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warnings and cautions
5 WARNINGS AND PRECAUTIONS Risks of Cardiorespiratory Adverse Reactions: Serious cardiorespiratory adverse reactions have occurred, sometimes resulting in death or permanent neurologic injury, after administration of midazolam. ( 5.4 ) Other Adverse Reactions: Agitation can occur. ( 5.5 ) Risks from Concomitant Use of Central Nervous System (CNS) Depressants: May increase risk of hypoventilation, airway obstruction, desaturation, or apnea, and may contribute to profound and/or prolonged drug effect. Practitioners administering SEIZALAM must have the skills necessary to manage serious cardiorespiratory adverse reactions, including skills in airway management. ( 5.6 ) Impaired Cognitive Function: Because of partial or complete impairment of recall, patients should not operate hazardous machinery or a motor vehicle until drug effects have subsided. ( 5.7 ) Glaucoma: Patients with open-angle glaucoma may need to have their ophthalmologic status evaluated following treatment with SEIZALAM. SEIZALAM is not recommended in patients with narrow-angle glaucoma. ( 5.8 ) Neonatal Sedation and Withdrawal Syndrome: SEIZALAM use during pregnancy can result in neonatal sedation and/or neonatal withdrawal ( 5.9 , 8.1 ) 5.1 Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including SEIZALAM, and opioids may result in profound sedation, respiratory depression, coma, and death. If a decision is made to use midazolam concomitantly with opioids, monitor patients closely for respiratory depression and sedation [see Drug Interactions ( 7.1 )]. Practitioners administering SEIZALAM must have the skills necessary to manage serious cardiorespiratory adverse reactions, including skills in airway management. 5.2 Abuse, Misuse, and Addiction The use of benzodiazepines, including SEIZALAM, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death [see Drug Abuse and Dependence ( 9.2 )] . Before prescribing SEIZALAM and throughout treatment, assess each patient's risk for abuse, misuse, and addiction. Use of SEIZALAM, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of SEIZALAM along with monitoring for signs and symptoms of abuse, misuse, and addiction. Do not exceed the recommended dosing frequency; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. If a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate. 5.3 Dependence and Withdrawal Reactions After Use of SEIZALAM More Frequently Than Recommended For patients using SEIZALAM more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue SEIZALAM (a patient-specific plan should be used to taper the dose). Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use. Acute Withdrawal Reactions The continued use of benzodiazepines may lead to clinically significant physical dependence. Although SEIZALAM is indicated only for intermittent use [see Indications and Usage ( 1 ) and Dosage and Administration ( 2 )] , if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of SEIZALAM, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) [see Drug Abuse and Dependence ( 9.3 )]. Protracted Withdrawal Syndrome In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months [see Drug Abuse and Dependence ( 9.3 )] . 5.4 Risks of Cardiorespiratory Adverse Reactions Serious cardiorespiratory adverse reactions have occurred after administration of midazolam. These have included respiratory depression, airway obstruction, oxygen desaturation, apnea, respiratory arrest and/or cardiac arrest, sometimes resulting in death or permanent neurologic injury. There have also been rare reports of hypotensive episodes requiring treatment during or after diagnostic or surgical manipulations, particularly in patients with hemodynamic instability. Hypotension occurs more frequently in patients premedicated with a narcotic. The danger of hypoventilation, airway obstruction, or apnea is greater in elderly patients and those with chronic disease states or decreased pulmonary reserve [see Use in Specific Populations ( 8.5 , 8.7 )] ; patients with COPD are highly sensitive to the respiratory depressant effect of midazolam. SEIZALAM should be administered with caution to patients in shock or coma with depression of vital signs. Practitioners administering SEIZALAM must have the skills necessary to manage serious cardiorespiratory adverse reactions, including skills in airway management. 5.5 Other Adverse Reactions Reactions such as agitation, involuntary movements (including tonic/clonic movements and muscle tremor), hyperactivity, and combativeness have been reported with midazolam when used for sedation. These reactions may be caused by inadequate or excessive dosing or improper administration of midazolam; however, consideration should be given to the possibility of cerebral hypoxia or true paradoxical reactions. Agitation also occurred in the randomized controlled clinical study of SEIZALAM in patients with status epilepticus [see Adverse Reactions ( 6.1 )]. 5.6 Risks from Concomitant Use of Central Nervous System Depressants Concomitant use of barbiturates, alcohol or other central nervous system depressants may increase the risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect. SEIZALAM should be administered with caution to patients in acute alcohol intoxication with depression of vital signs. Narcotic premedication also depresses the ventilatory response to carbon dioxide stimulation. The efficacy and safety of midazolam in clinical use are functions of the dose administered, the clinical status of the individual patient, and the use of concomitant medications capable of depressing the central nervous system (CNS). Anticipated effects range from mild sedation to deep levels of sedation virtually equivalent to a state of general anesthesia where the patient may require external support of vital functions. Practitioners administering SEIZALAM must have the skills necessary to manage serious cardiorespiratory adverse reactions, including skills in airway management. For information regarding withdrawal, see Drug Abuse and Dependence ( 9.3 ) . 5.7 Impaired Cognitive Function Midazolam is associated with a high incidence of partial or complete impairment of recall for several hours following an administered dose. Gross tests of recovery from the effects of midazolam cannot be relied upon to predict reaction time under stress. It is recommended that no patient operate hazardous machinery or a motor vehicle until the effects of the drug, such as drowsiness, have subsided, and as their medical condition permits. 5.8 Glaucoma Benzodiazepines, including SEIZALAM, can increase intraocular pressure in patients with glaucoma. Measurements of intraocular pressure in patients without eye disease show a moderate lowering following induction with midazolam; patients with glaucoma have not been studied. Patients with open-angle glaucoma may need to have their ophthalmologic status evaluated following treatment with SEIZALAM. SEIZALAM is not recommended in patients with narrow-angle glaucoma. 5.9 Neonatal Sedation and Withdrawal Syndrome Use of SEIZALAM late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate [see Use in Specific Populations ( 8.1 )] . Monitor neonates exposed to SEIZALAM during pregnancy or labor for signs of sedation and monitor neonates exposed to SEIZALAM during pregnancy for signs of withdrawal; manage these neonates accordingly. 5.10 Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative SEIZALAM is not approved for use in neonates or infants. Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and low birth weight infants treated with benzyl alcohol-preserved drugs, including SEIZALAM. The “gasping syndrome” is characterized by CNS depression, metabolic acidosis, and gasping respirations. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known (SEIZALAM contains 10 mg of benzyl alcohol per mL) [see Use in Specific Populations ( 8.4 )] .