INDICATIONS AND USAGE

NAYZILAM is a benzodiazepine indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure 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 nostril may be administered after 10 minutes if the patient has not responded to the initial dose. (2.2)

Maximum Dosage and Treatment Frequency: Do not use more than 2 doses of NAYZILAM to treat a seizure cluster. It is recommended that NAYZILAM be used to treat no more than one episode every three days and 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 mL solution. (3)