By using this site, you agree to the Privacy Policy and Terms of Use.
Accept
Medical Information, Documents, News - TheMediTary.Com Logo Medical Information, Documents, News - TheMediTary.Com Logo

TheMediTary.Com

Medical Information, Documents, News - TheMediTary.Com

  • Home
  • News
  • Drugs
  • Drugs A-Z
  • Medical Answers
  • About Us
  • Contact
Medical Information, Documents, News - TheMediTary.Com Logo Medical Information, Documents, News - TheMediTary.Com Logo
Search Drugs
  • Drugs
    • Latest Drugs
    • Drugs A-Z
    • Medical Answers
  • News
    • FDA Alerts
    • Medical News
    • Health
    • Consumer Updates
    • Children's Health
  • More TheMediTary.Com
    • About Us
    • Contact
Follow US
Home > Drugs > Drugs > Erythromycin (eent) (monograph) > Erythromycin Ophthalmic Ointment Prescribing Information
Drugs
https://themeditary.com/pro/erythromycin-ophthalmic-ointment-prescribing-information-15457.html

Erythromycin Ophthalmic Ointment Prescribing Information

Drug Detail:Erythromycin (eent) (monograph) (Medically reviewed)

Drug Class:

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Rx only

Erythromycin Ophthalmic Ointment 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 O-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-(dimethyl-amino)-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:

Structural Formula

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

Erythromycin Ophthalmic Ointment - 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 Erythromycin Ophthalmic Ointment

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.

Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Adverse Reactions/Side Effects

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

Erythromycin Ophthalmic Ointment Dosage and Administration

In the treatment of superficial ocular infections, a ribbon approximately 1 cm in length of Erythromycin Opthalmic 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, 0.5% is available as follows:

3.5 g (1/8 oz) sterile tamper-resistant tube

(NDC 0404-7191-01)

STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Avoid excessive heat.

Protect from freezing.

Distributed by (in US only):
HENRY SCHEIN INC.
135 DURYEA ROAD
MELVILLE, NY 11747 USA

BERT00N Rev. 08/14

Principal Display Panel Text for Container Label:

HENRY SCHEIN Logo

NDC 0404-7191-01

112-7191

ERYTHROMYCIN OPHTHALMIC

OINTMENT USP, 0.5%

Sterile

Rx only Net Wt. 3.5 g (1/8 oz.)

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

HENRY SCHEIN Logo

NDC 0404-7191-01

112-7191

ERYTHROMYCIN OPHTHALMIC

OINTMENT USP, 0.5%

Rx only Sterile Net Wt. 3.5 g (1/8 oz.)

Principal Display Panel Text for Carton Label
ERYTHROMYCIN
erythromycin ointment
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0404-7191
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:0404-7191-011 in 1 CARTON05/13/2015
13.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06403005/13/2015
Labeler - Henry Schein Inc. (012430880)
Registrant - Akorn Operating Company LLC (117693100)

Share this Article
Latest News
Medical News

Shingles vaccine may lower heart disease risk by up to 8 years

May 09, 2025
Obesity, unhealthy lifestyles may cause heart to age by 5–45 years
Aging: As little as 5 minutes of exercise may keep the brain healthy
Prostate cancer: Simple urine test may help with early detection
Cancer treatment side effects: Exercise may reduce pain, fatigue
Alzheimer's: Exercising in middle age may reduce beta-amyloid in brain...
Related Drugs
Fidanacogene Elaparvovec
Cerave Anti-Itch
Centrum Adult
Crovalimab
Cyltezo Prefilled Syringe
Zepbound Pen
Mylanta One
Uretron Ds
Medihoney Wound And Burn Dressing
Lidotrode

Other drugs

Name Drug Class Updated
Fidanacogene Elaparvovec Drugs 03-Oct-2024
Cerave Anti-Itch Drugs 02-Oct-2024
Centrum Adult Drugs 02-Oct-2024
Crovalimab Drugs 02-Oct-2024
Cyltezo Prefilled Syringe Drugs 01-Oct-2024
Zepbound Pen Drugs 30-Sep-2024
Mylanta One Drugs 27-Sep-2024
Uretron Ds Drugs 27-Sep-2024
Medihoney Wound And Burn Dressing Drugs 26-Sep-2024
Lidotrode Drugs 26-Sep-2024
Libervant Drugs 26-Sep-2024
Moderna Covid-19 Drugs 25-Sep-2024
Beqvez Drugs 24-Sep-2024
Beqvez Drugs 24-Sep-2024
Beqvez Drugs 24-Sep-2024

Categories

  • FDA Alerts
  • Medical News
  • Health
  • Consumer Updates
  • Children's Health

About US

Welcome to TheMediTary.Com

Our website provides reliable and up-to-date information on various medical topics. We empower individuals to take charge of their health by simplifying complex medical jargon and providing practical tips and advice. We prioritize the privacy and confidentiality of our users and welcome feedback to improve our services.

Website use data of FDA and other sources

DMCA.com Protection Status Truste Protection Status Trust Mark Protection Status
HONcode logo We comply with the HONcode standard for trustworthy health information.
Quick Link
  • About Us
  • Contact Us
  • Editorial Policy
  • Privacy Policy
  • Accessibility Policy
  • Terms & Conditions
  • Disclaimer
  • DMCA
  • Do Not Sell My Personal Information
  • Sitemap
  • Care Notes
  • Health Guide
  • Professional
Drugs
  • New Drugs
  • Medical Answers
  • Drugs A-Z
  • Drug Classes
  • Drug Dosage
  • Pill Identifier
  • Consumer Infor
  • Side Effects
  • Inactive Ingredients
  • Pregnancy Warnings
  • Patient Tips
  • Treatments
News
  • Latest News
  • FDA Alerts
  • Medical News
  • Health
  • Consumer Updates
  • Children's Health
Find US
  • Medium
  • Google Site
  • Blogspot
  • API
  • Reddit
  • Tumblr
  • Scoop.it
  • Substack
  • Wordpress
  • Wix
  • Behance

© 2025 TheMediTary.Com All rights reserved. Operated by