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Seizalam<sup>&reg;</sup> (midazolam injection), for intramuscular use

 
 

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FDA approval of intramuscular midazolam (trade name, Seizalam) expands the possible uses of the drug, enabling it to be used to treat status epilepticus in civilian and military hospitals, as well as in combat casualty care, providing greater utility to civilian and military communities.7

Seizalam should be administered by a healthcare professional who has had adequate training in the recognition and treatment of status epilepticus.8

Product indication

Indication:

Seizalam is a benzodiazepine indicated for the treatment of status epilepticus in adults.

Product Especification
To order or request a quote, call 1-800-638-8093
Key Product Specifications9:
NDC 11704-650-10
Delivers Seizalam (midazolam injection) is a clear, colorless to light yellow, sterile solution available in multiple-dose flip-top vials containing 50 mg/10 mL (5 mg/mL)
Administration Type Intramuscular injection
Dimensions W: 54 mm x L: 128 mm x H: 57 mm
Packaged 10 glass vials in 1 carton; 10 mL in 1 vial
Storage

Store at 20°C-25°C (68°F-77°F); excursions permitted between 15°C-30°C (59°F-86°F) [See USP Controlled Room Temperature].

DEA Schedule Schedule IV (CIV) substances
Prescription Required Yes

 

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IMPORTANT SAFETY INFORMATION AND INDICATION
<p style="margin-top: 10px;"><strong>IMPORTANT SAFETY INFORMATION</strong></p> <table align="center" border="1" cellpadding="1" cellspacing="1" class="isi-table-outside-border"> <tbody> <tr> <td> <div> <p align="center"><strong>WARNING:</strong> <strong>RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS</strong></p> <p align="center"><strong><em>See full <a href="/sites/default/files/USPI–Seizalam–midazolam-injection-Meridian-Medical_Multi-Use-Vial-5_mg_mL-Flip-top-vial-10mL.pdf" target="_blank">prescribing information</a> for complete boxed warning</em></strong></p> <ul> <li><strong>Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Monitor patients for respiratory depression and sedation.</strong></li><p></p> <li><strong>The use of benzodiazepines, including SEIZALAM, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing SEIZALAM and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction.</strong></li><p></p> <li><strong>Although SEIZALAM is indicated only for intermittent use, if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of SEIZALAM may precipitate acute withdrawal reactions, which can be life-threatening. For patients using SEIZALAM more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue SEIZALAM.</strong></li> </ul> </div> </td> </tr> </tbody> </table> <p></p> <p>SEIZALAM is contraindicated in patients with a known hypersensitivity to midazolam.</p> <p>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<em>.</em>&nbsp; Practitioners administering SEIZALAM must have the skills necessary to manage serious cardiorespiratory adverse reactions, including skills in airway management.</p> <p>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.</p> <p>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.</p> <p>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).</p> <p>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.</p> <p>The continued use of benzodiazepines may lead to clinically significant physical dependence. Although SEIZALAM is indicated only for intermittent use, 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)<em>.</em></p> <p>In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months.</p> <p>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; 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.</p> <p>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<em>.</em></p> <p>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.</p> <p>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.</p> <p>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.</p> <p>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.</p> <p>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).</p> <p>Caution is advised when SEIZALAM is administered concomitantly with drugs that are known to inhibit the P450-3A4 enzyme system (e.g., cimetidine, erythromycin, diltiazem, verapamil, ketoconazole, and itraconazole). These drug interactions may result in prolonged sedation caused by a decrease in plasma clearance of midazolam.</p> <p>Geriatric patients may have altered drug distribution; diminished hepatic and/or renal function; longer elimination half-lives for midazolam and its metabolites, and subjects over 70 years of age may be particularly sensitive<em>. </em>Administration of IM midazolam to elderly patients has been associated with rare reports of death under circumstances compatible with cardiorespiratory depression.&nbsp; In most of these cases, the patients received other central nervous system depressants capable of depressing respiration, especially narcotics. Close monitoring of geriatric patients is recommended.</p> <p>There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs during pregnancy. Encourage women who are taking SEIZALAM during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry by calling 1-888-233-2334 or visiting <a class="pfizermed-link external-disclaimer" href="http://www.aedpregnancyregistry.org/" target="_blank">http://www.aedpregnancyregistry.org/</a>.</p> <p>The manifestations of midazolam overdosage are similar to those observed with other benzodiazepines, including sedation, somnolence, confusion, impaired coordination, diminished reflexes, coma, and untoward effects on vital signs. Treatment of injectable midazolam overdosage is the same as that followed for overdosage with other benzodiazepines. Attention should be given to the maintenance of a patent airway and support of ventilation, including administration of oxygen.&nbsp; Flumazenil, a specific benzodiazepine-receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. The reversal of benzodiazepine effects may be associated with the onset of seizures in certain high-risk patients. Its use in patients with epilepsy is typically not recommended.</p>
<p class="title-indication"><strong>Indication<span class="colon">:</span></strong></p> <p><span class="uppercase">Seizalam</span> is a benzodiazepine indicated for the treatment of status epilepticus in adults.</p> <p class="indication-pi-link">Please see full <a href="/sites/default/files/USPI–Seizalam–midazolam-injection-Meridian-Medical_Multi-Use-Vial-5_mg_mL-Flip-top-vial-10mL.pdf" target="_blank">Prescribing Information</a>.</p>
Important Safety Information and Indication