Erythrom Eth 200mg/5ml Susp 200ml

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.
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Drug Class
Antibiotic
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Pharmacologic Class
Macrolide antibiotic
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Pregnancy Category
Not available
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FDA Approved
Jan 1953
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Erythromycin is an antibiotic medicine used to treat many different types of bacterial infections, such as chest infections, skin infections, and some 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, 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 differently. Before using the liquid form, shake the bottle well to ensure the medication is evenly mixed. Measure the liquid dose accurately using the measuring device provided with the medication. If no device is included, ask your pharmacist for a suitable measuring tool.

Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel 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 can be stored at room temperature. If you're unsure about the storage instructions, consult your pharmacist. Be aware of the expiration date or the length of time you can store the medication before it 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.
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Lifestyle & Tips

  • Take the medicine 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.
  • Shake the suspension well before each use.
  • Measure the liquid medicine with a special dose-measuring spoon or cup, not a household spoon.
  • Erythromycin can cause stomach upset. Taking it with food may help, but check with your pharmacist or doctor as some forms are best taken on an empty stomach.
  • Avoid grapefruit and grapefruit juice while taking this medicine, as it can increase the levels of erythromycin in your body.
  • Stay hydrated by drinking plenty of fluids.
  • If you are taking antacids, separate the dose of erythromycin by at least 2 hours.

Dosing & Administration

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Adult Dosing

Standard Dose: 250 mg to 500 mg every 6 hours or 333 mg every 8 hours, depending on infection severity and formulation. For the 200mg/5ml suspension, this would translate to 6.25ml to 12.5ml every 6 hours or 8.3ml every 8 hours.
Dose Range: 250 - 2000 mg

Condition-Specific Dosing:

Streptococcal infections: 250 mg every 6 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 to 1000 mg every 6 hours
Chlamydia trachomatis: 500 mg every 6 hours for 7 days or 250 mg every 6 hours for 14 days
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Pediatric Dosing

Neonatal: Not established for routine use; specific indications (e.g., ophthalmia neonatorum prophylaxis) may use topical or specific IV forms. Oral dosing generally not recommended due to risk of infantile hypertrophic pyloric stenosis (IHPS).
Infant: 30 to 50 mg/kg/day in divided doses every 6 hours. Max 2g/day. Caution due to risk of IHPS, especially in first 2 weeks of life.
Child: 30 to 50 mg/kg/day in divided doses every 6 hours. Max 2g/day.
Adolescent: Same as adult dosing, typically 250 mg to 500 mg every 6 hours or 333 mg every 8 hours.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: For CrCl < 10 mL/min, consider reducing dose by 25-50% or extending dosing interval. Max 2g/day.
Dialysis: Not significantly removed by hemodialysis or peritoneal dialysis. Administer after dialysis if dose adjustment is needed.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Erythromycin is a macrolide antibiotic that 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.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (20-60% for base, improved with ester forms)
Tmax: 1-4 hours (oral)
FoodEffect: Food may decrease absorption of erythromycin base, but may increase absorption of some ester forms (e.g., stearate). Erythromycin ethylsuccinate (EES) absorption is generally not affected by food.

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 (adults), 2-5 hours (neonates)
Clearance: Not available (primarily hepatic metabolism and biliary excretion)
ExcretionRoute: Primarily biliary/fecal (90-95%), minor renal excretion (2-5%)
Unchanged: Less than 5% (renal)
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Pharmacodynamics

OnsetOfAction: Rapid
PeakEffect: 1-4 hours (oral)
DurationOfAction: Dependent on dosing interval (typically 6-8 hours)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Immediately

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, 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 increase 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 (C. diff-associated diarrhea, or CDAD), which can lead to life-threatening bowel problems. CDAD can occur during or after antibiotic treatment. Contact your doctor if you experience stomach pain, cramps, or severe diarrhea.
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.

Common and Less Severe Side Effects

Most people taking this medication do not experience severe side effects, and some may not have any side effects at all. However, if you experience any of the following side effects and they bother you or do not go away, contact your doctor:

Diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite.

Reporting Side Effects

This list is not exhaustive, and you may experience other 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 stomach pain, watery or bloody diarrhea (even weeks after stopping the medicine)
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine, pale stools
  • Unusual tiredness or weakness
  • Hearing loss or ringing in the ears
  • Dizziness, fainting, or fast/pounding heartbeats
  • Severe skin rash, blistering, or peeling
  • Swelling of your face, lips, tongue, or throat; difficulty breathing (signs of allergic reaction)
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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 and its symptoms.
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

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.

