Azithromycin 200mg/5ml Susp 30ml

Azithromycin binds to the 50S ribosomal subunit of susceptible microorganisms, thereby inhibiting bacterial protein synthesis. It does not affect nucleic acid synthesis.

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when 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 or abnormal heartbeat
Dizziness or fainting
Changes in hearing
Fever
Changes in vision
Diarrhea, especially if it is severe, bloody, or watery (note: diarrhea is common with antibiotics, but rare cases of C. diff-associated diarrhea, or CDAD, can occur, potentially leading to life-threatening bowel problems)
Stomach pain, cramps, or very loose, watery, or bloody stools (if you experience these symptoms, contact your doctor before treating diarrhea)
Signs of liver problems, such as:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes (note: liver problems can be life-threatening)
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which can affect body organs and be life-threatening
+ 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 do 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:

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 health conditions, such as:
+ Abnormal heart rhythms, including a prolonged QTc interval on an electrocardiogram (ECG) or other irregular heartbeats.
+ Slow heartbeat or low levels of potassium or magnesium in your blood.
+ Heart failure, also known as a weak 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 is not an exhaustive list of all potential interactions or health problems that may be relevant to this medication. Therefore, it is vital to:

Inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor to ensure it is safe to take this medication.
* Never start, stop, or change the dose 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 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 signs of myasthenia gravis, such as new or worsening muscle weakness, difficulty chewing or swallowing, breathing problems, droopy eyelids, or changes in vision (e.g., blurred vision or double vision), can occur in people with or without a history of the condition. Seek immediate medical attention if you experience any of these symptoms.

Special Considerations for Older Adults
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

Pregnancy and Breast-Feeding
If you are pregnant, plan to become pregnant, or are breast-feeding, 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 (monitor INR).
• Nelfinavir: Significantly increases azithromycin serum concentrations (no dose adjustment needed for azithromycin, but monitor for adverse effects).
• Antacids containing aluminum or magnesium: Decreased peak serum levels of azithromycin (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 alkaloids (e.g., ergotamine, dihydroergotamine): Potential for acute ergotism (vasospasm and dysesthesia). Avoid concomitant use.
• Statins (e.g., simvastatin, lovastatin): Increased risk of myopathy/rhabdomyolysis (though less pronounced than with other macrolides like erythromycin).

• Zidovudine: Increased zidovudine phosphorylation to its active metabolite in peripheral blood mononuclear cells (clinical significance uncertain).

• Diarrhea (especially severe or bloody)
• Abdominal pain
• Nausea/Vomiting
• Rash or itching
• Signs of allergic reaction (e.g., swelling of face/throat, difficulty breathing)
• Yellowing of skin or eyes (jaundice)
• Dark urine
• Light-colored stools
• Unusual tiredness or weakness
• Palpitations or irregular heartbeat
• Dizziness or fainting

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 suggests no increased risk of congenital anomalies. Generally considered safe when clearly needed.

L3 (Moderately Safe). Azithromycin is excreted into breast milk in small amounts. While generally considered compatible with breastfeeding, monitor breastfed infants for potential adverse effects such as diarrhea, vomiting, or rash. Consider alternative if infant is premature or has underlying conditions.

Widely used in pediatric populations. Dosing is weight-based and varies by indication. Safety and efficacy established for children 6 months and older for specific indications. Neonatal use is generally off-label and requires specific clinical justification.

No specific dosage adjustment is necessary based on age alone. However, elderly patients may be more susceptible to QT prolongation and should be monitored for this risk, especially if they have underlying cardiac conditions or are on concomitant QT-prolonging medications. Monitor renal and hepatic function.

• Azithromycin's long half-life allows for shorter treatment courses (e.g., 1-5 days) and once-daily dosing, which can improve patient adherence.
• It achieves high and sustained concentrations in tissues, often exceeding plasma concentrations, which contributes to its efficacy.
• Less prone to drug interactions via CYP450 inhibition compared to erythromycin or clarithromycin.
• Risk of C. difficile-associated diarrhea (CDAD) is a concern with all antibiotics, including azithromycin, and can occur even weeks after therapy.
• Taste masking is important for oral suspensions; ensure patients are aware of proper administration to minimize taste issues.

• Other macrolides (e.g., clarithromycin, erythromycin)
• Penicillins (e.g., amoxicillin, amoxicillin/clavulanate)
• Cephalosporins (e.g., cefdinir, cefpodoxime)
• Tetracyclines (e.g., doxycycline, minocycline)
• Fluoroquinolones (e.g., levofloxacin, moxifloxacin) - generally reserved for specific indications due to broader spectrum and safety concerns.

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