Erythromycin 500mg EC Tablets

Manufacturer AMNEAL PHARMACEUTICALS Active Ingredient Erythromycin Delayed-Release Tablets and Capsules(er ith roe MYE sin) Pronunciation er-ith-roe-MYE-sin
It is used to treat or prevent bacterial infections.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antibiotic
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Pharmacologic Class
Macrolide Antibiotic; Protein Synthesis Inhibitor
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Pregnancy Category
Category B
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Erythromycin is an antibiotic that stops the growth of bacteria. It's used to treat various bacterial infections, like respiratory infections, skin infections, and some sexually transmitted infections. The 'EC' means it has a special coating to help it pass through your stomach without dissolving too quickly, which can reduce stomach upset.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food, unless your doctor advises you to take it differently. Swallow the medication whole, without chewing, breaking, or crushing it. Continue taking the medication as directed by your doctor or healthcare provider, even if you start feeling well.

Storing and Disposing of Your Medication

Store the medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of medications, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take the medication exactly as prescribed, even if you start feeling better. Do not skip doses or stop early.
  • Take with a full glass of water.
  • Enteric-coated tablets can be taken with or without food, but taking with food may help reduce stomach upset. Do not crush, chew, or break the tablets.
  • Avoid grapefruit juice as it can increase erythromycin levels.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking, especially if you are on blood thinners, heart medications, or cholesterol-lowering drugs.
  • If you experience severe diarrhea, especially with blood or mucus, contact your doctor immediately as it could be a sign of a serious infection (C. difficile).

Dosing & Administration

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Adult Dosing

Standard Dose: 500 mg every 12 hours or 333 mg every 8 hours for 7-14 days, depending on infection type and severity.
Dose Range: 250 - 1000 mg

Condition-Specific Dosing:

Streptococcal infections: 250 mg every 6 hours or 500 mg every 12 hours for 10 days.
Mycoplasma pneumoniae: 500 mg every 6 hours or 1000 mg every 12 hours for 5-10 days.
Legionnaires' disease: 500 mg every 6 hours or 1000 mg every 12 hours for 10-14 days.
Chlamydial infections: 500 mg every 6 hours or 1000 mg every 12 hours for 7 days.
Pertussis: 500 mg every 6 hours for 14 days.
Gastroparesis (prokinetic): 250 mg three times daily (off-label, lower doses often used).
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Pediatric Dosing

Neonatal: Not established for routine use; specific dosing for certain infections (e.g., ophthalmia neonatorum prophylaxis) may apply, typically 12.5 mg/kg every 6 hours.
Infant: 30-50 mg/kg/day in divided doses every 6-12 hours.
Child: 30-50 mg/kg/day in divided doses every 6-12 hours (maximum 4 g/day).
Adolescent: Same as adult dosing, typically 30-50 mg/kg/day in divided doses every 6-12 hours (maximum 4 g/day).
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: No adjustment needed for most infections; consider maximum dose of 2 g/day for severe impairment (CrCl < 10 mL/min) if prolonged therapy is needed.
Dialysis: Not significantly removed by hemodialysis or peritoneal dialysis; no supplemental dose needed after dialysis.

Hepatic Impairment:

Mild: No specific adjustment recommended, but use with caution.
Moderate: Use with caution; monitor for hepatotoxicity. Dose reduction may be necessary in severe cases.
Severe: Use with caution; monitor for hepatotoxicity. Dose reduction may be necessary.

Pharmacology

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Mechanism of Action

Erythromycin inhibits bacterial protein synthesis by reversibly binding to the 50S ribosomal subunit of susceptible microorganisms. This binding prevents the translocation of peptidyl tRNA, thereby inhibiting polypeptide synthesis and bacterial growth. It is generally considered bacteriostatic, but may be bactericidal at high concentrations or against highly susceptible organisms.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (20-60% for base, improved with enteric coating)
Tmax: 2-4 hours (for enteric-coated tablets)
FoodEffect: Food may delay absorption but does not significantly affect the extent of absorption for enteric-coated formulations. It is generally recommended to take enteric-coated tablets on an empty stomach or with food to minimize GI upset.

