Erythromycin Ethyl 400mg/5ml Susp

Manufacturer ANI PHARMACEUTICALS Active Ingredient Erythromycin Suspension(er ith roe MYE sin) Pronunciation er-ith-roe-MYE-sin ETH-il SUK-sin-ate
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 that stops the growth of bacteria. It's used to treat various bacterial infections, including those of the respiratory tract, skin, and some sexually transmitted infections. This suspension form is often used for children or those who have difficulty swallowing pills.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most benefit from your medication, follow these steps:

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food, unless your doctor specifies otherwise.
Before using the liquid form of this medication, shake the bottle well.
Measure liquid doses accurately using the measuring device provided with the medication. If one is not included, ask your pharmacist for a suitable measuring device.

Continuing Your Medication

Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling better.

Storing and Disposing of Your Medication

Some brands of this medication require refrigeration, while others should be stored at room temperature. If you're unsure, consult your pharmacist.
Check the expiration date or shelf life of your medication to determine how long it can be stored before disposal.
Keep all medications in a safe and secure location, out of 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.
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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.
  • Shake the suspension well before each use.
  • Measure the dose accurately using a special measuring spoon or cup, not a household spoon.
  • Erythromycin ethylsuccinate can be taken with or without food, but taking it with food may help reduce stomach upset.
  • Avoid grapefruit juice while taking this medication, as it can increase the amount of erythromycin in your body.
  • Stay hydrated, especially if experiencing diarrhea.

Dosing & Administration

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Adult Dosing

Standard Dose: 400 mg (5 mL) every 6 hours or 800 mg (10 mL) every 12 hours
Dose Range: 1600 - 4000 mg

Condition-Specific Dosing:

Streptococcal Infections: 400 mg (5 mL) every 6 hours for 10 days
Mycoplasma pneumoniae: 400 mg (5 mL) every 6 hours or 800 mg (10 mL) every 12 hours for 5-10 days
Legionnaires' Disease: 400 mg (5 mL) every 6 hours or 800 mg (10 mL) every 12 hours for 10-14 days
Chlamydial Infections: 800 mg (10 mL) every 12 hours for 7 days or 400 mg (5 mL) every 6 hours for 14 days
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Pediatric Dosing

Neonatal: Not established for routine use; specific indications (e.g., chlamydial conjunctivitis/pneumonia) may use 20-50 mg/kg/day in 4 divided doses.
Infant: 30-50 mg/kg/day in equally divided doses every 6-12 hours (max 4 g/day)
Child: 30-50 mg/kg/day in equally divided doses every 6-12 hours (max 4 g/day)
Adolescent: 30-50 mg/kg/day in equally divided doses every 6-12 hours (max 4 g/day) or adult dose if weight appropriate
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: Consider dose reduction or increased dosing interval (e.g., 25-50% of usual dose or every 12-24 hours) for CrCl <10 mL/min, monitor for adverse effects.
Dialysis: Not significantly removed by hemodialysis or peritoneal dialysis; administer after dialysis if dose adjustment is needed.

Hepatic Impairment:

Mild: Use with caution
Moderate: Use with caution; dose reduction may be necessary. Monitor liver function.
Severe: Use with caution; dose reduction may be necessary. Monitor liver function closely.

Pharmacology

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Mechanism of Action

Erythromycin binds to the 50S ribosomal subunit of susceptible bacteria, thereby inhibiting RNA-dependent protein synthesis. It is generally considered bacteriostatic but may be bactericidal at high concentrations or against highly susceptible organisms.
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Pharmacokinetics

Absorption:

Bioavailability: Varies (Erythromycin ethylsuccinate has improved acid stability and absorption compared to erythromycin base, especially with food).
Tmax: 2-4 hours
FoodEffect: Erythromycin ethylsuccinate absorption is enhanced by food, reducing gastrointestinal upset.

