NDC 54868-1387 Erythromycin Base Filmtab

NDC Product Code 54868-1387

NDC CODE: 54868-1387

Proprietary Name: Erythromycin Base Filmtab What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat certain eye infections (such as conjunctivitis). It is also used to prevent certain eye infections in newborns. It belongs to a class of drugs known as macrolide antibiotics. Erythromycin works by stopping the growth of bacteria. This medication treats only bacterial eye infections. It will not work for other types of eye infections. Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

Product Characteristics

Color(s):
PINK (C48328)
Shape: OVAL (C48345)
Size(s):
19 MM
Imprint(s):
EA
Score: 1

NDC Code Structure

NDC 54868-1387-0

Package Description: 20 TABLET, FILM COATED in 1 BOTTLE

NDC 54868-1387-1

Package Description: 30 TABLET, FILM COATED in 1 BOTTLE

NDC 54868-1387-2

Package Description: 15 TABLET, FILM COATED in 1 BOTTLE

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

NDC Product Information

Erythromycin Base Filmtab with NDC 54868-1387 is a product labeled by Physicians Total Care, Inc.. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 197650 and 598006.

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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • CROSPOVIDONE (UNII: 68401960MK)
  • D&C RED NO. 30 (UNII: 2S42T2808B)
  • HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POVIDONE (UNII: FZ989GH94E)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SORBIC ACID (UNII: X045WJ989B)
  • SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Physicians Total Care, Inc.
Labeler Code: 54868
Start Marketing Date: 12-09-1996 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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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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Erythromycin Base Filmtab 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 Erythromycin Base Filmtab tablets and other antibacterial
drugs, Erythromycin Base Filmtab tablets would be used only to treat or prevent
infections that are proven or strongly suspected to be caused by bacteria.

FILMTAB—Film-sealed tablets, Abbott.Abbott LaboratoriesNorth Chicago, IL 60064, U.S.A.Relabeling and Repackaging by:Physicians Total Care, Inc.Tulsa, OK     74146

250 mg

Description

Erythromycin Base Filmtab (erythromycin tablets, USP) is an
antibacterial product containing erythromycin, USP, in a unique, nonenteric film
coating for oral administration. Erythromycin Base Filmtab tablets are available
in two strengths containing either 250 mg or 500 mg of erythromycin base.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 IngredientsColloidal silicon dioxide, croscarmellose sodium, crospovidone,
D&C Red No. 30 Aluminum Lake, hydroxypropyl cellulose, hypromellose,
hydroxypropyl methylcellulose phthalate, magnesium stearate, microcrystalline
cellulose, povidone, polyethylene glycol, propylene glycol, sodium citrate,
sodium hydroxide, sorbic acid, 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.Optimal blood levels are obtained when Erythromycin Base Filmtab tablets are
given in the fasting state (at least ½ hour and preferably 2 hours before
meals). Bioavailability data are available from Abbott Laboratories, Dept.
42W.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 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 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 (µg/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 (µg/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-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≥ 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-µg
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 Erythromycin Base Filmtab tablets and other antibacterial
drugs, Erythromycin Base 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.Erythromycin Base Filmtab 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.3When tetracyclines are contraindicated or not tolerated, erythromycin is
indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum.3Primary 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

GeneralPrescribing Erythromycin Base 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.)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
Erythromycin Base Filmtab tablets should only be used to treat bacterial
infections. They do not treat viral infections (e.g., the common cold). When
Erythromycin Base Filmtab tablets is 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 Erythromycin Base
Filmtab tablets 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 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 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 USAGEand 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

Optimal blood levels are obtained when Erythromycin Base Filmtab
tablets are given in the fasting state (at least ½ hour and preferably 2 hours
before meals).AdultsThe usual dosage of Erythromycin Base Filmtab is one 250 mg
tablet four times daily in equally spaced doses 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.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 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.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 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 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 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 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 for 7 days.Intestinal AmebiasisAdults500 mg every 12 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 g daily in divided doses.

How Supplied

Erythromycin Base Filmtab tablets (erythromycin tablets, USP) are
supplied as pink, unscored oval tablets in the following strengths and
packages.250 mg tablets (debossed with Abbott “A” logo and
EB):Bottles of 20NDC 54868-1386-5Bottles of 30NDC 54868-1386-3Bottles of 40NDC 54868-1386-1Bottles of 60NDC 54868-1386-4Bottles of 100NDC 54868-1386-6500 mg tablets (debossed with Abbott “A” logo and
EA):
Bottles of 15NDC 54868-1387-2Bottles of 20NDC 54868-1387-0Bottles of 30NDC 54868-1387-1Recommended StorageStore below 86°F (30°C). Keep tightly closed.

References

  • National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for
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