Erythromycin Base 250mg Tablets

Manufacturer ARBOR Active Ingredient Erythromycin Tablets(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
Macrolide Antibiotic
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Pharmacologic Class
Protein Synthesis Inhibitor (50S Ribosomal Subunit)
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Pregnancy Category
Category B
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FDA Approved
Jan 1952
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Erythromycin is an antibiotic medication used to treat a wide variety of bacterial infections, including respiratory tract infections, skin infections, and certain sexually transmitted infections. It works by stopping the growth of bacteria.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. You can take this medication with or without food, unless your doctor specifies otherwise.

It's essential to continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well. This will help ensure that you receive the full benefits of the treatment.

Storing and Disposing of Your Medication

To maintain the quality and safety of your medication, store it at room temperature in a dry location, avoiding bathrooms. Keep all medications in a secure place, out of reach of children and pets.

When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist. Instead, consult with your pharmacist to determine the best disposal method. You may also want to inquire about drug take-back programs in your area.

What to Do If You Miss 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 scheduled dose, skip the missed dose and resume your regular dosing 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 by your doctor, even if you start to feel better. Do not skip doses or stop taking it early, as this can lead to antibiotic resistance.
  • Erythromycin base tablets are best taken on an empty stomach (at least 1 hour before or 2 hours after meals) for better absorption, but if it causes stomach upset, you may take it with food.
  • Avoid taking antacids containing aluminum or magnesium within 2 hours of taking erythromycin, as they can interfere with absorption.
  • Do not share this medication with others, even if they have similar symptoms.
  • Limit alcohol consumption as it may worsen gastrointestinal side effects.

Dosing & Administration

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Adult Dosing

Standard Dose: 250 mg to 500 mg orally every 6 to 12 hours, depending on infection severity and type.
Dose Range: 250 - 500 mg

Condition-Specific Dosing:

mild_to_moderate_infections: 250 mg orally every 6 hours or 500 mg orally every 12 hours.
severe_infections: 500 mg orally every 6 hours.
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Pediatric Dosing

Neonatal: Not established for routine use; specific dosing for certain conditions (e.g., ophthalmia neonatorum prophylaxis) may apply.
Infant: 30 to 50 mg/kg/day orally in divided doses every 6 to 12 hours.
Child: 30 to 50 mg/kg/day orally in divided doses every 6 to 12 hours (maximum 4 g/day).
Adolescent: Same as adult dosing, 250 mg to 500 mg orally every 6 to 12 hours.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: No adjustment needed.
Dialysis: No adjustment needed; not significantly removed by dialysis.

Hepatic Impairment:

Mild: No specific adjustment, use with caution.
Moderate: Use with caution; consider dose reduction or increased dosing interval if severe impairment.
Severe: Use with caution; dose reduction or increased dosing interval may be necessary due to primary hepatic elimination.

Pharmacology

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Mechanism of Action

Erythromycin binds to the 50S ribosomal subunit of susceptible bacteria, thereby inhibiting RNA-dependent protein synthesis by blocking the translocation reaction. This action is primarily bacteriostatic, but can be bactericidal at high concentrations or against highly susceptible organisms.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (30-65%), depends on formulation and presence of food. Erythromycin base is acid-labile and absorption is improved when taken on an empty stomach, though food may reduce GI upset.
Tmax: 1 to 4 hours (for base formulation).
FoodEffect: Food may decrease the absorption of erythromycin base, but may be taken with food to minimize gastrointestinal upset.

Distribution:

Vd: 0.7-0.8 L/kg
ProteinBinding: 70-90%
CnssPenetration: Limited (does not readily cross the blood-brain barrier, even with inflamed meninges).

Elimination:

HalfLife: 1.5 to 2 hours (prolonged in hepatic impairment).
Clearance: Not available
ExcretionRoute: Primarily biliary excretion into feces (90-95%); minor renal excretion (2-5% as unchanged drug).
Unchanged: 2-5% (renal)
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Pharmacodynamics

OnsetOfAction: Rapid, within hours of first dose.
PeakEffect: Within 1-4 hours of administration.
DurationOfAction: Dependent on dosing frequency (e.g., 6-12 hours).

