erythromycin stearate (Rx)

Brand and Other Names:Erythrocin Stearate
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Dosing & Uses

AdultPediatric

Dosing Form & Strengths

tablet

  • 250mg

General Dosing Recommendations

250 mg PO q6hr, OR

500 mg PO q12hr (if daily dose does not exceed 1 g)

May increase up to 4 g/day depending on infection severity

Amebiasis

500 mg PO q6hr for 10-14 days

Legionnaires Disease

1-4 g/day PO in divided doses for 21 days

Urethritis

Urethritis caused by C trachomatis or U urealyticum

500 mg PO q6hr for 7 days; alternatively 333 mg PO q8hr for 7 days

Syphilis

30-40 g PO in divided doses for 10-15 days

Renal Impairment

Dose adjustment not necessary

Hepatic Impairment

Use caution

Other Indications & Uses

Group A beta-hemolytic strep, Actinobacillus actinomycetemcomitans, Actinomyces israelii, Actinomyces naeslundii, Actinomyces odontolyticus, Afipia felis, Arachnia propionica, Arcanobacterium (Corynebacterium) haemolyticum, Bacillus anthracis, Bartonella henselae, Bartonella quintana, Bordetella pertussis, Borrelia burgdorferi, Borrelia recurrentis, C. diphtheriae, C. trachomatis, Klebsiella granulomatis, Campylobacter jejuni, Capnocytophaga ochracea, Chlamydia pneumonia (TWAR agent), Chlamydia psittaci, Chlamydia trachomatis, Chryseobacterium meningosepticum, Corynebacterium jeikeium (CDC group JK), Corynebacterium minutissimum, Corynebacterium ulcerans, Coxiella burnetii, E. histolytica, Erysipelothrix rhusiopathiae, H. ducreyi, H. influenzae, Kingella sp., Lactobacillus sp, Legionella pneumophilia, Leptospira interrogans, Leptotrichia buccalis, Leuconostoc species, Listeria, Mycobacterium chelonae, Mycobacterium fortuitum, M. catarrhalis, Mycoplasma pneumoniae, N. gonorrhoeae, Rhodococcus equi, S. aureus, S. pyogenes (group A beta-hemolytic streptococci), S. pneumoniae, Spirillum minus, Streptobacillus moniliformis, Streptococcus (Group C, G), Streptococcus agalactiae (Group B), Streptococcus bovis (Group D), Streptococcus intermedius group (S. anginosus, S intermedius, S. constellatus), Streptococcus pneumoniae (PCN sensitive, MIC <0.1 mcg/mL), Streptococcus pyogenes (Group A), Treponema pallidum, U. urealyticum, Ureaplasma urealyticum, Vibrio cholerae, Viridans streptococci

Off-label: Campylobacter jejuni, Calymmatobacterium granulomatis, Haemophilus ducreyi, prophylaxis in colorectal surgery, anthrax, tetanus, Lyme disease

First line: Afipia felis, Arcanobacterium (Corynebacterium) haemolyticum, Bartonella henselae, Bartonella quintana, Campylobacter jejuni, Capnocytophaga ochracea, Chlamydia pneumonia, Corynebacterium minutissimum, Corynebacterium ulcerans, Haemophilus ducreyi, Mycobacterium fortuitum, Ureaplasma urealyticum (others eg, Haemophilus ducreyi not unanimous)

Dosing Form & Strengths

tablet

  • 250mg

General Dosing Recommendations

Mild-to-moderate infections: 30-50 mg/kg/day PO divided q6-8hr  

Severe infection: 60-100 mg/kg/day PO divided q6-8hr

Not to exceed 4 g/day

Intestinal Amebiasis

30-50 mg/kg/day PO in divided doses for 10-14 days  

Pneumonia of Infancy

50 mg/kg/day PO divided q6hr for at least 3 weeks

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Interactions

Interaction Checker

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            Adverse Effects

            1-10%

            Abdominal pain (8%)

            Headache (8%)

            Nausea (8%)

            Diarrhea (7%)

            Rash (3%)

            Vomiting (3%)

            Dyspepsia (2%)

            Flatulence (2%)

            Pain (2%)

            Pruritus (1%)

