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FDA LABEL
MFR: Blenheim Pharmacal, Inc.
Erythrocin Stearate 500 Mg Oral Tablet
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 bacteria.
DESCRIPTION
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 C37H67NO13
•C18H36O2, and the molecular
weight is 1018.43. The structural formula is:
Inactive Ingredients
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.
500 mg tablet
Cellulosic polymers, cornstarch, FD&C
Red No. 3, magnesium hydroxide, polacrilin potassium, povidone, propylene
glycol, sorbitan monooleate, titanium dioxide and vanillin.
CLINICAL PHARMACOLOGY
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.
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.
Gram-positive organisms
Corynebacterium diphtheriae
Corynebacterium minutissimum
Listeria monocytogenes
Staphylococcus aureus (resistant organisms may emerge during treatment)
Streptococcus pneumoniae
Streptococcus pyogenes
Gram-negative organisms
Bordetella pertussis
Legionella pneumophila
Neisseria gonorrhoeae
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 µg/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.
Gram-positive organisms
Viridans group streptococci
Gram-negative organisms
Moraxella catarrhalis
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 method1 (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:
|
MIC (µg/mL)
|
Interpretation
|
| ≤ 0.5 |
Susceptible (S) |
| 1-4 |
Intermediate (I) |
| ≥ 8 |
Resistant (R) |
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:
|
Microorganism
|
MIC (µg/mL)
|
|
S. aureus ATCC 29213 |
0.12-0.5 |
|
E. faecalis ATCC
29212 |
1-4 |
Diffusion Techniques
Quantitative methods that require measurement
of zone diameters also provide reproducible estimates of the susceptibility
of bacteria to antimicrobial compounds. One such standardized procedure2 requires the use of standardized inoculum concentrations.
This procedure uses paper disks impregnated with 15-µg erythromycin
to test the susceptibility of microorganisms to erythromycin.
Reports from the laboratory providing results
of the standard single-disk susceptibility test with a 15-µg erythromycin
disk should be interpreted according to the following criteria:
|
Zone Diameter (mm)
|
Interpretation
|
| ≥ 23 |
Susceptible (S) |
| 14-22 |
Intermediate (I) |
| ≤ 13 |
Resistant (R) |
Interpretation should be as stated
above for results using dilution techniques. Interpretation involves
correlation of the diameter obtained in the disk test with the MIC
for erythromycin.
As with standardized
dilution techniques, diffusion methods require the use of laboratory
control microorganisms that are used to control the technical aspects
of the laboratory procedures. For the diffusion technique, the 15-µg
erythromycin disk should provide the following zone diameters in these
laboratory test quality control strains:
|
Microorganism
|
Zone Diameter (mm)
|
|
S. aureus ATCC
25923 |
22-30 |
INDICATIONS AND USAGE
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 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.
Prophylaxis
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).3 Erythromycin is indicated for the treatment of penicillin-allergic
patients. The therapeutic dose should be administered for ten days.
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).3
CONTRAINDICATIONS
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.)
WARNINGS
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.
Clostridium difficile associated
diarrhea (CDAD) has been reported with use of nearly all antibacterial
agents, including ERYTHROCIN® STEARATE Filmtab® Tablets, 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.
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.)
PRECAUTIONS
General
Prescribing
ERYTHROCIN STEARATE Filmtab tablets in the absence of a proven or
strongly suspected bacterial infection or a prophylactic indication
is unlikely to provide benefit to the patient and increases the risk
of the development of drug-resistant bacteria.
Since 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.)
Exacerbation of symptoms of myasthenia gravis and new onset of symptoms
of myasthenic syndrome have been reported in patients receiving erythromycin
therapy.
There have been reports
of infantile hypertrophic pyloric stenosis (IHPS) occurring in infants
following erythromycin therapy. In one cohort of 157 newborns who
were given erythromycin for pertussis prophylaxis, seven neonates
(5%) developed symptoms of non-bilious vomiting or irritability with
feeding and were subsequently diagnosed as having IHPS requiring surgical
pyloromyotomy. A possible dose-response effect was described with
an absolute risk of IHPS of 5.1% for infants who took erythromycin
for 8-14 days and 10% for infants who took erythromycin for 15-21
days.4 Since erythromycin may be used
in the treatment of conditions in infants which are associated with
significant mortality or morbidity (such as pertussis or neonatal Chlamydia trachomatis infections), the benefit of erythromycin
therapy needs to be weighed against the potential risk of developing
IHPS. Parents should be informed to contact their physician if vomiting
or irritability with feeding occurs.