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is vital to discuss all your medications and health conditions with your doctor and pharmacist. They will help you determine whether it is safe to take this medication with your other medications and health conditions.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor.
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Precautions & Cautions

Important Warnings and Precautions for Patients Taking This Medication

It is essential to inform all 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. Therefore, it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this medication.

Do not take this medication for a longer period than prescribed by your doctor, 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 before taking this medication. Monitor your symptoms closely, and contact your doctor immediately 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 (e.g., blurred vision or double vision), can occur in people without a history of the condition. Seek medical attention right away if you experience any of these symptoms.

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 of taking this medication to both 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
  • Diarrhea
  • Abdominal pain
  • Hearing loss (reversible)
  • Liver dysfunction
  • Cardiac arrhythmias (rare, but possible with very high doses)

What to Do:

Seek emergency medical attention or call Poison Control at 1-800-222-1222. Treatment is generally supportive, including gastric lavage and symptomatic management.

Drug Interactions

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Contraindicated Interactions

  • Astemizole
  • Cisapride
  • Pimozide
  • Terfenadine
  • Ergotamine
  • Dihydroergotamine
  • Colchicine (in renal/hepatic impairment)
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Major Interactions

  • Statins (e.g., Simvastatin, Lovastatin, Atorvastatin) - increased risk of myopathy/rhabdomyolysis
  • Warfarin - increased INR/bleeding risk
  • Carbamazepine - increased carbamazepine levels/toxicity
  • Cyclosporine - increased cyclosporine levels/nephrotoxicity
  • Theophylline - increased theophylline levels/toxicity
  • Digoxin - increased digoxin levels
  • QT-prolonging drugs (e.g., Class IA and III antiarrhythmics, Fluoroquinolones, Antipsychotics) - increased risk of Torsades de Pointes
  • Calcium channel blockers (e.g., Verapamil, Diltiazem, Amlodipine) - increased CCB levels/hypotension
  • Oral contraceptives - decreased efficacy (rare, but reported)
  • Sildenafil and other PDE5 inhibitors - increased levels/toxicity
  • Triazolam, Midazolam - increased sedation
  • Quetiapine - increased quetiapine levels/toxicity
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Moderate Interactions

  • Phenytoin - altered phenytoin levels
  • Valproic acid - altered valproic acid levels
  • Corticosteroids (e.g., Methylprednisolone) - increased corticosteroid levels
  • Tacrolimus - increased tacrolimus levels
  • Zidovudine - decreased zidovudine levels
  • Clindamycin, Lincomycin - antagonism (do not co-administer)
  • Chloramphenicol - antagonism (do not co-administer)
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Minor Interactions

  • Antacids (aluminum/magnesium hydroxide) - may decrease absorption of erythromycin base (separate administration by 2 hours)

Monitoring

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Baseline Monitoring

Liver function tests (ALT, AST, ALP, Bilirubin)

Rationale: To establish baseline and identify pre-existing hepatic impairment, as erythromycin can cause hepatotoxicity.

Timing: Prior to initiation, especially in patients with pre-existing liver disease.

Renal function (CrCl)

Rationale: To assess baseline renal function, though dose adjustment is usually only needed in severe impairment.

Timing: Prior to initiation in patients with suspected renal impairment.

ECG (QTc interval)

Rationale: To assess baseline cardiac conduction, especially in patients with risk factors for QT prolongation or on concomitant QT-prolonging drugs.

Timing: Prior to initiation in high-risk patients.

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Routine Monitoring

Liver function tests (ALT, AST, ALP, Bilirubin)

Frequency: Periodically, especially with prolonged therapy or in patients with pre-existing liver disease or symptoms of hepatotoxicity.

Target: Within normal limits or stable from baseline.

Action Threshold: Significant elevation (e.g., >3x ULN) or signs/symptoms of liver injury warrant discontinuation.

Signs/symptoms of hepatotoxicity (e.g., jaundice, dark urine, abdominal pain)

Frequency: Daily, patient education for self-monitoring.

Target: Absence of symptoms.

Action Threshold: Presence of symptoms warrants immediate medical evaluation and discontinuation.

