ERYTHROCIN SUMMARY
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.
Erythrocin Lactobionate-IV (erythromycin lactobionate for injection, USP) is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below when oral administration is not possible or when the severity of the infection requires immediate high serum levels of erythromycin. Intravenous therapy should be replaced by oral administration at the appropriate time.
Upper respiratory tract infections of mild to moderate degree caused by
Streptococcus pyogenes
(Group A beta-hemolytic streptococci);
Streptococcus pneumoniae
(Diplococcus pneumoniae);
Haemophilus influenzae
(when used concomitantly with adequate doses of sulfonamides, since many strains of
H. influenzae
are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.)
Lower respiratory tract infections of mild to moderate severity caused by
Streptococcus pyogenes
(Group A beta-hemolytic streptococci);
Streptococcus pneumoniae
(Diplococcus
pneumoniae).
Respiratory tract infections due to
Mycoplasma pneumoniae
.
Skin and skin structure infections of mild to moderate severity caused by
Streptococcus pyogenes
and
Staphylococcus aureus
(resistant staphylococci may emerge during treatment).
Diphtheria: As an adjunct to antitoxin infections due to
Corynebacterium diphtheriae
to prevent establishment of carriers and to eradicate the organism in carriers.
Erythrasma: In the treatment of infections due to
Corynebacterium minutissimum
.
Acute pelvic inflammatory disease caused by
Neisseria gonorrhoeae
: Erythrocin Lactobionate-IV (erythromycin lactobionate for injection, USP) followed by erythromycin stearate or erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by
N. gonorrhoeae
in female patients with a history of sensitivity to penicillin.
Before treatment of gonorrhea, patients who are suspected of also having syphilis should have a microscopic examination for
T. pallidum
(by immunofluorescence or darkfield) before receiving erythromycin and monthly serologic tests for a minimum of 4 months thereafter.
Legionnaires Disease caused by
Legionella pneumophila
. Although no controlled clinical efficacy studies have been conducted,
in vitro
and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires Disease.
Prevention of Initial Attacks of Rheumatic Fever
Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Group A beta-hemolytic streptococcal infections of the upper respiratory tract e.g., tonsillitis, or pharyngitis).4 Erythromycin is indicated for the treatment of penicillin-allergic patients. The therapeutic dose should be administered for ten days.
Prevention of Recurrent Attacks of Rheumatic Fever
Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).4
Prevention of Bacterial Endocarditis
Although no controlled clinical efficacy trials have been conducted, oral erythromycin has been recommended by the American Heart Association for prevention of bacterial endocarditis in penicillin-allergic patients with prosthetic cardiac valves, most congenital cardiac malformations, surgically constructed systemic pulmonary shunts, rheumatic or other acquired valvular dysfunction, idiopathic hypertrophic subaortic stenosis (IHSS), previous history of bacterial endocarditis and mitral valve prolapse with insufficiency when they undergo dental procedures and surgical procedures of the upper respiratory tract.5
To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin and other antibacterial drugs, erythromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
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NEWS HIGHLIGHTS
Published Studies Related to Erythrocin (Erythromycin)
Premedication with erythromycin improves endoscopic visualization of the gastric
mucosa in patients with subtotal gastrectomy: a prospective, randomized,
controlled trial. [2014] erythromycin improves gastric mucosa visualization in patients with STG... CONCLUSIONS: Premedication with erythromycin improves mucosal visualization
Effect of long-term, low-dose erythromycin on pulmonary exacerbations among
patients with non-cystic fibrosis bronchiectasis: the BLESS randomized controlled
trial. [2013] IMPORTANCE: Macrolide antibiotics such as erythromycin may improve clinical
outcomes in non-cystic fibrosis (CF) bronchiectasis, although associated risks of
macrolide resistance are poorly defined. OBJECTIVE: To evaluate the clinical efficacy and antimicrobial resistance cost of
low-dose erythromycin given for 12 months to patients with non-CF bronchiectasis
with a history of frequent pulmonary exacerbations...
