Erythromycin

Pronunciation: e-RITH-roe-MYE-sin
Class: Macrolide antibiotic

Trade Names

Akne-mycin
- Ointment, topical 2%

E.E.S. 400
- Tablets 400 mg as ethylsuccinate
- Suspension, oral 400 mg per 5 mL as ethylsuccinate

E.E.S. Granules
- Granules for oral suspension 200 mg per 5 mL when reconstituted as ethylsuccinate

Emgel
- Gel 2%

Eryc
- Capsules, delayed-release 250 mg

Ery-Tab
- Tablets, enteric-coated 250 mg
- Tablets, enteric-coated 333 mg
- Tablets, enteric-coated 500 mg

Erycette
- Pads 2%

Eryderm
- Solution 2%

Erygel
- Gel 2%

Ery Pads
- Pledgets, topical 2%

Ery-Ped 200
- Powder for oral suspension 200 mg per 5 mL as ethylsuccinate

Ery-Ped 400
- Powder for oral suspension 400 mg per 5 mL as ethylsuccinate

Ery-Ped Drops
- Suspension 100 mg per 2.5 mL as ethylsuccinate

Erythromycin Base
- Capsules, delayed-release 250 mg

Erythromycin Ethylsuccinate Suspension
- Suspension, oral 200 mg per 5 mL
- Suspension, oral 400 mg per 5 mL

Erythromycin Ointment
- Ointment, ophthalmic 5 mg/g

Erythrocin Lactobionate
- Injection, lyophilized powder for solution 500 mg
- Injection, lyophilized powder for solution 1 g

Erythrocin Stearate
- Tablets, film-coated 250 mg
- Tablets, film-coated 500 mg as stearate

PCE Dispertab
- Tablets with polymer-coated particles 333 mg
- Tablets with polymer-coated particles 500 mg

Romycin
- Ointment, ophthalmic 5 mg/g

Apo-Erythro Base (Canada)
Apo-Erythro E-C (Canada)
Apo-Erythro-ES (Canada)
Apo-Erythro-S (Canada)
Novo-Rrythro Estolate (Canada)
Novo-Rrythro Ethylsuccinate (Canada)

Pharmacology

Interferes with microbial protein synthesis.

Pharmacokinetics

Absorption

Orally administered erythromycin base and its salts are readily absorbed. Because of interindividual variation in absorption, some patients do not achieve optimal serum concentrations.

Distribution

Erythromycin diffuses into most body fluids. In the absence of meningeal inflammation, low concentrations are achieved in the spinal fluid; however, passage across the blood-brain barrier increases in meningitis. Although erythromycin crosses the placenta, fetal plasma levels are low. Erythromycin is extensively bound to plasma protein.

Elimination

Erythromycin is not removed by peritoneal dialysis. Erythromycin is concentrated in the liver and excreted in the bile. Less than 5% of the oral dose (12% to 15% IV) is recovered in the active form in the urine.

Indications and Usage

Oral/IV

Treatment of infections of respiratory tract, skin and skin structure, and STDs caused by susceptible organisms; treatment of pertussis, diphtheria, erythrasma, intestinal amebiasis, conjunctivitis of newborn, Legionnaire disease, listeriosis, nongonococcal urethritis, pneumonia of infancy, urogenital infections during pregnancy; treatment of acute pelvic inflammatory disease, syphilis, and uncomplicated urethral, endocervical, or rectal infections in adults; prevention of attacks of rheumatic fever; prevention of bacterial endocarditis (IV).

Ophthalmic

Treatment of superficial ocular infections caused by strains of susceptible organism; prophylaxis of neonatal conjunctivitis.

Topical

Treatment of acne vulgaris.

Unlabeled Uses

Erythromycin stearate oral

Treponema pallidum , Campylobacter jejuni , Lymphogranuloma venereum , Haemophilus ducreyi (chancroid), administration prior to elective colorectal surgery to reduce wound complications, anthrax, Vincents gingivitis, erysipeloid, tetanus, actinomycosis, Nocardia infection, Eikenella corrodens infections, Borrelia infections (including early Lyme disease).

Erythromycin estolate oral

Acne vulgaris, bacillary angiomatosis in immunocompromised patients, campylobacter enteritis, erysipelas cellulitis, chancroid, granuloma inguinale, impetigo, ecthyma, inclusion conjunctivitis in adults, extremity infected wounds, leptospirosis, early Lyme disease, lymphogranuloma venereum, relapsing fever, tetanus.

