NDC 54868-2840 Ery-tab

NDC Product Code 54868-2840

NDC 54868-2840-0

Package Description: 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC

NDC 54868-2840-1

Package Description: 20 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Ery-tab with NDC 54868-2840 is a product labeled by Physicians Total Care, Inc.. The generic name of Ery-tab is . The product's dosage form is and is administered via form.

Labeler Name: Physicians Total Care, Inc.

Dosage Form: -

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Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • AMMONIA (UNII: 5138Q19F1X)
  • COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • CROSPOVIDONE (UNII: 68401960MK)
  • HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POVIDONE (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • AMMONIA (UNII: 5138Q19F1X)
  • COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • CROSPOVIDONE (UNII: 68401960MK)
  • HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POVIDONE (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Labeler Information

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Labeler Name: Physicians Total Care, Inc.
Labeler Code: 54868
Start Marketing Date: 06-30-2004 What is the Start Marketing Date?
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Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
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Information for Patients

Erythromycin

Erythromycin is pronounced as (er ith roe mye' sin)

Why is erythromycin medication prescribed?
Erythromycin is used to treat certain infections caused by bacteria, such as infections of the respiratory tract, including bronchitis, pneumonia, Legionnaires' disease (...
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Ery-tab Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

To reduce the development of drug-resistant bacteria and maintain the
effectiveness of ERY-TAB and other antibacterial drugs, ERY-TAB should be used
only to treat or prevent infections that are proven or strongly suspected to be
caused by bacteria.

Description

ERY-TAB (erythromycin delayed-release tablets) is an
antibacterial product containing erythromycin base in a specially enteric-coated
tablet to protect it from the inactivating effects of gastric acidity and to
permit efficient absorption of the antibiotic in the small intestine. ERY-TAB
tablets for oral administration are available in three dosage strengths, each
white oval tablet containing either 250 mg, 333 mg, or 500 mg of erythromycin as
the free base. ERY-TAB tablets comply with USP Drug Release
Test 1.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-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The
molecular formula is C37H67NO13, and the molecular weight is 733.94. The structural formula
is:Inactive IngredientsAmmonium hydroxide, colloidal silicon dioxide, croscarmellose
sodium, crospovidone, diacetylated monoglycerides, hydroxypropyl cellulose,
hypromellose, hypromellose phthalate, magnesium stearate, microcrystalline
cellulose, povidone, propylene glycol, sodium citrate, sorbitan monooleate,
talc, and titanium dioxide.

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.ERY-TAB 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. The tablets are designed for optimal drug release and absorption
in the small intestine. In multiple-dose, steady-state studies, ERY-TAB tablets
have demonstrated adequate drug delivery in both fasting and non-fasting
conditions. Bioavailability data are available from Abbott Laboratories, Dept.
422.MicrobiologyErythromycin 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 OrganismsCorynebacterium diphtheriaeCorynebacterium minutissimumListeria monocytogenesStaphylococcus aureus (resistant organisms may
emerge during treatment)Streptococcus pneumoniaeStreptococcus pyogenesGram-negative OrganismsBordetella pertussisLegionella pneumophilaNeisseria gonorrhoeaeOther MicroorganismsChlamydia trachomatisEntamoeba histolyticaMycoplasma pneumoniaeTreponema pallidumUreaplasma urealyticumThe following in vitro data are available, but their clinical significance is unknown
.Erythromycin exhibits in vitro minimal inhibitory
concentrations (MIC's) of 0.5 mcg/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 OrganismsViridans group streptococciGram-negative OrganismsMoraxella catarrhalisSusceptibility TestsDilution TechniquesQuantitative 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 (mcg/mL)Interpretation ≤ 0.5Susceptible (S)1-4Intermediate (I)≥ 8Resistant (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:MicroorganismMIC (mcg/mL) S. aureus ATCC 292130.12-0.5E. faecalis ATCC 292121-4Diffusion TechniquesQuantitative 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-mcg 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-mcg erythromycin disk should be interpreted
according to the following criteria:Zone Diameter (mm)Interpretation ≥ 23Susceptible (S)14-22Intermediate (I)≤ 13Resistant (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-mcg
erythromycin disk should provide the following zone diameters in these
laboratory test quality control strains:MicroorganismZone Diameter (mm)S. aureus ATCC 2592322-30

Indications And Usage

To reduce the development of drug-resistant bacteria and maintain
the effectiveness of ERY-TAB and other antibacterial drugs, ERY-TAB 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.ERY-TAB 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.ProphylaxisPrevention of Initial Attacks of Rheumatic FeverPenicillin 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 FeverPenicillin 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.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.

