ILOTYCIN SUMMARY
ILOTYCINTM 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- 0 -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-(dimethylamino)-β-D- xylo -hexopyranosyl]oxy]oxacyclotetradecane-2, 10-dione) is an antibiotic produced from a strain of Streptomyces erythraeus.
ILOTYCIN (ERYTHROMYCIN) is indicated for the following:
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.
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NEWS HIGHLIGHTS
Published Studies Related to Ilotycin (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
A randomized clinical trial comparing pulsed ultrasound and erythromycin
phonophoresis in the treatment of patients with chronic rhinosinusitis. [2015]
Therapeutic ultrasound, an important physiotherapy modality, has been used
successfully in the treatment of patients with chronic rhinosinusitis (CRS). No
study has compared pulsed ultrasound (PUS) with erythromycin phonophoresis (EP)... EP was found to be superior over PUS
therapy.
[Erythromycin for improving enteral nutrition tolerance in adult critical
patients: a systematic review and meta-analysis]. [Article in Chinese] [2014]
enteral nutrition (EN) tolerance in adult critical care patients... CONCLUSIONS: Postpyloric EN tube placement rate can be improved by erythromycin,
Clinical Trials Related to Ilotycin (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.
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Page last updated: 2015-08-10
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