Contraindications

Hypersensitivity to erythromycin or any macrolide antibiotic; coadministration of cisapride or pimozide; preexisting liver disease (with estolate salt); epithelial herpes simplex keratitis; fungal disease of eye; vaccinia or varicella (ophthalmic).

Dosage and Administration

Duration of treatment will vary depending on site of systemic infection (eg, treat pneumonia of infancy for at least 3 wk). For adult dosage calculation of erythromycin ethylsuccinate, use a ratio of 400 mg of erythromycin activity as the ethylsuccinate salt to 250 mg of erythromycin activity as the base, stearate, or estolate. Depending on the severity of the infection, the dosage may be increased up to 4 g/day; however, twice-daily dosing is not recommended for doses larger than 1 g daily. For treatment of severe infections in adults and children, the recommended IV dose of erythromycin lactobionate is 15 to 20 mg/kg/day (max, 4 g/day).

Acne Vulgaris
Adults and Children

Topical Apply twice daily, morning and evening.

Topical Gel Apply sparingly as a thin film to affected areas once or twice daily.

Topical Pads Rub over affected area twice daily, morning and evening.

Acute Ocular Infection
Adults and Children

Ophthalmic 1-cm ribbon of ointment placed in eye up to 6 times daily, depending on severity of infection.

Acute Pelvic Inflammatory Disease

IV 500 mg every 6 h for 3 days, followed PO by 250 mg every 6 h, 333 mg every 8 h, or 500 mg every 12 h for 7 days.

Conjunctivitis of the Newborn

PO 50 mg/kg/day in 4 divided doses for at least 14 days.

Intestinal Amebiasis
Adults

PO 500 mg every 12 h, 400 mg every 6 h, 333 mg every 8 h, or 250 mg every 6 h for 10 to 14 days.

Children

PO 30 to 50 mg/kg/day in equally divided doses for 10 to 14 days (max, 4 g/day).

Legionnaire Disease

PO Optimal dose not established; 1 to 4 g in divided doses.

Nongonococcal Urethritis

PO 500 mg 4 times daily or 666 mg (two 333 mg tablets) every 8 h for at least 7 days.

Pertussis

PO 40 to 50 mg/kg/day in divided doses for 5 to 14 days.

Pneumonia of Infancy

PO 50 mg/kg/day in 4 divided doses for at least 21 days.

Prevention of Bacterial Endocarditis
Adults

PO 1 g 1 h before procedure followed by 500 mg 6 h later.

Children

PO 20 mg/kg 1 h before procedure followed by 10 mg/kg 6 h later.

Prevention of Initial Attack of Rheumatic Fever

PO , IV 400 mg every 6 h for 10 days.

Prevention of Recurrent Attacks of Rheumatic Fever

PO , IV 250 mg twice daily given continuously.

Primary Syphilis

PO 30 to 40 g (erythromycin ethylsuccinate 48 to 64 g) in divided doses over a period of 10 to 15 days.

Prophylaxis of Neonatal Gonococcal or Chlamydia Conjunctivitis
Newborns

Ophthalmic 1-cm ribbon of ointment placed in each conjunctival sac at time of delivery.

Skin Infections
Adults and children

Topical Apply 1 to 4 times daily to affected area.

Systemic Use
Adults

PO 250 to 500 mg every 6 h, 500 mg every 12 h, or 333 mg every 8 h. IV 15 to 20 mg/kg/day; up to 4 g/day in very severe infections.

Children

PO 30 to 50 mg/kg/day in divided doses (max, 4 g/day).

Uncomplicated Urethral, Endocervical, or Rectal Infections
Adults

PO 500 mg 4 times daily or two 333 mg tablets every 8 h for at least 7 days.

Children (less than 45 kg)

PO 50 mg/kg/day in 4 divided doses for 14 days.

Upper Respiratory Tract Infections
Adults

PO 250 mg every 6 h, 333 mg every 8 h, or 500 mg every 12 h for at least 10 days.

Children

PO 30 to 50 mg/kg/day in equally divided doses for at least 10 days (max, 4 g/day).

Urethritis Caused by Chlamydia trachomatis or Ureaplasma urealyticum

800 mg every 8 h for 7 days.

Urogenital Infections During Pregnancy
Adults

PO 500 mg 4 times daily or two 333 mg tablets every 8 h for at least 7 days. For women who cannot tolerate this regimen, 500 mg every 12 h, 333 mg every 8 h, or 250 mg 4 times daily for at least 14 days.

