Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3446
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ERYTHROCIN STEARATE (Tablet, Film Coated)
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Optimal serum levels of erythromycin are reached when
ERYTHROCIN STEARATE (erythromycin stearate) is taken in the fasting state
or immediately before meals.<br/>Adults: The usual dosage is 250 mg every 6 hours; or 500
mg every 12 hours. Dosage may be increased up to 4 g per day according to
the severity of the infection. However, twice-a-day dosing is not recommended
when doses larger than 1 g daily are administered.<br/>Children: Age, weight, and severity of the infection are important
factors in determining the proper dosage. The usual dosage is 30 to 50 mg/kg/day,
in equally divided doses. For more severe infections this dosage may be doubled
but should not exceed 4 g per day. In the treatment of streptococcal infections of the upper
respiratory tract (e.g., tonsillitis or pharyngitis), the therapeutic dosage
of erythromycin should be administered for at least ten days. The American Heart Association suggests a dosage of 250
mg of erythromycin orally, twice a day in long-term prophylaxis of streptococcal
upper respiratory tract infections for the prevention of recurring attacks
of rheumatic fever in patients allergic to penicillin and sulfonamides.<br/>Conjunctivitis of the Newborn Caused by Chlamydia
trachomatis: Oral erythromycin suspension 50 mg/kg/day in 4 divided
doses for at least 2 weeks.<br/>Pneumonia of Infancy Caused by Chlamydia
trachomatis: Although the optimal duration of therapy has not
been established, the recommended therapy is oral erythromycin suspension
50 mg/kg/day in 4 divided doses for at least 3 weeks.<br/>Urogenital Infections During Pregnancy Due to Chlamydia
trachomatis: Although the optimal dose and duration of therapy
have not been established, the suggested treatment is 500 mg of erythromycin
by mouth four times a day or two erythromycin 333 mg tablets orally every
8 hours on an empty stomach for at least 7 days. For women who cannot
tolerate this regimen, a decreased dose of one erythromycin 500 mg tablet
orally every 12 hours, one 333 mg tablet orally every 8 hours or 250 mg by
mouth four times a day should be used for at least 14 days.<br/>For Adults With Uncomplicated Urethral, Endocervical, or Rectal Infections
Caused by Chlamydia trachomatis, When
Tetracycline is Contraindicated or Not Tolerated: 500 mg of erythromycin by mouth four times a day
or two 333 mg tablets orally every 8 hours for at least 7 days.<br/>For Patients With Nongonococcal Urethritis Caused by Ureaplasma
urealyticum When Tetracycline is Contraindicated or Not Tolerated: 500 mg of erythromycin by mouth four times a day
or two 333 mg tablets orally every 8 hours for at least seven days.<br/>Primary Syphilis: 30 to 40 g given in divided doses over a period
of 10 to 15 days.<br/>Acute Pelvic Inflammatory Disease Caused by N.
gonorrhoeae: 500 mg Erythrocin Lactobionate-I.V. (erythromycin
lactobionate for injection, USP) every 6 hours for 3 days, followed by 500
mg of erythromycin base orally every 12 hours, or 333 mg of erythromycin
base orally every 8 hours for 7 days.<br/>Intestinal Amebiasis:<br/>Adults: 500 mg every 12 hours, 333 mg every 8 hours or
250 mg every 6 hours for 10 to 14 days.<br/>Children: 30 to 50 mg/kg/day in divided doses for 10 to
14 days.<br/>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/>Legionnaires' Disease: Although optimal dosage has not been established,
doses utilized in reported clinical data were 1 to 4 g daily in divided doses.
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dailymed-instance:descripti... |
ERYTHROCIN STEARATE Filmtab tablets (erythromycin
stearate tablets, USP) are an antibacterial product containing the stearate
salt of erythromycin in a unique film coating. 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. Erythromycin is a white to off-white
powder, slightly soluble in water, and soluble in alcohol, chloroform, and
ether. Erythromycin stearate is known chemically as erythromycin octadecanoate.
The molecular formula of erythromycin stearate is CHNO���CHO,
and the molecular weight is 1018.43. The structural formula is:<br/>Inactive Ingredients:<br/>250 mg tablet: Cellulosic polymers, corn starch, D&C Red
No. 7, polacrilin potassium, polyethylene glycol, povidone, propylene glycol,
sodium carboxymethylcellulose, sodium citrate, sorbic acid, sorbitan monooleate
and titanium dioxide.<br/>500 mg tablet: Cellulosic polymers, cornstarch, FD&C Red
No. 3, magnesium hydroxide, polacrilin potassium, povidone, propylene glycol,
sorbitan monooleate, titanium dioxide and vanillin.