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

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 medical help right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ 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, particularly 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. If you experience stomach pain, cramps, or severe diarrhea, contact your doctor right away.
Hearing loss, which is rare but may be more likely 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

Like all medications, this drug can cause side effects. While many people do not experience any significant side effects, others may have mild or moderate symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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 allergic reaction (hives, difficulty breathing, swelling of face/lips/tongue/throat)
  • Severe or persistent diarrhea, especially if bloody or watery (may be a sign of C. difficile infection)
  • Signs of liver problems (yellowing of skin or eyes, dark urine, pale stools, severe stomach pain, nausea/vomiting)
  • Unusual tiredness or weakness
  • Irregular heartbeats, dizziness, or fainting (may indicate a serious heart rhythm problem)
  • Hearing loss or ringing in the ears (tinnitus)
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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. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Abnormal heartbeat patterns, such as a prolonged QTc interval on an electrocardiogram (ECG)
+ Other irregular heartbeats
+ Slow heartbeat
+ Low levels of potassium or magnesium in your blood

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

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

This is crucial because some medications, such as those used to treat mood disorders, irregular heartbeats, or migraine headaches, may interact with this medication and should not be taken together.

It is not possible to list all the medications and health conditions that may interact with this drug. Therefore, it is vital to discuss all your medications and health problems with your doctor and pharmacist to ensure safe use.

Do not start, stop, or change the dose of any medication without first consulting your doctor. This will help prevent potential interactions and ensure your safety while taking this medication.
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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 medication.

If you are taking this medication long-term, your doctor may recommend regular blood tests to monitor your condition. Be sure to discuss this with your doctor.

This medication may interfere with certain laboratory tests, so it is essential to notify all of your healthcare providers and laboratory personnel that you are taking this medication.

Do not take this medication for longer than prescribed, as this may increase the risk of a second infection.

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.

If you have myasthenia gravis, discuss your treatment with your doctor. Monitor your symptoms closely, and contact your doctor if they worsen. Additionally, be aware that myasthenia gravis symptoms, such as new or worsening muscle weakness, difficulty chewing or swallowing, breathing problems, droopy eyelids, or changes in vision (including blurred vision or double vision), can occur in people without a history of the condition. Seek immediate medical attention if you experience any of these symptoms.

Special Considerations

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

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

Newborns

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

Overdose Symptoms:

  • Severe nausea, vomiting, and diarrhea
  • Abdominal pain
  • Hearing loss (reversible)
  • Acute pancreatitis (rare)
  • Cholestatic hepatitis (rare)

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is generally supportive and symptomatic. Gastric lavage may be considered if ingestion is recent.

Drug Interactions

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Contraindicated Interactions

  • Colchicine (in patients with renal or hepatic impairment)
  • Lurasidone
  • Pimozide
  • Ergot alkaloids (e.g., ergotamine, dihydroergotamine)
  • Statins (e.g., simvastatin, lovastatin) due to increased risk of rhabdomyolysis (especially with higher doses of statins)
  • Ticagrelor
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Major Interactions

  • Amiodarone (increased risk of QT prolongation, Torsades de Pointes)
  • Anticoagulants (e.g., warfarin, acenocoumarol) - increased INR/bleeding risk
  • Benzodiazepines (e.g., midazolam, triazolam) - increased sedation
  • Calcium channel blockers (e.g., verapamil, diltiazem, amlodipine) - increased levels, hypotension, bradycardia
  • Carbamazepine - increased levels, toxicity
  • Cilostazol - increased levels
  • Cisapride (increased risk of QT prolongation, Torsades de Pointes)
  • Clarithromycin (additive QT prolongation)
  • Cyclosporine - increased levels, nephrotoxicity
  • Digoxin - increased levels, toxicity
  • Disopyramide - increased levels, QT prolongation
  • Fentanyl - increased levels, respiratory depression
  • Ivabradine - increased levels, bradycardia
  • Quinidine - increased levels, QT prolongation
  • Sildenafil, Tadalafil, Vardenafil - increased levels, adverse effects
  • Theophylline - increased levels, toxicity
  • Tolterodine - increased levels, QT prolongation
  • Vincristine - increased levels, neurotoxicity
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Moderate Interactions

  • Corticosteroids (e.g., methylprednisolone) - increased levels
  • Oral contraceptives - decreased efficacy (rare, but possible)
  • Phenytoin - altered levels
  • Rifabutin - increased levels, uveitis
  • Zidovudine - decreased zidovudine levels
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Minor Interactions

  • Antacids (aluminum/magnesium hydroxide) - may decrease absorption if taken concurrently (separate by 2 hours)

Monitoring

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Baseline Monitoring

Liver Function Tests (LFTs)

Rationale: To establish baseline and identify pre-existing hepatic impairment, as erythromycin is primarily metabolized by the liver and can rarely cause cholestatic hepatitis.

Timing: Prior to initiation, especially in patients with pre-existing liver disease or those on prolonged therapy.

Electrocardiogram (ECG)

Rationale: To assess baseline QT interval, especially in patients with pre-existing cardiac conditions, electrolyte imbalances, or those taking other QT-prolonging drugs.

Timing: Prior to initiation in high-risk patients.

