Clobazam; Uses, Dosage, Side Effects, Interactions, Pregnancy

Clobazam, Clobazam; Uses, Dosage, Side Effects, Interactions, Pregnancy, Rx Harun
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Clobazam is a 1,5-benzodiazepine and partial gamma-aminobutyric acid (GABA) receptor agonist, with anxiolytic, sedative, and anticonvulsant activities. Clobazam binds to a specific site, distinct from the inhibitory neurotransmitter GABA binding site, on the benzodiazepine-GABA-A-chloride ionophore receptor complex located in the central nervous system (CNS). This binding causes an allosteric modification of the receptor and enhances the affinity of GABA to the receptor leading to an increase in the opening of chloride-channels. This leads to an increase in chloride ion conductance, neuronal hyperpolarization, inhibition of the action potential and a decrease in neuronal excitability.

Clobazam is a benzodiazepine that is used as an anticonvulsant in the therapy of severe childhood epilepsy. Therapy with clobazam has not been associated with serum aminotransferase elevations, and clinically apparent liver injury from clobazam has yet to be reported and must be rare if it occurs at all.

Mechanism of Action of Clobazam

Clobazam binds at distinct binding sites associated with the chloride ionophore at the post-synaptic GABA receptor. These GABA receptors are in various locations in the CNS (limbic, reticular formation) and clobazam increases the duration of time for which the chloride ionophore is open. As a result, hyperpolarization and stabilization of the membrane occur as the post-synaptic inhibitory effect of GABA is enhanced. Its similar to other benzodiazepines, clobazam binds to the interface of the α and γ2-subunit of the GABA-A receptor. However, it is considered a partial agonist to GABA-A receptors which sets clobazam apart from 1,4-benzodiazepines which are the full agonist. The significance of this difference is that one may experience less sedation with clobazam than with other benzodiazepines. Unlike the endogenous GABA ligand, clobazam binds allosterically to the GABA receptor to increase the frequency of the chloride channel opening and membrane permeability to chloride ions.

Indications of Clobazam

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Therapeutic Indications of Clobazam

  • Anticonvulsants
  • Clobazam is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.
  • Treatment of seizures associated with Lennox-Gastaut syndrome. However, the drug has demonstrated broad anticonvulsant activity and has been used extensively in adults and pediatric patients with a wide range of other seizure disorders, which have sometimes been refractory, including partial, generalized, and myoclonic seizures.
  • Clobazam has been used in the treatment of anxiety disorders and has been labeled for the short-term (2-4 weeks) treatment of anxiety in some countries outside the US. However, the drug currently is not FDA-labeled for the treatment of anxiety disorders in the US.

Contraindications of Clobazam

Dosage of Clobazam

Strengths: 5 mg; 10 mg; 20 mg; 2.5 mg/mL

Convulsant or Seizure

  • 20mg – 30mg daily divided into 1 or 2 doses, up to 60mg.
  • 1 month – 6 years: 250micrograms/kg twice daily, up to 500 micrograms/kg twice daily. From 6 years: 0.3mg/kg – 1mg/kg daily, up to 60mg daily.

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

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
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Maximum dose

  • Body weight 30 kg or less: 20 mg/day
  • Body weight 30 kg or more: 40 mg/day

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

Side Effects of Clobazam

The most common

Common

Rare

Drug  Interactions of Clobazam

Clobazam may interact with following drugs, supplyments, & may change the efficacy of drugs

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Pregnancy & Lactation of Clobazam

FDA Pregnancy Category C

Pregnancy 

There are limited amount of data from the use of Clobazam in pregnant women.Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. In animal studies, no congenital malformations have been found in mice, rats and rabbits.

If the product is prescribed to a woman of childbearing potential, she should be warned to contact her physician regarding discontinuation of the product if she intends to become pregnant or suspects that she is pregnant.

Lactation

Limited information indicates that maternal doses of clobazam up to 30 mg daily produce low levels in milk. Short-term use would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. During long-term administration, monitor the infant for possible sedation and poor sucking.

References

Clobazam, Clobazam; Uses, Dosage, Side Effects, Interactions, Pregnancy, Rx HarunClobazam, Clobazam; Uses, Dosage, Side Effects, Interactions, Pregnancy, Rx Harun

Clobazam, Clobazam; Uses, Dosage, Side Effects, Interactions, Pregnancy, Rx Harun

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