Indications for NAYZILAM:
Acute treatment of intermittent, stereotypic episodes of frequent seizure activity (eg, seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in those with epilepsy.
Give as single spray into one nostril; if no response after 10mins, may give additional spray into opposite nostril; max 2 sprays/episode. Max treatment: one episode every 3 days or 5 episodes/month.
<12yrs: not established.
Acute narrow-angle glaucoma.
Risks from concomitant use with opioids.
Increased risk of drug-related mortality from concomitant use with opioids. Decreased pulmonary reserve. COPD. Monitor for the emergence or worsening of depression, suicidal thoughts/behavior, and/or unusual changes in mood or behavior. Open-angle glaucoma. Impaired cognitive function. Obesity. CHF. Avoid abrupt cessation. Drug or alcohol abuse. Hepatic or moderate to severe renal impairment. Elderly. Debilitated. Labor & delivery. Neonatal withdrawal and floppy infant syndrome. Pregnancy. Nursing mothers.
Increased risk of profound sedation, respiratory depression, coma, and death with opioids or other CNS depressants (eg, other benzodiazepines, sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, alcohol); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor. Avoid concomitant with moderate/strong CYP3A4 inhibitors (eg, erythromycin, diltiazem, verapamil, ketoconazole, itraconazole, clarithromycin). Caution with concomitant mild CYP3A inhibitors.
Somnolence, headache, nasal discomfort, throat irritation, rhinorrhea; severe cardiorespiratory reactions, agitation, involuntary movements (including tonic/clonic movements and muscle tremor), hyperactivity, combativeness.
Generic Drug Availability:
Single-dose nasal spray—2 units