Seizalam

— THERAPEUTIC CATEGORIES —
  • Seizure disorders

Seizalam Generic Name & Formulations

General Description

Midazolam (as HCl) 5mg/mL; soln for IM inj; contains benzyl alcohol.

Pharmacological Class

Benzodiazepine.

How Supplied

Multiple-dose vial (10mL)—1, 10

Generic Availability

NO

Seizalam Indications

Indications

Status epilepticus.

Seizalam Dosage and Administration

Adult

10mg, given by IM inj into the mid-outer thigh.

Children

Not established.

Seizalam Contraindications

Not Applicable

Seizalam Boxed Warnings

Boxed Warning

Risks from concomitant use with opioids. Abuse, misuse, and addiction. Dependence and withdrawal reactions.

Seizalam Warnings/Precautions

Warnings/Precautions

To be administered under the supervision of experienced clinicians. Have resuscitation equipment available. Increased risk of drug-related mortality from concomitant use with opioids. Hemodynamic instability. Chronic disease states. Decreased pulmonary reserve. COPD. Shock, coma, or acute alcohol intoxication with depression of vital signs. Impaired cognitive function. Narrow-angle glaucoma: not recommended. Open-angle glaucoma: may need post-treatment eye evaluation. Obesity. CHF. Assess patient's risk for abuse, misuse, addiction prior to and during therapy. Avoid abrupt cessation. Withdraw gradually. Drug or alcohol abusers. Renal impairment. Premature neonates/infants: gasping syndrome (due to benzyl alcohol content). Neonatal sedation and withdrawal syndrome; monitor neonates exposed during pregnancy or labor. Pregnancy (esp. late stage). Nursing mothers: monitor infants.

Seizalam Pharmacokinetics

Metabolism

Hepatic (CYP3A4).

Elimination

Renal. Half-life: 4.2 (±1.87) hours.

Seizalam Interactions

Interactions

Increased risk of profound sedation, respiratory depression, coma, and death with opioids or other CNS depressants (eg, other benzodiazepines, sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, alcohol); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor. Caution when concomitant CYP3A4 inhibitors (eg, cimetidine, erythromycin, diltiazem, verapamil, ketoconazole, itraconazole).

Seizalam Adverse Reactions

Adverse Reactions

Decreased tidal volume, respiratory rate decrease, upper airway obstruction, agitation, pyrexia, inj site reactions; severe cardiorespiratory reactions, agitation, involuntary movements (including tonic/clonic movements and muscle tremor), hyperactivity, combativeness, paradoxical reactions, increased intraocular pressure.

Seizalam Clinical Trials

See Literature

Seizalam Note

Not Applicable

Seizalam Patient Counseling

See Literature