Zithromax 500mg Tablets

Azithromycin is a macrolide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit of susceptible microorganisms. This binding interferes with the translocation of peptides, thereby inhibiting RNA-dependent protein 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 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
+ 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 (common with antibiotics), especially if severe, bloody, or watery; stomach pain or cramps (may be a sign of C. diff-associated diarrhea, a potentially life-threatening condition)
Liver problems, 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 reactions, which may also affect internal organs
+ 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 experience either no side effects or mild ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Headache
Diarrhea
Stomach pain
Upset stomach
* Vomiting

This is not an exhaustive list of potential side effects. If you have concerns or questions, 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 conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. 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, such as:
+ Abnormal heart rhythms, including a prolonged QTc interval on an electrocardiogram (ECG) or other irregular heartbeats.
+ Slow heartbeat.
+ Low potassium or magnesium levels.
+ 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, particularly those that prolong the QT interval. There are many medications that can have this effect, so it is crucial to consult with your doctor or pharmacist if you are unsure.

This list is not exhaustive, and it is vital to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine whether it is safe to take this medication in combination with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

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 treatment duration, as prolonged use may increase the risk of a second infection.

Severe Heart Rhythm Changes
This medication can cause severe heart rhythm changes, including 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 condition 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 taking this medication, a severe stomach problem can occur. If your child vomits or becomes irritable during feeding, contact your doctor immediately.

• QT-prolonging drugs (e.g., Class IA and III antiarrhythmics, cisapride, pimozide, some antipsychotics, tricyclic antidepressants, fluoroquinolones): Increased risk of QT prolongation and Torsades de Pointes.
• Warfarin: Increased anticoagulant effect (INR elevation).
• Nelfinavir: Significantly increased azithromycin serum concentrations (monitor for adverse effects).

• Antacids (containing aluminum or magnesium): Decreased peak serum concentrations of azithromycin (administer azithromycin at least 2 hours before or after antacids).
• Cyclosporine: Increased cyclosporine levels (monitor cyclosporine levels and adjust dose).
• Digoxin: Increased serum digoxin levels (monitor digoxin levels).
• Ergot alkaloids (e.g., ergotamine, dihydroergotamine): Potential for acute ergotism (vasospasm and dysesthesia).

• Diarrhea (especially severe, watery, 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 severe allergic reaction/angioedema)
• Yellowing of skin or eyes, dark urine, unusual fatigue (signs of liver problems)
• Palpitations, dizziness, fainting (signs of QT prolongation/arrhythmia)
• Muscle weakness, vision changes, difficulty speaking or swallowing (rare, but possible signs of myasthenia gravis exacerbation)

Generally considered safe for use during pregnancy when clearly needed. Studies in animals have not shown harm to the fetus, and human data suggest a low risk.

Considered compatible with breastfeeding. Azithromycin is excreted into breast milk in low amounts. Monitor breastfed infant for gastrointestinal upset (e.g., diarrhea, vomiting) or rash.

Widely used in pediatric populations for various infections. Dosing is weight-based and varies by indication. Safety and efficacy established for specific age groups and indications. Oral suspension is available for easier administration.

No specific dose adjustment is required based on age alone. However, elderly patients may be more susceptible to QT prolongation due to a higher prevalence of underlying cardiac conditions or concomitant medications. Monitor for adverse effects.

• Azithromycin has a very long half-life, allowing for once-daily dosing and shorter treatment courses (e.g., 3-day or 5-day regimens).
• It achieves high concentrations in tissues and phagocytes, leading to sustained antibacterial activity.
• Unlike erythromycin and clarithromycin, azithromycin has minimal interaction with the CYP450 system, reducing the risk of drug-drug interactions with CYP substrates.
• Despite its generally good safety profile, it carries a risk of QT prolongation, especially in patients with pre-existing cardiac conditions or those on other QT-prolonging drugs.
• Can cause severe gastrointestinal side effects (nausea, vomiting, diarrhea), which may be mitigated by taking with food.
• Risk of Clostridioides difficile-associated diarrhea (CDAD) is present with all antibiotics, including azithromycin.
• Rare but serious adverse effects include hepatotoxicity, cholestatic jaundice, and severe cutaneous adverse reactions (SCARs) like Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).

• Other macrolides (e.g., clarithromycin, erythromycin)
• Tetracyclines (e.g., doxycycline, minocycline)
• Beta-lactam antibiotics (e.g., amoxicillin, penicillin, cephalexin) - depending on the specific infection and pathogen
• Fluoroquinolones (e.g., levofloxacin, moxifloxacin) - for certain respiratory or complicated infections
• 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 discuss them with 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 information about the medication taken, the amount, and the time it happened.