Distribution:

Vd: 0.7-0.8 L/kg
ProteinBinding: 70-90%
CnssPenetration: Limited (poor penetration into CSF, even with inflamed meninges)

Elimination:

HalfLife: 1.5-2 hours (prolonged in hepatic impairment)
Clearance: Not available (highly variable)
ExcretionRoute: Primarily biliary/fecal (90-95%), small amount via renal (2-5%)
Unchanged: Less than 5% (renal)
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Pharmacodynamics

OnsetOfAction: Within 1-2 hours (antibacterial effect)
PeakEffect: Not directly applicable for antibacterial effect; peak plasma concentrations reached in 2-4 hours.
DurationOfAction: 6-12 hours (based on dosing interval)
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of a severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), such as:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Urination problems, including inability to pass urine or changes in urine output
Severe dizziness or fainting
Rapid heartbeat
Abnormal heartbeat (long QT on ECG), which can be life-threatening. This risk may be increased when taking other medications with this drug. Seek medical help immediately if you experience an irregular heartbeat.
Diarrhea, especially if it is severe, bloody, or watery. Although diarrhea is common with antibiotics, a rare but potentially deadly condition called C. diff-associated diarrhea (CDAD) may occur. Contact your doctor right away if you experience stomach pain, cramps, or severe diarrhea. Do not treat diarrhea without consulting your doctor.
Hearing loss, which may be temporary or permanent. This risk is higher if you have kidney problems or take high doses of this medication. If you experience hearing problems, contact your doctor immediately.

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:

Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite

This is not an exhaustive list of possible side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe stomach pain, nausea, vomiting, or diarrhea (especially if bloody or watery)
  • Yellowing of skin or eyes (jaundice)
  • Dark urine
  • Unusual tiredness or weakness
  • Hearing loss, ringing in the ears (tinnitus), or dizziness
  • Fast, pounding, or irregular heartbeat
  • Fainting or severe dizziness
  • Rash, itching, or hives
  • Difficulty breathing or swallowing
  • Swelling of the face, throat, tongue, lips, or eyes
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Abnormal heart rhythms, such as a prolonged QTc interval on an electrocardiogram (ECG)
+ Other irregular heartbeats
+ Slow heartbeat
+ Low potassium or magnesium levels

Additionally, tell your doctor about all the medications you are taking, including:

Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins

Some medications, particularly those used to treat mood disorders, abnormal heart rhythms, or migraine headaches, should not be taken with this medication. There are many other drugs that may interact with this medication, so it is crucial to disclose all your medications to your doctor.

To ensure your safety, inform your doctor and pharmacist about all your medications and health problems. Verify that it is safe to take this medication with your existing medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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Precautions & Cautions

Important Information for Patients Taking This Medication

It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this drug. If you are taking this medication long-term, your doctor may recommend regular blood tests to monitor your condition.

Please note that this medication may interfere with certain laboratory tests. Be sure to notify all of your healthcare providers and laboratory personnel that you are taking this drug.

Duration of Use and Potential Risks

Do not take this medication for longer than prescribed by your doctor. Prolonged use may increase the risk of a second infection.

Dietary Considerations and Interactions

If you are following a low-sodium or sodium-free diet, consult with your doctor before taking this medication, as some products may contain sodium.

Special Precautions for Certain Medical Conditions

If you have myasthenia gravis, discuss your treatment with your doctor. Monitor your condition closely, and contact your doctor immediately if your symptoms worsen. Additionally, be aware that this medication may cause signs of myasthenia gravis in people who do not have the condition. Seek medical attention right away if you experience new or worsening muscle weakness, difficulty chewing or swallowing, breathing problems, droopy eyelids, or changes in vision, such as blurred vision or double vision.

Age-Related Considerations

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

Pregnancy and Breastfeeding

If you are pregnant, planning to become pregnant, or breastfeeding, consult with your doctor to discuss the potential benefits and risks of this medication to you and your baby.

Special Considerations for Newborns

In rare cases, newborns taking this medication may develop a severe stomach problem. If your child vomits or becomes irritable during feeding, contact your doctor immediately.
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Overdose Information

Overdose Symptoms:

  • Severe nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Hearing loss (reversible)
  • Acute pancreatitis
  • QT prolongation
  • Torsades de Pointes

What to Do:

Call 911 or your local poison control center immediately (e.g., 1-800-222-1222 in the US). Seek emergency medical attention. Treatment is supportive and symptomatic. Gastric lavage may be considered if ingestion is recent. Monitor ECG and vital signs.

