Azithromycin 500mg Tablets Tri-Pack

Azithromycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, thereby blocking the translocation of peptides. This action is typically bacteriostatic, but can be bactericidal at high concentrations against 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
Chest pain or pressure
Fast heartbeat or abnormal heartbeat
Dizziness or fainting
Changes in hearing
Fever
Changes in eyesight
Diarrhea, especially if it is severe, bloody, or watery (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 cause stomach pain, cramps, or bloody stools)
Liver problems, which may be indicated by:
+ Dark urine
+ Tiredness
+ 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
+ Signs of these reactions 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 or seek medical attention if they bother you or do not go away:

Headache
Diarrhea
Stomach pain
Upset stomach
* Vomiting

Reporting Side Effects

This is not an exhaustive list of possible 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 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 and its symptoms.
If you have previously experienced liver problems or jaundice (yellowing of the skin or eyes) while taking this medication.
Certain heart conditions, such as:
+ Abnormal heart rhythms, including a prolonged QT interval on an electrocardiogram (ECG)
+ 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, including 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.

To ensure your safety, it is vital to provide your doctor and pharmacist with a comprehensive list of:

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

Do not start, stop, or change the dosage of any medication without first consulting your doctor to confirm that it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.

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 prolonged QT interval, which may be life-threatening or fatal. If you have any questions or concerns, discuss them with your doctor.

Myasthenia Gravis
If you have myasthenia gravis, consult your doctor before taking this medication. 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.

• Nelfinavir (increased azithromycin concentrations)
• QT-prolonging drugs (e.g., Class IA and III antiarrhythmics, cisapride, pimozide, terfenadine, astemizole, some antipsychotics, tricyclic antidepressants, fluoroquinolones, antifungals) - increased risk of QT prolongation and Torsades de Pointes.
• Warfarin (increased anticoagulant effect, monitor INR)

• Antacids containing aluminum or magnesium (decreased azithromycin absorption, administer azithromycin at least 2 hours before or after antacids)
• Digoxin (increased digoxin levels, monitor digoxin levels)
• Cyclosporine (increased cyclosporine levels, monitor cyclosporine levels)
• Ergot derivatives (e.g., ergotamine, dihydroergotamine) - theoretical risk of ergotism, avoid concomitant use.
• Colchicine (increased colchicine exposure)

• Zidovudine (increased zidovudine phosphorylation to its active metabolite in peripheral blood mononuclear cells, clinical significance unknown)

• Severe diarrhea (especially if persistent or bloody)
• Abdominal pain or cramping
• Nausea, vomiting
• Yellowing of skin or eyes (jaundice)
• Dark urine
• Unusual fatigue or weakness
• Pruritus (itching)
• Palpitations, dizziness, fainting spells (suggestive of arrhythmia)
• Rash, severe skin reactions (e.g., Stevens-Johnson syndrome, TEN)
• Swelling of face, lips, tongue, or throat (angioedema)
• Difficulty breathing or swallowing

Category B. Studies in animals have shown no evidence of harm to the fetus. Adequate and well-controlled studies in pregnant women are lacking, but available data from observational studies have not identified an increased risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Use during pregnancy only if clearly needed.

L2 (Likely Compatible). Azithromycin is present in human milk in low concentrations. Limited data suggest that adverse effects in breastfed infants are unlikely. Monitor breastfed infants for gastrointestinal symptoms (e.g., diarrhea, vomiting, candidiasis) and rash. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for azithromycin and any potential adverse effects on the breastfed infant.

Safe and effective for use in pediatric patients 6 months of age and older for specific indications (e.g., acute otitis media, pharyngitis/tonsillitis, community-acquired pneumonia). Dosing is weight-based. Safety and effectiveness in pediatric patients under 6 months of age have not been established.

No overall differences in safety or effectiveness were observed between elderly and younger patients. However, elderly patients may be more susceptible to drug-associated QT prolongation and should be monitored carefully, especially if they have underlying cardiac conditions or are on concomitant medications that prolong the QT interval.

• Azithromycin's long half-life allows for shorter treatment courses (e.g., 3-day or 5-day regimens) compared to other antibiotics.
• It concentrates well in tissues, leading to sustained antibacterial activity.
• Counsel patients on the importance of completing the full course of therapy, even if symptoms improve, to prevent resistance and recurrence.
• Be vigilant for signs of C. difficile-associated diarrhea, which can occur weeks after therapy completion.
• Caution with patients at risk for QT prolongation (e.g., pre-existing cardiac conditions, electrolyte imbalances, concomitant QT-prolonging drugs).
• The 500mg Tri-Pack is a convenient dosing regimen for certain infections, typically 500mg once daily for 3 days.

• Amoxicillin
• Doxycycline
• Levofloxacin
• Moxifloxacin
• Clarithromycin
• Erythromycin
• Cefdinir
• Cefpodoxime

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 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.