NEODOSE

INDICATIONS

• Bordetella; Treatment and Postexposure Prophylaxis: Azithromycin is the preferred agent for the treatment and postexposure prophylaxis of pertussis in infants younger than 1 month of age. Treat infants younger than 1 year within 6 weeks of cough onset. Prophylaxis should be administered within 21 days of onset of cough in the index patient.
• Bronchopulmonary Dysplasia (BPD), Prevention: Azithromycin compared with no treatment reduced the risk of BPD (55% vs 67% (RR = 0.83, 95% CI 0.71 to 0.98)) in extremely premature neonates in 3 randomized controlled studies. Dosages were 10 mg/kg/day IV for 1 week, then 5 mg/kg/day IV for 1 to 5 weeks.
• Chlamydia Infections: Erythromycin base or ethylsuccinate is the first-line agent and azithromycin a second-line agent for the treatment of ophthalmia neonatorum caused by Chlamydia trachomatis ; however, data are limited on azithromycin.

CONTRAINDICATIONS

Contraindicated in patients allergic to macrolide or ketolide antibiotics and patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin

PRECAUTIONS

• Cardiovascular:
  • QT-interval prolongation has been reported including cases of torsade de pointes. Patients with known or congenital QT prolongation, history of torsade de pointes, bradyarrhythmias, uncompensated heart failure, ongoing proarrhythmic conditions (eg, significant bradycardia, uncorrected hypokalemia or hypomagnesemia, or those receiving class IA or class III antiarrhythmic agents), or concomitant drugs known to prolong the QT interval are at increased risk.
  • Compared with penicillin or a cephalosporin, azithromycin was not associated with greater prevalence of cardiac arrest, overall mortality, or ventricular arrhythmias in a retrospective cohort study of 82,982 pediatric patients (median age 2.6 years) with community acquired pneumonia.
• Gastrointestinal:
  • Infantile hypertrophic pyloric stenosis has been reported in neonates up to 42 days of life treated with azithromycin.
• Hepatic:
  • Hepatotoxicity (eg, abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure), including fatalities, has been reported; if signs and symptoms of hepatitis occur, discontinue therapy.
• Immunologic:
  • Serious and sometimes fatal allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions such as acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported. Immediate discontinuation recommended; however, recurrence of allergic symptoms without further azithromycin exposure may occur.
• Long-term Use:
  • Avoid long-term azithromycin use for prophylaxis of bronchiolitis obliterans syndrome (unapproved use) to patients who undergo donor stem cell transplants due to the increased potential for cancer relapse and death.
• Neurologic:
  • Worsening of myasthenia gravis symptoms as well as new onset of myasthenia gravis has been reported rarely in association with azithromycin.

ADVERSE EFFECTS

Diarrhea and/or vomiting occur in 5% to 12% of patients. Irritability, rash, and blood in stool have also been reported. The most frequently reported gastrointestinal symptoms were vomiting, diarrhea, abdominal tenderness, and feeding intolerance in a systematic review of 11 articles (n=473 neonates) The use of macrolide antibiotics was associated with infantile hypertrophic pyloric stenosis with a 30-fold increased risk in infants exposed at 0 to 13 days of age and 3-fold increased risk in infants exposed at 14 to 120 days of age in an observational study (n=6591). Similar outcomes (highest risk of pyloric stenosis when exposed within the first couple weeks of life; although risk still present at 6 weeks of life) were demonstrated in another observational study (n= 4875 exposed to azithromycin)

ADMINISTRATION

• Intravenous: Intravenous: Dilute reconstituted solution (100 mg/mL) to a final concentration of 1 to 2 mg/mL. Give the 1 mg/mL concentration over 3 hours or 2 mg/mL concentration over 1 hour.
• Oral: Oral suspension can be given with or without feeding.

Assess gastrointestinal tolerance.