SEIZALAM is indicated for the treatment of status epilepticus in adults.

Injection: 50 mg/10 mL (5 mg/mL) of a sterile, clear, colorless to light yellow liquid solution in a multiple-dose vial.

SEIZALAM is contraindicated in patients with a known hypersensitivity to midazolam.

The following serious adverse reactions are discussed in greater detail in other sections:

Overdosage of benzodiazepines is characterized by central nervous system depression ranging from drowsiness to coma. In mild to moderate cases, symptoms can include drowsiness, confusion, dysarthria, lethargy, hypnotic state, diminished reflexes, ataxia, and hypotonia. Rarely, paradoxical or disinhibitory reactions (including agitation, irritability, impulsivity, violent behavior, confusion, restlessness, excitement, and talkativeness) may occur. In severe overdosage cases, patients may develop respiratory depression and coma. Overdosage of benzodiazepines in combination with other CNS depressants (including alcohol and opioids) may be fatal

In managing benzodiazepine overdosage, employ general supportive measures, including intravenous fluids and airway maintenance. Flumazenil, a specific benzodiazepine receptor antagonist indicated for the complete or partial reversal of the sedative effects of benzodiazepines in the management of benzodiazepine overdosage, can lead to withdrawal and adverse reactions, including seizures, particularly in the context of mixed overdosage with drugs that increase seizure risk (e.g., tricyclic and tetracyclic antidepressants) and in patients with long-term benzodiazepine use and physical dependency. The risk of withdrawal seizures with flumazenil use may be increased in patients with epilepsy. Flumazenil is contraindicated in patients who have received a benzodiazepine for control of a potentially life-threatening condition (e.g., status epilepticus). If the decision is made to use flumazenil, it should be used as an adjunct to, not as a substitute for, supportive management of benzodiazepine overdosage. See the flumazenil injection Prescribing Information.

Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

Midazolam is a white to light yellow crystalline compound, insoluble in water. The hydrochloride salt of midazolam, which is formed

SEIZALAM is a sterile, nonpyrogenic solution for intramuscular injection. Each mL contains 5 mg midazolam (equivalent to 5.6 mg midazolam hydrochloride) compounded with 1% benzyl alcohol as preservative, 0.01% edetate disodium, and 0.8% sodium chloride. The pH is adjusted to approximately 3 with hydrochloric acid and, if necessary, sodium hydroxide.

The safety and effectiveness of SEIZALAM for the treatment of status epilepticus was established in a multi-center, randomized, double-blind (double-dummy), active-control trial comparing midazolam administered intramuscularly (IM) via an auto-injector to lorazepam administered intravenously (IV). Patients meeting the diagnosis of status epilepticus, with continuing convulsive seizure activity after the arrival of paramedics, were eligible for enrollment. The ITT population consisted of 893 patients who were randomized to receive either IM midazolam (n=448) or IV lorazepam (n=445). Following randomization, each patient received study treatments administered by a healthcare professional (e.g., paramedic) prior to arrival at a hospital. According to the double-dummy design, adult patients received 10 mg IM midazolam followed by IV placebo or received IM placebo followed by 4 mg IV lorazepam. The primary efficacy endpoint was the termination of convulsive seizure activity (without the need for rescue medication) prior to arrival at the emergency department (ED) as determined by the ED attending physician. A statistically significantly higher percentage of midazolam-treated patients met the primary efficacy endpoint, as shown in

Patients having seizures will likely be unresponsive or may have difficulty in comprehending counseling information.