Drug Guide
Clobazam
Classification
Therapeutic: Anticonvulsant, Anxiolytic
Pharmacological: Benzodiazepine
FDA Approved Indications
- Lennox-Gastaut syndrome (management of seizures)
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
- Hypersensitivity to benzodiazepines or any component of the formulation.
Precautions
- Use with caution in patients with a history of substance abuse, respiratory impairment, hepatic impairment, or pregnancy. Risk of dependence, withdrawal, and respiratory depression. Not recommended during breastfeeding.
Adverse Reactions - Common
- Somnolence (Common)
- Sedation (Common)
- Dizziness (Common)
- Fatigue (Common)
Adverse Reactions - Serious
- Respiratory depression (Serious)
- Abnormal behaviors, including aggression and hallucinations (Serious)
- Withdrawal symptoms upon discontinuation (Serious)
- Seizures with abrupt withdrawal in some cases (Serious)
Drug-Drug Interactions
- CNS depressants (e.g., opioids, other benzodiazepines), increasing sedation and respiratory depression risk.
- CYP3A4 inhibitors (e.g., ketoconazole) may increase clobazam levels.
- CYP3A4 inducers (e.g., rifampin) may decrease effectiveness.
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing 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
- Teach patient to avoid alcohol and other CNS depressants.
- Warn about potential for drowsiness and impaired alertness.
- Advise against abrupt discontinuation to prevent withdrawal.
- Instruct patients to report any unusual mood changes or worsening seizures.
Special Considerations
Black Box Warnings:
- Risk of respiratory depression and dependence
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.