NEODOSE

INDICATIONS

• General: Treatment of infections caused by Chlamydia, Mycoplasma, and Ureaplasma intolerance.
• Chlamydial Infection: Oral erythromycin base or erythromycin ethylsuccinate is recommended as the first-line agent for the treatment of ophthalmia neonatorum or pneumonia caused by Chlamydia trachomatis,
• Gonococcal Ophthalmia Neonatorum; Prophylaxis: Universal prophylaxis with ophthalmic erythromycin to all newborns, regardless of gestational age, is recommended to prevent gonococcal ophthalmia neonatorum.

CONTRAINDICATIONS

Concomitant use with astemizole, terfenadine, cisapride, pimozide, ergotamine, or dihydroergotamine. Concomitant use with HMG CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin or simvastatin).

PRECAUTIONS

• Cardiovascular:
  • Life-threatening episodes of ventricular tachycardia associated with prolonged QT intervals (torsades de pointes) have been reported; increased risk in patients with electrolyte imbalance, hepatic dysfunction, myocardial ischemia, left ventricular dysfunction, idiopathic QT prolongation, and concurrent antiarrhythmic treatment.
  • QT interval prolongation, including rare cases of arrhythmia, torsade de pointes, and fatalities, has been reported;avoid use with known QT prolongation, uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and with Class IA(quinidine, procainamide), or Class III(dofetilide, amiodarone, sotalol) antiarrhythmic agents.
• Gastrointestinal:
  • Clostridium difficile associated diarrhea(CDAD) has been reported;may range in severity from mild diarrhea to fatal colitis.If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C.difficile may need to be discontinued;initiate appropriate fluid/electrolyte management, protein supplementation, antibacterial drug treatment for C difficile, and surgical evaluation if clinically indicated.
  • Infantile hypertrophic pyloric stenosis (IHPS) has been reported in infants following erythromycin treatment; weigh benefits against potential risk of developing IHPS.
• Hepatic:
  • Hepatic dysfunction, with or without jaundice, has been reported with oral erythromycin products; monitoring recommended for patients with impaired liver function.
• Immunologic:
  • Superinfection may occur with prolonged or repeated use; discontinue treatment and institute appropriate therapy.
• Musculoskeletal:
  • Exacerbation of weakness in patients with myasthenia gravis has been reported.

ADVERSE EFFECTS

The use of macrolide antibiotics was associated with infantile hypertrophic pyloric stenosi with a 30-fold increased risk in infants exposed at 0 to 13 days of age and 3-fold increase risk in infants exposed at 14 to 120 days of age in an observational study (n=6591).

ADMINISTRATION

Intravenous: Give as intermittent infusion over at least 60 minutes at a concentration of 1 to 5 mg/mL. IV push administration is not recommended.

MONITORING

Watch for diarrhea and signs of abdominal discomfort. Control CBC for eosinophilia. Monitor heart rate and blood pressure closely during IV administration. Observe IV site for signs of infiltration.