(Erythromycin Delayed-Release Tablets, USP)
Enteric-Coated
DESCRIPTION
ACTIONS
INDICATIONS
CONTRAINDICATIONS
WARNINGS
PRECAUTIONS
ADVERSE REACTIONS
OVERDOSAGE
DOSAGE AND ADMINISTRATION
HOW SUPPLIED
Erythromycin is produced by a strain of
Streptomyces erythraeus and belongs to
the macrolide group of antibiotics. It is
basic and readily forms salts with acids.
The base is white to off-white crystals or
powder slightly soluble in water, soluble
in alcohol, in chloroform, and in ether.
ERY-TAB (erythromycin delayed-release
tablets) is specially enteric-coated to protect the contents from the inactivating
effects of gastric acidity and to permit
efficient absorption of the antibiotic in the
small intestine.
ERY-TAB is available in three dosage
strengths, each tablet containing either
250 mg, 333 mg, or 500 mg of erythromycin as the free base.
Inactive Ingredients:
250 mg tablet: cellulosic polymers, corn
starch, diacetylated monoglycerides, D&C
red No. 30, iron oxide, magnesium
hydroxide, magnesium stearate, sodium
starch glycolate, titanium dioxide and
vanillin.
333 mg tablet: cellulosic polymers,
diacetylated monoglycerides, FD&C blue
No. 1, magnesium stearate, microcrystalline cellulose, povidone, sodium citrate,
soybean derivatives, talc, titanium dioxide
and vanillin.
500 mg tablet: cellulosic polymers,
diacetylated monoglycerides, FD&C red no. 40, iron oxide, magnesium stearate, microcrystalline
cellulose, povidone, sodium citrate, soybean derivatives, talc, titanium dioxide and vanillin.
The mode of action of erythromycin is
inhibition of protein synthesis without
affecting nucleic acid synthesis.
Resistance to erythromycin of some
strains of Hemophilus influenzae and staphylococci has been demonstrated.
Culture and susceptibility testing should
be done. If the Kirby-Bauer method of
disc susceptibility is used, a 15 mcg erythromycin disc should give a zone diameter of at least 18mm when tested against
an erythromycin susceptible organism.
Bioavailability data are available from
Abbott Laboratories, Dept. 355.
ERY-TAB is well absorbed and may be
given without regard to meals.
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 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. After oral administration, less than 5 percent of the activity of
the administered dose can be recovered in
the urine.
Erythromycin crosses the placental barrier but fetal plasma levels are low.
Streptococcus pyogenes (Group A beta
hemolytic streptococcus): For upper and
lower respiratory tract, skin, and soft tissue infections of mild to moderate severity.
Injectable benzathine penicillin G is
considered by the American Heart
Association to be the drug of choice in the
treatment and prevention of streptococcal
pharyngitis and in long-term prophylaxis
of rheumatic fever.
When oral medication is preferred for
treatment of the above conditions, penicillin G, V, or erythromycin are alternate
drugs of choice.
When oral medication is given, the
importance of strict adherence by the
patient to the prescribed dosage regimen
must be stressed. A therapeutic dose
should be administered for at least 10
days.
Alpha-hemolytic streptococci (viridans
group): Although no controlled clinical
efficacy trials have been conducted, oral
erythromycin has been suggested by the
American Heart Association and
American Dental Association for use in a
regimen for prophylaxis against bacterial
endocarditis in patients hypersensitive to
penicillin who have congenital heart disease, or rheumatic or other acquired
valvular heart disease when they undergo
dental procedures and surgical procedures
of the upper respiratory tract.1
Erythromycin is not suitable prior to genitourinary or gastrointestinal tract surgery.
NOTE: When selecting antibiotics for the
prevention of bacterial endocarditis the
physician or dentist should read the full
joint statement of the American Heart
Association and the American Dental
Association.1
Staphylococcus aureus: For acute infections of skin and soft tissue of mild to
moderate severity. Resistant organisms
may emerge during treatment.
Streptococcus pneumoniae (Diplococcus
pneumoniae): For upper respiratory tract
infections (e.g., otitis media, pharyngitis)
and lower respiratory tract infection (e.g.,
pneumonia) of mild to moderate degree.
Mycoplasma pneumoniae (Eaton agent,
PPLO): for respiratory infections due to
this organism.
Hemophilus influenzae: For upper respiratory tract infections of mild to moderate
severity when used concomitantly with
adequate doses of sulfonamides. Not all
strains of this organism are susceptible at
the erythromycin concentrations ordinarily
achieved (see appropriate sulfonamide labeling for prescribing information).
Chlamydia trachomatis: Erythromycin is 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.2
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.
Corynebacterium diptheriae and C. minutissimum: As an adjunct to antitoxin,
to prevent establishment of carriers, and to
eradicate the organism in carriers.