Drug Interactions

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Contraindicated Interactions

  • Astemizole
  • Cisapride
  • Pimozide
  • Terfenadine
  • Ergotamine
  • Dihydroergotamine
  • Colchicine (in patients with renal/hepatic impairment)
  • Lomitapide
  • Simvastatin
  • Lovastatin
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Major Interactions

  • Amiodarone
  • Disopyramide
  • Dofetilide
  • Procainamide
  • Quinidine
  • Sotalol
  • Warfarin
  • Carbamazepine
  • Theophylline
  • Cyclosporine
  • Tacrolimus
  • Sirolimus
  • Digoxin
  • Alprazolam
  • Midazolam
  • Triazolam
  • Felodipine
  • Nifedipine
  • Verapamil
  • Diltiazem
  • Rifampin
  • Phenytoin
  • Valproic acid
  • Clarithromycin
  • Azithromycin (additive QT prolongation risk)
  • Fluconazole
  • Itraconazole
  • Ketoconazole
  • Voriconazole
  • Ritonavir
  • Saquinavir
  • Atazanavir
  • Nelfinavir
  • Statins (atorvastatin, rosuvastatin, fluvastatin, pravastatin - increased risk of myopathy/rhabdomyolysis)
  • Quetiapine
  • Ziprasidone
  • Clozapine
  • Fentanyl
  • Alfentanil
  • Sildenafil
  • Tadalafil
  • Vardenafil
  • Tolterodine
  • Solifenacin
  • Eletriptan
  • Zolmitriptan
  • Ranolazine
  • Ivabradine
  • Domperidone
  • Hydroxychloroquine
  • Chloroquine
  • Citalopram
  • Escitalopram
  • Ondansetron
  • Tramadol
  • Methadone
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Moderate Interactions

  • Oral contraceptives (reduced efficacy)
  • Corticosteroids (methylprednisolone)
  • Cimetidine
  • Ranitidine
  • Omeprazole
  • Lansoprazole
  • Antacids (may reduce absorption of some erythromycin formulations)
  • Zidovudine
  • Didanosine
  • Clindamycin
  • Lincomycin (antagonistic effect)
  • Sulfonylureas (increased hypoglycemia risk)
  • Metoprolol
  • Propranolol
  • Warfarin (increased INR)
  • Colchicine (increased toxicity in normal renal/hepatic function)
  • Bosentan
  • Eplerenone
  • Fesoterodine
  • Darifenacin
  • Tolvaptan
  • Conivaptan
  • Dabigatran
  • Rivaroxaban
  • Apixaban
  • Edoxaban
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Minor Interactions

  • Food (for non-EC formulations)
  • Grapefruit juice (potential minor interaction)

Monitoring

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Baseline Monitoring

Liver function tests (ALT, AST, bilirubin)

Rationale: To assess baseline hepatic function, especially in patients with pre-existing liver disease, due to risk of hepatotoxicity.

Timing: Prior to initiation, if clinically indicated.

Renal function (CrCl)

Rationale: To assess baseline renal function, though dose adjustment is generally not needed, it's important for overall patient assessment.

Timing: Prior to initiation, if clinically indicated.

ECG

Rationale: To assess baseline QT interval, especially in patients with risk factors for QT prolongation (e.g., pre-existing cardiac conditions, electrolyte imbalances, concomitant QT-prolonging drugs).

Timing: Prior to initiation, if clinically indicated.

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Routine Monitoring

Liver function tests (ALT, AST, bilirubin)

Frequency: Periodically, especially with prolonged therapy or in patients with hepatic impairment.

Target: Within normal limits

Action Threshold: Significant elevation (e.g., >3x ULN) warrants discontinuation or dose adjustment.

Signs and symptoms of hepatotoxicity

Frequency: Daily during therapy

Target: Absence of symptoms

Action Threshold: Nausea, vomiting, abdominal pain, jaundice, dark urine, fatigue warrant immediate evaluation.