General Advice

• Injection
• For administration by continuous or intermittent IV infusion only. Not for intradermal, subcutaneous, IM, IV bolus, or intra-arterial administration.
• For intermittent infusion, infuse prescribed dose over a period of 20 to 60 min at intervals of 6 h or less.
• Inspect solution visually before administration. Do not administer if solution is cloudy or discolored, or contains particulate matter.

• Ophthalmic ointment
• For topical instillation in the eye only. Not for use in the ear or on the skin.
• Wash hands before and after instilling ointment. Have patient tilt head backward or lie down and gaze upward. Gently pull down lower lid to form a pouch. Place prescribed amount of ointment with a sweeping motion inside the lower eyelid. Have patient close eye(s) for 1 to 2 min and roll the eyeball in all directions. Remove excessive ointment from around eye with tissue.
• If using more than 1 ophthalmic ointment, wait at least 10 min before instilling second drug.

• Oral
• Administer erythromycin base or stearate on an empty stomach.
• Administer erythromycin ethylsuccinate, estolate, or enteric-coated erythromycin without regard to meals. Administer with food if GI upset occurs.
• Advise patient receiving tablets or capsules of erythromycin base to swallow whole and not to crush, chew, open, or break.
• Administer tablets and capsules with a full glass of water.
• Shake suspension and oral drops well before measuring dose. Measure and administer prescribed dose of suspension or oral drops using dosing syringe, dosing spoon, or medicine cup.

• Topical
• For topical use only. Keep away from mouth, nose, eyes, and other mucus membranes.
• Apply sparingly to affected areas morning and evening using gloved finger or applicator. Wash hands before and after applying medication.
• Before applying, thoroughly wash affected areas with warm water and soap, rinse, and pat dry.

Storage/Stability

Oral

Store erythromycin estolate oral suspension in refrigerator (36° to 46°F) to maintain optimal taste. Store reconstituted erythromycin ethylsuccinate oral suspension in refrigerator to preserve taste and use within 10 days. Store reconstituted erythromycin ethylsuccinate oral drops at or below 77°F and use within 35 days. Store premixed erythromycin ethylsuccinate oral suspension in refrigerator to preserve taste until dispensed. Refrigeration is not required if used within 14 days of initial use.

Injection

Store powder for injection at controlled room temperature (59° to 86°F). Reconstituted solution is stable for 2 wk if refrigerated (36° to 46°F) or for 24 h at room temperature. Final diluted solution must be completely administered within 8 h of dilution in order to ensure proper potency.

Topical

Store Erygel and Emgel between 59° and 77°F. Store Akne-Mycin ointment below 80°F. Store Eryderm solution below 86°F. Store Ery 2% Pad at 68° to 77°F.

Erythromycin base, ethylsuccinate, stearate, and powder for oral suspension

Store below 86°F.

Ery-Ped

Prior to mixing, store below 86°F. After reconstitution, store below 77°F and use within 35 days. Refrigeration is not required.

Injection Erythrocin lactobionate IV

Store lyophilized powder at 68° to 77°F. Administer final diluted solution within 2 hours to ensure proper potency (in dextrose 5% injection). Administer final diluted solution within 8 h to ensure proper potency (in sodium chloride 0.9% injection).

Ophthalmic ointment

Store at 59° to 86°F. Avoid excessive heat. Protect from freezing.

Drug Interactions

Anticoagulants (eg, warfarin)

May increase anticoagulant effects.

Bromocriptine

May increase serum bromocriptine levels.

Cisapride, pimozide, ranolazine

Plasma levels may be elevated, increasing the risk of life-threatening cardiac arrhythmia and torsades de pointes; coadministration with erythromycin is contraindicated.

Class 1A antiarrhythmic agents (eg, procainamide, quinidine) and class III antiarrhythmic agents (eg, dofetilide, sotalol)

Risk of life-threatening cardiac arrhythmias, including torsades de pointes, may be increased.

Clopidogrel

Antiplatelet effect of clopidogrel may be inhibited.

Colchicine

Plasma levels may be elevated by erythromycin, increasing the risk of toxicity.