Signs/symptoms of ototoxicity (e.g., hearing loss, tinnitus, vertigo)

Frequency: Daily, patient education for self-monitoring.

Target: Absence of symptoms.

Action Threshold: Presence of symptoms warrants immediate medical evaluation and discontinuation.

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 requires dose adjustment of warfarin.

Drug levels of co-administered narrow therapeutic index drugs (e.g., Theophylline, Carbamazepine, Cyclosporine, Digoxin)

Frequency: As per standard monitoring for the co-administered drug, with increased frequency during co-administration with erythromycin.

Target: Therapeutic range for the specific drug.

Action Threshold: Levels outside target range require dose adjustment of the co-administered drug.

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Symptom Monitoring

  • Diarrhea (especially severe or bloody, indicative of C. difficile infection)
  • Nausea
  • Vomiting
  • Abdominal pain/cramping
  • Jaundice (yellowing of skin/eyes)
  • Dark urine
  • Pale stools
  • Unusual fatigue/weakness
  • Hearing loss
  • Tinnitus (ringing in ears)
  • Vertigo (dizziness)
  • Chest pain
  • Palpitations
  • Fainting/dizziness (signs of QT prolongation)
  • Rash
  • Itching
  • Swelling of face/lips/tongue (allergic reaction)

Special Patient Groups

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Pregnancy

Erythromycin is generally considered safe for use during pregnancy when indicated. It is often used as an alternative for penicillin-allergic pregnant women. However, some studies have suggested a possible, though small, increased risk of cardiovascular malformations or infantile hypertrophic pyloric stenosis (IHPS) in offspring when used in early pregnancy, but data are conflicting and overall risk is considered low.

Trimester-Specific Risks:

First Trimester: Conflicting data regarding a small increased risk of cardiovascular malformations or IHPS. Overall risk considered low.
Second Trimester: Generally considered safe.
Third Trimester: Generally considered safe.
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Lactation

Erythromycin is excreted into breast milk in small amounts. It is generally considered compatible with breastfeeding (Lactation Risk Category L2). Monitor breastfed infant for gastrointestinal disturbances (e.g., diarrhea, candidiasis) and, rarely, infantile hypertrophic pyloric stenosis (IHPS).

Infant Risk: Low risk. Potential for mild GI upset in infant. Rare reports of IHPS in breastfed infants whose mothers received erythromycin, but causality is not definitively established.
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Pediatric Use

Use with caution in neonates and young infants due to the risk of infantile hypertrophic pyloric stenosis (IHPS), especially when administered during the first 2 weeks of life. Monitor for signs of IHPS (e.g., projectile vomiting, abdominal mass). Dosing is weight-based. Ototoxicity can occur, especially with high doses or in renal impairment.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Erythromycin is a potent CYP3A4 inhibitor, leading to numerous significant drug interactions. Always review concomitant medications.
  • GI upset (nausea, vomiting, abdominal cramps) is a very common side effect, often dose-related. Taking with food may help, but check specific formulation instructions.
  • Risk of QT prolongation and Torsades de Pointes, especially with pre-existing cardiac conditions, electrolyte imbalances, or concomitant QT-prolonging drugs.
  • Can cause reversible hearing loss, particularly with high doses or in patients with renal or hepatic impairment.
  • Infantile hypertrophic pyloric stenosis (IHPS) is a rare but serious risk in neonates and young infants, especially if exposed in the first 2 weeks of life (either directly or via breast milk).
  • Erythromycin is effective against atypical pathogens like Mycoplasma, Chlamydia, and Legionella.
  • Not effective against MRSA or most Gram-negative bacteria (except some specific ones like Bordetella pertussis).
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Alternative Therapies

  • Azithromycin (another macrolide, longer half-life, less frequent dosing, fewer CYP interactions)
  • Clarithromycin (another macrolide, similar spectrum, more CYP interactions than azithromycin)
  • Doxycycline (tetracycline, for atypical pathogens, some STIs)
  • Amoxicillin (penicillin, for susceptible bacterial infections)
  • Cephalexin (cephalosporin, for susceptible bacterial infections)
  • Levofloxacin (fluoroquinolone, for susceptible bacterial infections, but with different side effect profile and resistance concerns)
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Cost & Coverage

Average Cost: Varies widely, typically $10 - $50 per 200ml bottle of suspension
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.