Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3765
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PCE (Tablet)
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dailymed-instance:dosage |
In most patients, PCE tablets
are well absorbed and may be dosed orally without regard to meals.
However, optimal blood levels are obtained when either PCE 333 mg
or PCE 500 mg tablets are given in the fasting state (at least��hour and preferably 2 hours before meals).<br/>Adults: The usual dosage
of PCE is one 333 mg tablet every 8 hours or one 500 mg tablet
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... |
PCE (erythromycin particles
in tablets) is an antibacterial product containing specially coated
erythromycin base particles for oral administration. The coating
protects the antibiotic from the inactivating effects of gastric acidity
and permits efficient absorption of the antibiotic in the small intestine.
PCE is available in two strengths containing either 333 mg or 500
mg of erythromycin base. PCE 500 mg tablets contain no synthetic
dyes or artificial colors. 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
is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*,
13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-��-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-��-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione.
The molecular formula is CHNO, and the molecular weight is 733.94. The structural formula is:<br/>Inactive Ingredients:<br/>PCE 333 mg Tablets: Cellulosic
polymers, citrate ester, colloidal silicon dioxide, D&C Red No.
30, hydrogenated vegetable oil wax, lactose, magnesium stearate, microcrystalline
cellulose, povidone, propylene glycol, sodium starch glycolate, stearic
acid and vanillin.<br/>PCE 500 mg Tablets: Cellulosic
polymers, citrate ester, colloidal silicon dioxide, crospovidone,
hydrogenated vegetable oil wax, iron oxide, microcrystalline cellulose,
polyethylene glycol, povidone, propylene glycol, stearic acid, talc,
titanium dioxide and vanillin.
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dailymed-instance:clinicalP... |
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. The erythromycin particles in PCE tablets are coated with a polymer
whose dissolution is pH dependent. This coating allows for minimal
release of erythromycin in acidic environments, e.g., stomach. This
delivery system is designed for optimal drug release and absorption
in the small intestine. In multiple-dose, steady-state studies, PCE
tablets have demonstrated rapid and generally adequate drug delivery
in both fasting and nonfasting conditions. However, the presence
of food results in lower blood levels, and optimal blood levels are
obtained when PCE tablets are given in the fasting state (at least��hour and preferably 2 hours before meals). Bioavailability
data are available from Abbott Laboratories, Dept. 4PI.<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 (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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dailymed-instance:contraind... |
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 |
PCE (erythromycin particles
in tablets) is supplied as unscored, ovaloid, Dispertab tablets in
the following strengths and packages. 333 mg, pink-speckled white (imprinted with Abbott���A���logo and PCE): Bottles of 60���������������������������������������������������������������..(NDC 0074-6290-60). 500 mg, white (imprinted with Abbott���A���logo and EK): Bottles of 100���������������������������������������������������������������(NDC 0074-3389-13).<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._30,
dailymed-ingredient:citrate_ester,
dailymed-ingredient:colloidal_silicon_dioxide,
dailymed-ingredient:hydrogenated_vegetable_oil_wax,
dailymed-ingredient:lactose,
dailymed-ingredient:magnesium_stearate,
dailymed-ingredient:microcrystalline_cellulose,
dailymed-ingredient:povidone,
dailymed-ingredient:propylene_glycol,
dailymed-ingredient:sodium_starch_glycolate,
dailymed-ingredient:stearic_acid,
dailymed-ingredient:vanillin
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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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dailymed-instance:genericMe... |
erythromycin
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dailymed-instance:fullName |
PCE (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.) 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.) Clostridium difficile associated
diarrhea (CDAD) has been reported with use of nearly all antibacterial
agents, including PCE, and may range in severity from mild diarrhea
to fatal colitis. Treatment with antibacterial agents alters the
normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins
A and B which contribute to the development of CDAD. Hypertoxin producing
strains of C. difficile cause
increased morbidity and mortality, as these infections can be refractory
to antimicrobial therapy and may require colectomy. CDAD must be
considered in all patients who present with diarrhea following antibiotic
use. Careful medical history is necessary since CDAD has been reported
to occur over two months after the administration of antibacterial
agents. If CDAD is suspected or confirmed,
ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate
fluid and electrolyte management, protein supplementation, antibiotic
treatment of C. difficile,
and surgical evaluation should be instituted as clinically indicated.
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dailymed-instance:indicatio... |
To reduce the development
of drug-resistant bacteria and maintain the effectiveness of PCE and
other antibacterial drugs, PCE 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. PCE 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 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. 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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PCE
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