Erythrom Eth 200mg/5ml Susp 100ml

Manufacturer ANI PHARMACEUTICALS Active Ingredient Erythromycin Suspension(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.
đŸˇī¸
Drug Class
Antibiotic
đŸ§Ŧ
Pharmacologic Class
Macrolide antibiotic; Protein synthesis inhibitor (50S ribosomal subunit)
🤰
Pregnancy Category
Category B
✅
FDA Approved
Mar 1952
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Erythromycin is an antibiotic used to treat various bacterial infections, such as respiratory tract infections, skin infections, and certain sexually transmitted infections. It works by stopping the growth of bacteria.
📋

How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions 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 advises you to take it in a specific way. Before using, shake the liquid well to ensure the ingredients are mixed properly.

When measuring a liquid dose, use the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device to accurately measure your dose.

Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling better. It's essential to complete the full course of treatment as prescribed.

Storing and Disposing of Your Medication

Different brands of this medication may have specific storage requirements. Some may need to be refrigerated, while others should be stored at room temperature. If you're unsure about the storage instructions, consult your pharmacist.

It's also important to know how long you can store your medication before it expires or needs to be discarded. Keep all medications in a safe and secure location, out of the reach of children and pets.

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.
💡

Lifestyle & Tips

  • Take this medication exactly as prescribed by your doctor. Do not skip doses or stop taking it early, even if you feel better, to prevent the infection from returning and to reduce the risk of antibiotic resistance.
  • Erythromycin ethylsuccinate suspension is generally better absorbed when taken with food. Shake the suspension well before each use.
  • Do not take antacids containing aluminum or magnesium within 2 hours of taking erythromycin, as they may interfere with absorption.
  • Avoid grapefruit juice while taking this medication, as it can increase the levels of erythromycin in your body.
  • Store the suspension in the refrigerator after reconstitution, and discard any unused portion after the recommended period (usually 10-14 days, check specific product label).

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: 400 mg (as ethylsuccinate) every 6 hours or 800 mg every 12 hours
Dose Range: 400 - 4000 mg

Condition-Specific Dosing:

mildToModerateInfections: 400 mg every 6 hours or 800 mg every 12 hours
severeInfections: Up to 4 g/day in divided doses
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established (use caution, consult specific guidelines for neonates)
Infant: 30-50 mg/kg/day (as ethylsuccinate) in divided doses every 6-12 hours
Child: 30-50 mg/kg/day (as ethylsuccinate) in divided doses every 6-12 hours, up to a maximum of 4 g/day
Adolescent: 30-50 mg/kg/day (as ethylsuccinate) in divided doses every 6-12 hours, up to a maximum of 4 g/day (or adult dose if weight appropriate)
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed for most patients; however, for patients with severe renal impairment (CrCl < 10 mL/min) and hepatic impairment, consider dose reduction or increased dosing interval.
Dialysis: Not significantly removed by hemodialysis or peritoneal dialysis; supplemental dose not required.

Hepatic Impairment:

Mild: Use with caution
Moderate: Use with caution; consider dose reduction or increased dosing interval
Severe: Use with caution; consider dose reduction or increased dosing interval. Monitor liver function closely.

Pharmacology

đŸ”Ŧ

Mechanism of Action

Erythromycin binds to the 50S ribosomal subunit of susceptible bacteria, thereby inhibiting bacterial protein synthesis. It is primarily bacteriostatic but can be bactericidal at high concentrations or against highly susceptible organisms.
📊

Pharmacokinetics

Absorption:

Bioavailability: Variable (20-60% for ethylsuccinate)
Tmax: 2-4 hours
FoodEffect: Erythromycin ethylsuccinate absorption is enhanced by food, unlike other erythromycin salts which may be decreased or unaffected.

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: 1.5-3 hours (prolonged in hepatic impairment)
Clearance: Not available
ExcretionRoute: Primarily biliary/fecal (90-95%), minor renal excretion (2-5%)
Unchanged: Less than 5% (renal)
âąī¸

Pharmacodynamics

OnsetOfAction: Rapid
PeakEffect: Within 2-4 hours (plasma concentration)
DurationOfAction: Dependent on dosing interval (typically 6-12 hours)

Safety & Warnings

âš ī¸

Side Effects

Urgent Side Effects: Seek Medical Help 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 attention right away:

Signs of an allergic reaction: rash, 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, or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin or eyes.
Signs of a severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis): red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in the mouth, throat, nose, or eyes.
Urination problems: 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, as this can be a sign of a potentially life-threatening condition called C. diff-associated diarrhea (CDAD). CDAD can occur during or after antibiotic treatment.
Hearing loss, which is rare but may be more likely if you have kidney problems or take high doses of this medication.