In the treatment of erythrasma.
Entamoeba histolytica: In the treatment
of intestinal amebiasis only. Extra-enteric
amebiasis requires treatment with other
agents.
Listeria monocytogenes: Infections due
to this organism.
Neisseria gonorrhoeae: Erythrocin®
Lactobionate-I.V. (erythromycin lactobionate for injection, USP) in conjunction
with 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. Before treatment
of gonorrhea, patients who are suspected
of also having syphilis should have a
microscopic examination for T. pallidum
(by immunofluorescence or darkfield)
before receiving erythromycin, and
monthly serologic tests for a minimum of
4 months.
Bordetella pertussis: Erythromycin is
effective in eliminating the organism from
the nasopharynx of infected individuals,
rendering them non-infectious. Some clinical studies suggest that erythromycin may
be helpful in the prophylaxis of pertussis in exposed susceptible individuals.
Legionnaires’ Disease: Although no
controlled clinical efficacy studies have
been conducted, in vitro and limited preliminary clinical data suggest that erythromycin can be effective in treating
Legionnaires’ Disease.
Erythromycin is contraindicated in
patients with known hypersensitivity to
this antibiotic.
There have been reports of hepatic dysfunction with or without jaundice, occurring in patients receiving oral
erythromycin products.
General: Erythromycin is principally
excreted by the liver. Caution should be
exercised when erythromycin is administered to patients with impaired hepatic
function. (See “Clinical Pharmacology”
and “Warnings” sections).
Prolonged or repeated use of erythromycin may result in an overgrowth of
nonsusceptible bacteria or fungi. If superinfection occurs, erythromycin should be
discontinued and appropriate therapy
instituted.
When indicated, incision and drainage
or other surgical procedures should be performed in conjunction with antibiotic therapy.
Laboratory Tests: Erythromycin interferes with the fluorometric determination
of urinary catecholamines.
Drug Interactions: Erythromycin use in
patients who are receiving high doses of
theophylline may be associated with an
increase in serum theophylline levels and
potential theophylline toxicity. In case of
theophylline toxicity and/or elevated
serum theophylline levels, the dose of
theophylline should be reduced while the
patient is receiving concomitant erythromycin therapy.
Concomitant administration of erythromycin and digoxin has been reported
to result in elevated digoxin serum levels.
There have been reports of increased
anticoagulant effects when erythromycin
and oral anticoagulants were used concomitantly .
Concurrent use of erythromycin and
ergotamine or dihydroergotamine has been
associated in some patients with acute
ergot toxicity characterized by severe
peripheral vasospasm and dysesthesia.
Erythromycin has been reported to
decrease the clearance of triazolam and
thus may increase the pharmacologic
effect of triazolam.
The use of erythromycin in patients
concurrently taking drugs metabolized by
the cytochrome P450 system may be associated with elevations in serum erythromycin with carbamazepine cyclosporine, hexobarbital and phenytoin.
Serum concentrations of drugs metabolized by the cytochrome P450 system
should be monitored closely in patients
concurrently receiving erythromycin.
Troleandomycin significantly alters the
metabolism of terfenadine when taken
concomitantly; therefore, observe caution
when erythromycin and terfenadine are
used concurrently.
Patients receiving concomitant lovastatin and erythromycin should be carefully
monitored; cases of rhabdomyolysis have
been reported in seriously ill patients.
Carcinogenesis, Mutagenesis, Impairment
of Fertility: Long-term (2-year) oral studies conducted in rats with erythromycin base did not provide
evidence of tumorigenicity. Mutagenicity
studies have not been conducted. There
was no apparent effect on male or female
fertility in rats fed erythromycin (base) at
levels up to 0.25 percent of diet.
Pregnancy: Pregnancy Category B:
There is no evidence of teratogenicity or
any other adverse effect on reproduction
in female rats fed erythromycin base (up
to 0.25 percent of diet) prior to and during
mating, during gestation, and through weaning of two successive litters. There
are, however, no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are
not always predictive of human response,
this drug should be used during pregnancy
only if clearly needed. Erythromycin has
been reported to cross the placental barrier
in humans, but fetal plasma levels are generally low.
Labor and Delivery: The effect of erythromycin on labor and delivery is
unknown.
Nursing Mothers: Erythromycin is
excreted in breast milk, therefore, caution
should be exercised when erythromycin is
administered to a nursing woman.
Pediatric Use: See “Indications and
Usage” and “Dosage and Administration”
sections.
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 hepatic dysfunction and/or abnormal liver function test
results may occur (see “Warnings” section). Pseudomembranous colitis has been
rarely reported in association with erythromycin therapy.
There have been isolated reports of transient central nervous system side effects
including confusion, hallucinations,
seizures, and vertigo; however, a cause and effect relationship has not been established.
