Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1150
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Erythromycin Ethylsuccinate (Tablet)
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Erythromycin ethylsuccinate tablets may be administered
without regard to meals. To avoid unpleasant taste, the 400 mg tablets
should not be chewed.<br/>Children: Age, weight, and severity of the infection are important
factors in determining the proper dosage. In mild to moderate infections
the usual dosage of erythromycin ethylsuccinate for children is 30 to 50 mg/kg/day
in equally divided doses every 6 hours. For more severe infections this dosage
may be doubled. If twice-a-day dosage is desired, one-half of the total daily
dose may be given every 12 hours. Doses may also be given three times daily
by administering one-third of the total daily dose every 8 hours. The following dosage schedule is suggested for mild to moderate
infections:<br/>Adults: 400 mg erythromycin ethylsuccinate every 6 hours
is the usual dose. Dosage may be increased up to 4 g per day according to
the severity of the infection. If twice-a-day dosage is desired, one-half
of the total daily dose may be given every 12 hours. Doses may also be given
three times daily by administering one-third of the total daily dose every
8 hours. For adult dosage calculation, use
a ratio of 400 mg of erythromycin activity as the ethylsuccinate to 250 mg
of erythromycin activity as the stearate, base or estolate. In the treatment of streptococcal infections, a therapeutic
dosage of erythromycin ethylsuccinate should be administered for at least
10 days. In continuous prophylaxis against recurrences of streptococcal infections
in persons with a history of rheumatic heart disease, the usual dosage is
400 mg twice a day.<br/>For Treatment of Urethritis Due to C.
trachomatis or U. urealyticum: 800 mg three times a day for 7 days.<br/>For Treatment of Primary Syphilis:<br/>Adults: 48 to 64 g given in divided doses over a period
of 10 to 15 days.<br/>For Intestinal Amebiasis:<br/>Adults: 400 mg four times daily for 10 to 14 days.<br/>Children: 30 to 50 mg/kg/day in divided doses for 10 to
14 days.<br/>For Use in Pertussis: Although optimal dosage and duration have not been
established, doses of erythromycin utilized in reported clinical studies were
40 to 50 mg/kg/day, given in divided doses for 5 to 14 days.<br/>For Treatment of Legionnaires' Disease: Although optimal doses have not been established,
doses utilized in reported clinical data were those recommended above (1.6
to 4 g daily in divided doses.)
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dailymed-instance:descripti... |
Erythromycin is produced by a strain of Saccharopolyspora
erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic
and readily forms salts with acids. The base, the stearate salt, and the
esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester
of erythromycin suitable for oral administration. Erythromycin ethylsuccinate
is known chemically as erythromycin 2'-(ethylsuccinate). Erythromycin ethylsuccinate tablets for oral administration
are intended primarily for adults or older children. Each tablet contains
erythromycin ethylsuccinate equivalent to 400 mg of erythromycin activity.
The molecular formula is CHNOand
the molecular weight is 862.06. The structural formula is:<br/>Inactive Ingredients: Confectioner's sugar (contains corn starch),
corn starch, FD&C Red No. 40, magnesium stearate, polacrilin potassium
and sodium citrate.
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dailymed-instance:clinicalP... |
Orally administered erythromycin ethylsuccinate tablets
are readily and reliably absorbed under both fasting and nonfasting conditions. Erythromycin diffuses readily into most body fluids. Only
low concentrations are normally achieved in the spinal fluid, but passage
of the drug across the blood-brain barrier increases in meningitis. In the
presence of normal hepatic function, erythromycin is concentrated in the liver
and excreted in the bile; the effect of hepatic dysfunction on excretion of
erythromycin by the liver into the bile is not known. Less than 5 percent
of the orally administered dose of erythromycin is excreted in active form
in the urine. Erythromycin crosses the placental
barrier, but fetal plasma levels are low. The drug is excreted in human milk.<br/>Microbiology: Erythromycin acts by inhibition of protein synthesis by binding
50 S ribosomal subunits of susceptible
organisms. It does not affect nucleic acid synthesis. Antagonism has been
demonstrated in vitro between erythromycin
and clindamycin, lincomycin, and chloramphenicol. Many
strains of Haemophilus influenzae are
resistant to erythromycin alone but are susceptible to erythromycin and sulfonamides
used concomitantly. Staphylococci resistant to
erythromycin may emerge during a course of therapy. Erythromycin
has been shown to be active against most strains of the following microorganisms,
both in vitro and in clinical infections
as described in the INDICATIONS AND USAGE section.<br/>Gram-positive organisms: Corynebacterium
diphtheriae Corynebacterium minutissimum Listeria monocytogenes Staphylococcus
aureus (resistant organisms may emerge during treatment) Streptococcus pneumoniae Streptococcus
pyogenes<br/>Gram-negative organisms: Bordetella
pertussis Legionella pneumophila Neisseria gonorrhoeae<br/>Other microorganisms: Chlamydia
trachomatis Entamoeba histolytica Mycoplasma
pneumoniae Treponema pallidum Ureaplasma urealyticum The following in vitro data are available, but their clinical significance is unknown. Erythromycin exhibits in vitro minimal inhibitory concentrations
(MIC's) of 0.5 mcg/mL or less against most (���90%) strains of
the following microorganisms; however, the safety and effectiveness of erythromycin
in treating clinical infections due to these microorganisms have not been
established in adequate and well-controlled clinical trials.<br/>Gram-positive organisms: Viridans group streptococci<br/>Gram-negative organisms: Moraxella
catarrhalis<br/>Susceptibility Tests:
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Erythromycin is contraindicated in patients with known
hypersensitivity to this antibiotic. Erythromycin
is contraindicated in patients taking terfenadine, astemizole, pimozide, or
cisapride. (See PRECAUTIONS - Drug Interactions .)