            Pseudomembranous colitis

            Hypertrophic pyloric stenosis

            Anaphylaxis

            Fever

            Mild allergic reactions

            Urticaria

            Skin eruptions

            Tinnitus

            <1%

            Cholestatic hepatitis

            Confusion

            Hallucinations

            Hearing loss

            Hypotension

            Nervous system effects including seizures

            Torsade de pointes

            Ventricular tachycardia

            Vertigo

            Postmarketing reports

            Interstitial nephritis

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            Warnings

            Contraindications

            Documented hypersensitivity

            Coadministration with terfenadine

            Coadministration with HMG-CoA reductase inhibitors that are extensively metabolized by CYP3A4 (lovastatin or simvastatin)

            Co-administration of erythromycin with ergotamine or dihydroergotamine

            Cautions

            Hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice reported in patients receiving oral erythromycin products

            Prescribing therapy in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to patient and increases risk of 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

            Exacerbation of symptoms of myasthenia gravis and new onset of symptoms of myasthenic syndrome reported in patients receiving erythromycin therapy

            Infantile hypertrophic pyloric stenosis (IHPS) in infants following erythromycin therapy reported; a possible dose-response effect reported; 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 therapy needs to be weighed against 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; observational studies in humans have reported cardiovascular malformations after exposure to drug products containing erythromycin during early pregnancy

            QT Prolongation

            • Therapy has been associated with prolongation of QT interval and infrequent cases of arrhythmia; elderly patients may be more susceptible to drug-associated effects on QT interval
            • Cases of torsades de pointes spontaneously reported during postmarketing surveillance in patients receiving erythromycin; fatalities reported
            • Therapy should be avoided in patients with known prolongation of QT interval, patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents

            Syphilis in pregnancy

            • There have been reports suggesting 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 appropriate penicillin regimen

            Clostridium difficile associated diarrhea

            • Clostridium difficile associated diarrhea (CDAD) reported with use of nearly all antibacterial agents, including erythromycin and may range in severity from mild diarrhea to fatal colitis
            • Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile; C. difficile produces toxins A and B which contribute to development of CDAD
            • Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy
            • CDAD must be considered in all patients who present with diarrhea following antibiotic use; careful medical history is necessary since CDAD has been reported to occur over two months after administration of antibacterial agents
            • If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued; appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated

            Drug interaction overview

            • There have been post-marketing reports of cardiac arrhythmias, ventricular tachycardia, ventricular fibrillation, and torsades de pointes, caused by coadministration of drugs that result in QT prolongation; fatalities reported
            • Increased anticoagulant effects, which may be more pronounced in elderly when erythromycin and oral anticoagulants (eg, warfarin) are used concomitantly, reported
            • Colchicine is a substrate for both CYP3A4 and the efflux transporter P-glycoprotein (P-gp); erythromycin is considered moderate inhibitor of CYP3A4; a significant increase in colchicine plasma concentration is anticipated when co-administered with moderate CYP3A4 inhibitors such as erythromycin; if coadministration of colchicine and erythromycin is necessary, may need to reduce starting dose of colchicine, and maximum colchicine dose lowered; monitor patients for clinical symptoms of colchicine toxicity
            • Erythromycin may increase systemic exposure (AUC) of sildenafil; consider reduction of sildenafil dosage
            • Erythromycin may decrease clearance of triazolam, midazolam and related benzodiazepines, increasing their effect
            • Post-marketing reports indicate that co-administration with ergotamine or dihydroergotamine has been associated with acute ergot toxicity characterized by vasospasm and ischemia of central nervous system, extremities and other tissues
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            Pregnancy & Lactation

            Pregnancy Category: B

            Lactation: distributed in breast milk, use with caution; AAP categorizes as compatible with breastfeeding

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Inhibits bacterial growth, possibly by blocking dissociation of peptidyl tRNA from ribosomes, causing RNA-dependent protein synthesis to arrest

            Absorption

            Oral: variable but better with salt forms than with base form

            Peak Plasma Time: 4 hr (base)

            Distribution

            Protein Bound: 75-80%

            Crosses placenta; enters breast milk

            Relative diffusion from blood into CSF: minimal even with inflammation

            Metabolism

            Via P450 enzyme CYP3A4

            Enzymes inhibited: CYP1A2, CYP3A4

            Elimination

            Half-Life: 1.4 hr

            Excretion: Primarily feces; urine (2-15% as unchanged drug)

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            erythromycin stearate oral
            -
            250 mg tablet
            Erythrocin (as stearate) oral
            -
            250 mg tablet
            Erythrocin (as stearate) oral
            -
            250 mg tablet

            Copyright © 2010 First DataBank, Inc.

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.