Drugs inhibited by CYP3A metabolism (eg, alfentanil, buspirone, cabergoline, carbamazepine, cilostazol, clozapine, cyclosporine, diltiazem, disopyramide, eletriptan, felodipine, HMG-CoA reductase inhibitors [eg, lovastatin, simvastatin], lidocaine IV, phosphodiesterase type 5 inhibitors [eg, sildenafil, tadalafil, vardenafil], quetiapine, quinidine, repaglinide, tacrolimus, theophyllines, triazolobenzodiazepines [eg, alprazolam, midazolam, triazolam], valproate, verapamil, vinblastine)

Plasma levels may be elevated by erythromycin, increasing the pharmacologic effects and risk of toxicity (eg, rhabdomyolysis with lovastatin or simvastatin).

Clindamycin, topical

Antagonism may occur with topical erythromycin; coadministration is not recommended.

Digoxin

May cause increased digoxin levels.

Ergot derivative

Ergot toxicity may occur.

Food Erythromycin base

Administer capsules containing enteric-coated pellets and film-coated tablets at least 2 h before or after a meal to achieve optimal blood levels. Erythromycin was 28% bioavailable following administration of the polymer-coated particle formulation with a high-fat meal.

Erythromycin stearate

Plasma concentrations may be reduced when administered with food. Optimum levels are achieved when administered at least 1 h before or 2 h after meals. High blood levels were achieved when administered immediately before a meal.

Erythromycin estolate and ethylsuccinate

Food may enhance the absorption; however, may be given without regard to meals.

Grapefruit juice

May inhibit erythromycin metabolism, increasing plasma levels and adverse reactions.

Methylprednisolone

May decrease Cl of methylprednisolone.

Quinolone antibiotics (eg, gatifloxacin, levofloxacin, moxifloxacin, sparfloxacin)

Risk of life-threatening cardiac arrhythmias, including torsades de pointes, may be increased.

Rifamycins (eg, rifabutin)

Rifabutin plasma levels may be increased while erythromycin levels and antibiotic activity may be decreased.

Laboratory Test Interactions

Erythromycin interferes with fluorometric urinary catecholamine determinations.

Adverse Reactions

Cardiovascular

QT prolongation and ventricular arrhythmia (including torsades de pointes).

CNS

Convulsions.

Dermatologic

Dryness, erythema, itching, oiliness, peeling, tenderness, urticaria (topical use); erythema and peeling; erythema multiforme; mild eruptions; Stevens-Johnson syndrome; toxic epidermal necrolysis (topical use).

EENT

Eye irritation (topical use); hypersensitivity, minor ocular irritation, redness (ophthalmic use). Reversible hearing loss primarily in patients with renal function impairment.

GI

Abdominal pain; anorexia; diarrhea; nausea; pancreatitis; pseudomembranous colitis; vomiting.

Hepatic

Hepatitis; hepatic function impairment.

Lab Tests

Abnormal LFTs.

Miscellaneous

Allergic reactions ranging from urticaria to anaphylaxis.

Precautions

Warnings Hepatic function impairment with or without jaundice has occurred primarily in adults in association with erythromycin estolate administration. Symptoms include abdominal colic, fever, malaise, nausea, and vomiting. Severe abdominal pain may stimulate an abdominal surgical emergency.

Monitor Before treating gonorrhea, patients suspected of also having syphilis should have a microscopic examination for T. pallidum (ie, immunofluorescence, darkfield) before receiving erythromycin and monthly serologic tests for at least 4 mo thereafter. Response to therapy Monitor patient's response to therapy. Sensitivity tests Review results of culture and sensitivity testing as appropriate. Ensure erythromycin is discontinued and another antimicrobial agent is started if sensitivity tests indicate the organism is resistant to erythromycin. Topical Assess patient's response to therapy. Be prepared to reduce frequency of application if dryness and peeling occurs. Be prepared to discontinue therapy if more severe reactions (eg, burning, allergic reaction, severe peeling, desquamation) occur.

Pregnancy

Category B .

Lactation

Excreted in breast milk.

Children

Topical

Safety and efficacy not established.

Hypersensitivity

Serious reactions, including anaphylaxis, have occurred.

Hepatic Function

Use drug cautiously. Hepatic function impairment, with or without jaundice, has occurred. Cholestatic hepatitis has occurred. Monitor patient for signs and symptoms of liver dysfunction (eg, dark urine, fatigue, flu-like symptoms, persistent nausea, right-upper quadrant abdominal pain, yellowing of skin or eyes). Discontinue therapy immediately if noted or suspected.

Superinfection

Prolonged use of antibiotics may result in bacterial or fungal overgrowth of nonsusceptible microorganisms.

