Azithromycin 500mg Tablets

Azithromycin is a macrolide antibacterial drug. It acts by binding to the 50S ribosomal subunit of susceptible microorganisms, thereby inhibiting microbial protein synthesis. It does not affect nucleic acid synthesis.

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 immediately or seek emergency 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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Chest pain or pressure
Fast or abnormal heartbeat
Dizziness or fainting
Changes in hearing
Fever
Changes in vision
Diarrhea, especially if it is severe, bloody, or accompanied by stomach pain or cramps (note: diarrhea is a common side effect of antibiotics, but in rare cases, it can lead to a serious condition called C. diff-associated diarrhea, which may be life-threatening)
Liver problems, which can be indicated by:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious skin reactions, which can affect body organs and be life-threatening
+ Symptoms may include:
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in the mouth, throat, nose, eyes, genitals, or skin
- Fever
- Chills
- Body aches
- Shortness of breath
- Swollen glands

Other Possible Side Effects

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

Headache
Diarrhea
Stomach pain
Upset stomach
* Vomiting

Reporting 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.

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.
If you have previously experienced liver problems or jaundice (yellowing of the skin or eyes) while taking this medication.
Certain health conditions, including:
+ Abnormal heart rhythms, such as a prolonged QTc interval on an electrocardiogram (ECG) or other irregular heartbeats.
+ Slow heartbeat.
+ Low levels of potassium or magnesium in your blood.
+ Heart failure (a weakened heart).
+ A history of torsades de pointes, a specific type of abnormal heartbeat.
If you are taking any medications that can cause abnormal heart rhythms, such as those that prolong the QT interval. There are many medications that can have this effect, so be sure to ask your doctor or pharmacist if you are unsure.

This is not an exhaustive list of all potential interactions or health problems that may affect your use of this medication. Therefore, it is crucial to inform your doctor and pharmacist about:

All prescription and over-the-counter medications you are taking.
Any natural products, vitamins, or supplements you are using.
* Your complete medical history, including any health problems you have or have had in the past.

Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety.

Important Warnings and Cautions 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. Adhere to the prescribed duration of treatment, as prolonged use may increase the risk of a second infection.

Severe Heart Rhythm Changes
This medication can cause severe heart rhythm changes, including a prolonged QT interval, which may be life-threatening or fatal. If you have any questions or concerns, consult your doctor.

Myasthenia Gravis
If you have myasthenia gravis, discuss your treatment with your doctor. Monitor your symptoms closely, and contact your doctor if they worsen. Additionally, be aware that myasthenia gravis symptoms can occur in people without a prior diagnosis. Seek immediate medical attention 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.

Special 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, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.

Newborns
In newborns, this medication can cause a severe stomach problem. If your child vomits or becomes irritable during feeding, contact your doctor immediately.

• Pimozide (risk of QT prolongation)

• Amiodarone (increased risk of QT prolongation and Torsades de Pointes)
• Dofetilide (increased risk of QT prolongation and Torsades de Pointes)
• Sotalol (increased risk of QT prolongation and Torsades de Pointes)
• Quinidine (increased risk of QT prolongation and Torsades de Pointes)
• Colchicine (increased colchicine exposure and toxicity)
• Nelfinavir (increased azithromycin serum concentrations)
• Warfarin (increased INR and bleeding risk)

• Antacids containing aluminum or magnesium (decreased azithromycin absorption if co-administered simultaneously; separate by 2-4 hours)
• Digoxin (increased digoxin levels)
• Statins (e.g., simvastatin, lovastatin - theoretical increased risk of myopathy/rhabdomyolysis, though less pronounced than with other macrolides)
• Cyclosporine (potential for increased cyclosporine levels, monitor levels)

• Ergot alkaloids (theoretical risk of ergotism, but less common than with other macrolides)

• Diarrhea (especially severe, persistent, or bloody, which may indicate Clostridioides difficile-associated diarrhea)
• Nausea, vomiting, abdominal pain
• Rash, itching, hives (signs of allergic reaction)
• Swelling of face, lips, tongue, or throat; difficulty breathing (signs of angioedema or anaphylaxis)
• Palpitations, chest pain, dizziness, fainting (signs of cardiac arrhythmia, including QT prolongation)
• Unusual fatigue, dark urine, yellowing of skin/eyes (signs of liver problems)
• Muscle pain or weakness (if co-administered with statins)

Azithromycin is classified as Pregnancy Category B. Studies in animals have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed and the potential benefit outweighs the potential risk to the fetus.

Azithromycin is excreted in human milk in low concentrations. The American Academy of Pediatrics considers azithromycin to be compatible with breastfeeding. Monitor breastfed infants for potential adverse effects such as diarrhea, vomiting, or rash.

Dosing is weight-based and established for various indications in pediatric patients aged 6 months and older. Safety and efficacy in infants younger than 6 months have not been established for most indications. Close monitoring for adverse effects is important.

No dosage adjustment is necessary based on age alone. However, elderly patients may be more susceptible to the QT-prolonging effects of azithromycin due to a higher prevalence of underlying cardiac conditions, electrolyte imbalances, and concomitant use of other QT-prolonging drugs. Monitor carefully for cardiac adverse events.

• Azithromycin has a long tissue half-life, allowing for shorter treatment courses (e.g., 5-day course provides 10 days of coverage due to post-antibiotic effect).
• It is a common choice for community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis, and certain STIs (e.g., Chlamydia).
• Counsel patients on the importance of completing the full course of therapy, even if symptoms improve, to prevent resistance and relapse.
• Warn patients about the potential for C. difficile-associated diarrhea, which can occur even weeks after treatment.
• Be mindful of the cardiac risk (QT prolongation) in high-risk patients, including those with pre-existing cardiac conditions, electrolyte abnormalities, or on other QT-prolonging medications.
• Unlike erythromycin and clarithromycin, azithromycin has minimal interaction with the CYP450 system, making it a safer choice for patients on many other medications.

• Other macrolides (e.g., Clarithromycin, Erythromycin)
• Tetracyclines (e.g., Doxycycline, Minocycline)
• Beta-lactam antibiotics (e.g., Amoxicillin, Amoxicillin/clavulanate, Cephalexin)
• Fluoroquinolones (e.g., Levofloxacin, Moxifloxacin)
• Lincosamides (e.g., Clindamycin)

If your symptoms or health issues persist or worsen, it is 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.