NEODOSE

INDICATIONS

Treatment of severe recurrent or prolonged seizures that do not respond to first-line therapies.

CONTRAINDICATIONS

• Complete heart block and wide complex tachycardia attributable to accessory conduction pathways.
• Stokes-Adams syndrome.
• Wolff-Parkinson-White Syndrome.
• Severe degrees of sinoatrial, atrioventricular, or intraventricular block.
• Known hypersensitivity to local anesthetics of the amide type.

PRECAUTIONS

• Cardiovascular:
  • Acceleration of ventricular rate may occur, particularly in patients with atrial fibrillation or flutter.
  • More frequent or serious ventricular arrhythmias or complete heart block may occur in patients with sinus bradycardia, or incomplete heart block without prior acceleration in heart rate.
• Endocrine & Metabolic:
  • Malignant hyperthermia may occur; discontinue use immediately and institute countermeasures. Hematologic: Methemoglobinemia has been reported with local anesthetic use; increased risk in patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites; close monitoring recommended in these patients.
• Hepatic:
  • Possible increased risk of toxicity in patients with impaired hepatic function.
• Immunologic:
  • Hypersensitivity reactions have been reported; immediate discontinuation required.
• Musculoskeletal:
  • Chondrolysis may occur with intraarticular infusions following arthroscopic or other surgical procedures (unapproved use).
• Renal:
  • Possible increased risk of toxicity in patients with impaired renal function.
• Special Populations:
  • Viscous lidocaine is not recommended or approved for teething pain. Seizures, cardiopulmonary arrest, and death have been associated with the use of viscous lidocaine for teething pain or oral irritation in infants and children.

ADVERSE EFFECTS

Do not use concurrently with phenytoin due to cardiac effects. Stop infusion immediately if significant cardiac arrhythmia occurs. Arrhythmias and significant bradycardia have occurred in 5% of reported cases. Slowing of the heart rate is common. In a retrospective study (n=521), the incidence of cardiac events with lidocaine treatment for seizures in term and preterm infants was 1.3% to 1.9%. Cardiac events included bradycardia (n=6) with 2:1 AV block in 2 infants and QRS prolongation in 1 infant. Irregular heart rate occurred in 2 infants, decreased heart rate not fulfilling bradycardia criteria occurred in 3, with a prolonged QT interval in 1 infant, and ventricular extrasystoles were reported in 2 infants. Tachycardia, hypotension, and asystole following bradycardia were reported in 1 infant each.

ADMINISTRATION

Administer loading dose as an IV bolus over 10 minutes at a concentration not exceeding 20 mg/mL. For continuous infusion, dilute in compatible diluent to a concentration of 0.8 to not exceeding 8 mg/mL or use available premixed solutions (4 to 8 mg/mL).

MONITORING

Continuous monitoring of EKG, heart rate, and blood pressure. Observe for worsening of seizure activity. Measuring blood concentrations is not clinically useful except when accumulation is suspected.