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ERYTHROMYCIN STEARATE
Overview
What is Erythrocin Stearate?
ERYTHROCIN STEARATE Film-coated 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
(formerly
) 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 C
H
NO
•C
H
O
, and the molecular weight is 1018.43. The structural formula is:
What does Erythrocin Stearate look like?
What are the available doses of Erythrocin Stearate?
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What should I talk to my health care provider before I take Erythrocin Stearate?
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How should I use Erythrocin Stearate?
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ERYTHROCIN STEARATE Film-coated tablets and other antibacterial drugs, ERYTHROCIN STEARATE Film-coated 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 micro organisms in the diseases listed below:
Upper respiratory tract infections of mild to moderate degree caused by
(when used concomitantly with adequate doses of sulfonamides, since many strains of
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
or
.
Listeriosis caused by
.
Respiratory tract infections due to
.
Skin and skin structure infections of mild to moderate severity caused by
or
(resistant staphylococci may emerge during treatment).
Pertussis (whooping cough) caused by
. 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
, 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
.
Intestinal amebiasis caused by
(oral erythromycins only). Extraenteric amebiasis requires treatment with other agents.
Acute Pelvic Inflammatory Disease Caused by
: 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
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 followup serologic test for syphilis after 3 months.
Erythromycins are Indicated for Treatment of the Following Infections Caused by
: 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
.
When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by
.
Primary syphilis caused by
. 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
. Although no controlled clinical efficacy studies have been conducted,
and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease.
Optimal serum levels of erythromycin are reached when ERYTHROCIN STEARATE (erythromycin stearate) is taken in the fasting state or immediately before meals.
What interacts with Erythrocin Stearate?
Erythromycin is contraindicated in patients with known hypersensitivity to this antibiotic.
Erythromycin is contraindicated in patients taking terfenadine, astemizole, pimozide or cisapride. (See .)
What are the warnings of Erythrocin Stearate?
Since benztropine mesylate contains structural features of atropine, it may produce anhidrosis. For this reason, it should be administered with caution during hot weather, especially when given concomitantly with other atropine-like drugs to the chronically ill, the alcoholic, those who have central nervous system disease, and those who do manual labor in a hot environment. Anhidrosis may occur more readily when some disturbance of sweating already exists. If there is evidence of anhidrosis, the possibility of hyperthermia should be considered. Dosage should be decreased at the discretion of the physician so that the ability to maintain body heat equilibrium by perspiration is not impaired. Severe anhidrosis and fatal hyperthermia have occurred.
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.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against
may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of
, 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.)
What are the precautions of Erythrocin Stearate?
General
Prescribing ERYTHROCIN STEARATE Film-coated 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
and
.)
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.
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 Film-coated tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When ERYTHROCIN STEARATE Film-coated 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 Film-coated 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
.)
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/QT
interval prolongation, cardiac arrest, torsades de pointes, and other ventricular arrhythmias, have been observed. (See
.) 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
).
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
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
and
.
Geriatric Use
Elderly patients, particularly those with reduced renal or hepatic function, may be at increased risk for developing erythromycin-induced hearing loss. (See
and
).
Elderly patients may be more susceptible to the development of torsades de pointes arrhythmias than younger patients. (See
).
Elderly patients may experience increased effects of oral anticoagulant therapy while undergoing treatment with erythromycin. (See
).
Erythrocin Stearate Film-coated Tablets (250 mg) contain 56.7 mg (2.5 mEq) of sodium and 5.0 mg (0.1 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.
What are the side effects of Erythrocin Stearate?
The most frequent side effects of oral erythromycin preparations are gastrointestinal and are doserelated. They include nausea, vomiting, abdominal pain, diarrhea and anorexia. Symptoms of hepatitis, hepatic dysfunction and/or abnormal liver function test results may occur. (See
.)
Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment. (See
.)
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.
What should I look out for while using Erythrocin Stearate?
Erythromycin is contraindicated in patients with known hypersensitivity to this antibiotic.
Erythromycin is contraindicated in patients taking terfenadine, astemizole, pimozide or cisapride. (See
.)
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
C. difficile
C. difficile
C. difficile
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against
may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of
, 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.)
What might happen if I take too much Erythrocin Stearate?
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.
How should I store and handle Erythrocin Stearate?
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense in well-closed containers as defined in the USP.Keep out of reach of children.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense in well-closed containers as defined in the USP.Keep out of reach of children.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Dispense in well-closed containers as defined in the USP.Keep out of reach of children.ERYTHROCIN STEARATE Film-coated Tablets (erythromycin stearate tablets, USP) are supplied in the following strengths and packages.ERYTHROCIN STEARATE Film-coated, 250 mg pink tablets imprinted with the Product Code designation ES:Bottles of 4, 10, 15, 20, 28, 40, 56, 100 and 120.ERYTHROCIN STEARATE Film-coated Tablets (erythromycin stearate tablets, USP) are supplied in the following strengths and packages.ERYTHROCIN STEARATE Film-coated, 250 mg pink tablets imprinted with the Product Code designation ES:Bottles of 4, 10, 15, 20, 28, 40, 56, 100 and 120.ERYTHROCIN STEARATE Film-coated Tablets (erythromycin stearate tablets, USP) are supplied in the following strengths and packages.ERYTHROCIN STEARATE Film-coated, 250 mg pink tablets imprinted with the Product Code designation ES:Bottles of 4, 10, 15, 20, 28, 40, 56, 100 and 120.
Clinical Information
Chemical Structure
No Image foundClinical 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.
Non-Clinical Toxicology
Erythromycin is contraindicated in patients with known hypersensitivity to this antibiotic.Erythromycin is contraindicated in patients taking terfenadine, astemizole, pimozide or cisapride. (See .)
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
C. difficile
C. difficile
C. difficile
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , 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.)
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:
Prescribing ERYTHROCIN STEARATE Film-coated 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 and .)
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. 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.
The most frequent side effects of oral erythromycin preparations are gastrointestinal and are doserelated. They include nausea, vomiting, abdominal pain, diarrhea and anorexia. Symptoms of hepatitis, hepatic dysfunction and/or abnormal liver function test results may occur. (See .)
Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment. (See .)
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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