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.
Information for Patients
Patients should be counseled that antibacterial drugs including ERYTHROCIN
STEARATE Filmtab tablets should only be used to treat bacterial infections.
They do not treat viral infections (e.g., the common cold). When
ERYTHROCIN STEARATE Filmtab tablets are prescribed to treat a bacterial
infection, patients should be told that although it is common to feel
better early in the course of therapy, the medication should be taken
exactly as directed. Skipping doses or not completing the full course
of therapy may (1) decrease the effectiveness of the immediate treatment
and (2) increase the likelihood that bacteria will develop resistance
and will not be treatable by ERYTHROCIN STEARATE Filmtab tablets or
other antibacterial drugs in the future.
Diarrhea is a common problem caused by antibiotics
which usually ends when the antibiotic is discontinued. Sometimes
after starting treatment with antibiotics, patients can develop watery
and bloody stools (with or without stomach cramps and fever) even
as late as two or more months after having taken the last dose of
the antibiotic. If this occurs, patients should contact their physician
as soon as possible.
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.
Hypotension, bradyarrhythmias, and lactic acidosis have been observed
in patients receiving concurrent verapamil, belonging to the calcium
channel blockers drug class.
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.
Increased anticoagulation effects due to interactions of erythromycin
with oral anticoagulants may be more pronounced in the elderly.
Erythromycin is a substrate and inhibitor
of the 3A isoform subfamily of the cytochrome p450 enzyme system (CYP3A).
Coadministration of erythromycin and a drug primarily metabolized
by CYP3A may be associated with elevations in drug concentrations
that could increase or prolong both the therapeutic and adverse effects
of the concomitant drug. Dosage adjustments may be considered, and
when possible, serum concentrations of drugs primarily metabolized
by CYP3A should be monitored closely in patients concurrently receiving
erythromycin.
The following are
examples of some clinically significant CYP3A based drug interactions.
Interactions with other drugs metabolized by the CYP3A isoform are
also possible. The following CYP3A based drug interactions have been
observed with erythromycin products in post-marketing experience:
Ergotamine/dihydroergotamine
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.
Triazolobenzodiazepines
(Such as triazolam and alprazolam) and Related Benzodiazepines
Erythromycin has been reported to decrease
the clearance of triazolam and midazolam, and thus, may increase the
pharmacologic effect of these benzodiazepines.
HMG-CoA Reductase Inhibitors
Erythromycin has been reported to increase
concentrations of HMG-CoA reductase inhibitors (e.g., lovastatin and
simvastatin). Rare reports of rhabdomyolysis have been reported in
patients taking these drugs concomitantly.
Sildenafil (Viagra)
Erythromycin has been reported to increase
the systemic exposure (AUC) of sildenafil. Reduction of sildenafil
dosage should be considered. (See Viagra package insert.)
There have been spontaneous or published
reports of CYP3A based interactions of erythromycin with cyclosporine,
carbamazepine, tacrolimus, alfentanil, disopyramide, rifabutin, quinidine,
methylprednisolone, cilostazol, vinblastine, and bromocriptine.
Concomitant administration of erythromycin
with cisapride, pimozide, astemizole, or terfenadine is contraindicated.
(See CONTRAINDICATIONS.)
In addition, there have been reports of interactions
of erythromycin with drugs not thought to be metabolized by CYP3A,
including hexobarbital, phenytoin, and valproate.
Erythromycin has been reported to significantly alter
the metabolism of the nonsedating antihistamines terfenadine and astemizole
when taken concomitantly. Rare cases of serious cardiovascular adverse
events, including electrocardiographic QT/QTc interval prolongation, cardiac arrest, torsades de pointes, and
other ventricular arrhythmias, have been observed. (See CONTRAINDICATIONS.) In addition, deaths have been reported rarely with concomitant
administration of terfenadine and erythromycin.
