Indicted for:

Acute Bacterial Sinusitis in Adults and Community-Acquired Pneumonia:

For the treatment with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below:

• Acute bacterial sinusitis in adults due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae.
• Community-acquired pneumonia in adults and pediatric patients six months of age or older due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae, in patients appropriate for oral therapy. Pediatric use in this indication is based on extrapolation of adult efficacy.

Safety and effectiveness in the treatment of pediatric patients with acute bacterial sinusitis have not been established.

Zithromycin is not indicated for prophylaxis of bronchiolitis obliterans syndrome (BOS) in patients undergoing HSCT.

Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen in treatment with macrolides, including azithromycin. Providers should consider the risk of QT prolongation which can be fatal when weighing the risks and benefits of azithromycin for at-risk groups including:

• patients with known prolongation of the QT interval, a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias or uncompensated heart failure

• patients on drugs known to prolong the QT interval

• patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents

• Elderly patients may be more susceptible to drug-associated effects on the QT interval 

Some observational studies have shown an approximately two-fold increased short-term potential risk of acute cardiovascular death in adults exposed to azithromycin relative to other antibacterial drugs, including amoxicillin. The five-day cardiovascular mortality observed in these studies ranged from 20 to 400 per million azithromycin treatment courses. This potential risk was noted to be greater during the first five days of azithromycin use and does not appear to be limited to those patients with preexisting cardiovascular diseases. 

Serious allergic reactions, including angioedema, anaphylaxis, Acute Generalized Exanthematous Pustulosis (AGEP), Stevens Johnson syndrome, and toxic epidermal necrolysis have been reported in patients on azithromycin therapy using other formulations. Fatalities have been reported. Cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have also been reported.

Zmax is not recommended for use in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following:

• patients with cystic fibrosis
• patients with nosocomial infections
• patients with known or suspected bacteremia
• patients requiring hospitalization
• elderly or debilitated patients
• patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia) 

Zmax is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.

Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure have been reported, some of which have resulted in death.

Caution should be exercised when Zmax is administered to patients with GFR <10 mL/min, due to a higher incidence of gastrointestinal adverse events.

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Zmax, and may range in severity from mild diarrhea to fatal colitis.

Exacerbation of symptoms of myasthenia gravis and new onset of myasthenic syndrome have been reported in patients receiving azithromycin therapy.

Co-administration of nelfinavir at steady-state with a single oral dose of azithromycin resulted in increased azithromycin serum concentrations.

Spontaneous post-marketing reports suggest that concomitant administration of azithromycin may potentiate the effects of oral anticoagulants such as warfarin, although the prothrombin time was not affected in the dedicated drug interaction study with azithromycin and warfarin.

Interactions with digoxin or phenytoin have not been reported in clinical trials with azithromycin; however, no specific drug interaction studies have been performed to evaluate potential drug-drug interactions. However, drug interactions have been observed with other macrolide products.

Following the use of azithromycin in neonates (treatment up to 42 days of life), infantile hypertrophic pyloric stenosis has been reported. Direct parents and caregivers to contact their physician if vomiting or irritability with feeding occurs.

There are, however, no adequate and well-controlled studies in pregnant women. Decreased viability and delayed development were observed in the offspring of pregnant rats administered azithromycin from day 6 of pregnancy through weaning at a dose equivalent to an adult human oral dose of 2 g based on body  surface area.

Azithromycin has been reported to be excreted in human breast milk in small amounts.

GoToSource

• Use in patients under the age of 6 months. GoToSource

• Acute bacterial sinusitis in patients under the age of 18. GoToSource

• Pertussis. GoToSource

• Acne. GoToSource 

• Pelvic inflammatory disease. GoToSource

• Traveler’s diarrhea. GoToSource

• Dental abscess. GoToSource

• Prostatitis. GoToSource

• Urinary tract infections. GoToSource

• Syphilis. GoToSource

• Mediterranean spotted fever. GoToSource

• Prevention of streptococcal endocarditis. GoToSource

• Gastroparesis. GoToSource

• Cystic fibrosis. GoToSource

• Cat scratch disease. GoToSource

• Preventing mycobacterium avium complex infection in HIV-positive patients. GoToSource

• Prevention of exacerbations of COPD. GoToSource

Clostridium difficile-associated diarrhea. GoToSource

Prolonged cardiac repolarization and QT interval with risk of developing cardiac arrhythmia and torsades de pointes. GoToSource

Stevens-johnson syndrome (severe skin disorder). GoToSource

Exacerbation of myasthenia gravis. GoToSource

Severe hepatocellular toxicity (drug-induced liver injury) and hepatic encephalopathy (neuropsychiatric abnormalities in patients with liver dysfunction). GoToSource

Cholestatic hepatitis, jaundice and vanishing bile duct syndrome. GoToSource

Hearing loss. GoToSource

Sudden cardiac death. GoToSource

Interstitial nephritis (kidney disorder). GoToSource

Increased rate of relapse in cancers affecting the blood and lymph nodes, including death in cancer patients who undergo a donor stem cell transplant. GoToSource

Drug reaction with eosinophilia and systemic symptoms syndrome (life-threatening hypersensitivity reaction). GoToSource

Lawsuits filed for sudden cardiac death.