is Erythromycin Ophthalmic Ointment Supplied

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

3.5 g (1/8 oz) tamper-evident tubes NDC 0574-4024-35

24 x 3.5 g (1/8 oz) Hospital-Pak (for hospital use only) NDC 0574-4024-39

Carton of fifty (50) Unit Dose 1 g tubes NDC 0574-4024-50

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

Protect from freezing.

Manufactured For

Perrigo®

Minneapolis, MN 55427

SW700 RC J1 Rev 09-13 A

R1013

Ini 0813

Package/Label Display Panel - Label

Rx Only

NDC 0574-4024-35

Erythromycin Ophthalmic Ointment USP

NET WT 3.5 g (1/8 OZ)

STERILE

Package/Label Display Panel - Carton

Rx Only

NDC 0574-4024-35

Erythromycin Ophthalmic Ointment USP

NET WT 3.5 g (1/8 OZ)

STERILE

Package/Label Display Panel-Hospital - Pak

HOSPITAL-PAK

Rx Only

NDC 0574-4024-39

Erythromycin Ophthalmic Ointment USP

STERILE – 5 mg per Gram

For Use in High Volume Neonatal Care

HOSPITAL USE ONLY

24 x 1/8 OZ (3.5 g)

Each gram contains 5 mg of Erythromycin USP in a sterile ophthalmic base of mineral oil and white petrolatum.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - 50 Unit Doses

Rx Only

NDC 0574-4024-50

Erythromycin Ophthalmic Ointment USP, 0.5% (5 mg/g)

DO NOT REUSE. ONCE OPENED, DISCARD

STERILE

50 Unit Doses

Sterile Ophthalmic Ointment weighing 1 gram each.

ERYTHROMYCIN 
erythromycin ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0574-4024
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ERYTHROMYCIN (ERYTHROMYCIN) ERYTHROMYCIN 5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM  
MINERAL OIL  
Packaging
# Item Code Package Description
1 NDC:0574-4024-35 1 TUBE in 1 CARTON
1 3.5 g in 1 TUBE
2 NDC:0574-4024-39 24 TUBE in 1 CARTON
2 3.5 g in 1 TUBE
3 NDC:0574-4024-50 50 TUBE in 1 CARTON
3 1 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062447 05/08/2014
Labeler - Paddock Laboratories, LLC (967694121)
Revised: 06/2014
 
Paddock Laboratories, LLC



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