Occasional case reports of cardiac
arrhythmias such as ventricular tachycardia have been documented in patients
receiving erythromycin therapy. There
have been isolated reports of other cardiovascular symptoms such as chest pain,
dizziness, and palpitations; however, a
cause and effect relationship has not been
established.
Allergic reactions ranging from urticaria
and mild skin eruptions to anaphylaxis
have occurred.
There have been isolated reports of
reversible hearing loss occurring chiefly in
patients with renal insufficiency and in
patients receiving high doses of erythromycin.
In case of o4 ]osage, erythromycin
should be discontinued. Overdosage
should be handled with the prompt elimination of unabsorbed drug and all other
appropriate measures.
Erythromycin is not removed by peritoneal dialysis or hemodialysis.
ERY-TAB (erythromycin delayed-release
tablets) is well absorbed and may be given
without regard to meals.
Adults: The usual dose is 250 mg four
times daily in equally spaced doses. The
333 mg tablet is recommended if dosage is
desired every 8 hours. If twice-a-day
dosage is desired, the recommended dose
is 500 mg every 12 hours.
Dosage may be increased up to 4 or
more grams per day according to the
severity of the infection. Twice-a-day dosing is not recommended when doses larger
than 1 gram daily are administered.
Children: Age, weight, and severity of
the infection are important factors in
determining the proper dosage. 30 to 50
mg/kg/day, in divided doses, is the usual
dose. For more severe infections, this dose
may be doubled.
In the treatment of streptococcal infections, a therapeutic dosage of erythromycin should be administered for at
least 10 days. In continuous prophylaxis
of streptococcal infections in persons with
a history of rheumatic heart disease, the
dose is 250 mg twice a day.
For prophylaxis against bacterial endocarditis1 in patients with congenital heart
disease, or rheumatic or other acquired
valvular heart disease when undergoing
dental procedures or surgical procedures
of the upper respiratory tract, give 1 g (20
mg/kg for children) orally l l/2 to 2 hours
before the procedure, and then, 500 mg
(10 mg/kg in children) orally every 6
hours for 8 doses.
For Conjunctivitis of the newborn caused by
Chlamydia trachomatis: Oral
erythromycin suspension 50 mg/kg/day in 4 divided doses for at least 2 weeks.2
For 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.2
For urogenital infections during pregnancy due to Chlamydia trachomatis:
Although the optimal dose and duration of
therapy have not been established the
suggested treatment is erythromycin 500
mg, by mouth, 4 times a day for at least 7
days. For women who cannot tolerate this
regimen, a decreased dose of 250 mg, by
mouth, 4 times a day should be used for at
least 14 days.2
For adults with uncomplicated urethral,
endocervical, or rectal infections caused
by Chlamydia trachomatis in whom tetracyclines are contraindicated or not tolerated: 500 mg, by mouth, 4 times a day for
at least 7 days.2
For treatment of primary syphilis: 30
to 40 grams given in divided doses over a
period of 10 to 15 days.
For treatment of acute pelvic inflammatory disease Caused by N. gonorrhoeae:
After initial treatment with Erythrocin®
Lactobionate-I.V. (erythromycin lactobionate for injection, USP) 500 mg every
6 hours for 3 days, the oral dosage recommendation is 250 mg every 6 hours for 7
days.
For dysenteric amebiasis: 250 mg
four times daily for 10 to 14 days, for
adults; 30 to 50 mg/kg/day in divided
doses for l0 to 14 days, for children.
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.
For treatment of Legionnaires’ Disease:
Although optimal doses have not been
established, doses utilized in reported
clinical data were 1 to 4 grams erythromycin
base daily in divided doses.
ERY-TAB (erythromycin delayed-release
tablets, USP), 250 mg, is supplied as pink
tablets in bottles of 100 (NDC 0074-6304-13), botlles of 500 (NDC 0074-6304-53),
and Abbo-Pac® unit dose packages of 100
(NDC 0074-6304-11).
ERY-TAB, 333mg, is supplied as white
tablets in bottles of 100 (NDC 0074-6320-13), bottles of 500 (NDC 0074-6320-53),
and Abbo-Pac® unit dose packages of 100
(NDC 0074-6320-11).
ERY-TAB, 500 mg, is supplied as pink
tablets in bottles of 100 (NDC 0074-6321-13) and Abbo-Pac® unit dose packages of
100 (NDC 0074-6321-11).
Recommended Storage: Store below
86°F (30°C).
1. American Heart Association, 1977.
Prevention of bacterial endocarditis,
Circulation 56: 139A –
2. CDC Sexually Transmitted Diseases
Treatment Guidelines 1982
____
333 mg and 500 mg tablets — U.S. Pat. No.
4,340,582.
Revised: August 1991.
