Azithromycin for injection package insert

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Discover the power of Azithromycin for quick and effective treatment.

Whether you are seeking relief from a bacterial infection or looking for a trusted antibiotic solution, Azithromycin for injection is your answer. With its proven track record of efficacy and safety, Azithromycin delivers fast and reliable results.

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Azithromycin for Injection Package Insert

Here is an overview of the important information regarding Azithromycin for injection package insert:

Product Name Azithromycin for Injection
Drug Class Antibiotic
Route of Administration Parenteral
Composition Azithromycin
Manufacturer [Manufacturer’s Name]
Release Form Injection

Azithromycin for Injection is a potent antibiotic indicated for the treatment of various bacterial infections. It is administered intravenously and quickly reaches therapeutic levels in the bloodstream, ensuring efficacy in combating infections.

Indications and Usage

Indications and Usage

Azithromycin for Injection is indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below.

Community-Acquired Pneumonia (CAP):

  • Adult patients with moderate to severe community-acquired pneumonia due to susceptible microorganisms
  • Patients with known or suspected atypical pneumonia may be treated with azithromycin as monotherapy.

Acute Bacterial Sinusitis:

  • Adult patients with acute bacterial sinusitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae.

Chronic Obstructive Pulmonary Disease (COPD) Exacerbations:

  • Adult patients with acute exacerbations of chronic obstructive pulmonary disease due to susceptible microorganisms.
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Pharyngitis/Tonsillitis:

  • Adult patients and pediatric patients with pharyngitis/tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci).

Uncomplicated Skin and Skin Structure Infections:

  • Adult patients with uncomplicated skin and skin structure infections due to susceptible strains of Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae.

Acute Bacterial Exacerbations of Chronic Bronchitis:

  • Adult patients with acute bacterial exacerbations of chronic bronchitis due to susceptible microorganisms.

Urethritis and Cervicitis:

  • One single 1 gram dose.

Indications and Usage

Azithromycin for Injection is indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below:

  • Community-Acquired Pneumonia
  • Acute Bacterial Exacerbations of Chronic Bronchitis
  • Skin and Skin Structure Infections
  • Pharyngitis/tonsillitis
  • Uncomplicated Gonorrhea
  • Urethritis and Cervicitis

Azithromycin for Injection is also indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.

When treating infections, it is important to use Azithromycin for Injection only when it is considered appropriate to prescribe. The antimicrobial spectrum of Azithromycin for Injection includes many gram-positive, gram-negative, anaerobic, and atypical microorganisms.

Dosage and Administration

It is important to follow the recommended dosage and administration guidelines for Azithromycin for Injection to ensure safe and effective treatment. The dosage of Azithromycin for Injection should be individualized based on the severity and type of infection, as well as the patient’s weight and overall health.

The typical dosing regimen for Azithromycin for Injection in adults is 500 mg to 2000 mg administered intravenously once daily, depending on the indication. The duration of treatment will also vary based on the specific infection being treated. It is important to complete the full course of treatment as prescribed by a healthcare provider, even if symptoms improve before the course is finished.

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Pediatric dosing for Azithromycin for Injection will be determined based on the child’s weight and the severity of the infection. The pediatric dosing guidelines should be carefully followed to ensure the correct amount of medication is administered.

Important Administration Tips:
Administer Azithromycin for Injection as directed by a healthcare provider.
Do not mix Azithromycin for Injection with other medications or solutions.
Follow proper aseptic technique when preparing and administering Azithromycin for Injection.
Administer the medication slowly over a recommended period of time to prevent adverse reactions.

Contraindications and Precautions

Azithromycin for injection is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, or any macrolide antibiotics.

Special care should be taken in patients with a history of liver disease or impairment, as azithromycin is primarily eliminated through hepatic metabolism.

Precautions

  • Prolonged use may result in bacterial or fungal overgrowth.
  • Patients with known QT interval prolongation, electrolyte abnormalities, or concomitant use of medications that prolong the QT interval should use azithromycin with caution.
  • As with any antibiotic, overuse or inappropriate use of azithromycin may lead to the development of resistant bacteria.

Adverse Reactions

Adverse reactions to Azithromycin for Injection may include:

System/Organ Class Adverse Reaction Frequency
Infections and Infestations Superinfection Common
Clostridioides difficile colitis Uncommon
Blood and Lymphatic System Disorders Leukopenia Rare
Thrombocytopenia Rare
Skin and Subcutaneous Tissue Disorders Stevens-Johnson syndrome Rare

Serious Adverse Reactions

In rare cases, Azithromycin for Injection may lead to severe allergic reactions like anaphylaxis. Patients should seek immediate medical attention if they experience symptoms such as difficulty breathing, swelling of the face or throat, or a severe skin rash.

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Storage and Handling

Azithromycin for Injection should be stored at controlled room temperature 20°C to 25°C (68°F to 77°F) with excursions permitted to 15°C to 30°C (59°F to 86°F).

Reconstitution and Dilution Instructions

Reconstitution and Dilution Instructions

Reconstitute with 4.8mL of Sterile Water for Injection, USP resulting in a concentration of 100 mg/mL. Shake well until dissolved. Further dilute the reconstituted solution with a compatible intravenous fluid to a final concentration of 1 mg/mL to 2 mg/mL. Discard any unused portion.

Storage Stability
Azithromycin for Injection Once reconstituted and further diluted in intravenous fluids, the solution should be used immediately. If not used immediately, store in a refrigerator at 2°C to 8°C (36°F to 46°F) for no more than 24 hours before administration. Do not freeze.