Erythromycin DR 250mg Capsules

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.

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, 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
Difficulty urinating 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 a severe form called C. diff-associated diarrhea (CDAD), which can lead to life-threatening bowel problems. Contact your doctor right away if you experience:
+ Stomach pain
+ Cramps
+ Watery, bloody, or loose stools
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 severe side effects, but some may occur. If you notice any of the following symptoms or if they persist or bother you, 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.

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. 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

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

Prescription and over-the-counter (OTC) medications
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 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 to confirm it is safe to do so with 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 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.

Please note that this medication may interfere with certain laboratory tests. 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 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 with your doctor before taking this medication, as some products may contain sodium.

If you have myasthenia gravis, it is essential to 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, 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 prior diagnosis of the condition. If you experience any of these symptoms, seek medical attention promptly.

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.

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

• Statins (e.g., simvastatin, lovastatin, atorvastatin) - increased risk of rhabdomyolysis
• Antiarrhythmics (e.g., amiodarone, disopyramide, dofetilide, dronedarone, procainamide, quinidine, sotalol) - increased risk of QT prolongation and Torsades de Pointes
• Calcium channel blockers (e.g., verapamil, diltiazem, amlodipine, felodipine) - increased levels of CCBs, leading to hypotension, bradycardia
• Warfarin - increased anticoagulant effect
• Carbamazepine - increased carbamazepine levels, leading to toxicity
• Theophylline - increased theophylline levels, leading to toxicity
• Sildenafil, Tadalafil, Vardenafil - increased PDE5 inhibitor levels
• Tacrolimus, Cyclosporine - increased immunosuppressant levels, leading to nephrotoxicity
• Cisapride (removed from market in many countries due to QT prolongation)
• Other drugs known to prolong QT interval (e.g., some antipsychotics, antidepressants, fluoroquinolones)

• Benzodiazepines (e.g., midazolam, triazolam) - increased sedation
• Corticosteroids (e.g., methylprednisolone) - increased corticosteroid levels
• Digoxin - increased digoxin levels
• Phenytoin - altered phenytoin levels
• Oral contraceptives - theoretical risk of reduced efficacy (though not consistently proven)
• Zidovudine - decreased zidovudine levels
• Clindamycin, Lincomycin, Chloramphenicol - antagonism of antibacterial effects

• Antacids (aluminum/magnesium hydroxide) - may reduce absorption of some erythromycin formulations (less relevant for DR)

• Severe or persistent diarrhea (may indicate C. difficile-associated diarrhea)
• Yellowing of skin or eyes (jaundice)
• Dark urine
• Unusual fatigue or weakness
• Abdominal pain (especially right upper quadrant)
• Chest pain, palpitations, irregular heartbeat, dizziness, fainting (signs of QT prolongation)
• Hearing loss or tinnitus (rare, usually reversible ototoxicity)

Erythromycin is generally considered safe for use during pregnancy (Category B). Studies in pregnant women have not shown an increased risk of fetal abnormalities. It is often used as an alternative for penicillin-allergic pregnant women.

Erythromycin is excreted into breast milk in small amounts. It is generally considered compatible with breastfeeding (Lactation Risk Category L2 - Likely Compatible). Monitor breastfed infants for potential adverse effects such as diarrhea, candidiasis (thrush, diaper rash), or allergic reactions.

Erythromycin is widely used in pediatric patients. Dosing is weight-based. Caution is advised in neonates due to potential for infantile hypertrophic pyloric stenosis (IHPS), especially with erythromycin ethylsuccinate. Delayed-release formulations are generally not recommended for very young infants due to swallowing difficulties.

No specific dose adjustment is required based solely on age. However, elderly patients may be more susceptible to QT prolongation and hearing loss, especially if they have pre-existing cardiac conditions, electrolyte imbalances, or renal/hepatic impairment. Monitor closely for adverse effects and drug interactions.

• Erythromycin is a potent CYP3A4 inhibitor, leading to numerous significant drug interactions. Always review concomitant medications carefully.
• While generally well-tolerated, GI upset (nausea, vomiting, abdominal cramps) is a common side effect, especially with higher doses or non-enteric coated forms. Delayed-release formulations aim to reduce this.
• Erythromycin can prolong the QT interval and should be used with caution in patients with known QT prolongation, uncorrected hypokalemia/hypomagnesemia, bradycardia, or those receiving other QT-prolonging drugs.
• It is an effective alternative for patients with penicillin allergies, particularly for respiratory tract infections, skin infections, and atypical pneumonia.
• Infantile hypertrophic pyloric stenosis (IHPS) has been reported in neonates receiving erythromycin, particularly erythromycin ethylsuccinate. Use with caution in this population.

• Other macrolides (e.g., azithromycin, clarithromycin)
• Penicillins (e.g., amoxicillin, penicillin V)
• Cephalosporins (e.g., cephalexin, cefdinir)
• Tetracyclines (e.g., doxycycline)
• Fluoroquinolones (e.g., levofloxacin, moxifloxacin)
• Clindamycin

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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this 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 information about the medication taken, the amount, and the time it happened.