IENT COUNSELING INFORMATION and MedicationGuide.
Revised: 5/2019
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FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Instructions Prior to Dosing
2.2 Dosage Information
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Risks from Concomitant Use with Opioids
5.2 Risks of Cardiorespiratory Adverse Reactions
5.3 CNS Depression from Concomitant Use with Other CNSDepressants, or Moderate or Strong CYP3A4 Inhibitors
5.4 Suicidal Behavior and Ideation
5.5 Impaired Cognitive Function
5.6 Glaucoma
5.7 Other Adverse Reactions
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
7.1 CYP3A4 Inhibitors
7.2 Opioids
7.3 Other CNS Depressants
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Congestive Heart Failure
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
9.2 Abuse
9.3 Dependence
9.4 Chronic Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED / STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are notlisted
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FULL PRESCRIBING INFORMATION
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound sedation,respiratory depression, coma, and death [see Warnings and Precautions (5.1), Drug
Interactions (7.2)].
• Reserve concomitant prescribing of these drugs for use in patients for whomalternative treatment options are inadequate.
• Limit dosages and durations to the minimum required.
• Follow patients for signs and symptoms of respiratory depression and sedation.
1 INDICATIONS AND USAGE
NAYZILAM is indicated for the acute treatment of intermittent, stereotypic episodes offrequent 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.
2 DOSAGE AND ADMINISTRATION
2.1 Instructions Prior to Dosing
NAYZILAM prescribers should consider the following prior to initiation of treatment:For patients at increased risk of respiratory depression from benzodiazepines, administrationof NAYZILAM under healthcare professional supervision should be considered prior totreatment with NAYZILAM; this administration may be performed in the absence of aseizure episode [see Warnings and Precautions (5.2)].
Prior to treatment, the healthcare professional should instruct the individual administeringNAYZILAM on how to identify seizure clusters and use the product appropriately [seePatient Counseling Information: Administration Information (17)].
Patients and caregiversshould be counseled to read carefully the “Instructions for Use” for complete directions onhow to properly administer NAYZILAM.
2.2 Dosage Information
Administer NAYZ |
