Azithromycin suspension package insert pdf

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Important Information: Read the package insert carefully before using Azithromycin suspension. This document contains essential instructions for proper dosing and administration of this medication.

For full prescribing information, including dosage and possible side effects, please refer to the PDF document provided with the package.

Azithromycin Suspension: Package Insert PDF

Azithromycin Suspension: Package Insert PDF

Azithromycin suspension is indicated for the treatment of mild to moderate infections caused by susceptible strains of bacteria in the following conditions:

Infections of the Respiratory Tract: Acute bacterial exacerbations of chronic bronchitis
Mild to moderate community-acquired pneumonia
Skin and Soft Tissue Infections: Uncomplicated skin and skin structure infections
Sexually Transmitted Diseases: Genital ulcer disease in men

The recommended dosage of azithromycin suspension varies based on the type and severity of the infection. It is important to follow the prescribing physician’s instructions and complete the full course of treatment to ensure effectiveness.

Indications and Dosage


Azithromycin oral suspension is indicated for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below:

  • Pharyngitis/tonsillitis
  • Acute bacterial sinusitis
  • Mild to moderate community-acquired pneumonia
  • Skin and skin structure infections
  • Urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae


The dosage of azithromycin oral suspension is based on weight. The recommended dosage for most infections is as follows:

  • Pharyngitis/Tonsillitis: 12 mg/kg once daily for 5 days
  • Acute bacterial sinusitis: 10 mg/kg once daily for 3 days
  • Community-acquired pneumonia: 10 mg/kg once daily for 3 days
  • Skin and skin structure infections: 5-10 mg/kg once daily for 5 days
  • Urethritis and cervicitis: Single dose of 1 gram
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For specific dosing recommendations based on indication and weight, consult the prescribing information or healthcare provider.

Warnings and Precautions

Cardiovascular Risk: Azithromycin may increase the risk of cardiovascular events, particularly in patients with a history of cardiovascular disease. Monitor patients for signs of cardiovascular complications and consider alternative therapies in high-risk individuals.

Hepatotoxicity: Azithromycin has been associated with cases of severe hepatotoxicity, including liver failure and death. Monitor liver function tests periodically during treatment and discontinue therapy if signs of liver injury develop.

Clostridium difficile-Associated Diarrhea: Use of azithromycin has been linked to the development of Clostridium difficile-associated diarrhea. Consider this possibility in patients presenting with diarrhea and discontinue azithromycin if C. difficile infection is suspected.

Adverse Reactions

Adverse reactions to Azithromycin suspension may include:

System Organ Class Adverse Reactions
Nervous System Disorders Headache, dizziness
Gastrointestinal Disorders Diarrhea, abdominal pain, nausea, vomiting
Skin and Subcutaneous Tissue Disorders Rash, pruritus
General Disorders and Administration Site Conditions Injection site reactions, fatigue

Patients should be advised to report any adverse reactions to their healthcare provider.

Drug Interactions

Drug Interactions

Azithromycin suspension may interact with certain medications, potentially leading to adverse effects or reduced effectiveness. It is important to consult with a healthcare provider or pharmacist before taking this medication if you are currently taking any other drugs. Some of the known drug interactions include:

1. Antacids: Taking azithromycin with antacids may reduce the absorption of the medication, so it is recommended to separate the doses by at least 2 hours.

2. Warfarin: Azithromycin may potentiate the effects of warfarin, increasing the risk of bleeding. Regular monitoring of INR levels is recommended when these medications are used together.

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3. Digoxin: Azithromycin can increase the serum levels of digoxin, leading to potential toxicity. Close monitoring of digoxin levels and symptoms of toxicity is advised.

4. Rifampin: Rifampin may decrease the effectiveness of azithromycin by increasing its metabolism. Consider alternative antibiotics or adjust the dosing regimen if co-administration is necessary.

5. Statins: Some statins, such as simvastatin, atorvastatin, or lovastatin, may have an increased risk of myopathy or rhabdomyolysis when taken with azithromycin. Caution is advised when using these medications together.

It is essential to inform your healthcare provider about all the medications, supplements, or herbal products you are currently taking to avoid potential drug interactions with azithromycin suspension.

Storage and Handling

Azithromycin suspension should be stored at room temperature, between 68°F to 77°F (20°C to 25°C).

Protect from light and moisture. Do not freeze.

Keep the bottle tightly closed when not in use.

Keep out of reach of children.