Distribution:

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

Elimination:

HalfLife: 1.5-2 hours
Clearance: Not readily available as a specific rate, primarily hepatic clearance.
ExcretionRoute: Primarily biliary excretion (90-95%), with a small amount (2-5%) excreted unchanged in urine.
Unchanged: 2-5% (renal)
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Pharmacodynamics

OnsetOfAction: Rapid
PeakEffect: Within 2-4 hours of oral administration
DurationOfAction: Dependent on dosing interval (typically every 6-12 hours due to short half-life)

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 medical attention immediately:

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
+ 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
+ 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 a severe form called C. diff-associated diarrhea (CDAD), which can lead to life-threatening bowel problems. If you experience stomach pain, cramps, or loose, watery, or bloody stools, 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, such as hearing loss, 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 side effects or any other symptoms that bother you or do not go away, contact your doctor:

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 or persistent diarrhea (especially if bloody or watery, which could indicate C. difficile infection)
  • Yellowing of skin or eyes (jaundice), dark urine, pale stools, or severe stomach pain (signs of liver problems)
  • New or worsening heart palpitations, dizziness, or fainting (signs of heart rhythm problems)
  • Significant hearing loss or ringing in the ears
  • Signs of a new infection (e.g., oral thrush, vaginal yeast infection)
  • Signs of an allergic reaction (rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
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Before Using This Medicine

Before taking this medication, it is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Abnormal heartbeat patterns, including a prolonged QTc interval on an electrocardiogram (ECG)
+ Slow heartbeat
+ Low potassium or magnesium levels
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and 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.
It is important to note that this is not an exhaustive list of all potential interactions. Therefore, it is vital to discuss all your medications and health conditions with your doctor and pharmacist to ensure safe use.

To guarantee your safety, always consult with your doctor before:
Starting or stopping any medication
Changing the dosage of any medication
* Taking this medication with other drugs or substances

By providing your doctor and pharmacist with a comprehensive list of your medications and health conditions, you can help ensure that it is safe for you to take this medication.
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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. Be sure to discuss this with your doctor.

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

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 your doctor before taking this medication, as some products may contain sodium.

If you have myasthenia gravis, discuss your condition with your doctor. If your symptoms worsen, contact your doctor immediately. 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. If you experience any of these symptoms, seek medical attention promptly.

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 your doctor to discuss the potential benefits and risks to you and your baby.

Special Considerations for Newborns

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

Overdose Symptoms:

  • Severe nausea
  • Vomiting
  • Abdominal pain
  • Diarrhea
  • Hearing loss (reversible)
  • Liver dysfunction

What to Do:

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

Drug Interactions

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Contraindicated Interactions

  • Pimozide
  • Ergot alkaloids (e.g., ergotamine, dihydroergotamine)
  • Colchicine (in patients with renal or hepatic impairment)
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Major Interactions

  • Statins (e.g., simvastatin, lovastatin, atorvastatin) - increased risk of myopathy/rhabdomyolysis
  • Warfarin - increased INR and bleeding risk
  • Carbamazepine - increased carbamazepine levels and toxicity
  • Cyclosporine - increased cyclosporine levels and nephrotoxicity
  • Digoxin - increased digoxin levels
  • Theophylline - increased theophylline levels and toxicity
  • QT-prolonging drugs (e.g., antiarrhythmics like quinidine, disopyramide; antipsychotics like thioridazine, ziprasidone; tricyclic antidepressants) - increased risk of QT prolongation and Torsades de Pointes
  • Oral contraceptives - reduced efficacy of contraceptives (rare, but possible)
  • Cisapride (removed from market in many countries due to cardiac risk)
  • Domperidone
  • Flibanserin
  • Lurasidone
  • Midazolam (oral)
  • Triazolam
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Moderate Interactions

  • Phenytoin - altered phenytoin levels
  • Valproic acid - altered valproic acid levels
  • Corticosteroids - increased corticosteroid levels
  • Sildenafil, Tadalafil, Vardenafil - increased PDE5 inhibitor levels
  • Tacrolimus - increased tacrolimus levels
  • Clindamycin, Lincomycin - potential antagonism (do not use concurrently)
  • Chloramphenicol - potential antagonism (do not use concurrently)
  • Grapefruit juice - may increase erythromycin levels
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Minor Interactions

  • Antacids (aluminum/magnesium hydroxide) - may reduce absorption of erythromycin base (less relevant for ethylsuccinate)

Monitoring

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Baseline Monitoring

Liver Function Tests (LFTs)

Rationale: To establish baseline and identify pre-existing hepatic impairment, especially for prolonged therapy or in patients with liver disease history.

Timing: Prior to initiating therapy if risk factors are present or for prolonged use.