Acne therapy

Cumulative irritant effect may occur.

Infantile hypertrophic pyloric stenosis

Has been reported.

Myasthenia gravis

Aggravation of myasthenia gravis has been reported.

Ophthalmic ointments

May slow corneal epithelial healing.

Ototoxicity

May occur, especially in patients with renal or hepatic function impairment, elderly patients, and patients administered large doses.

Pseudomembranous colitis

Consider possibility in patients in whom diarrhea develops. Immediately report severe diarrhea, diarrhea containing blood or pus, or severe abdominal cramping.

Rhabdomyolysis

Ensure patient receiving concomitant lovastatin and erythromycin is carefully monitored for development of rhabdomyolysis.

Overdosage

Symptoms

In case of overdosage, discontinue erythromycin.

Patient Information

• Review dosing schedule and prescribed length of therapy with patient. Advise patient that dose, dosing frequency, and duration of therapy are dependent on site and cause of infection and response to treatment.
• Advise patient or caregiver that injection is used when infection is severe and needs immediate treatment with large doses of antibiotic, or if oral therapy is not feasible. Advise patient or caregiver that injection will be prepared by health care provider, in a health care setting, and that oral therapy will be started as soon as possible.
• Instruct patient using tablets and capsules to take prescribed dose with a full glass of water and to swallow whole and not to crush, chew, break, or open.
• Instruct patient or caregiver using oral suspension to shake suspension well and then measure and administer prescribed dose using dosing spoon, dosing syringe, or medicine cup.
• Instruct patient or caregiver using oral drops to shake drops well and then measure and administer prescribed dose using dosing spoon or dosing syringe.
• Advise patient using erythromycin base or stearate to take each dose on an empty stomach.
• Advise patient using erythromycin ethylsuccinate, estolate, or enteric-coated erythromycin to take each dose without regard to meals but to take with food if stomach upset occurs.
• Reinforce the need to take exactly as prescribed and complete the entire course of therapy, even if symptoms of infection have disappeared. Caution patient or caregiver that skipping doses or not completing the full course of therapy may allow the infection to worsen and increase the possibility that the bacteria will become resistant to the antibiotic and may cause infections that will not be treatable in the future.
• Advise patient to discontinue therapy and contact health care provider immediately if any of the following occurs: dark urine, fatigue, hives, itching, persistent nausea, persistent or worsening flu-like symptoms, shortness of breath, skin rash, right upper belly pain, yellowing of skin or eyes.
• Advise patient to report signs of superinfection to health care provider: black, furry tongue; foul-smelling stools; vaginal itching or discharge; white patches in mouth.
• Warn patient that diarrhea containing blood or pus may be a sign of a serious disorder and to seek medical care if noted and not treat at home, even if diarrhea occurs after stopping the antibiotic.
• Advise patient to notify health care provider if infection does not improve or appears to worsen.
• Advise patient to inform health care provider if infection appears to not be improving, appears to be worsening, or if eye or eyelid inflammation are noted.

• Ophthalmic Ointment
• Remind patient that ointment is only for instillation in the eye and is not to be used in the ear or on the skin.
• Instruct patient in proper use of ointment: wash hands before and after instilling ointment; tilt head backward or lie down and gaze upward; gently pull down lower lid to form a pouch and place prescribed amount of ointment with a sweeping motion inside the lower eyelid; close eye(s) for 1 to 2 min and roll the eyeball in all directions; remove excessive ointment around eye with tissue.
• Caution patient to avoid contaminating ointment by not touching the tip of tube to any surface and to replace cap after using.
• Advise patient that ointment may cause temporary blurring of vision and to avoid activities requiring visual acuity until blurring clears.
• Advise patient using more than 1 ophthalmic ointment product to wait at least 10 min before instilling second drug.
• Advise patient to notify health care provider if eye infection does not improve, if it worsens, or if eye or eyelid irritation occurs.

• Topical
• Caution patient that medication is for topical use only and to keep medication away from the mouth, nose, eyes, and other mucus membranes.
• Advise patient to apply sparingly to affected areas morning and evening using fingers or applicator. Remind patient to wash hands before and after applying medication.
• Instruct patient to thoroughly wash affected areas with warm water and soap, then rinse and pat dry before applying medication.
• Caution patient not to use any other topical acne medication unless ordered by health care provider.
• Advise patient to notify health care provider if acne does not improve, if it worsens, or if application-site reactions occur.

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