Common Side Effects

Most people experience no side effects or only mild ones. However, if you notice any of the following side effects, contact your doctor if they bother you or do not go away:

Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite

Reporting Side Effects

This is not an exhaustive list of potential 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.
🚨

Seek Immediate Medical Attention If You Experience:

  • Severe watery diarrhea or bloody stools (even weeks after stopping the medication)
  • Yellowing of the skin or eyes (jaundice), dark urine, pale stools, or severe stomach pain (signs of liver problems)
  • Severe allergic reaction (e.g., rash, hives, itching, swelling of the face/lips/tongue/throat, difficulty breathing or swallowing)
  • New or worsening hearing loss or ringing in the ears (tinnitus)
  • Unusual tiredness or weakness, muscle pain (especially if taking statins)
  • Fast, pounding, or irregular heartbeat, dizziness, or fainting
📋

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

Additionally, disclose all 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, abnormal heart rhythms, or migraine headaches, may interact with this drug and should not be taken concurrently. There are numerous medications that are contraindicated with this drug, and this list is not exhaustive.

To ensure your safety, consult with your doctor and pharmacist about all your medications and health conditions. Verify that it is safe to take this medication with your existing regimen before starting, stopping, or modifying any drug or dosage. Never adjust your medication without first consulting your doctor.
âš ī¸

Precautions & Cautions

Important Information for Patients Taking This Medication

It is crucial that you inform all 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 your healthcare providers and laboratory personnel that you are taking this drug.

Usage and Duration

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

Dietary Considerations

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

Special Precautions

If you have myasthenia gravis, discuss your condition with your doctor. Monitor your symptoms closely, and contact your doctor immediately if they worsen. Additionally, be aware that myasthenia gravis symptoms can occur in people without a prior diagnosis. 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 to you and your baby.

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.
🆘

Overdose Information

Overdose Symptoms:

  • Severe nausea
  • Vomiting
  • Diarrhea
  • Hearing loss (reversible)
  • Cholestatic hepatitis (rare)

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is generally supportive, including gastric lavage and general supportive measures.

Drug Interactions

đŸšĢ

Contraindicated Interactions

  • Colchicine (in patients with renal or hepatic impairment)
  • Lurasidone
  • Pimozide
  • Ergotamine, Dihydroergotamine
  • Lovastatin, Simvastatin (due to increased risk of myopathy/rhabdomyolysis)
  • Ticagrelor
🔴

Major Interactions

  • Amiodarone (increased risk of QT prolongation/TdP)
  • Astemizole (increased risk of QT prolongation/TdP)
  • Cisapride (increased risk of QT prolongation/TdP)
  • Disopyramide (increased risk of QT prolongation/TdP)
  • Dofetilide (increased risk of QT prolongation/TdP)
  • Flibanserin (increased flibanserin exposure)
  • Ivabradine (increased ivabradine exposure)
  • Midazolam (oral) (increased midazolam exposure)
  • Nelfinavir (increased nelfinavir exposure)
  • Quinidine (increased risk of QT prolongation/TdP)
  • Ranolazine (increased ranolazine exposure)
  • Sildenafil, Tadalafil, Vardenafil (increased PDE5 inhibitor exposure)
  • Theophylline (increased theophylline levels, toxicity)
  • Warfarin (increased INR, bleeding risk)
  • Carbamazepine (increased carbamazepine levels, toxicity)
  • Cyclosporine (increased cyclosporine levels, nephrotoxicity)
  • Digoxin (increased digoxin levels, toxicity)
  • Phenytoin (increased phenytoin levels, toxicity)
  • Verapamil, Diltiazem (increased erythromycin levels, increased risk of QT prolongation)
🟡

Moderate Interactions

  • Oral contraceptives (potential decreased efficacy)
  • Corticosteroids (increased corticosteroid exposure)
  • Tacrolimus (increased tacrolimus levels)
  • Zolpidem (increased zolpidem exposure)
  • Clopidogrel (decreased clopidogrel active metabolite, reduced antiplatelet effect)
  • Statins (other than lovastatin/simvastatin, increased risk of myopathy)
đŸŸĸ

Minor Interactions

  • Antacids (may reduce absorption if taken concurrently, separate by 2 hours)
  • Food (for ethylsuccinate, absorption is enhanced)

Monitoring

đŸ”Ŧ

Baseline Monitoring

Liver function tests (ALT, AST, bilirubin)

Rationale: To assess baseline hepatic function, especially in patients with pre-existing liver disease, as erythromycin is hepatically metabolized and can cause hepatotoxicity.

Timing: Prior to initiation, if clinically indicated (e.g., history of liver disease).