Electrocardiogram (ECG)

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

Timing: Prior to initiating therapy if risk factors for QT prolongation are present.

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Routine Monitoring

Clinical response to therapy

Frequency: Daily during acute treatment, then as clinically indicated.

Target: Resolution of infection symptoms (e.g., fever, pain, inflammation)

Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure, resistance, or incorrect diagnosis.

Liver Function Tests (LFTs)

Frequency: Periodically (e.g., weekly to bi-weekly) for prolonged therapy (over 10-14 days) or in patients with hepatic impairment.

Target: Within normal limits or stable for patient's baseline.

Action Threshold: Significant elevation (e.g., >3x ULN) of ALT/AST or bilirubin may require dose reduction or discontinuation.

INR (International Normalized Ratio)

Frequency: More frequently (e.g., daily to every few days) if co-administered with warfarin.

Target: Patient-specific therapeutic range.

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

Electrolytes (Potassium, Magnesium)

Frequency: As clinically indicated, especially in patients at risk for QT prolongation or severe diarrhea.

Target: Within normal limits.

Action Threshold: Hypokalemia or hypomagnesemia should be corrected to reduce risk of Torsades de Pointes.

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Symptom Monitoring

  • Gastrointestinal upset (nausea, vomiting, abdominal pain, diarrhea)
  • Signs of hepatotoxicity (jaundice, dark urine, pale stools, persistent fatigue, severe abdominal pain)
  • Cardiac symptoms (palpitations, dizziness, syncope, chest pain) - indicative of QT prolongation
  • Hearing changes (tinnitus, temporary hearing loss, especially with high doses or renal/hepatic impairment)
  • Signs of superinfection (new or worsening fever, oral thrush, vaginal yeast infection, severe diarrhea/pseudomembranous colitis)
  • Allergic reactions (rash, itching, swelling, severe dizziness, trouble breathing)

Special Patient Groups

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Pregnancy

Erythromycin is generally considered safe for use during 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.
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 (L2).

Infant Risk: Low risk. Monitor breastfed infant for gastrointestinal upset (e.g., diarrhea, vomiting, fussiness) or rash. Theoretical risk of pyloric stenosis in young infants, but data are conflicting and risk is very low.
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Pediatric Use

Commonly used in pediatric patients. Dosing is weight-based. Caution in neonates due to potential for infantile hypertrophic pyloric stenosis (IHPS), though the risk is low and more associated with erythromycin base. Monitor for GI side effects.

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Geriatric Use

No specific dose adjustment is typically required based on age alone. However, geriatric patients may be more susceptible to adverse effects, particularly hearing loss and QT prolongation, especially if they have underlying renal or hepatic impairment, or are on concomitant medications. Monitor renal and hepatic function and cardiac status.

Clinical Information

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Clinical Pearls

  • Erythromycin ethylsuccinate is preferred over erythromycin base for oral administration due to better acid stability and absorption, especially when taken with food.
  • It is a potent CYP3A4 inhibitor, leading to numerous significant drug interactions. Always review concomitant medications.
  • Can cause gastrointestinal upset (nausea, vomiting, abdominal cramps, diarrhea) which is a common reason for non-compliance or discontinuation.
  • Risk of QT prolongation and Torsades de Pointes, especially with higher doses, pre-existing cardiac conditions, electrolyte imbalances, or co-administration of other QT-prolonging drugs.
  • Rarely, hepatotoxicity (cholestatic hepatitis) can occur, usually reversible upon discontinuation.
  • Transient hearing loss has been reported, particularly with high doses or in patients with renal or hepatic impairment.
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Alternative Therapies

  • Azithromycin (another macrolide, longer half-life, less frequent dosing, fewer CYP interactions)
  • Clarithromycin (another macrolide, similar spectrum, more potent CYP3A4 inhibitor than azithromycin)
  • Amoxicillin (for susceptible bacterial infections, especially respiratory)
  • Doxycycline (for atypical pneumonia, chlamydia, skin infections)
  • Levofloxacin/Moxifloxacin (fluoroquinolones, broader spectrum, reserved for specific indications due to side effects)
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Cost & Coverage

Average Cost: Varies widely, typically $20-$100+ per 100 mL (400mg/5mL)
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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.