There have been post-marketing reports of drug interactions
when erythromycin was co-administered with cisapride, resulting in
QT prolongation, cardiac arrhythmias, ventricular tachycardia, ventricular
fibrillation, and torsades de pointes, most likely due to the inhibition
of hepatic metabolism of cisapride by erythromycin. Fatalities have
been reported. (See CONTRAINDICATIONS).
Drug/Laboratory Test
Interactions
Erythromycin
interferes with the fluorometric determination of urinary catecholamines.
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
Teratogenic effects
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.
Labor and Delivery
The effect of erythromycin on labor and delivery is unknown.
Nursing Mothers
Erythromycin is excreted in human milk.
Caution should be exercised when erythromycin is administered to
a nursing woman.
Pediatric Use
See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION.
Geriatric Use
Elderly patients, particularly those with
reduced renal or hepatic function, may be at increased risk for developing
erythromycin-induced hearing loss. (See ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION).
Elderly patients may be more susceptible to the development
of torsades de pointes arrhythmias than younger patients. (See ADVERSE REACTIONS).
Elderly
patients may experience increased effects of oral anticoagulant therapy
while undergoing treatment with erythromycin. (See PRECAUTIONS
- Drug Interactions).
Erythrocin Stearate Filmtab ® Tablets (250 mg) contain 56.7 mg (2.5
mEq) of sodium and 5.0 mg (0.1 mEq) of potassium per tablet.
Erythrocin Stearate Filmtab ® Tablets (500
mg) contain no sodium and 7.0 mg (0.2 mEq) of potassium per tablet.
The geriatric population may respond with
a blunted natriuresis to salt loading. This may be clinically important
with regard to such diseases as congestive heart failure.
ADVERSE REACTIONS
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.
OVERDOSAGE
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.
DOSAGE AND ADMINISTRATION
Optimal serum levels of erythromycin are reached when ERYTHROCIN
STEARATE (erythromycin stearate) is taken in the fasting state or
immediately before meals.
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.
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.3
Conjunctivitis of the
Newborn Caused by
Oral erythromycin suspension 50 mg/kg/day
in 4 divided doses for at least 2 weeks.3
Pneumonia of Infancy
Caused by
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.
Urogenital Infections
During Pregnancy Due to
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.5
For Adults With Uncomplicated
Urethral, Endocervical, or Rectal Infections Caused by , 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.5
For Patients With Nongonococcal
Urethritis Caused by 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.5
Primary Syphilis
30 to 40 g given in divided doses over
a period of 10 to 15 days.
Acute Pelvic Inflammatory
Disease Caused by
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.
Intestinal Amebiasis
Adults
500 mg every 12 hours, 333 mg every 8 hours
or 250 mg every 6 hours for 10 to 14 days.
Children
30 to 50 mg/kg/day in divided doses for
10 to 14 days.
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.
Legionnaires' Disease
Although optimal dosage has not been established,
doses utilized in reported clinical data were 1 to 4 g daily in divided
doses.
HOW SUPPLIED
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)
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)
Recommended Storage
Store below 86°F (30°C).
REFERENCES
- National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria
that Grow Aerobically , Third Edition. Approved Standard
NCCLS Document M7-A3, Vol. 13, No. 25 NCCLS, Villanova , PA, December
1993.
- National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Disk Susceptibility Tests, Fifth Edition. Approved Standard NCCLS Document M2-A5, Vol. 13,
No. 24 NCCLS, Villanova , PA, December 1993.
- Committee on Rheumatic Fever, Endocarditis, and Kawasaki
Disease of the Council on Cardiovascular Disease in the Young, the
American Heart Association: Prevention of Rheumatic Fever. Circulation. 78(4):1082-1086, October 1988.
- Honein, M.A., et. al.: Infantile hypertrophic pyloric stenosis
after pertussis prophylaxis with erythromycin: a case review and
cohort study. The Lancet 1999;354 (9196):2101-5.
- Data on file, Abbott Laboratories.
FILMTAB-Film-sealed tablets, Abbott.
Abbott Laboratories
North Chicago, IL 60064, U.S.A.
Principal Display Panel
Erythrocin® Stearate Filmtab® (Erythromycin Stearate Tablets, USP) 250mg
28 Tablets
NDC 10544-594-28
Principal Display Panel
Erythrocin® Stearate Filmtab® (Erythromycin Stearate Tablets, USP) 500mg
28 Tablets
NDC 10544-595-28