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. Abuse, misuse, and addiction. Dependence and withdrawal reactions.
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. Assess patient's risk for abuse, misuse, addiction prior to and during therapy. Avoid abrupt cessation. Withdraw gradually. Drug or alcohol abusers. 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; withdrawal reactions.
Generic Drug Availability:
Single-dose nasal spray—2 units