Randomized double-blind crossover study to determine the effects of erythromycin
on small intestinal nutrient absorption and transit in the critically ill. [2012] on small intestinal nutrient absorption and transit in the critically ill... CONCLUSIONS: Acute administration of erythromycin increases small intestinal
A comparison between the effectiveness of erythromycin, single-dose clarithromycin and topical fusidic acid in the treatment of erythrasma. [2011.09.18] Abstract Although erythrasma is a superficial skin infection, there is no consensus on the treatment model of erythrasma... Conclusion: Topical fusidic acid proved to be the most effective treatment; however, clarithromycin therapy may be an alternative regimen in the treatment of erythrasma because of its efficiency and better patient's compliance.
[Comparison of maternal and perinatal outcomes in the conservative treatment preterm premature membrane rupture between the use of erythromycin and clindamycin]. [2011.07] BACKGROUND: premature rupture of membranes occurs between 5 and 15% of pregnancies, of these, 10% occurs at term and preterm 2 to 3.5%. OBJECTIVE: To compare maternal and perinatal outcomes from the use of erythromycin or clindamycin in women with preterm premature rupture of membranes with conservative treatment at the Regional General Hospital No. 36... CONCLUSIONS: comparing the maternal and perinatal outcomes with conservative management of premature rupture of membranes, results were better in the group treated with erythromycin. It is not possible to prove it statistically because of the sample size.
Clinical Trials Related to Erythrocin (Erythromycin)
Erythromycin Versus Azithromycin in Preterm Premature Rupture of Membranes [Withdrawn]
Preterm Premature Rupture of Membranes (PPROM) is treated with an antibiotic, erythromycin
or azithromycin, to prolong pregnancy. Erythromycin is taken for several days and can result
in stomach upset in some patients, causing them to stop taking the medication. Therefore,
azithromycin is often prescribed instead. Azithromycin is usually taken only once and
stomach upset is not seen or greatly reduced. The goal of this study is to see if there is a
difference between the antibiotic (azithromycin) compared to the antibiotic (erythromycin)
in prolonging pregnancy in patients with Preterm Premature Rupture of Membranes (PPROM). The
working hypothesis is that there is no difference in the clinical effectiveness between
antibiotic regimens containing the macrolides azithromycin and erythromycin for prolonging
latency in PPROM.
Erythromycin Treatment for Readthrough of APC Gene Stop Codon Mutations in Familial Adenomatous Polyposis [Recruiting]
Colorectal cancer (CRC) is a leading cause for cancer related mortality in the western world
with a lifetime risk of 6%. Etiology is complex, while genetic background significantly
affects the risk. Around one third of all genetic disorders as well as most cases of
Familial Adenomatous Polyposis (FAP) and a large proportion of all sporadic CRC cases occur
as a result of premature nonsense mutations (creating a stop codon) in an individual's
adenomatous polyposis coli (APC) gene. Nonsense mutations are single-point alterations in
the DNA that prematurely halt the protein translation process, producing a shortened,
nonfunctional protein. In many of these cases, if the cell can be 'persuaded' to ignore the
premature stop codon signal, the resulting protein may be able to ameliorate or stop the
disease.
Recently, members of the aminoglycoside family of antibiotics have been found to induce
ribosomal read-through of nonsense mutations, leading to expression of a full length,
functional protein. Investigators have recently shown that members of the aminoglycoside and
macrolide antibiotic families can induce read-through of the nonsense mutations in the APC
gene and lead to reduced oncogenic phenotypes in CRC cells and in different mice models.
The aim of this project is to determine the ability of the macrolide antibiotic-erythromycin
to induce read-through of the nonsense mutations in the APC gene and to induce expression of
a full length, functional APC protein in patients suffering from FAP and to tests its effect
on adenoma number and size and on desmoid tumors in these patients. The future goal is to
maximize the effect of stop-codon suppressors on APC while minimizing side effects.
