Azithromycin [ZITHROMAX] 250MG 18/Pack

NDC: 65862-641-63

Azithromycin 250 mg Tablets, 18 count — Aurobindo Pharma

Indications and Usage

A macrolide antibacterial indicated for mild to moderate infections caused by susceptible bacteria, including acute bacterial exacerbations of chronic bronchitis, acute bacterial sinusitis, community-acquired pneumonia, pharyngitis/tonsillitis, uncomplicated skin and skin structure infections, and certain sexually transmitted infections. It should be used only for infections proven or strongly suspected to be bacterial.

Dosage and Administration

Dosing varies by indication. Common adult regimens are 500 mg as a single dose on Day 1 followed by 250 mg once daily on Days 2 through 5, or 500 mg once daily for 3 days for sinusitis. Tablets may be taken with or without food.

Warnings and Precautions

• Serious allergic reactions and severe skin reactions, including angioedema, anaphylaxis, Stevens-Johnson syndrome, and DRESS, have been reported
• Hepatotoxicity, including cases of fatal liver failure, may occur; discontinue if signs of liver dysfunction appear
• QT prolongation and torsades de pointes, along with a small increased risk of cardiovascular death, have been observed
• Clostridioides difficile-associated diarrhea may occur and can range from mild to fatal colitis

Contraindications

Contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, or any macrolide or ketolide, and in those with a history of cholestatic jaundice or hepatic dysfunction associated with prior azithromycin use.

Adverse Reactions

The most common adverse reactions are gastrointestinal, including diarrhea, nausea, abdominal pain, and vomiting. Serious reactions such as angioedema, anaphylaxis, and severe skin and hepatic reactions occur rarely.

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F), with excursions permitted to 15°C to 30°C.

How Supplied

Supplied as 250 mg film-coated tablets in unit-of-use packaging containing 18 tablets.

Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.