a decision is made to prescribe NAYZILAMconcomitantly with opioids, instruct caregivers to follow patients closely for signs andsymptoms of respiratory depression and sedation [see Warnings and Precautions (5.1)].
Risks of Cardiorespiratory Adverse Reactions
Warn patients and caregivers about the risks of respiratory depression, cardiac andrespiratory arrest [see Warnings and Precautions (5.2)].
Advise caregivers on the signs and symptoms of respiratory depression to look for, how longto observe patients after administering NAYZILAM, the circumstances under which a seconddose should not be given, and the circumstances under which emergency medical care shouldbe summoned [see Dosage and Administration (2.1)].
CNS Depression from Concomitant Use with Other CNS DepressantsWarn patients and caregivers that the use of NAYZILAM in combination with alcohol orother CNS depressant drugs may increase the risk of hypoventilation, airway obstruction,desaturation, or apnea and may contribute to profound and/or prolonged drug effect [seeWarnings and Precautions (5.3)].
Caution patients against engaging in hazardous occupations requiring mental alertness, suchas operating machinery, driving a motor vehicle or riding a bicycle until they havecompletely returned to their level of baseline functioning.
Suicidal Behavior and Ideation
Counsel patients, their caregivers, and families that AEDs, including NAYZILAM, mayincrease the risk of suicidal thoughts and behavior and that they should be alert for theemergence or worsening of the signs and symptoms of depression, any unusual changes inmood or behavior or the emergence of suicidal thoughts, behavior or thoughts about selfharm.Behaviors of concern should be reported immediately to healthcare providers [seeWarnings and Precautions (5.4)].
Impaired Cognitive Function
Warn patients that midazolam, including NAYZILAM, is associated with a high incidence ofpartial or complete impairment of recall for the next several hours. Counsel patients on whenthey can engage in activities requiring complete mental alertness, operate hazardousmachinery, or drive a motor vehicle after taking NAYZILAM [see Warnings andPrecautions (5.5)].
Pregnancy
Instruct patients to inform their physician if they are pregnant or are planning to becomepregnant. Several studies have suggested an increased risk of congenital malformationsassociated with the use of benzodiazepine drugs. Animal studies have demonstrated an effecton early brain development and long-term cognitive effects with exposure to anesthetic andsedation drugs in the third trimester of gestation. Encourage patients to enroll in the NorthAmerican Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. Theregistry is collecting information about the safety of antiepileptic drugs during pregnancy[see Use in Specific Populations (8.1)].
Lactation
Instruct patients to inform their physicians if they are nursing [see Use in SpecificPopulations (8.2)].
Important Treatment Instructions
Instruct patients and caregivers on what is and is not an intermittent and stereotypic episodeof increased seizure activity (i.e., seizure cluster) that is appropriate for treatment, and thetiming of administration in relation to the onset of the episode.
Instruct patients and caregivers on what to observe following administration, and what wouldconstitute an outcome requiring immediate medical attention.
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