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Routine Monitoring

Liver Function Tests (LFTs)

Frequency: Periodically, especially with prolonged therapy (e.g., >2 weeks) or in patients with hepatic impairment.

Target: Within normal limits.

Action Threshold: Significant elevation (e.g., >3x ULN) may warrant dose reduction or discontinuation.

Renal Function (BUN, Creatinine)

Frequency: Not routinely required as erythromycin is minimally renally excreted, but may be considered in critically ill or elderly patients.

Target: Within normal limits.

Action Threshold: Not applicable for dose adjustment, but monitor for overall patient health.

INR (for patients on warfarin)

Frequency: More frequently (e.g., daily to every few days) upon initiation and during co-administration.

Target: Therapeutic range for indication.

Action Threshold: INR above target range requires dose adjustment of warfarin.

Signs/Symptoms of Ototoxicity

Frequency: Monitor throughout therapy, especially with high doses or renal impairment (though rare).

Target: Not applicable.

Action Threshold: Report tinnitus, vertigo, or hearing loss immediately.

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Symptom Monitoring

  • Gastrointestinal upset (nausea, vomiting, abdominal pain, diarrhea)
  • Allergic reactions (rash, itching, hives, swelling of face/lips/tongue)
  • Signs of liver dysfunction (yellowing of skin/eyes, dark urine, pale stools, severe abdominal pain)
  • Signs of C. difficile-associated diarrhea (severe, watery or bloody diarrhea, abdominal cramps, fever)
  • Cardiac symptoms (palpitations, dizziness, fainting, especially with QT prolongation)
  • Hearing changes (tinnitus, hearing loss, vertigo)

Special Patient Groups

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Pregnancy

Erythromycin is generally considered safe for use during pregnancy (Pregnancy Category B). Studies in animals have not shown fetal harm, and adequate and well-controlled studies in pregnant women have not demonstrated a risk to the fetus.

Trimester-Specific Risks:

First Trimester: No increased risk of major birth defects observed.
Second Trimester: Generally considered safe.
Third Trimester: Generally considered safe.
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Lactation

Erythromycin is considered compatible with breastfeeding (Lactation Risk L1). It is excreted into breast milk in small amounts, which are generally not expected to cause adverse effects in breastfed infants. Monitor infant for gastrointestinal upset (diarrhea, candidiasis).

Infant Risk: Low risk; generally considered safe.
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Pediatric Use

Commonly used in pediatric patients for various infections. Dosing is weight-based. Caution should be exercised in neonates due to potential for infantile hypertrophic pyloric stenosis (IHPS), especially with erythromycin ethylsuccinate, though risk with base is lower. Monitor for GI symptoms.

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Geriatric Use

No specific dose adjustment is typically needed based on age alone. However, elderly patients may be more susceptible to QT prolongation and hearing loss, especially if they have underlying cardiac conditions, electrolyte imbalances, or are on other ototoxic or QT-prolonging medications. Monitor for these adverse effects.

Clinical Information

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Clinical Pearls

  • Erythromycin base is acid-labile; enteric-coated or film-coated formulations (like Ery-Tab) improve absorption and reduce GI upset. If using non-coated base, advise taking on an empty stomach, but with food if GI upset is significant.
  • A common side effect is gastrointestinal upset (nausea, vomiting, abdominal cramps, diarrhea), which can be dose-limiting. Taking with food may help mitigate this.
  • Erythromycin is a potent CYP3A4 inhibitor, leading to numerous significant drug interactions. Always review concomitant medications carefully.
  • Risk of QT prolongation and Torsades de Pointes, especially in patients with pre-existing cardiac conditions, electrolyte disturbances, or concurrent use of other QT-prolonging drugs.
  • Rarely, erythromycin can cause reversible hearing loss, particularly with high doses or in patients with renal or hepatic impairment.
  • Consider alternative macrolides (e.g., azithromycin, clarithromycin) if drug interactions or GI intolerance are major concerns, though they also have CYP interactions and QT prolongation risk.
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Alternative Therapies

  • Azithromycin (another macrolide, longer half-life, less frequent dosing, fewer CYP interactions but still present)
  • Clarithromycin (another macrolide, similar spectrum, more potent CYP3A4 inhibitor than azithromycin)
  • Clindamycin (lincosamide, different mechanism, similar spectrum for some anaerobes and Gram-positives)
  • Penicillins (e.g., amoxicillin, penicillin V) for susceptible organisms, especially in penicillin-allergic patients where erythromycin is an alternative.
  • Tetracyclines (e.g., doxycycline) for certain atypical infections or STIs.
  • Fluoroquinolones (e.g., levofloxacin, moxifloxacin) for broader spectrum coverage, but with different side effect profiles.
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (250mg)
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's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about your 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.