Erythrocin Stearate

Erythromycin Stearate is a prescription medication used to treat bacterial and parasitic infections such as Amebiasis, Legionnaires Disease, Urethritis, and Syphilis. 

• Erythromycin Stearate is available under the following different brand name: Erythrocin Stearate

Adult and pediatric dosage

Tablet

• 250mg

General Dosing Recommendations

Adult dosage

• 250 mg orally every 6 hours, or
• 500 mg orally every 12 hours (if daily dose does not exceed 1 g)
• May increase up to 4 g/day depending on infection severity

Pediatric dosage

• Mild-to-moderate infections: 30-50 mg/kg/day orally divided every 6-8 hours
• Severe infection: 60-100 mg/kg/day orally divided every 6-8 hours
• Not to exceed 4 g/day

Amebiasis

Adult dosage

• 500 mg orally every 6 hours for 10-14 days
• Not to exceed 0.5 mg/4 hours

Pediatric dosage

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

Legionnaires Disease

Adult dosage

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

Urethritis

Adult dosage

• 500 mg orally every 6 hours for 7 days; alternatively, 333 mg orally every 8 hours for 7 days

Syphilis

Adult dosage

• 30-40 g orally in divided doses for 10-15 days

Pneumonia of Infancy

Pediatric dosage

• 50 mg/kg/day orally divided every 6 hours for at least 3 weeks

Dosage Considerations – Should be Given as Follows: 

• See "Dosages."

Common side effects of Erythromycin Stearate include:

• nausea, 
• vomiting, 
• diarrhea, 
• stomach pain or cramping, and
• loss of appetite

Serious side effects of Erythromycin Stearate include:

• hives, 
• difficult breathing, 
• swelling in the face, tongue, or throat, 
• persistent nausea, 
• persistent vomiting, 
• yellowing eyes or skin (jaundice), 
• dark urine, 
• severe stomach pain, 
• unusual tiredness, 
• muscle weakness, 
• slurred speech, 
• blurred vision, 
• drooping eyelids, 
• hearing loss, 
• severe dizziness, 
• fainting, 
• fast or irregular heartbeat, 
• persistent diarrhea (can occur months after treatment has stopped), 
• blood or mucus in the stool, 
• white patches in the mouth, 
• change in vaginal discharge,
• rash, and
• itching

Rare side effects of Erythromycin Stearate include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Erythromycin Stearate has severe interactions with at least 20 other drugs.
• Erythromycin Stearate has serious interactions with at least 260 other drugs. 
• Erythromycin Stearate has moderate interactions with at least 270 other drugs.
• Erythromycin Stearate has minor interactions with at least 40 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

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

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Erythromycin Stearate?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Erythromycin Stearate?”

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

Pregnancy and Lactation

• May be acceptable during pregnancy. 
• Lactation: distributed in breast milk, use with caution; AAP categorizes as compatible with breastfeeding.