ERY-TAB

ERY-TAB- erythromycin tablet, delayed release
Carilion Materials Management

Rx only

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ERY-TAB and other antibacterial drugs, ERY-TAB should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ® ®

DESCRIPTION

ERY-TAB (erythromycin delayed-release tablets) is an antibacterial product containing erythromycin base in a specially enteric-coated tablet. The coating protects the antibiotic from the inactivating effects of gastric acidity and permits efficient absorption of the antibiotic in the small intestine. ERY-TAB tablets for oral administration are available in three dosage strengths, each white oval tablet containing either 250 mg, 333 mg, or 500 mg of erythromycin as the free base. ERY-TAB tablets comply with ® ® ® USP Dissolution Test 1.

Erythromycin is produced by a strain of (formerly ) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. Erythromycin is a white to off-white powder, slightly soluble in water, and soluble in alcohol, chloroform, and ether. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*,13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α -L- -hexopyranosyl)oxy]-14-ethyl-7,12,13-trihdroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D- -hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C H NO , and the molecular weight is 733.94. The structural formula is: Saccharopolyspora erythraea Streptomyces erythraeus ribo xylo 37 67 13

Chemical Structure
(click image for full-size original)

Inactive Ingredients

Ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, crospovidone, diacetylated monoglycerides, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, povidone, propylene glycol, sodium citrate, sorbitan monooleate, talc, and titanium dioxide.

CLINICAL PHARMACOLOGY

Orally administered erythromycin base and its salts are readily absorbed in the microbiologically active form. Interindividual variations in the absorption of erythromycin are, however, observed, and some patients do not achieve optimal serum levels. Erythromycin is largely bound to plasma proteins. After absorption, erythromycin diffuses readily into most body fluids. In the absence of meningeal inflammation, low concentrations are normally achieved in the spinal fluid but the passage of the drug across the blood-brain barrier increases in meningitis. Erythromycin crosses the placental barrier, but fetal plasma levels are low. The drug is excreted in human milk. Erythromycin is not removed by peritoneal dialysis or hemodialysis.

In the presence of normal hepatic function, erythromycin is concentrated in the liver and is excreted in the bile; the effect of hepatic dysfunction on biliary excretion of erythromycin is not known. After oral administration, less than 5% of the administered dose can be recovered in the active form in the urine.

ERY-TAB tablets are coated with a polymer whose dissolution is pH dependent. This coating allows for minimal release of erythromycin in acidic environments, e.g., stomach. The tablets are designed for optimal drug release and absorption in the small intestine. In multiple-dose, steady-state studies, ERY-TAB tablets have demonstrated adequate drug delivery in both fasting and non-fasting conditions. Bioavailability data are available. ® ®

Microbiology

Mechanism of Action

Erythromycin acts by inhibition of protein synthesis by binding 50S ribosomal subunits of susceptible organisms. It does not affect nucleic acid synthesis.

Mechanism of Resistance

The major route of resistance is modification of the 23S rNA in the 50S ribosomal subunit to insensitivity while efflux can also be significant.

Interactions with Other Antibiotics

Antagonism exists between erythromycin and clindamycin, lincomycin, and chloramphenicol. in vitro

Erythromycin has been shown to be active against most isolates of the following bacteria both and in clinical infections as described in the section. in vitro INDICATIONS AND USAGE

Gram-positive Bacteria

Corynebacterium diphtheriae
Corynebacterium minutissimum
Listeria monocytogenes
Staphylococcus aureus (resistant organisms may emerge during treatment)
Streptococcus pneumoniae
Streptococcus pyogenes

Gram-negative Bacteria

Bordetella pertussis
Haemophilus influenzae
Legionella pneumophila
Neisseria gonorrhoeae

Other Microorganisms

Chlamydia trachomatis
Entamoeba histolytica
Mycoplasma pneumoniae
Treponema pallidum
Ureaplasma urealyticum

The following data are available, in vitro but their clinical significance is unknown.

At least 90% of the following bacteria exhibit minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for erythromycin. However, the efficacy of erythromycin in treating clinical infections due to these bacteria has not been established in adequate and well controlled clinical trials. in vitro

Gram-positive Bacteria

Viridans group streptococci

Gram-negative Bacteria

Moraxella catarrhalis

Susceptibility Test Methods

When available the clinical microbiology laboratory should provide the results of susceptibility test results for antimicrobial drug products used in resident hospitals to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting an antibacterial drug product for treatment. in vitro

Dilution Techniques

Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MIC’s). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized test method (broth and/or agar). The MIC values should be interpreted according to criteria provided in . 1, 2 Table 1

Diffusion techniques

Quantitative methods that require measurement of zone diameters can also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. The zone size provides an estimate of the susceptibility of bacteria to antimicrobial compounds. The zone size should be determined using a standardized test method. This procedure uses paper disks impregnated with 15 mcg erythromycin to test the susceptibility of microorganisms to erythromycin. The disc diffusion interpretive criteria are provided in . 2,3 Table 1

Table 1. In Vitro Susceptibility Test Interpretive Criteria for Erythromycin
Minimum Inhibitory Concentrations (mcg/mL)
Disk Diffusion (zone diameters in mm)
Pathogen S I R S I R
Staphylococcus aureus ≤0.5 1-4 ≥8 ≥23 14-22 ≤13
Streptococcus pneumoniae ≤0.25 0.5 ≥1 ≥21 16-20 ≤15
Streptococcus pyogenes ≤0.25 0.5 ≥1 ≥21 16-20 ≤15

A report of “Susceptible” indicates that the antimicrobial is likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentrations at the site of infection necessary to inhibit growth of the pathogen. A report of “Intermediate” indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug product is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of “Resistant” indicates that the antimicrobial is not likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentrations usually achievable at the infection site; other therapy should be selected.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.