NEODOSE

INDICATIONS :

• Anesthesia Induction
  • Efficacy could not be validated and safety concerns were raised in a review of 3 studies (n=146 preterm neonates) of continuous infusion midazolam (30 to 60 mcg/kg/hr) for procedural sedation in the neonatal intensive care unit
  • Refractory seizures

CONTRAINDICATIONS

• Allergy to cherries (Oral syrup).
• Acute narrow-angle glaucoma.
• Open-angle glaucoma, untreated.

PRECAUTIONS

• Cardiovasculer :
  • Hypotension is common when used in conjunction with narcotics, or following rapid bolus administration.
  • Rarely hypotensive episodes requiring treatment during or after diagnostic or surgical manipulations have been reported; increased risk in patients with hemodynamic instability or in those premedicated with a narcotic.
  • Serious cardiorespiratory events, including cardiac arrest resulting in death or permanent injury have been reported with use of midazolam.
• Endocrin & Metabolic: Use particular caution in uncompensated acute illness (eg, severe fluid or electrolyte disturbances).
• Respiratory:
  • Serious respiratory events including respiratory depression, airway obstruction, oxygen desaturation, apnea, respiratory arrest, sometimes resulting in death or permanent injury have been reported with use of midazolam; the risk is greatest in those with chronic obstructive pulmonary disease, chronic disease states, or decreased pulmonary reserve, and concomitant use of barbiturates, alcohol, or other CNS depressants.
  • Serious respiratory events including respiratory depression, airway obstruction, oxygen desaturation, apnea, respiratory arrest, sometimes resulting in death or permanent injury have been reported with use of midazolam; the risk is greatest in those with chronic obstructive pulmonary disease, chronic disease states, or decreased pulmonary reserve, and concomitant use of barbiturates, alcohol, or other CNS depressants
• Neurologic:
  • CNS depression may occur; increased risk with concomitant use of alcohol, other CNS depressants (eg, opioids), barbiturates, and moderate or strong CYP3A4 inhibitors
  • Partial or complete impairment of recall may exist for several hours following an administered dose.
  • Brain development in children may be affected by repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures, especially in children younger than 3 years or in fetuses of pregnant women during the third trimester; balance appropriate anesthesia use and timing of elective procedures that can be delayed against potential risks in children younger than 3 years and pregnant women, particularly with procedures that are longer than 3 hours or multiple procedures.
• Psychiatric :
  • Antiepileptic drugs, including midazolam, may increase the risk of suicidal thoughts or behavior; monitoring is recommended.
  • Agitation, involuntary movements (including tonic/clonic movements and muscle tremor), hyperactivity, and combativeness have been reported with midazolam when used for sedation; consider the possibility of cerebral hypoxia or true paradoxical reactions.
• Ophthalmic: May increase intraocular pressure in patients with glaucoma; may be used in patients with open-angle glaucoma only if they are receiving appropriate therapy; monitoring is recommended.
• Spacial Populations :Gasping syndrome or other severe or fatal adverse effects can occur in neonates and low birth weight infants, as formulation contains benzyl alcohol
  • Surgery: Risk of desaturation and hypoventilation from partial airway obstruction increased in pediatric patients undergoing procedures involving upper airway (eg, upper endoscopy, dental care); those with cardiac or respiratory compromise may be unusually sensitive. Dosage adjustment may be required in higher-risk patients
  • Withdrawal: Symptoms of withdrawal have occurred following discontinuation

ADVERSE EFFECTS

Respiratory depression and hypotension are common when used in conjunction with narcotics, or following rapid bolus administration. Seizure-like myoclonus has been reported in 8% of premature infants receiving continuous infusions – this also may occur following rapid bolus administration and in patients with underlying CNS disorders. Nasal administration may be uncomfortable because of a burning sensation.

ADMINISTRATION

Intravenous: Administer slow IV push over 10 minutes at a concentration of 1 to 5 mg/mL.The recommended standard neonatal concentration is 1 mg/mL. For continuous IV infusion, may dilute in NS or D5W to a concentration of 0.5 mg/mL. Caution should be taken to avoid intra-arterial injection or extravasation.

MONITORING

Follow respiratory status and blood pressure closely, especially when used concurrently with narcotics. Assess hepatic function. Observe for signs of withdrawal after discontinuation of prolonged therapy.