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ErythromycinOphthalmic Ointment USP, 0.5%Sterile | Erythromycin [Akorn, Inc.] | BioPortfolio

12:25 EST 27th January 2019 | BioPortfolio

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Rx only

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-trihy-droxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethyl-amino)-β-D-xylo-hexopyranosyl]oxy]oxacy-clotetradecane-2,10-dione)) is an antibiotic produced from a strain of Streptomyces erythraeus.

It has the following structural formula:

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

Microbiology: Erythromycin inhibits protein synthesis without affecting nucleic acid synthesis. Erythromycin is usually active against the following organisms in vitro and in clinical infections:

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.

This drug is contraindicated in patients with a history of hypersensitivity to erythromycin.

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.

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

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.

Sterile Erythromycin Ophthalmic Ointment USP, 0.5% is available as follows:

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

(NDC 17478-824-35)

Carton of fifty (50) Unit Dose 1 g tube

(NDC 17478-824-01)

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

Avoid excessive heat.

Protect from freezing.

PREMIERProRx Manufactured by: Akorn IncLake Forest, IL 60045

PremierProRx is a registered trademark of Premier Inc., used under license.

PERT00NRev. 10/15

Principal Display Panel Text for Container Label:

NDC 17478-824-35 Premier Logo

ERYTHROMYCIN OPHTHALMIC

OINTMENT USP, 0.5%

Rx only Sterile

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

Principal Display Panel Text for Carton Label:

NDC 17478-824-35

ERYTHROMYCIN OPHTHALMIC

OINTMENT USP, 0.5%

Sterile

Net Wt 3.5 g (1/8 oz.)

Rx only Premier Logo

Manufacturer

Akorn, Inc.

Active Ingredients

Source

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Clinical Trials [39 Associated Clinical Trials listed on BioPortfolio]

Effect of the Motilin Receptor Agonist, Erythromycin, on Hunger and Food Intake; Study of Role of Cholinergic Pathways

In this study, the investigators will evaluate if the food intake associated with the infusion of erythromycin is caused by the phase 3 contractions or by another yet unknown effect of ery...

Intravenous Erythromycin Before Endoscopy in Patients With Variceal Bleeding: A Randomized, Double-Blind Trial

Objectives: Blood in stomach & oesophagus in patients with variceal bleeding often obscures the endoscopic view & makes endoscopic intervention difficult to perform. Erythromycin, a ...

Study to Evaluate the Effect of Coadministered Erythromycin on the Pharmacokinetics and Safety of Padsevonil

The purpose of this study is to evaluate and compare the Pharmacokinetics (PK) of concomitant administration of Padsevonil (PSL) in the presence and absence of erythromycin in healthy stud...

Use of Erythromycin in Mustard-Induced Bronchiolitis

We looked for the effectiveness of low-dose long-term prescription of erythromycin in mustard-induced bronchiolitis obliterans

The Effect of Erythromycin on Occurrence of Leaks From Cervical Esophageal-Gastric Anastomosis After Trans-Hiatal Esophagectomy

Cervical anastomotic leak is one of the most common complications after trans-hiatal esophagectomy. Hypothesis: An early post operative administration of a pro-kinetic dosage of erythromy...

PubMed Articles [74 Associated PubMed Articles listed on BioPortfolio]

Erythromycin relaxes BALB/c mouse airway smooth muscle.

Bitter taste receptor (TAS2R) agonists have bronchodilatory potentials. Erythromycin is a ligand of TAS2R10, but its relaxant profile is unknown. This study was performed to understand the relaxant ef...

Synthesis of the erythromycin-conjugated nanodendrimer and its antibacterial activity.

The development and spread of bacterial resistance to antimicrobial drugs necessitates the need to search for novel and effective antimicrobial agents. In the last few decades, innovative nanomaterial...

Effect of erythromycin and modulating effect of CeO NPs on the toxicity exerted by the antibiotic on the microalgae Chlamydomonas reinhardtii and Phaeodactylum tricornutum.

Erythromycin is an antibiotic employed in the treatment of infections caused by Gram positive microorganisms and the increasing use has made it a contaminant of emerging concern in aqueous ecosystems....

Precursor supply for erythromycin biosynthesis: engineering of propionate assimilation pathway based on propionylation modification.

Erythromycin is necessary in the medical treatment and known to be biosynthesized with propionyl-CoA as direct precursor. Over-supply of propionyl-CoA induced hyper propionylation, which was demonstra...

Erythromycin sensitivity across different taxa of marine phytoplankton. A novel approach to sensitivity of microalgae and the evolutionary history of the 23S gene.

Erythromycin has been recorded in coastal waters and could pose a severe threat to marine microbial life. Macrolides such as erythromycin may affect microalgae by inhibiting the pathways involved in p...

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