In this study investigators will select FAP patients which carry APC nonsense mutations,
treat them with erythromycin PO for 4-6 months and examine colonic and duodenal adenomas as
well as abdominal desmoid tumors, that will be documented before during and after treatment.
In parallel, investigators will test polyp, adenoma and desmoid tissue samples as well as
blood samples from these patients for changes in expression levels of the APC protein and
related oncogenic markers.
Suppression of nonsense mutations within the APC gene should be of benefit for patients
suffering from FAP, attenuated FAP or multiple adenomas and for patients with advanced or
diffuse CRC. Furthermore, given the rapid progress being made in the identification of
different nonsense mutations in human genes that lead to mostly un-curable disease, the
identification of clinically approved compounds that suppress nonsense mutations and that
can be administered long-term without significant side effects would open new venues in the
treatment of genetic human diseases that arise from pre-mature stop codons in important
coding sequences.
Immediate goal: establish the ability of erythromycin to read-through APC nonsense mutation
in FAP patients. The read-through effect of erythromycin will be clinically tested by
counting and measuring the number and size of both colonic and duodenal adenomas before and
over treatment and by measuring the size of known desmoid tumors. Samples of the adenomas
and desmoid tumors will be tested by western blot, immunofluorescence and
immunohistochemistry for restoration of APC expression and changes in oncogenic markers.
These experiments should be conducted within 6 month.
Long term objective:
1. Determine the lowest dose of erythromycin that can inhibit growth of colonic neoplasia
and CRC in patients expressing a truncated APC protein due to nonsense mutations.
2. Examine the ability of a panel of additional macrolide antibiotics to induce APC
nonsense mutation suppression using in-vitro methods. Investigators will focus on
macrolide antibiotics that are currently in clinical use and are administrated for long
terms. These objectives should take around 6 month and will be conducted in parallel.
Erythromycin Treatment for Readthrough of APC Gene Stop Codon Mutation in Familial Adenomatous Polyposis-minors' Adjusted Version [Not yet recruiting]
Colorectal cancer (CRC) is a leading cause for cancer related mortality in the western world
with a lifetime risk of 6%. Etiology is complex, while genetic background significantly
affects the risk. Around one third of all genetic disorders as well as most cases of
Familial Adenomatous Polyposis (FAP) and a large proportion of all sporadic CRC cases occur
as a result of premature nonsense mutations (creating a stop codon) in an individual's
adenomatous polyposis coli (APC) gene. Nonsense mutations are single-point alterations in
the DNA that prematurely halt the protein translation process, producing a shortened,
nonfunctional protein. In many of these cases, if the cell can be 'persuaded' to ignore the
premature stop codon signal, the resulting protein may be able to ameliorate or stop the
disease.
Recently, members of the aminoglycoside family of antibiotics have been found to induce
ribosomal read-through of nonsense mutations, leading to expression of a full length,
functional protein. Investigators have recently shown that members of the aminoglycoside and
macrolide antibiotic families can induce read-through of the nonsense mutations in the APC
gene and lead to reduced oncogenic phenotypes in CRC cells and in different mice models.
The aim of this project is to determine the ability of the macrolide antibiotic-erythromycin
to induce read-through of the nonsense mutations in the APC gene and to induce expression of
a full length, functional APC protein in patients suffering from FAP and to tests its effect
on adenoma number and size and on desmoid tumors in these patients. The future goal is to
maximize the effect of stop-codon suppressors on APC while minimizing side effects.
In this study investigators will select FAP patients which carry APC nonsense mutations,
treat them with erythromycin PO for 4-6 months and examine colonic and duodenal adenomas as
well as abdominal desmoid tumors, that will be documented before during and after treatment.
In parallel, investigators will test polyp, adenoma and desmoid tissue samples as well as
blood samples from these patients for changes in expression levels of the APC protein and
related oncogenic markers.