Electrocardiogram (ECG)

Rationale: To assess baseline QT interval, especially in patients with known QT prolongation, uncorrected hypokalemia/hypomagnesemia, or concurrent use of other QT-prolonging drugs.

Timing: Prior to initiation, if risk factors for QT prolongation are present.

📊

Routine Monitoring

Liver function tests (ALT, AST, bilirubin)

Frequency: Periodically, if therapy is prolonged (e.g., >2 weeks) or if symptoms of hepatotoxicity develop.

Target: Within normal limits

Action Threshold: Discontinue if significant elevation or signs of cholestatic hepatitis occur.

INR (International Normalized Ratio)

Frequency: More frequently (e.g., daily or every few days) during co-administration with warfarin, then as needed.

Target: Therapeutic range for indication

Action Threshold: Adjust warfarin dose if INR is outside target range.

Serum drug levels (e.g., theophylline, carbamazepine, cyclosporine, digoxin)

Frequency: As clinically indicated, especially during initiation or dose changes of erythromycin.

Target: Therapeutic range for co-administered drug

Action Threshold: Adjust dose of co-administered drug if levels are outside target range.

Hearing assessment

Frequency: If high doses are used or in patients with renal/hepatic impairment, or if symptoms of hearing loss develop.

Target: Normal hearing

Action Threshold: Discontinue if ototoxicity occurs.

đŸ‘ī¸

Symptom Monitoring

  • Severe or persistent diarrhea (may indicate Clostridioides difficile-associated diarrhea)
  • Signs of liver injury (e.g., jaundice, dark urine, pale stools, severe abdominal pain, nausea, vomiting)
  • Signs of allergic reaction (e.g., rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
  • Hearing changes (e.g., tinnitus, hearing loss)
  • Muscle pain or weakness (especially if on statins)
  • Palpitations, dizziness, fainting (may indicate QT prolongation)

Special Patient Groups

🤰

Pregnancy

Erythromycin is generally considered safe for use during pregnancy (Category B). Studies in pregnant women have not shown an increased risk of fetal abnormalities. However, some studies have suggested a possible association with cardiovascular malformations or pyloric stenosis in infants exposed in utero, but these findings are not consistently replicated and overall risk is considered low.

Trimester-Specific Risks:

First Trimester: Low risk; some conflicting data regarding cardiovascular malformations or pyloric stenosis, but generally considered safe.
Second Trimester: Low risk.
Third Trimester: Low risk.
🤱

Lactation

Erythromycin is excreted into breast milk in small amounts. It is generally considered compatible with breastfeeding. Monitor the infant for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions.

Infant Risk: L2 (Safer; limited data suggest no adverse effect or adverse effects are minor and non-life-threatening).
đŸ‘ļ

Pediatric Use

Erythromycin is commonly used in pediatric patients. Dosing is weight-based. Caution is advised in neonates due to potential for infantile hypertrophic pyloric stenosis (IHPS), especially with exposure in the first few weeks of life. Monitor for vomiting and feeding intolerance.

👴

Geriatric Use

Elderly patients may be at increased risk for hearing loss, especially with high doses or pre-existing renal/hepatic impairment. They may also be more susceptible to QT prolongation and associated arrhythmias. Use with caution and monitor closely for adverse effects and drug interactions.

Clinical Information

💎

Clinical Pearls

  • Erythromycin ethylsuccinate is the preferred oral form for pediatric use due to better taste and absorption with food.
  • Always complete the full course of antibiotics, even if symptoms improve, to prevent resistance and recurrence.
  • Be vigilant for drug interactions, especially with CYP3A4 substrates/inhibitors and QT-prolonging agents.
  • Advise patients to report any signs of severe diarrhea, as it could indicate C. difficile infection.
  • Counsel patients on the importance of taking ethylsuccinate with food to enhance absorption and reduce GI upset.
  • Monitor for signs of hepatotoxicity (jaundice, dark urine) and ototoxicity (hearing loss, tinnitus), especially with high doses or prolonged therapy.
🔄

Alternative Therapies

  • Azithromycin (another macrolide, often preferred due to longer half-life and fewer drug interactions)
  • Clarithromycin (another macrolide, similar spectrum but different PK/PD)
  • Penicillins (e.g., Amoxicillin, Penicillin V, depending on susceptibility)
  • Cephalosporins (e.g., Cephalexin, Cefdinir, depending on susceptibility)
  • Tetracyclines (e.g., Doxycycline, Minocycline, for specific indications like atypical pneumonia, acne)
  • Clindamycin (for anaerobic infections or penicillin-allergic patients)
💰

Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 100ml bottle (200mg/5ml)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
📚

General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 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.