Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/944
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E.E.S. (Suspension)
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Erythromycin ethylsuccinate
suspensions and Filmtab tablets may be administered without regard
to meals.<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: 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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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).
The molecular formula is CHNOand the molecular weight is 862.06. The structural formula is: E.E.S. Granules are intended
for reconstitution with water. Each 5-mL teaspoonful of reconstituted
cherry-flavored suspension contains erythromycin ethylsuccinate equivalent
to 200 mg of erythromycin. The pleasant tasting, fruit-flavored liquids are supplied ready for
oral administration. E.E.S.
200 Liquid: Each 5-mL teaspoonful of fruit-flavored suspension contains
erythromycin ethylsuccinate equivalent to 200 mg of erythromycin. E.E.S. 400 Liquid: Each 5-mL teaspoonful
of orange-flavored suspension contains erythromycin ethylsuccinate
equivalent to 400 mg of erythromycin. Granules and ready-made suspensions are intended primarily for pediatric
use but can also be used in adults. E.E.S. 400 Filmtab Tablets: Each
tablet contains erythromycin ethylsuccinate equivalent to 400 mg of
erythromycin. The Filmtab tablets are intended primarily for adults or older children.<br/>Inactive Ingredients: E.E.S. 200 Liquid:
FD&C Red No. 40, methylparaben, polysorbate 60, propylparaben,sodium citrate, sucrose, water, xanthan gum and natural and artificial
flavors. E.E.S.
400 Liquid: D&C Yellow No. 10, FD&C Yellow No. 6, methylparaben,
polysorbate 60, propylparaben, sodium citrate, sucrose, water, xanthan
gum and natural and artificial flavors. E.E.S. Granules: Citric acid, FD&C Red No. 3, magnesium aluminum
silicate, sodium carboxymethylcellulose, sodium citrate, sucrose and
artificial flavor. E.E.S. 400 Filmtab Tablets: Cellulosic polymers, confectioner's
sugar (contains corn starch), corn starch, D&C Red No. 30, D&C
Yellow No. 10, FD&C Red No. 40, magnesium stearate, polacrilin
potassium, polyethylene glycol, propylene glycol, sodium citrate,
sorbic acid, and titanium dioxide.
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Orally administered erythromycin
ethylsuccinate suspensions and Filmtab tablets are readily and reliably
absorbed. Comparable serum levels of erythromycin are achieved in
the fasting and nonfasting states. 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. Staphylocci 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��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:
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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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E.E.S. 200 LIQUID (erythromycin
ethylsuccinate oral suspension, USP) is supplied in 1 pint bottles
(NDC 0074-6306-16) and in 100-mL
bottles (NDC 0074-6306-13). E.E.S. 400 LIQUID
(erythromycin ethylsuccinate oral suspension, USP) is supplied in
1 pint bottles (NDC 0074-6373-16)
and in 100-mL bottles (NDC 0074-6373-13). Both liquid products require refrigeration
to preserve taste until dispensed. Refrigeration by patient is not
required if used within 14 days. E.E.S. GRANULES (erythromycin ethylsuccinate for oral suspension,
USP) is supplied in 100-mL (NDC 0074-6369-02) and 200-mL (NDC 0074-6369-10) size bottles. E.E.S. 400 Filmtab tablets (erythromycin ethylsuccinate tablets,
USP) 400 mg, are supplied as pink tablets imprinted with the Abbott���A���logo, and two
letter Abbo-Code designation, EE, in bottles of 100 (NDC 0074-5729-13), 500 (NDC 0074-5729-53) and 1000 (NDC 0074-5729-19) and in ABBO-PAC unit
dose strip packages of 100 (NDC 0074-5729-11).<br/>Recommended storage: Store tablets below
86��F (30��C). Store granules, prior to mixing, below 86��F (30��C). After
mixing, refrigerate and use within 10 days.
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dailymed-ingredient:FD&C_Red_No._40,
dailymed-ingredient:methylparaben,
dailymed-ingredient:natural_and_artificial_flavors,
dailymed-ingredient:polysorbate_60,
dailymed-ingredient:propylparaben,
dailymed-ingredient:sodium_citrate,
dailymed-ingredient:sucrose,
dailymed-ingredient:water,
dailymed-ingredient:xanthan_gum
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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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erythromycin ethylsuccinate
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E.E.S. (Suspension)
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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 antibiotic 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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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. 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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To reduce the development
of drug-resistant bacteria and maintain the effectiveness of E.E.S.
and other antibacterial drugs, E.E.S. 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
antibacterialtherapy. In the absence of such data, local epidemiology
and susceptibility patterns may contribute to the empiric selection
of therapy. E.E.S. is
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 patients
allergic to the penicillins. In treatment of 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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E.E.S.
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