Erythromycin (injection)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]
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Overview
Erythromycin (injection) is a macrolide, antibiotic and anti-infective agent that is FDA approved for the treatment of {{{indication}}}. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Erythromycin (injection) FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Erythromycin (injection) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Erythromycin (injection) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Erythromycin (injection) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Erythromycin (injection) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Erythromycin (injection) in pediatric patients.
Contraindications
There is limited information regarding Erythromycin (injection) Contraindications in the drug label.
Warnings
There is limited information regarding Erythromycin (injection) Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Erythromycin (injection) Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Erythromycin (injection) Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Erythromycin (injection) Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Erythromycin (injection) in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Erythromycin (injection) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Erythromycin (injection) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Erythromycin (injection) in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Erythromycin (injection) in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Erythromycin (injection) in geriatric settings.
Gender
There is no FDA guidance on the use of Erythromycin (injection) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Erythromycin (injection) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Erythromycin (injection) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Erythromycin (injection) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Erythromycin (injection) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Erythromycin (injection) in patients who are immunocompromised.
Administration and Monitoring
Administration
- Intravenous
Monitoring
There is limited information regarding Erythromycin (injection) Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Erythromycin (injection) and IV administrations.
Overdosage
There is limited information regarding Erythromycin (injection) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Erythromycin (injection) Pharmacology in the drug label.
Mechanism of Action
- Erythromycin acts by inhibition of protein synthesis by binding 50 S ribosomal subunits of susceptible organisms. It does not affect nucleic acid synthesis.
Structure
- Erythromycin is produced by a strain of Streptomyces erythraeus and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids.
- Erythrocin Lactobionate (erythromycin lactobionate for injection, USP), is a soluble salt of erythromycin suitable for intravenous administration. It is available as a sterile, lyophilized powder in vials containing the equivalent of 500 mg of erythromycin activity. It is prepared as a solution and lyophilized in its final container.
- Erythromycin lactobionate is chemically known as erythromycin mono (4-0-β-D-galactopyranosyl-D-gluconate) (salt). The structural formula is:
Pharmacodynamics
Microbiology
- Erythromycin is a macrolide antibiotic with activity against Gram-positive and Gram-negative bacteria.
Interactions with Other Antibiotics
- Antagonism has been demonstrated in vitro between erythromycin and clindamycin, lincomycin and chloramphenicol.
- Many strains of Haemophilus influenzae are resistant to erythromycin, but are susceptible to erythromycin and sulfonamides used concomitantly.
Development of Resistance
- Resistance to erythromycin in S. aureus may emerge during therapy.
- Erythromycin has been shown to be active against most strains of the following organisms both in vitro and in clinical infections (see INDICATIONS AND USAGE):
Gram-positive bacteria Aerobic
- Corynebacterium diphtheriae
- Corynebacterium minutissimum
- Staphylococcus aureus (methicillin-susceptible strains only)
- Streptococcus pneumoniae
- Streptococcus pyogenes
- Gram-negative bacteria
- Legionella pneumophila
- Neisseria gonorrhoeae
Other Microorganisms
- Mycoplasma pneumoniae
- At least 90 percent of the following microorganisms exhibit an in vitro 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 microorganisms has not been established in adequate and well-controlled trials.
Gram-negative bacteria
- Moraxella catarrhalis
Susceptibility Testing
- When available, the clinical microbiology laboratory should provide cumulative results of the in vitro susceptibility test results for antimicrobial drugs 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 the most effective antimicrobial.
Dilution techniques
- Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized procedure. Standardized procedures are based on a dilution method (broth or agar)1 or equivalent with standardized inoculum concentrations and standardized concentrations of erythromycin powder. The MIC values should be interpreted according to the criteria provided in Table 1.
Diffusion technique
- Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure2 requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 15 mcg of erythromycin to test the susceptibility of microorganisms to erythromycin. The disk diffusion interpretive criteria are provided in Table 1.
tab
- A report of Susceptible indicates that the antimicrobial is likely to inhibit growth of the pathogen if the antimicrobial compound in the blood reaches the concentrations usually achievable. 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 is physiologically concentrated or in situations where a 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 in the blood reaches the concentrations usually achievable and other therapy should be selected.
Quality Control
Standardized susceptibility test procedures require the use of quality control microorganisms to control the technical aspects of the test procedures3. Standard Erythromycin powder should provide the following range of values noted in Table 2.
Pharmacokinetics
- 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 and is excreted in breast 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. From 12 to 15 percent of intravenously administered erythromycin is excreted in active form in the urine.
- Intravenous infusion of 500 mg of erythromycin lactobionate at a constant rate over 1 hour in fasting adults produced a mean serum erythromycin level of approximately 7 mcg/mL at 20 minutes, 10 mcg/mL at 1 hour, 2.6 mcg/mL at 2.5 hours, and 1 mcg/mL at 6 hours.
Nonclinical Toxicology
There is limited information regarding Erythromycin (injection) Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Erythromycin (injection) Clinical Studies in the drug label.
How Supplied
There is limited information regarding Erythromycin (injection) How Supplied in the drug label.
Storage
There is limited information regarding Erythromycin (injection) Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Erythromycin (injection) Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Erythromycin (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Erythromycin (injection) Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Erythromycin (injection) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.