NEODOSE

INDICATIONS

Skeletal muscle relaxation/paralysis for neonates requiring rapid sequence intubation or nonemergent endotracheal intubation . Premedication is recommended in neonates for all non-emergent intubations if time permits. Premedication regimens for endotracheal intubation typically include a skeletal muscle relaxant in combination with an analgesic (an opioid) and/or sedative and a vagolytic agent (usually atropine). Use of a muscle relaxant without an analgesic agent is not recommended. Premedication has been shown to decrease the time to successful intubation and decrease the occurrence of adverse effects (ie, increased intracranial pressure, hypertension, decreased heart rate and oxygenation) in neonates. Use of succinylcholine has resulted in fewer intubation attempts and more successful intubations compared with no succinylcholine in clinical studies in neonates.

FDA APPROVED INDICATION

Adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

CONTRAINDICATIONS/PRECAUTIONS

Contraindicated in the acute phase of injury after multiple trauma, major burns, extensive denervation of skeletal muscle, or upper motor neuron injury; may result in severe hyperkalemia, and possible onset of cardiac arrest. Also contraindicated in patients with a personal or family history of malignant hyperthermia and in patients with skeletal muscle myopathies. Serious anaphylactic reactions, including fatal cases, have been reported. Bradycardia and possible asystole may occur; higher risk with second dose; incidence and severity increased in pediatric patients compared with adults; premedication regimen that includes atropine may protect against bradyarrhythmias induced by succinylcholine. Hyperkalemia may occur. Serious cardiac arrhythmias or cardiac arrest due to hyperkalemia may occur in patients with massive digitalis toxicity or patients with electrolyte abnormalities. Increased risk of severe hyperkalemia in patients with subarachnoid hemorrhage or chronic abdominal infection, or conditions causing degeneration of central and peripheral nervous systems. Risk of prolonged neuromuscular blockade in patients with reduced plasma cholinesterase activity, such as those with genetic abnormalities of plasma cholinesterase (eg, heterozygous or homozygous for atypical plasma cholinesterase gene) or conditions associated with pregnancy, severe liver or kidney disease, malignant tumors, infections, burns, anemia, decompensated heart disease, peptic ulcer, or myxedema. Neuromuscular blockade may also be prolonged in patients with hypokalemia or hypocalcemia. Prolonged administration may result in a block resembling a nondepolarizing block (Phase II block). Risk of tachyphylaxis with repeated use. Malignant hyperthermia has been reported rarely in children who have received succinylcholine ; increased risk with coadministration of volatile anesthetics; monitoring recommended. Intracranial pressure increase (transient) may occur. Increased intraocular pressure has been reported in patients with narrow angle glaucoma or penetrating eye injury. Intragastric pressure increase may occur, resulting in regurgitation and possible aspiration of stomach contents. Initial muscle fasciculations may cause additional trauma in patients with fractures or muscle spasm . Muscle fasciculations have been rarely reported in children.

ADVERSE EFFECTS

Hypertension, hypotension, prolonged respiratory depression or apnea, jaw rigidity, postoperative muscle pain, excessive salivation, and rash have been reported.

ADMINISTRATION

May administer undiluted as an IV bolus or further dilute in compatible solution to a concentration of 1 to 2 mg/mL.

BLACK BOX WARNING

Acute rhabdomyolysis with hyperkalemia followed by ventricular dysrhythmias, cardiac arrest, and death have been rarely reported in seemingly healthy children (usually, but not exclusively, males, and most frequently 8 years of age or younger) who were subsequently found to have undiagnosed skeletal muscle myopathy (most frequently Duchenne’s muscular dystrophy) after administration of succinylcholine chloride. This syndrome often presents as peaked T-waves and sudden cardiac arrest within minutes after the administration of the drug. Treatment for hyperkalemia should be immediately instituted for infants or children who appear healthy but develop cardiac arrest, not felt to be due to inadequate ventilation, oxygenation, or anesthetic overdose after administration of succinylcholine chloride. Routine resuscitative measures are likely to be unsuccessful; extraordinary and prolonged resuscitative efforts may be required. If there are signs present for malignant hyperthermia, appropriate treatment should be instituted concurrently. It is recommended that succinylcholine chloride use in children be restricted to emergency intubation or instances where immediate securing of the airway is necessary.

MONITORING

Monitor oxygen saturation, heart rate, and blood pressure continuously. Closely monitor ECG for peaked T-waves, an early sign of potential cardiac arrest secondary to acute rhabdomyolysis with hyperkalemia. Monitor temperature and expired carbon dioxide continuously for early recognition of malignant hyperthermia.