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Seizalam<sup>TM</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
IMPORTANT SAFETY INFORMATION AND INDICATION

SeizalamTM (midazolam injection), for intramuscular use

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Monitor patients for respiratory depression and sedation.

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

Serious cardiorespiratory adverse reactions have occurred after administration of midazolam, sometimes resulting in death or permanent neurologic injury, after administration of midazolam. 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.

Reactions such as agitation, involuntary movements, hyperactivity, and combativeness have been reported with midazolam when used for sedation.

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.

Midazolam is associated with a high incidence of partial or complete impairment of recall for several hours following an administered dose. It is recommended that no patient operate hazardous machinery or a motor vehicle until the effects of the drug have subsided, and as their medical condition permits.

Benzodiazepines, including Seizalam, can increase intraocular pressure in patients with glaucoma. Seizalam is not recommended in patients with narrow-angle glaucoma.

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.

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.

Based on animal data, midazolam may cause fetal harm. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs during pregnancy. Encourage women who are administered Seizalam during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry by calling 1‑888‑233‑2334 or visiting http://www.aedpregnancyregistry.org/.

Safety and effectiveness in pediatric patients have not been established. Seizalam is not approved for use in neonates or infants.

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. Administration of IM midazolam to elderly patients has been associated with rare reports of death under circumstances compatible with cardiorespiratory depression.

Patients with renal impairment may have a slower elimination of midazolam and its metabolites, which may result in prolonged drug exposure.

Patients with congestive heart failure eliminate midazolam more slowly, which may result in prolonged drug exposure.

Seizalam contains midazolam hydrochloride, a Schedule IV controlled substance. Midazolam was actively self-administered in primate models used to assess the positive reinforcing effects of psychoactive drugs. Midazolam produced physical dependence of a mild to moderate intensity in cynomolgus monkeys after 5 to 10 weeks of administration.

Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, hallucinations, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuation of benzodiazepines, including midazolam. Abdominal distention, nausea, vomiting, and tachycardia are prominent symptoms of withdrawal in infants. The more severe withdrawal symptoms have usually been limited to those patients who had received excessive doses over an extended period of time. 

The manifestations of midazolam overdosage reported 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. 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.

Indication:

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