NEODOSE

INDICATIONS

• Severe Sepsis and Septic Shock: A small observational study (n=22; gestational age greater than 35 weeks) suggested that norepinephrine be used for shock associated with hypotension and poor perfusion (cold shock) that has not responded to fluid therapy and dopamine/dobutamine. Norepinephrine was started via central venous catheter at 0.2 to 0.5 mcg/kg/min and titrated every 30 minutes to target mean blood pressure; maximum individual infusion rate was 7.1 mcg/kg/min. Mean values for systemic blood pressure (diastolic greater than systolic), heart rate, and urine output increased, while oxygen need and plasma lactate levels decreased. Three infants required extracorporeal membrane oxygenation due to persistent pulmonary hypertension. The mortality rate was 18%.
• Persistent pulmonary hypertension (PPHN) with circulatory failure. A small observational study (n=18; gestational age greater than 35 weeks) demonstrated that norepinephrine improved lung function in neonates with PPHN having low systemic blood pressure and reduced cardiac output despite fluid resuscitation. Norepinephrine was started via central venous catheter at 0.5 mcg/kg/min and titrated every 30 minutes to target systemic artery pressure (SAP); the maximum infusion rate was 1 mcg/kg/min. Mean SAP and mean pulmonary artery pressure (PAP) were both increased, with a concomitant decrease in the mean PAP/SAP ratio, resulting in increased pulmonary blood flow and cardiac output. In addition, median oxygen need was progressively reduced over time. No study patient required extracorporeal membrane oxygenation.

CONTRAINDICATIONS/PRECAUTIONS

• • Hypotension due to blood volume deficits (except in emergency until blood can be administered).

• • During cyclopropane and halothane anesthesia.
  • In presence of profound hypoxia or hypercarbia.
  • Contains sodium metabisulfite, which may cause allergic-type reactions (eg, anaphylactic symptoms; life-threatening or less severe asthmatic episodes) in certain susceptible people.
  • Sensitivity is more common in asthmatic than nonasthmatic patients.

ADMINISTRATION

• Must be diluted before infusion and administered via large peripheral vein (antecubital or femoral). Preferred route is umbilical arterial and venous catheter.
• Intraosseous route is an option, but is not preferred especially in preterm newborns. at a concentration of 16 to 100 mcg/mL. Avoid the catheter tie-in technique.
• Constantly watch the flow rate and never leave patient unattended .

BLACK BOX WARNING

To prevent sloughing and necrosis in areas in which extravasation has taken place, the area should be infiltrated as soon as possible with saline solution containing phentolamine mesylate 1 to 5 mg diluted in 5 mL of normal saline, an adrenergic blocking agent. Synthetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours. Phentolamine should be given as soon as possible after the extravasation is noted. A syringe with a fine hypodermic needle should be used, with the solution being infiltrated liberally throughout the area, which is easily identified by its cold, hard, and pallid appearance.

MONITORING

Monitor blood pressure every 2 minutes from start of administration until target blood pressure is obtained and every 5 minutes thereafter until infusion is discontinued. Observe for signs of extravasation. Assess for plasma volume depletion during prolonged treatment. When used for septic shock, monitor hemodynamics and oxygen saturation using techniques appropriate for clinical status. Target heart rate and perfusion pressure appropriate for patient’s gestational and postnatal age. For a full-term newborn, the target heart rate and perfusion pressure (mean arterial pressure minus central venous pressure) are 110 to 160 beats/min and 55 mm Hg, respectively