Erythromycin Eth 400mg Tablets

Erythromycin binds to the 50S ribosomal subunit of susceptible microorganisms, thereby inhibiting bacterial protein synthesis without affecting nucleic acid synthesis. It is generally considered bacteriostatic but may be bactericidal at high concentrations or against highly susceptible organisms.

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: 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 and 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, particularly 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 or seek medical attention if they bother you or persist:

Diarrhea
Stomach pain
Upset stomach
Vomiting
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, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

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 heart rhythms, such as a prolonged QTc interval on an electrocardiogram (ECG)
+ Other irregular heartbeats
+ Slow heartbeat (bradycardia)
+ 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, 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 vital to disclose all your medications and health conditions to your doctor.

To ensure your safety, always check with your doctor before:
Starting any new medication
Stopping any medication
Changing the dose of any medication

Your doctor and pharmacist need to know about all your medications and health conditions to determine if it is safe for you to take this medication.

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. Be sure to discuss this with your doctor.

This medication may interfere with certain laboratory tests. Therefore, it is essential to notify all of 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 with 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 right away.

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.

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.

• Simvastatin, Lovastatin (increased risk of rhabdomyolysis)
• Ergot alkaloids (e.g., ergotamine, dihydroergotamine) (acute ergot toxicity)
• Colchicine (in patients with renal or hepatic impairment, due to increased colchicine levels and toxicity)
• Pimozide (increased risk of QT prolongation and arrhythmias)

• Other CYP3A4 substrates (e.g., carbamazepine, cyclosporine, tacrolimus, sildenafil, quinidine, disopyramide, alfentanil, some benzodiazepines like midazolam, triazolam) - increased levels of these drugs
• QT-prolonging drugs (e.g., antiarrhythmics like amiodarone, sotalol; antipsychotics; tricyclic antidepressants; fluoroquinolones) - increased risk of torsades de pointes
• Warfarin (increased anticoagulant effect)
• Digoxin (increased digoxin levels)
• Theophylline (increased theophylline levels)
• Oral contraceptives (potential for decreased efficacy of contraceptives)
• Clindamycin, Lincomycin, Chloramphenicol (antagonistic effects)

• Corticosteroids (potential for increased corticosteroid effects)
• Phenytoin (altered phenytoin metabolism)
• Valproic acid (potential for increased valproic acid levels)
• Cimetidine (may increase erythromycin levels)
• Grapefruit juice (may increase erythromycin levels)

• Antacids (may reduce absorption if taken concurrently, separate by 2 hours)

• Gastrointestinal upset (nausea, vomiting, abdominal pain, diarrhea)
• Signs of hepatotoxicity (jaundice, dark urine, fatigue, abdominal pain)
• Signs of ototoxicity (hearing loss, tinnitus, vertigo)
• Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
• Signs of C. difficile-associated diarrhea (severe, persistent diarrhea, abdominal cramps, fever)
• Signs of cardiac arrhythmias (palpitations, dizziness, fainting)

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

Erythromycin is excreted in breast milk in small amounts. It is generally considered compatible with breastfeeding (L1 - Safest). Monitor breastfed infant for gastrointestinal disturbances (e.g., diarrhea, candidiasis) or allergic reactions.

Dosing is weight-based. Caution is advised in neonates due to potential for infantile hypertrophic pyloric stenosis (IHPS), especially with erythromycin base or estolate. Erythromycin ethylsuccinate has a lower, but still present, risk. Monitor for signs of IHPS (e.g., projectile vomiting).

No specific dose adjustment is required based on age alone. However, elderly patients may be more susceptible to hearing loss, especially with high doses, and may have age-related decline in renal or hepatic function, requiring careful monitoring. Increased risk of drug interactions due to polypharmacy.

• Erythromycin ethylsuccinate is a prodrug formulation designed to improve absorption and reduce gastric irritation compared to erythromycin base.
• It is a potent inhibitor of CYP3A4, leading to numerous significant drug interactions. Always review concomitant medications.
• Risk of QT prolongation and Torsades de Pointes, especially with pre-existing cardiac conditions, electrolyte imbalances, or concomitant QT-prolonging drugs.
• Can cause gastrointestinal upset (nausea, vomiting, abdominal pain, diarrhea) which is often dose-related. Taking with food may help mitigate this.
• Rarely, can cause reversible hearing loss, particularly with high doses or in patients with renal/hepatic impairment.
• Considered an alternative for penicillin-allergic patients for susceptible infections.

• Other macrolides (e.g., Azithromycin, Clarithromycin)
• Tetracyclines (e.g., Doxycycline, Minocycline)
• Penicillins (e.g., Amoxicillin, Penicillin V)
• Cephalosporins (e.g., Cephalexin, Cefdinir)
• Fluoroquinolones (e.g., Levofloxacin, Moxifloxacin) - depending on the specific infection and susceptibility.

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 occurred.