Drug Detail:Clobazam (Clobazam [ kloe-ba-zam ])
Drug Class: Benzodiazepine anticonvulsants Benzodiazepines
Usual Adult Dose for Lennox-Gastaut Syndrome
Initial total daily dose:
- Body weight 30 kg or less: 5 mg orally per day
- Body weight 30 over kg: 10 mg orally per day
- Body weight 30 kg or less: 10 mg orally per day
- Body weight over 30 kg: 20 mg orally per day
- Body weight 30 kg or less: 20 mg orally per day
- Body weight over 30 kg: 40 mg orally per day
Comments:
- A daily dose greater than 5 mg should be administered in divided doses 2 times 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- Doses should be withdrawn gradually by tapering the total daily dose by 5 to 10 mg on a weekly basis until discontinued.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 over 30 kg: 10 mg orally per day
- Body weight 30 kg or less: 10 mg orally per day
- Body weight over 30 kg: 20 mg orally per day
- Body weight 30 kg or less: 20 mg/day
- Body weight over 30 kg: 40 mg/day
Comments:
- Daily doses greater than 5 mg should be administered in divided doses 2 times 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- Doses should be withdrawn gradually by tapering the total daily dose by 5 to 10 mg on a weekly basis until discontinued.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 over 30 kg: 10 mg orally per day
- Body weight 30 kg or less: 10 mg orally per day
- Body weight over 30 kg: 20 mg orally per day
- Body weight 30 kg or less: 20 mg orally per day
- Body weight over 30 kg: 40 mg orally per day
Comments:
- Daily dose greater than 5 mg should be administered in divided doses 2 times 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- Doses should be withdrawn gradually by tapering the total daily dose by 5 to 10 mg on a weekly basis until discontinued.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 over 30 kg: 10 mg orally per day
- Body weight 30 kg or less: 10 mg orally per day
- Body weight over 30 kg: 20 mg orally per day
- Body weight 30 kg or less: 20 mg/day
- Body weight over 30 kg: 40 mg/day
Comments:
- Daily doses greater than 5 mg should be administered in divided doses 2 times 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.
Severe liver dysfunction: Data not available
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 over 30 kg: 10 mg orally per day
- Body weight 30 kg or less: 10 mg orally per day
- Body weight over 30 kg: 20 mg orally per day
- Body weight 30 kg or less: 20 mg/day
- Body weight over 30 kg: 40 mg/day
Comments:
- Daily doses greater than 5 mg should be administered in divided doses 2 times 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.
Treatment Discontinuation:
- Abrupt discontinuation should be avoided.
- The dose should be reduced by 5 to 10 mg every week until discontinuation.
- Patients who develop withdrawal symptoms may benefit from the following:
- Pausing the taper.
- Increasing the dose to the previously tapered dose, and then subsequently decreasing the dosage more slowly until discontinuation is complete.
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.
- Concomitant prescribing of these drugs should be reserved for patients for whom alternative treatment options are inadequate.
- Doses and durations of treatment should be limited to the minimum required.
- Patients should be followed for signs/symptoms of respiratory depression and sedation.
ABUSE, MISUSE, AND ADDICTION:
- The use of benzodiazepines, including this drug, exposes users to risks of abuse, misuse, and addiction, which may result in overdose or death.
- Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes.
- Each patient's risk for abuse, misuse, and addiction should be assessed prior to prescribing this drug and throughout treatment.
DEPENDENCE AND WITHDRAWAL REACTIONS:
- The continued use of benzodiazepines, including this drug, may lead to clinically significant physical dependence.
- The risks of dependence and withdrawal increase with an increased duration of treatment and higher daily dose.
- Abrupt discontinuation or rapid dose reductions of this drug after continued use may precipitate acute withdrawal reactions, which may be life-threatening.
- A gradual taper should be used when discontinuing treatment or reducing the dose to reduce the risk of withdrawal reactions.
CONTRAINDICATIONS:
- Hypersensitivity to the active component or to any of the ingredients
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 film formulations should be allowed to dissolve on the tongue without the administration of additional fluids; patients may swallow saliva normally as the film dissolves, but should avoid chewing, spitting, or talking. A second dose (if required) should not be taken until the first film has completely dissolved.
- Oral suspension: The manufacturer product information should be consulted.
Storage requirements:
- Oral suspension: Store upright in the original bottle and protect from light.
Reconstitution/preparation techniques:
- Oral suspension: Shake well prior to administration.
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.
- A new steady-state plasma level will not be attained for several days after each dosage change for the parent compound, and may be prolonged further for its principal metabolite.
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, emergenceworsening 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. Patients should be cautioned 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; patients should be instructed to report any behavior of concern to their healthcare provider as soon as possible.
- This drug may cause drowsiness and dizziness and reduce alertness. Patients should avoid driving a car or operating dangerous machinery until they know how this drug affects them.
- Patients should avoid drinking alcohol or taking other drugs that may increase sleepiness or dizziness while taking this drug.
- Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.
Frequently asked questions
- What is the difference between Sympazan and Onfi?
