Drug Guide

Generic Name

Clobazam

Brand Names Onfi, Sympazan

Classification

Therapeutic: Anticonvulsant, Anxiolytic

Pharmacological: Benzodiazepine

FDA Approved Indications

Mechanism of Action

Clobazam enhances the effect of the neurotransmitter gamma-aminobutyric acid (GABA) at the GABA-A receptor, resulting in sedative, anxiolytic, anticonvulsant, and muscle-relaxant properties.

Dosage and Administration

Adult: Initial dose typically 10-20 mg daily, divided into two doses; dose may be titrated based on response and tolerability.

Pediatric: Dosing varies based on age and weight; specific pediatric dosing guidance should be consulted. Use with caution in children.

Geriatric: Start at lower doses due to increased sensitivity and risk of sedation; monitor closely.

Renal Impairment: Adjust dosage based on severity of impairment.

Hepatic Impairment: Use with caution; start at lower doses, monitor liver function.

Pharmacokinetics

Absorption: Well absorbed after oral administration.

Distribution: Widely distributed; crosses the blood-brain barrier.

Metabolism: Metabolized in the liver primarily via CYP3A4 to norclobazam.

Excretion: Excreted mainly in urine as metabolites.

Half Life: Approximately 18 hours for clobazam; metabolite norclobazam has a longer half-life (~36-42 hours).

Contraindications

Precautions

Adverse Reactions - Common

Adverse Reactions - Serious

Drug-Drug Interactions

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor for effectiveness in seizure control, sedation levels, and signs of over-sedation. Assess for history of substance abuse.

Diagnoses:

  • Risk for sedation or injury
  • Impaired respiratory function
  • Risk for dependence

Implementation: Administer as prescribed, preferably with food to decrease gastrointestinal upset. Monitor for adverse effects.

Evaluation: Evaluate seizure frequency and severity, sedation level, and patient adherence.

Patient/Family Teaching

Special Considerations

Black Box Warnings:

Genetic Factors: Monitor for variations in CYP2C19 enzyme activity which may affect metabolism.

Lab Test Interference: May interfere with certain liver function tests.

Overdose Management

Signs/Symptoms: Extreme sedation, confusion, diminished reflexes, respiratory depression, coma.

Treatment: Supportive care, airway management, possibly administration of flumazenil (a benzodiazepine antagonist); avoid if benzodiazepine dependence is present.

Storage and Handling

Storage: Store at room temperature away from light and moisture.

Stability: Stable for the duration of labeled shelf life.

This guide is for educational purposes only and is not intended for clinical use.