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Clobazam Dosage

Medically reviewed on October 20, 2016.

Applies to the following strengths: 5 mg; 10 mg; 20 mg; 2.5 mg/mL

Usual Adult Dose for:

Usual Geriatric Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Lennox-Gastaut Syndrome

Initial daily dose:
-Body weight 30 kg or less: 5 mg orally per day
-Body weight 30 kg or more: 10 mg orally per day
Day 7 total daily dose:
-Body weight 30 kg or less: 10 mg orally per day
-Body weight 30 kg or more: 20 mg orally per day
Day 14 daily dose:
-Body weight 30 kg or less: 20 mg orally per day
-Body weight 30 kg or more: 40 mg orally per day

Comments:
-A daily dose greater than 5 mg should be administered in divided doses twice a day.
-Doses should be escalated no more rapidly than weekly.
-Doses should be withdrawn gradually by tapering the total daily dose by 5 to 10 mg on a weekly basis until discontinued.

Use: Adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS)

Usual Geriatric Dose for Lennox-Gastaut Syndrome

Initial dose: 5 mg orally per day
Day 7 total daily dose:
-Body weight 30 kg or less: 5 mg orally per day
-Body weight 30 kg or more: 10 mg orally per day
Day 14 daily dose:
-Body weight 30 kg or less: 10 mg orally per day
-Body weight 30 kg or more: 20 mg orally per day
Maximum dose:
-Body weight 30 kg or less: 20 mg/day
-Body weight 30 kg or more: 40 mg/day

Comments:
-A daily dose greater than 5 mg should be administered in divided doses twice a day.
-Doses should be escalated no more rapidly than weekly.
-Based on clinical response, maximum doses may be started after 21 days.
-Doses should be withdrawn gradually by tapering the total daily dose by 5 to 10 mg on a weekly basis until discontinued.

Use: Adjunctive treatment of seizures associated with LGS

Usual Pediatric Dose for Lennox-Gastaut Syndrome

2 years or older:
Initial daily dose:
-Body weight 30 kg or less: 5 mg orally per day
-Body weight 30 kg or more: 10 mg orally per day
Day 7 total daily dose:
-Body weight 30 kg or less: 10 mg orally per day
-Body weight 30 kg or more: 20 mg orally per day
Day 14 daily dose:
-Body weight 30 kg or less: 20 mg orally per day
-Body weight 30 kg or more: 40 mg orally per day

Comments:
-A daily dose greater than 5 mg should be administered in divided doses twice a day.
-Doses should be escalated no more rapidly than weekly.
-Doses should be withdrawn gradually by tapering the total daily dose by 5 to 10 mg on a weekly basis until discontinued.

Use: Adjunctive treatment of seizures associated with LGS

Renal Dose Adjustments

Mild to moderate renal dysfunction (30 to 80 mL/min): No adjustment recommended.
Severe renal dysfunction (less than 30 mL/min) or ESRD: Data not available

Liver Dose Adjustments

Mild to moderate liver dysfunction (Child-Pugh score 5 to 9):
Initial dose: 5 mg orally per day
Day 7 total daily dose:
-Body weight 30 kg or less: 5 mg orally per day
-Body weight 30 kg or more: 10 mg orally per day
Day 14 daily dose:
-Body weight 30 kg or less: 10 mg orally per day
-Body weight 30 kg or more: 20 mg orally per day
Maximum dose:
-Body weight 30 kg or less: 20 mg/day
-Body weight 30 kg or more: 40 mg/day

Comment: Based on clinical response, maximum doses may be started after 21 days.

Severe liver dysfunction: Dose adjustments may be required; however, no specific guidelines have been suggested.

Dose Adjustments

CYP450 2C19 poor metabolizers:
Initial dose: 5 mg orally per day
Day 7 total daily dose:
-Body weight 30 kg or less: 5 mg orally per day
-Body weight 30 kg or more: 10 mg orally per day
Day 14 daily dose:
-Body weight 30 kg or less: 10 mg orally per day
-Body weight 30 kg or more: 20 mg orally per day
Maximum dose:
-Body weight 30 kg or less: 20 mg/day
-Body weight 30 kg or more: 40 mg/day

Comment: Based on clinical response, maximum doses may be started after 21 days.

Treatment Discontinuation:
-Abrupt discontinuation should be avoided.
-The dose should be reduced by 5 to 10 mg every week until discontinuation.

Precautions

US BOXED WARNINGS:
RISKS FROM CONCOMITANT USE WITH OPIOIDS:
-Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.
-Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
-Limit dosages and durations to the minimum required.
-Follow patients for signs and symptoms of respiratory depression and sedation.

Safety and efficacy have not been established in patients younger than 2 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule IV

Dialysis

Data not available

Other Comments

Administration advice:
-Once titrated to an effective dose, patients should remain on their treatment and care should be exercised when changing between different formulations.
-Tablets can be administered whole, broken in half along the score, or crushed and mixed in applesauce.
-This drug can be administered without regard to meals.
-Oral suspension: The manufacturer product information should be consulted.

Storage requirements:
-Oral suspension: Store upright in the original bottle and protect from light.

General:
-Limitation of use: Treatment of short-term, mild anxiety may be inappropriate and/or unsuitable.
-Patients with schizophrenia or other psychotic illnesses should limit benzodiazepines to adjunctive treatment; primary treatment with benzodiazepines should be avoided in this patient population.

Monitoring:
-Hematologic: Periodic blood counts
-Hepatic: Regular liver function tests, especially in patients with liver or renal dysfunction receiving long-term treatment
-Nervous system: Signs/symptoms of sedation
-Other: Signs/symptoms of paradoxical reactions
-Psychiatric: Signs/symptoms of anxiety, emergence/worsening of depression, suicidal thoughts or behavior, any unusual changes in mood or behavior, withdrawal side effects
-Renal: Regular renal function tests, especially in patients with liver or renal dysfunction receiving long-term treatment
-Respiratory: Respiratory function

Patient advice:
-This medicine may increase the risk of suicidal thoughts and behavior. Be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Report any behavior of concern to your healthcare provider as soon as possible.
-This drug may cause drowsiness and dizziness and reduce alertness. Do not drive a car or operate dangerous machinery until you know how this drug affects you.
-Do not drink alcohol or take other drugs that may cause sleepiness or dizziness while taking this drug until you talk to your healthcare provider.
-Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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