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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. Orally administered
ERYTHROCIN STEARATE tablets are readily and reliably absorbed. Optimal serum
levels of erythromycin are reached when the drug is taken in the fasting state
or immediately before meals.<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 erythromycin 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 (resistantorganisms 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��g/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: Dilution Techniques Quantitative methods are used
to determine antimicrobial minimum inhibitory concentrations (MIC's).
These MIC's provide estimates of the susceptibility of bacteria to antimicrobial
compounds. The MIC's should be determined using a standardized procedure.
Standardized procedures are based on a dilution method(broth
or agar) or equivalent with standardized inoculum concentrations and standardized
concentrations of erythromycin powder. The MIC values should be interpreted
according to the following criteria: A report of "Susceptible" indicates that the
pathogen is likely to be inhibited 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 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 pathogen is not likely to be inhibited if the antimicrobial compound in
the blood reaches the concentrations usually achievable; other therapy should
be selected. Standardized susceptibility
test procedures require the use of laboratory control microorganisms to control
the technical aspects of the laboratory procedures. Standard erythromycin
powder should provide the following MIC values:
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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 |
ERYTHROCIN STEARATE Filmtab Tablets (erythromycin
stearate tablets, USP) are supplied in the following strengths and packages. ERYTHROCIN STEARATE Filmtab, 250 mg pink tablets imprinted
with the corporate Abbott���A���logo and the Abbo-Code designation ES: Bottles
of 100���...���������������������������������������������������������..(NDC 0074-6346-20) Bottles
of 500���...���������������������������������������������������������..(NDC 0074-6346-53) Bottles
of 1000���...���������������������������������������������������������(NDC 0074-6346-19) ABBO-PAC unit
dose strip packages of 100 tablets���������������...
(NDC 0074-6346-38) ERYTHROCIN
STEARATE Filmtab, 500 mg pink tablets imprinted with the corporate Abbott���A���logo and the Abbo-Code
designation ET: Bottles of 100���������������������������������������������������������������.(NDC 0074-6316-13)<br/>Recommended Storage: Store below 86��F (30��C).
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dailymed-instance:inactiveI... |
dailymed-ingredient:Cellulosic_polymers,
dailymed-ingredient:D&C_Red_No._7,
dailymed-ingredient:corn_starch,
dailymed-ingredient:polacrilin_potassium,
dailymed-ingredient:polyethylene_glycol,
dailymed-ingredient:povidone,
dailymed-ingredient:propylene_glycol,
dailymed-ingredient:sodium_carboxymethylcellulose,
dailymed-ingredient:sodium_citrate,
dailymed-ingredient:sorbic_acid,
dailymed-ingredient:sorbitan_monooleate,
dailymed-ingredient:titanium_dioxide
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dailymed-instance:overdosag... |
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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ERYTHROMYCIN STEARATE
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ERYTHROCIN STEARATE (Tablet, Film Coated)
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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.) Onset of
pseudomembranous colitis symptoms may occur during or after antibacterial
treatment. (See WARNINGS.) Erythromycin has been associated with QT prolongation and
ventricular arrhythmias, including ventricular tachycardia and torsades de
pointes. 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 rare
reports of pancreatitis and convulsions. 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 cholestatic 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. 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.) 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.
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dailymed-instance:indicatio... |
To reduce the development of drug-resistant bacteria
and maintain the effectiveness of ERYTHROCIN STEARATE Filmtab tablets and
other antibacterial drugs, ERYTHROCIN STEARATE Filmtab 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. ERYTHROCIN STEARATE tablets are indicated in the treatment
of infections caused by susceptible strains of the designated microorganisms
in the diseases listed below: Upper respiratory
tract infections of mild to moderate degree caused by Streptococcus
pyogenes; Streptococcus 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 or Streptococcus
pneumoniae. Listeriosis caused by Listeria monocytogenes. 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). 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. 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:Erythrocin'
Lactobionate-I.V. (erythromycin lactobionate for injection, USP) followed
by 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.
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. Erythromycins are Indicated for
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 treatmentof 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. Primary syphilis caused
by Treponema pallidum. Erythromycin
(oral forms only) is an alternative choice of treatment for primary syphilis
in patients allergic to the penicillins. In treatment of primary syphilis,
spinal fluid should be examined before treatment and as part of the follow-up
after therapy. 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 ten 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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ERYTHROCIN STEARATE
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