Seizalam

What Is Seizalam?

Seizalam (midazolam injection) is a benzodiazepine used to treat status epilepticus in adults.

What Are Side Effects of Seizalam?

Side effects of Seizalam include:

• upper airway obstruction,
• agitation,
• fever, and
• decreased tidal volume and/or decreased respiratory rate.

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.

Dosage for Seizalam

The recommended dose of Seizalam is 10 mg, administered by intramuscular injection.

Seizalam In Children

Safety and effectiveness in pediatric patients have not been established. Benzodiazepines are not recognized as a treatment for status epilepticus in neonates and should not be used in this population. Seizalam is not approved for use in neonates or infants.

What Drugs, Substances, or Supplements Interact with Seizalam?

Seizalam may interact with other medicines such as:

• opioids,
• other CNS depressants and alcohol, and
• cytochrome P450-3A4 inhibitors (e.g., cimetidine, erythromycin, diltiazem, verapamil, ketoconazole, and itraconazole)

Tell your doctor all medications and supplements you use.

Seizalam During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Seizalam; it may harm a fetus. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as Seizalam, during pregnancy. Seizalam passes into breast milk. Breastfed infants of mothers taking benzodiazepines, such as Seizalam, may have effects of lethargy, somnolence, and poor sucking. Consult your doctor before breastfeeding.

Additional Information

Our Seizalam (midazolam injection), for Intramuscular Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Midazolam can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing. Your caregivers will watch you for symptoms such as weak or shallow breathing.

Tell your caregivers right away if you have:

• wheezing, trouble breathing, weak or shallow breathing;
• slow heart rate;
• a light-headed feeling, like you might pass out;
• tremors, uncontrolled muscle movements; or
• confusion, hallucinations, unusual thoughts or behavior.

The sedative effects of midazolam may last longer in older adults. Accidental falls are common in elderly patients who use benzodiazepines.

Common side effects may include:

• headache;
• drowsiness;
• amnesia or forgetfulness after your procedure;
• hiccups;
• nausea, vomiting; or
• pain, redness, or tenderness where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Seizalam (Midazolam for Injection)

 

Seizalam Professional Information

SIDE EFFECTS

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

• Risks from Concomitant Use with Opioids [see WARNINGS AND PRECAUTIONS]
• Risks of Cardiorespiratory Adverse Reactions [see WARNINGS AND PRECAUTIONS]
• Other Adverse Reactions [see WARNINGS AND PRECAUTIONS]
• Risks from Concomitant Use of Central Nervous System Depressants [see WARNINGS AND PRECAUTIONS]
• Glaucoma [see WARNINGS AND PRECAUTIONS]
• Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse Reactions In The Controlled Study Of Intramuscular Midazolam In Patients With Status Epilepticus

In a double-blind, randomized, active-controlled clinical study, 448 patients were assigned to receive intramuscular (IM) midazolam via an autoinjector, and 445 were assigned to receive intravenous (IV) lorazepam. Approximately 45% of patients were female, and the mean age was 43 years. Patients were administered treatment by a healthcare professional (e.g., paramedic) prior to arrival at a hospital.

Table 1 lists the adverse reactions occurring in 2% or more of the IM midazolam-treated patients and at a rate greater than the IV lorazepam-treated patients.

Table 1 : Adverse Reactions in 2% or More of IM Midazolam-Treated Patients and More Frequent than in IV Lorazepam-Treated Patients in Out of Hospital Treatment of Status Epilepticus

Adverse Reaction	IM Midazolam N=448 (%)	IV Lorazepam N=445 (%)
Upper airway obstruction	5	3
Agitation	4	3
Pyrexia	4	3
Mental status changes	3	2
Postictal state	3	2
Acute renal failure	2	1

Adverse Reactions In Other Midazolam Studies

Fluctuations in vital signs were the most frequently seen findings following parenteral administration of midazolam in adults for uses other than that for which Seizalam is indicated, and included decreased tidal volume and/or respiratory rate decrease [11% of patients following intramuscular administration], as well as variations in blood pressure and pulse rate. The majority of serious adverse effects, particularly those associated with oxygenation and ventilation, have been reported when midazolam was administered with other medications capable of depressing the CNS. The incidence of such events was higher in patients undergoing procedures involving the airwaywithout the protective effect of an endotracheal tube (e.g., upper endoscopy and dental procedures).

The following additional adverse reactions were reported after intramuscular administration in adults: Headache (1.3%), and local effects at the IM injection site including pain (3.7%), induration (0.5%), redness (0.5%), and muscle stiffness (0.3%).

Read the entire FDA prescribing information for Seizalam (Midazolam for Injection)