ILAM by the nasal route only.
Initial Dose: Administer one spray (5 mg dose) into one nostril.
Second Dose (if needed): One additional spray (5 mg dose) into the opposite nostril may beadministered after 10 minutes if the patient has not responded to the initial dose.
A second dose of NAYZILAM should not be administered if the patient has trouble breathingor if there is excessive sedation that is uncharacteristic of the patient during a seizure clusterepisode [see Warnings and Precautions (5.2)].
Maximum Dosage and Treatment Frequency: Do not use more than 2 doses of NAYZILAMto treat a single episode.
It is recommended that NAYZILAM be used to treat no more than one episode every threedays and no more than 5 episodes per month [see Drug Abuse and Dependence (9.4)].
3 DOSAGE FORMS AND STRENGTHS
NAYZILAM is supplied as a single-dose nasal spray unit containing 5 mg of midazolam in0.1 mL solution.
4 CONTRAINDICATIONS
NAYZILAM is contraindicated in patients with:
• Known hypersensitivity to midazolam.
• Acute narrow-angle glaucoma [see Warnings and Precautions (5.6)].
5 WARNINGS AND PRECAUTIONS
5.1 Risks from Concomitant Use with Opioids
Concomitant use of benzodiazepines, including NAYZILAM, and opioids may result inprofound sedation, respiratory depression, coma, and death. Because of these risks, reserveconcomitant prescribing of benzodiazepines and opioids for use in patients for whomalternative treatment options are inadequate.
Observational studies have demonstrated that concomitant use of opioid analgesics andbenzodiazepines increases the risk of drug-related mortality compared to use of opioids alone.
If a decision is made to prescribe NAYZILAM concomitantly with opioids, prescribe thelowest effective dosages and minimum durations of concomitant use, and follow patientsclosely for signs and symptoms of respiratory depression and sedation. Advise both patientsand caregivers about the risks of respiratory depression and sedation when NAYZILAM isused with opioids [see Drug Interactions (7.2)].
5.2 Risks of Cardiorespiratory Adverse Reactions
Serious cardiorespiratory adverse reactions have occurred after administration of midazolam.
These have included respiratory depression, airway obstruction, oxygen desaturation, apnea,respiratory arrest and/or cardiac arrest, sometimes resulting in death or permanent neurologicinjury.
There have also been rare reports of hypotensive episodes requiring treatment during or after diagnostic or surgical manipulations, particularly in patients with hemodynamicinstability. Hypotension occurs more frequently in patients premedicated with a narcotic.
Thedanger of hypoventilation, airway obstruction, or apnea is greater in elderly patients andthose with chronic disease states or decreased pulmonary reserve [see Use in SpecificPopulations (8.5)]; patients with chronic obstructive pulmonary disease are highly sensitiveto the respiratory depressant effect of midazolam.
Respiratory depression was observed with the administration of NAYZILAM during clinicaltrials [see Adverse Reactions (6.1)]. Cardiac or respiratory arrest caused by NAYZILAM wasnot reported during clinical trials.
5.3 Central Nervous System Depression from Concomitant Use with Other CentralNervous System Depressants, or Moderate or Strong CYP3A4 InhibitorsDrug products containing midazolam, including NAYZILAM, have a central nervous system(CNS) depressant e |