Suppression of nonsense mutations within the APC gene should be of benefit for patients
suffering from FAP, attenuated FAP or multiple adenomas and for patients with advanced or
diffuse CRC. Furthermore, given the rapid progress being made in the identification of
different nonsense mutations in human genes that lead to mostly un-curable disease, the
identification of clinically approved compounds that suppress nonsense mutations and that
can be administered long-term without significant side effects would open new venues in the
treatment of genetic human diseases that arise from pre-mature stop codons in important
coding sequences.
Immediate goal: establish the ability of erythromycin to read-through APC nonsense mutation
in FAP patients. The read-through effect of erythromycin will be clinically tested by
counting and measuring the number and size of both colonic and duodenal adenomas before and
over treatment and by measuring the size of known desmoid tumors. Samples of the adenomas
and desmoid tumors will be tested by western blot, immunofluorescence and
immunohistochemistry for restoration of APC expression and changes in oncogenic markers.
These experiments should be conducted within 6 month.
Long term objective:
1. Determine the lowest dose of erythromycin that can inhibit growth of colonic neoplasia
and CRC in patients expressing a truncated APC protein due to nonsense mutations.
2. Examine the ability of a panel of additional macrolide antibiotics to induce APC
nonsense mutation suppression using in-vitro methods. Investigators will focus on
macrolide antibiotics that are currently in clinical use and are administrated for long
terms. These objectives should take around 6 month and will be conducted in parallel.
Comparison of Two Macrolides, Azithromycin and Erythromycin, for Symptomatic Treatment of Gastroparesis [Terminated]
Erythromycin is effectively used in the treatment of Gastroparesis (GP) patients. In
susceptible patients however, it has been associated with sudden cardiac death due to
prolongation of QT intervals and subsequent cardiac risks through its interaction some other
drugs. Azithromycin (AZI) is a macrolide antibiotic but does not have the mentioned druf
interactions , has fewer gastrointestinal side effects, and fewer risks of QT prolongation
and cardiac arrhythmias. Consequently, AZI avoids drawbacks of dosing with erythromycin and
may be preferred as a prokinetic agent in patients on other concomitant medications.
We hope to demonstrate the effectiveness of Azithromycin (AZI) as compared to Erythromycin
in the treatment of Gastroparesis (GP), and later, form the framework for larger
randomized-controlled parallel studies to investigate use of AZI for treatment of GP.
Our novel hypothesis is to determine whether AZI can be used to treat GP.
Treatment of Dowling Maera Type of Epidermolysis Bullosa Simplex by Oral Erythromycin [Recruiting]
Dowling Meara type of epidermolysis bullosa simplex (EBS-DM) is a rare genodermatosis due to
keratin 5 and 14 mutation, characterized by skin fragility and spontaneous or post traumatic
blisters. Neonatal period and infancy are critical since this autonomic dominant affection
usually improves with age. Cyclins seem to be efficient in some cases of EBS but are
prohibited in children younger than 8 years old. Erythromycin can be a good alternative in
this population due to its antibacterial and anti-inflammatory potential.
The aim of this study is the evaluation of the efficiency of oral erythromycin to decrease
the number of cutaneous blisters in severe EBS-DM patients from 6 months to 8 years old
after 3 months of treatment.
Primary end point is the number of patients with decrease of blisters' number of at least
20% after 3 months of treatment by oral erythromycin.
It is a preliminary study on 8 patients. Treatment is oral erythromycin twice a day during 3
months. Follow up for each patient is 5 months. The duration of the study is 1 year.
Reports of Suspected Erythrocin (Erythromycin) Side Effects
Pancreatitis Acute (3),
Disseminated Intravascular Coagulation (3),
Arrhythmia (3),
Respiratory Failure (3),
Cardiac Arrest (3),
Acidosis (2),
COR Pulmonale (2),
Chest Pain (2),
Electrolyte Imbalance (2),
Anuria (2), more >>
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Page last updated: 2015-08-10
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