Azithromycin 600mg 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, including:
+ 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 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 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 skin reactions, which may also affect internal organs and can be life-threatening
+ Signs of severe skin reactions 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 do not experience significant side effects, but some may occur. 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

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 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:
+ Long QTc interval on an electrocardiogram (ECG) or other abnormal heart rhythms
+ 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 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 in conjunction with 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 can 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
Newborns taking this medication are at risk of developing a severe stomach problem. If your child vomits or becomes irritable during feeding, contact your doctor immediately.

• QTc-prolonging drugs (e.g., Class IA and III antiarrhythmics, cisapride, pimozide, terfenadine, certain antipsychotics, tricyclic antidepressants, fluoroquinolones): Increased risk of Torsades de Pointes.
• Nelfinavir: Significantly increases azithromycin serum concentrations; monitor for adverse effects.

• Antacids (containing aluminum or magnesium): Decreased peak plasma concentrations of azithromycin (administer azithromycin at least 2 hours before or 4 hours after antacids).
• Warfarin: Potentiation of anticoagulant effects (increased INR); monitor INR closely.
• Digoxin: Increased serum digoxin levels; monitor digoxin levels.
• Cyclosporine: Increased cyclosporine levels; monitor cyclosporine levels.
• Ergot alkaloids (e.g., ergotamine, dihydroergotamine): Potential for acute ergot toxicity (vasospasm, dysesthesia); avoid concomitant use.
• Statins (e.g., atorvastatin, simvastatin): Increased risk of myopathy/rhabdomyolysis (less pronounced than with erythromycin/clarithromycin, but caution advised).

• Diarrhea (especially severe or persistent)
• Abdominal pain
• Nausea
• Vomiting
• Rash
• Hives
• Swelling of face/lips/tongue/throat (signs of allergic reaction)
• Difficulty breathing
• Yellowing of skin or eyes (jaundice)
• Dark urine
• Unusual fatigue
• Palpitations or irregular heartbeat
• Dizziness or lightheadedness
• Fainting spells

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 human experience has not shown an increased risk of fetal abnormalities. Use only if clearly needed.

L3 (Moderately Safe). Azithromycin is excreted in human milk in small amounts. While generally considered compatible with breastfeeding, monitor the infant for potential adverse effects such as diarrhea, vomiting, or rash. The benefits of breastfeeding should be weighed against the potential risks.

Dosing is weight-based and specific for indications. The 600mg tablet is a high dose and typically reserved for older children/adolescents for specific infections like MAC, where the weight-based dose approaches or reaches the adult maximum. Safety and efficacy in infants younger than 6 months have not been established for all indications. Close monitoring for adverse effects is crucial.

No dosage adjustment is generally required based on age alone. However, elderly patients may be more susceptible to QTc prolongation and should be monitored closely, especially if they have underlying cardiac conditions or are on concomitant QTc-prolonging medications. Renal and hepatic function should be considered.

• Azithromycin has a very long tissue half-life, allowing for short courses of therapy (e.g., 5-day or 3-day regimens) or less frequent dosing (e.g., once weekly for MAC prophylaxis).
• Despite its long half-life, it's crucial to complete the full prescribed course to prevent resistance and ensure eradication of the infection.
• While generally well-tolerated, GI upset (nausea, diarrhea, abdominal pain) is common. Taking with food may help, though absorption of tablets is not significantly affected.
• Be vigilant for signs of C. difficile-associated diarrhea, which can occur even weeks to months after stopping the antibiotic.
• Counsel patients on the risk of QTc prolongation, especially if they have pre-existing heart conditions or are taking other medications that affect heart rhythm. Advise them to seek immediate medical attention for palpitations, dizziness, or fainting.

• Other macrolides (e.g., Clarithromycin, Erythromycin) - often used for similar infections, but with different pharmacokinetic profiles and drug interaction risks.
• Other classes of antibiotics depending on the specific infection and susceptibility (e.g., Beta-lactams, Fluoroquinolones, Tetracyclines, Aminoglycosides).
• For MAC treatment, other antimycobacterials like Ethambutol, Rifabutin, or Rifampin are used in combination with azithromycin.

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 details. 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 emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.