NAYZILAM- midazolam spray

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

midazolam (UNII: R60L0SM5BC) (midazolam - UNII:R60L0SM5BC)

Verfügbar ab:

UCB, Inc.

Verabreichungsweg:

NASAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

NAYZILAM is 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. NAYZILAM is contraindicated in patients with: - Known hypersensitivity to midazolam. - Acute narrow-angle glaucoma [see Warnings and Precautions (5.8)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as NAYZILAM, during pregnancy. Healthcare providers are encouraged to recommend that pregnant women who are taking NAYZILAM during pregnancy enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. Risk Summary Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal

Produktbesonderheiten:

NAYZILAM is supplied as a solution of midazolam. Each single-dose nasal spray unit delivers 5 mg of midazolam in 0.1 mL of solution. NAYZILAM is supplied in boxes of 2 nasal spray units (NDC 50474-500-15), each contained within an individual blister pack. Do not open the blister packaging until ready to use. Do not test or prime before use. Do not use if the nasal spray unit appears damaged. Store at controlled room temperature 20°C to 25°C (68°F to 77°F). Excursions permitted to 15°C to 30°C (59°F to 86°F).

Berechtigungsstatus:

New Drug Application

Gebrauchsinformation

UCB, Inc.
----------
MEDICATION GUIDE
NAYZILAM® (NAY-ZIL-AM)
(MIDAZOLAM) NASAL SPRAY, CIV
This Medication Guide has been approved by the U.S.
Food and Drug Administration
Issued: 1/2023
What is the most important information I should know about NAYZILAM?
•
NAYZILAM is a benzodiazepine medicine. Taking benzodiazepines with
opioid medicines, alcohol,
or other central nervous system (CNS) depressants (including street
drugs) can cause severe
drowsiness, breathing problems (respiratory depression), coma, and
death.
•
Get emergency medical help right away if any of the following happens:
•
shallow or slowed breathing
•
breathing stops (which may lead to the heart stopping)
•
excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking
NAYZILAM with
opioids may affect you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines, including NAYZILAM, which can lead to overdose and
serious side effects
including coma and death.
•
Serious side effects including coma and death have happened in people
who have abused or
misused benzodiazepines, including midazolam (the active ingredient in
NAYZILAM). These
serious side effects may also include delirium, paranoia, suicidal
thoughts or actions, seizures,
and difficulty breathing. Call your healthcare provider or go to the
nearest hospital emergency
room right away if you have any of these serious side effects.
•
You can develop an addiction even if you use NAYZILAM as prescribed by
your healthcare
provider.
•
Use NAYZILAM exactly as your healthcare provider prescribed.
•
Do not share your NAYZILAM with other people.
•
Keep NAYZILAM in a safe place and away from children.
•
Physical dependence and withdrawal reactions. Benzodiazepines,
including NAYZILAM, can cause
physical dependence and withdrawal reactions, especially if you use
NAYZILAM daily.
NAYZILAM is not intended for daily use.
•
Do not suddenly stop using NAYZILAM without talking to your healthcare
prov

Fachinformation

NAYZILAM- MIDAZOLAM SPRAY
UCB, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NAYZILAM SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NAYZILAM .
NAYZILAM (MIDAZOLAM) NASAL SPRAY, CIV
INITIAL U.S. APPROVAL: 1985
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND
ADDICTION; AND DEPENDENCE AND WITHDRAWAL REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN PROFOUND
SEDATION,
RESPIRATORY DEPRESSION, COMA, AND DEATH (5.1, 7.2)
THE USE OF BENZODIAZEPINES, INCLUDING NAYZILAM, EXPOSES USERS TO RISKS
OF ABUSE,
MISUSE, AND ADDICTION, WHICH CAN LEAD TO OVERDOSE OR DEATH. BEFORE
PRESCRIBING
NAYZILAM AND THROUGHOUT TREATMENT, ASSESS EACH PATIENT'S RISK FOR
ABUSE, MISUSE,
AND ADDICTION (5.2).
ALTHOUGH NAYZILAM IS INDICATED ONLY FOR INTERMITTENT USE (1, 2), IF
USED MORE
FREQUENTLY THAN RECOMMENDED, ABRUPT DISCONTINUATION OR RAPID DOSAGE
REDUCTION OF
NAYZILAM MAY PRECIPITATE ACUTE WITHDRAWAL REACTIONS, WHICH CAN BE
LIFE-
THREATENING. FOR PATIENTS USING NAYZILAM MORE FREQUENTLY THAN
RECOMMENDED, TO
REDUCE THE RISK OF WITHDRAWAL REACTIONS, USE A GRADUAL TAPER TO
DISCONTINUE
NAYZILAM (5.3).
RECENT MAJOR CHANGES
Warnings and Precautions (5.9)
1/2023
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 N