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NDC 63187-0608-35 Erythromycin 5 mg/g Details

Erythromycin 5 mg/g

Erythromycin is a OPHTHALMIC OINTMENT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is ERYTHROMYCIN.

MedlinePlus Drug Summary

Ophthalmic erythromycin is used to treat bacterial infections of the eye. This medication is also used to prevent bacterial infections of the eye in newborn babies. Erythromycin is in a class of medications called macrolide antibiotics. It works by killing bacteria that cause infections.

Related Packages: 63187-0608-35
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Erythromycin Ophthalmic

Product Information

NDC	63187-0608
Product ID	63187-608_bb8e6b6b-70fd-48b7-b43d-23180531dc9f
Associated GPIs	86101025004210
GCN Sequence Number	007948
GCN Sequence Number Description	erythromycin base OINT. (G) 5 MG/GRAM OPHTHALMIC
HIC3	Q6W
HIC3 Description	OPHTHALMIC ANTIBIOTICS
GCN	33540
HICL Sequence Number	004022
HICL Sequence Number Description	ERYTHROMYCIN BASE
Brand/Generic	Generic
Proprietary Name	Erythromycin
Proprietary Name Suffix	n/a
Non-Proprietary Name	Erythromycin
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	OINTMENT
Route	OPHTHALMIC
Active Ingredient Strength	5
Active Ingredient Units	mg/g
Substance Name	ERYTHROMYCIN
Labeler Name	Proficient Rx LP
Pharmaceutical Class	Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA064067
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63187-0608-35 (63187060835)

Pricing Information	N/A
NDC Package Code	63187-608-35
Billing NDC	63187060835
Package	1 TUBE in 1 CARTON (63187-608-35) / 3.5 g in 1 TUBE
Marketing Start Date	2018-12-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5101bf55-cacf-42bf-8dd1-2a29e80ca6f1 Details

SPL UNCLASSIFIED SECTION

Rx only

DESCRIPTION

Erythromycin Ophthalmic Ointment USP belongs to the macrolide group of antibiotics. The sterile ophthalmic ointment flows freely over the conjunctiva. Erythromycin base, as crystals or powder, is slightly soluble in water, moderately soluble in ether, and readily soluble in alcohol or chloroform. Erythromycin is an antibiotic produced from a strain of Streptomyces erythraeus. It is basic and readily forms a salt when combined with an acid. It has the following structural formula:

C37H67NO13

Mol. Wt. 733.94

Chemical Name: (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

Each Gram Contains: ACTIVE: Erythromycin, USP 5 mg (0.5%); INACTIVES: Mineral Oil, 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.

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 non-susceptible organisms including fungi; in such a case, antibiotic administration should be stopped and appropriate measures taken.

Information for Patients:

Avoid contaminating the tip of container 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 or harm to the fetus that appeared related to erythromycin was reported in these studies.

Pregnancy:

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. 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, erythromycin ophthalmic ointment approximately 1 cm in length should be applied directly to the infected eye(s) up to six times daily, depending on the severity of the infection.

For prophylaxis of neonatal gonococcal or chlamydial ophthalmia, 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

Erythromycin Ophthalmic Ointment USP, 0.5% is available in the following sizes:

1/8 oz. (3.5 g) tamper-resistant tube - NDC 63187-608-35

DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.

Storage:

Store between 15°-25°C (59°-77°F).

KEEP OUT OF REACH OF CHILDREN.

Revised: January 2013

9043403 (Folded)

9043503 (Flat)

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 63187-608-35

Bausch & Lomb

Erythromycin Ophthalmic Ointment USP,

0.5% (Sterile)