Precautions

General PrecautionsPrescribing ERY-TAB 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.)There have been reports that erythromycin may aggravate the weakness of
patients with myasthenia gravis.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 PatientsPatients should be counseled that antibacterial drugs including
ERY-TAB should only be used to treat bacterial infections. They do not treat
viral infections (e.g., the common cold). When ERY-TAB is prescribed to treat a
bacterial infection, patients should be told thatalthough 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
ERY-TAB or other antibacterial drugs in the future.Drug InteractionsErythromycin 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. 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/dihydroergotamineConcurrent 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 BenzodiazepinesErythromycin has been reported to decrease the clearance of
triazolam and midazolam, and thus, may increase the pharmacologic effect of
these benzodiazepines.HMG-CoA Reductase InhibitorsErythromycin 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 coadministered 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 InteractionsErythromycin interferes with the fluorometric determination of
urinary catecholamines.Carcinogenesis, Mutagenesis, Impairment of
FertilityLong-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.PregnancyTeratogenic effectsPregnancy Category BThere 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 DeliveryThe effect of erythromycin on labor and delivery is
unknown.Nursing MothersErythromycin is excreted in human milk. Caution should be
exercised when erythromycin is administered to a nursing woman.Pediatric UseSee INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION.

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

In most patients, ERY-TAB (erythromycin delayed-release tablets)
are well absorbed and may be given without regard to meals.AdultsThe 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 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.ChildrenAge, 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 dose 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.3Conjunctivitis of the Newborn Caused by Chlamydia trachomatisOral erythromycin suspension 50 mg/kg/day in 4 divided doses for
at least 2 weeks.3Pneumonia of Infancy Caused by Chlamydia
trachomatisAlthough 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 Chlamydia trachomatisAlthough 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.5For Adults With Uncomplicated Urethral, Endocervical, or
Rectal Infections Caused by Chlamydia trachomatis,
When Tetracycline is Contraindicated or Not Tolerated500 mg of erythromycin by mouth four times a day or two 333 mg tablets orally
every 8 hours for at least 7 days.5For Patients With Nongonococcal Urethritis Caused by Ureaplasma Urealyticum When Tetracycline is Contraindicated
or Not Tolerated500 mg of erythromycin by mouth four times a day or two 333 mg
tablets orally every 8 hours for at least seven days.5Primary Syphilis30 to 40 g given in divided doses over a period of 10 to 15
days.Acute Pelvic Inflammatory Disease Caused by N. Gonorrhoeae500 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 AmebiasisAdults500 mg every 12 hours, 333 mg every 8 hours or 250 mg every 6
hours for 10 to 14 days.Children30 to 50 mg/kg/day in divided doses for 10 to 14 days.PertussisAlthough 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' DiseaseAlthough optimal dosage has not been established, doses utilized
in reported clinical data were 1 to 4 grams daily in divided doses.Preoperative Prophylaxis for Elective Colorectal
SurgeryListed below is an example of a recommended bowel preparation
regimen. A proposed surgery time of 8:00 a.m. has been used.Pre-op Day 3: Minimum residue or clear liquid diet. Bisacodyl, 1 tablet
orally at 6:00 p.m.Pre-op Day 2: Minimum residue or clear liquid diet. Magnesium sulfate, 30 mL,
50% solution (15 g) orally at 10:00 a.m., 2:00 p.m. and 6:00 p.m. Enema at 7:00
p.m. and 8:00 p.m.Pre-op Day 1: Clear liquid diet. Supplemental (IV) fluids as needed.
Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m. and 2:00 p.m.
Neomycin sulfate (1.0 g) and erythromycin base (two 500 mg tablets, three 333 mg
tablets or four 250 mg tablets) orally at 1:00 p.m., 2:00 p.m. and 11:00 p.m. No
enema.Day of Operation: Patient evacuates rectum at 6:30 a.m. for scheduled
operation at 8:00 a.m.

How Supplied

ERY-TAB (erythromycin delayed-release tablets, USP) are supplied
as white oval enteric-coated tablets debossed on one side with the Abbott “A” logo, and on the other side with a two letter
Abbo-Code designation, EC for the 250 mg tablets, EH for the 333 mg tablets, and
ED for the 500 mg tablets, in the following package sizes:333 mg tablets: NDC 54868-0840-5NDC 54868-0840-4Bottles of 10Bottles of 15NDC 54868-0840-0Bottles of 20NDC 54868-0840-2Bottles of 30NDC 54868-0840-1Bottles of 40NDC 54868-0840-3Bottles of 100500 mg tablets: NDC 54868-2840-1Bottles of 20NDC 54868-2840-0Bottles of 30Recommended StorageStore 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.333 mg and 500 mg tablets-U.S. Pat. No. 4,340,582Abbott LaboratoriesNorth Chicago, IL 60064, U.S.A.Relabeling and Repackaging by:Physicians Total Care, Inc.Tulsa, OK      74146

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