HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
NAYZILAM® safely and effectively. See full prescribing informationfor NAYZILAM®.
NAYZILAM® (midazolam) nasal spray, CIV
Initial U.S. Approval: 1985
WARNING: RISKS FROM CONCOMITANT USE WITH
OPIOIDS
See full prescribing information for complete boxed warning.
Concomitant use of benzodiazepines and opioids may result inprofound sedation, respiratory depression, coma, and death (5.1,7.2)
INDICATIONS AND USAGE
NAYZILAM is a benzodiazepine indicated for the acute treatment ofintermittent, stereotypic episodes of frequent seizure activity (i.e., seizure
clusters, acute repetitive seizures) that are distinct from a patient’s usualseizure pattern in patients with epilepsy 12 years of age and older. (1)
DOSAGE AND ADMINISTRATION
Administer NAYZILAM by the nasal route only. (2.2)
Initial Dose: Administer one spray (5 mg dose) into one nostril. (2.2)
Second Dose: One additional spray (5 mg dose) into the opposite nostrilmay be administered after 10 minutes if the patient has not responded tothe initial dose. (2.2)
Maximum Dosage and Treatment Frequency: Do not use more than 2doses of NAYZILAM to treat a seizure cluster. It is recommended that NAYZILAM be used to treat no more than one episode every three daysand treat no more than five episodes per month. (2.2)
DOSAGE FORMS AND STRENGTHS
Single-dose nasal spray unit containing 5 mg midazolam per 0.1 mLsolution. (3)
CONTRAINDICATIONS
Patients with hypersensitivity to midazolam (4)
Patients with acute narrow-angle glaucoma (4)
WARNINGS AND PRECAUTIONS
CNS Depression From Concomitant Use With Other CNS Depressants orModerate or Strong CYP3A4 Inhibitors: May cause an increased CNSdepressanteffect when used with alcohol or other CNS depressants.
Concomitant use with moderate or strong CYP3A4 inhibitors may resultin prolonged sedation because of a decrease in plasma clearance ofmidazolam. (5.3, 7.3)
Suicidal Behavior and Ideation: Antiepileptic drugs increase the risk ofsuicidal ideation and behavior. (5.4)
Impaired Cognitive Function: Midazolam is associated with a highincidence of partial or complete impairment of recall for the next severalhours. (5.5)
ADVERSE REACTIONS
The most common adverse reactions (≥5% in any NAYZILAM treatment group)were somnolence, headache, nasal discomfort, throat irritation, and rhinorrhea(6.1)
To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at1-844-599-2273 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
CYP3A4 Inhibitors: Avoid co-administration of NAYZILAM withmoderate or strong CYP3A4 inhibitors. NAYZILAM should be used withcaution when co-administered with mild CYP3A4 inhibitors. (7.1)
Opioids: Risk of respiratory depression is increased. (7.2)
Other CNS Depressants: May increase the risks of hypoventilation, airwayobstruction, desaturation, or apnea and may contribute to profound and/orprolonged drug effect. (7.3)
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm. (8.1)
Lactation: Midazolam is excreted in human milk. Caution should beexercised when NAYZILAM is administered to a nursing woman. (8.2)
Renal Impairment: Patients with renal impairment may have longerelimination half-lives for midazolam and its metabolites which may result
in prolonged exposure. (8.6)
See 17 for PAT |
