NAYZILAM

Nayzilam Generic Name & Formulations

Legal Class

CIV

General Description

Midazolam 5mg/0.1mL soln; per nasal spray.

Pharmacological Class

Benzodiazepine.

How Supplied

Single-dose nasal spray—2 units

Manufacturer

UCB Inc.

Generic Availability

Nayzilam Indications

Indications

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.

Nayzilam Dosage and Administration

Adult

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.

Children

<12yrs: not established.

Nayzilam Contraindications

Contraindications

Acute narrow-angle glaucoma.

Nayzilam Boxed Warnings

Boxed Warning

Risks from concomitant use with opioids. Abuse, misuse, and addiction. Dependence and withdrawal reactions.

Nayzilam Warnings/Precautions

Warnings/Precautions

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. Neonatal sedation and withdrawal syndrome; monitor neonates exposed during pregnancy or labor. Pregnancy (esp. late stage). Nursing mothers: monitor infants.

Nayzilam Pharmacokinetics

Distribution

Midazolam is ~97% bound to plasma protein, principally albumin. In healthy volunteers, 1-hydroxy midazolam is bound to the extent of 89%.

The estimated total volume of distribution of midazolam is 226.5 L.

Metabolism

Hepatic (CYP3A4).

Elimination

Renal. Half-life: 2.1–6.2 hours (midazolam); and 2.7–7.2 hours (1-hydroxy midazolam).

Nayzilam Interactions

Interactions

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.

Nayzilam Adverse Reactions

Adverse Reactions

Somnolence, headache, nasal discomfort, throat irritation, rhinorrhea; severe cardiorespiratory reactions, agitation, involuntary movements (including tonic/clonic movements and muscle tremor), hyperactivity, combativeness; withdrawal reactions.

Nayzilam Clinical Trials

See Literature

Nayzilam Note

Not Applicable

Nayzilam Patient Counseling