Signs and symptoms of ototoxicity

Frequency: Daily during therapy, especially with high doses or renal impairment.

Target: Absence of symptoms

Action Threshold: Tinnitus, vertigo, hearing loss warrant immediate evaluation.

INR (if on warfarin)

Frequency: More frequently (e.g., daily to every few days) during co-administration and for several days after discontinuation.

Target: Therapeutic range for indication

Action Threshold: INR outside target range warrants warfarin dose adjustment.

ECG (QTc interval)

Frequency: Periodically, especially in patients with risk factors for QT prolongation or on concomitant QT-prolonging drugs.

Target: <450 ms (men), <470 ms (women)

Action Threshold: QTc >500 ms or increase >60 ms from baseline warrants discontinuation or close monitoring.

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Symptom Monitoring

  • Diarrhea
  • Nausea
  • Vomiting
  • Abdominal pain/cramping
  • Jaundice
  • Dark urine
  • Fatigue
  • Tinnitus
  • Hearing loss
  • Vertigo
  • Rash
  • Pruritus
  • Signs of superinfection (e.g., oral thrush, vaginal yeast infection, C. difficile-associated diarrhea)
  • Chest pain
  • Palpitations
  • Dizziness
  • Fainting

Special Patient Groups

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Pregnancy

Erythromycin is generally considered safe for use during pregnancy (Pregnancy Category B). It is often used as an alternative for penicillin-allergic pregnant women.

Trimester-Specific Risks:

First Trimester: No increased risk of major birth defects observed in human studies.
Second Trimester: No increased risk of adverse outcomes observed.
Third Trimester: No increased risk of adverse outcomes observed.
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Lactation

Erythromycin is excreted into breast milk in small amounts. It is generally considered compatible with breastfeeding (Lactation Risk L2 - likely compatible). Monitor breastfed infant for potential adverse effects.

Infant Risk: Low risk of adverse effects. Potential for changes in infant gut flora (e.g., diarrhea, candidiasis) or allergic reaction, though rare. Monitor for signs of GI upset.
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Pediatric Use

Dosing is weight-based. Use with caution in neonates due to potential for infantile hypertrophic pyloric stenosis (IHPS), especially when used in the first few weeks of life. Monitor for vomiting and feeding intolerance.

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Geriatric Use

No specific dose adjustment is generally needed based on age alone. However, elderly patients may be more susceptible to QT prolongation and hearing loss, especially with higher doses or pre-existing renal/hepatic impairment. Monitor closely for adverse effects and drug interactions.

Clinical Information

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Clinical Pearls

  • Erythromycin is a potent CYP3A4 inhibitor, leading to numerous significant drug interactions. Always review concomitant medications.
  • Enteric-coated (EC) formulations are designed to reduce gastrointestinal upset and improve absorption by protecting the drug from stomach acid. Do not crush or chew EC tablets.
  • While generally safe, erythromycin can cause QT prolongation and Torsades de Pointes, especially in patients with pre-existing cardiac conditions, electrolyte imbalances, or on other QT-prolonging drugs.
  • Hepatotoxicity (cholestatic hepatitis) and ototoxicity (reversible hearing loss, tinnitus) are rare but serious side effects, more common with high doses or in patients with renal/hepatic impairment.
  • Erythromycin has prokinetic properties and is sometimes used off-label for gastroparesis, typically at lower doses than for antibacterial effects.
  • Resistance to macrolides is increasing, limiting their empirical use in some regions for certain infections.
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Alternative Therapies

  • Azithromycin (another macrolide, longer half-life, less frequent dosing, fewer CYP interactions)
  • Clarithromycin (another macrolide, fewer doses per day than erythromycin, significant CYP interactions)
  • Penicillins (e.g., Amoxicillin, Penicillin V - for susceptible streptococcal infections)
  • Tetracyclines (e.g., Doxycycline - for atypical pneumonia, chlamydial infections)
  • Fluoroquinolones (e.g., Levofloxacin, Moxifloxacin - for respiratory tract infections, but with broader spectrum and different side effect profile)
  • Clindamycin (for anaerobic infections, skin/soft tissue infections, but different spectrum and C. difficile risk)
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Cost & Coverage

Average Cost: Varies widely, typically $20-$100+ per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.