ERYTHROMYCIN- erythromycin ointment 
Paddock Laboratories, LLC

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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:

Structure Image

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)

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. gonorrheae 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.

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 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

Erythromycin Ophthalmic Label.jpg

The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

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Package/Label Display Panel - Carton

Rx Only

NDC 0574-4024-35

Erythromycin Ophthalmic Ointment USP

NET WT 3.5 g (1/8 OZ)

STERILE

5w7-rc-erythromycin-ophthalmic-ointment-35.jpg

The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

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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.

5w7-rc-erythromycin-ophthalmic-ointment-39.jpg

The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

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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.

5w7-rc-erythromycin-ophthalmic-ointment-50.jpg

The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

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ERYTHROMYCIN 
erythromycin ointment
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0574-4024
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:0574-4024-351 in 1 CARTON05/08/2014
13.5 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0574-4024-3924 in 1 CARTON05/08/2014
23.5 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:0574-4024-5050 in 1 CARTON05/08/2014
31 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06244705/08/2014
Labeler - Paddock Laboratories, LLC (967694121)

Revised: 11/2018
Document Id: 6d0f0fc4-48d7-482b-95e7-7eec192facf7
Set id: 87b45f99-a4d1-47e0-bbb6-50ca19c10010
Version: 2
Effective Time: 20181112
 
Paddock Laboratories, LLC