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dailymed-instance:supply |
Erythromycin ethylsuccinate Tablets, USP, 400 mg are
supplied as mottled pink, oval tablets bearing the Code 74 ZE in bottles of
100 (NDC 0074-2589-13) and 500 (NDC 0074-2589-53).<br/>Recommended Storage: Protect tablets from exposure to light and moisture.
Store below 86��F (30��C).
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In case of overdosage, erythromycin should be discontinued.
Overdosage should be handled with the prompt elimination of unabsorbed drug
and all other appropriate measures should be instituted. Erythromycin is not removed by peritoneal dialysis or hemodialysis.
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dailymed-instance:genericMe... |
erythromycin ethylsuccinate
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dailymed-instance:fullName |
Erythromycin Ethylsuccinate (Tablet)
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dailymed-instance:adverseRe... |
The most frequent side effects of oral erythromycin
preparations are gastrointestinal and are dose-related. They include nausea,
vomiting, abdominal pain, diarrhea and anorexia. Symptoms of hepatitis, hepatic
dysfunction and/or abnormal liver function test results may occur. (See WARNINGS section.) Onset
of pseudomembranous colitis symptoms may occur during or after antibacterial
treatment. (See WARNINGS.) Rarely, erythromycin has been associated with the production
of ventricular arrhythmias, including ventricular tachycardia and torsades
de pointes, in individuals with prolonged QT intervals. Allergic
reactions ranging from urticaria to anaphylaxis have occurred. Skin reactions
ranging from mild eruptions to erythema multiforme, Stevens-Johnson syndrome,
and toxic epidermal necrolysis have been reported rarely. There have been isolated reports of reversible hearing loss occurring
chiefly in patients with renal insufficiency and in patients receiving high
doses of erythromycin.
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dailymed-instance:warning |
There have been reports of hepatic dysfunction, including
increased liver enzymes, and hepatocellular and/or chloestatic hepatitis,
with or without jaundice, occurring in patients receiving oral erythromycin
products. There have been reports suggesting
that erythromycin does not reach the fetus in adequate concentration to prevent
congenital syphilis. Infants born to women treated during pregnancy with
oral erythromycin for early syphilis should be treated with an appropriate
penicillin regimen. Pseudomembranous
colitis has been reported with nearly all antibacterial agents, including
erythromycin, and may range in severity from mild to life threatening. Therefore,
it is important to consider this diagnosis in patients who present with diarrhea
subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora
of the colon and may permit overgrowth of clostridia. Studies indicate that
a toxin produced by Clostridium difficile is
a primary cause of "antibiotic-associated colitis". After
the diagnosis of pseudomembranous colitis has been established, therapeutic
measures should be initiated. Mild cases of pseudomembranous colitis usually
respond to discontinuation of the drug alone. In moderate to severe cases,
consideration should be given to management with fluids and electrolytes,
protein supplementation, and treatment with an antibacterial drug clinically
effective against Clostridium difficile colitis. Rhabdomyolysis with or without renal impairment has been reported
in seriously ill patients receiving erythromycin concomitantly with lovastatin.
Therefore, patients receiving concomitant lovastatin and erythromycin should
be carefully monitored for creatine kinase (CK) and serum transaminase levels.
(See package insert for lovastatin.)
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dailymed-instance:indicatio... |
To reduce the development of drug-resistant bacteria
and maintain the effectiveness of erythromycin ethylsuccinate tablets and
other antibacterial drugs, erythromycin ethylsuccinate tablets 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. Erythromycin ethylsuccinate tablets are indicated in the treatment
of infections caused by susceptible strains of the designated organisms in
the diseases listed below: Upper respiratory
tract infections of mild to moderate degree caused by Streptococcus
pyogenes, Streptococcus pneumoniae , or 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
pneumoniae or Streptococcus pyogenes . Listeriosis caused by Listeria
monocytogenes. Pertussis (whooping
cough) caused by Bordetella pertussis.
Erythromycin is effective in eliminating the organism from the nasopharynx
of infected individuals rendering them noninfectious. Some clinical studies
suggest that erythromycin may be helpful in the prophylaxis of pertussis in
exposed susceptible individuals. Respiratory
tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections
of mild to moderate severity caused by Streptococcus
pyogenes or Staphylococcus aureus (resistant
staphylococci may emerge during treatment). Diphtheria:
Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers
and to eradicate the organism in carriers. Erythrasma:
In the treatment of infections due to Corynebacterium
minutissimum. Intestinal amebiasis
caused by Entamoeba histolytica (oral
erythromycins only). Extraenteric amebiasis requires treatment with other
agents. Acute pelvic inflammatory disease caused
by Neisseria gonorrhoeae: 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. Patients should have a serologic
test for syphilis before receiving erythromycin as treatment of gonorrhea
and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema Pallidum : Erythromycin is an alternate choice of treatment for primary
syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid
examinations should be done before treatment and as part of follow-up after
therapy. Erythromycins are indicated for the
treatment of the following infections caused by Chlamydia
trachomatis: Conjunctivitis of the newborn, pneumonia of infancy,
and urogenital infections during pregnancy. When tetracyclines are contraindicated
or not tolerated, erythromycin is indicated for the treatment of uncomplicated
urethral, endocervical, or rectal infections in adults due to Chlamydia
trachomatis. When tetracyclines are
contraindicated or not tolerated, erythromycin is indicated for the treatment
of nongonococcal urethritis caused by Ureaplasma
urealyticum. 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.<br/>Prophylaxis:<br/>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 Streptococcus
pyogenes infections of the upper respiratory tract, e.g., tonsillitis
or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic
patients.The therapeutic dose should be administered for 10
days.<br/>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).
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Erythromycin Ethylsuccinate
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