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Presentation

Oral formulations of clobazam.

Drugs List

  • clobazam 10mg tablets
  • clobazam 10mg/5ml oral suspension sugar-free
  • clobazam 5mg/5ml oral suspension sugar-free
  • FRISIUM 10mg tablets
  • PERIZAM 1mg/ml oral suspension sugar-free
  • PERIZAM 2mg/ml oral suspension sugar-free
  • TAPCLOB 10mg/5ml oral suspension
  • TAPCLOB 5mg/5ml oral suspension
  • ZACCO 10mg/5ml oral suspension
  • ZACCO 5mg/5ml oral suspension
  • Therapeutic Indications

    Uses

    Anxiety state (severe) - short term relief
    Epilepsy (adjunctive treatment)

    Dosage

    Adults

    Anxiety
    20mg to 30mg once a day at bedtime, or given in divided doses.
    Doses may be increased, if necessary, depending on the severity. Maximum dose should not exceed 60mg a day.

    The lowest effective dose should be used, after improvement of the symptoms the dose may be reduced.

    Epilepsy in association with one or more other anticonvulsants
    20mg to 30mg a day.
    Maximum dose should not exceed 60mg a day.

    Treatment should be initiated at the lowest effective dose and then increased with gradual dose increments under observation.

    Elderly

    Anxiety
    10mg to 20mg a day.

    Epilepsy in association with one or more other anticonvulsants
    Reduce initial dose of the recommended adult dosage, then increase gradually.

    Children

    Epilepsy in association with one or more other anticonvulsants
    Children aged 6 to 18 years
    Initial dose: 5mg a day.
    Maintenance dose: 0.3mg/kg to 1mg/kg of bodyweight a day.

    Children aged 2 to 6 years
    Initial dose: 5mg a day or 0.1mg/kg a day in younger patients. Doses may be increased, if necessary, in increments of 0.1mg/kg to 0.2mg/kg a day, at intervals of at least 7 days.
    Maintenance dose: 0.3mg/kg to 1mg/kg of bodyweight a day.

    The daily dose can be taken in divided doses or as a single dose at night.

    Children 6 months to 2 years
    Only under exceptional situations, where there is a clear epilepsy indication.
    0.1mg/kg a day in divided doses twice daily increasing not more often than every 5 days.

    The following alternative dosing schedule may be suitable for epilepsy (adjunct) and menstruation seizures (monotherapy):
    Children aged 6 to 18 years
    Initial dose: 5mg a day. Doses may be increased, if necessary, at intervals of at least 5 days.
    Maintenance dose: 0.3mg/kg to 1mg/kg of bodyweight a day.
    Maximum dose should not exceed 60mg a day. Doses up to 30mg may be given once a day at bedtime, or given in divided doses. It is recommended doses greater than 30mg should be divided.

    Children aged 1 month to 6 years (unlicensed)
    Initial dose: 125micrograms/kg administered twice a day. Doses may be increased, if necessary, at intervals of at least 5 days.
    Maintenance dose: 250micrograms/kg twice a day.
    Maximum dose should not exceed 500micrograms/kg twice a day (or 30mg a day).

    Additional Dosage Information

    Switching between formulations
    In some patients taking the oral suspension of clobazam, the medicinal product reaches higher plasma levels than the same dose taken as a tablet. This may lead to an increased risk of respiratory depression and sedation. Therefore, caution is advised when switching between clobazam products.

    Contraindications

    Acute alcohol intoxication
    Drug intoxication
    Neonates
    Breastfeeding
    First trimester of pregnancy
    History of alcohol abuse
    History of drug misuse
    Myasthenia gravis
    Severe hepatic impairment
    Severe respiratory impairment
    Sleep apnoea

    Precautions and Warnings

    Children aged 1 month to 2 years
    Elderly
    Females of childbearing potential
    Restricted sodium intake
    Suicidal ideation
    Brain damage
    Cerebellar ataxia
    CYP2C19 poor metaboliser genotype
    Hereditary fructose intolerance
    Mild hepatic impairment
    Muscle weakness
    Personality disorder
    Renal impairment
    Respiratory impairment
    Second trimester of pregnancy
    Spinal ataxia
    Third trimester of pregnancy

    Patients at risk of suicide should be closely supervised
    Reduce dose in patients with hepatic impairment
    Reduce dose in patients with severe renal impairment
    Sodium content of formulation may be significant
    Advise impaired alertness may affect ability to drive or operate machinery
    Advise patient ability to drive or operate machinery may be impaired
    Advise patient not to drive until they know how the medicine affects them
    Advise patient this medicine may be subject to driving restrictions
    Consider prescribing by manufacturer to ensure seizure control maintenance
    Not all available brands are licensed for all age groups
    Not suitable as sole treatment of depression or anxiety with depression
    May contain polysorbate
    Oral liquid contains hydroxybenzoate: caution in hypersensitivity
    Presentations with sorbitol unsuitable in hereditary fructose intolerance
    Some formulations contain maltitol
    Some formulations contain propylene glycol
    Different oral formulations are not interchangeable (not bioequivalent)
    If rash develops, consider possibility of Stevens-Johnson Syndrome
    Monitor closely for signs and symptoms of toxic epidermal necrolysis
    Monitor closely for signs and sypmtoms of Stevens-Johnson syndrome
    Monitor hepatic function on long term therapy
    Monitor patients with risk factors for respiratory symptoms
    Monitor renal function on long term therapy
    Patients on prolonged therapy should be regularly reviewed
    Potential for drug abuse
    Review therapy after 4 weeks
    Tolerance and dependence may occur
    Aggressive behaviour may occur
    Amnesia may occur
    Patient should be made aware of possible adverse effects on mood/behaviour
    Potential for withdrawal symptoms
    Psychological adjustment may be impaired in loss or bereavement
    Rebound effect may occur after cessation of treatment
    Avoid abrupt withdrawal
    Advise patient to seek advice at first indications of pregnancy
    Discontinue if paradoxical reactions occur
    Discontinue permanently if severe skin reaction occurs
    Maintain treatment at the lowest effective dose
    Not licensed for all indications in all age groups
    Reduce dose in debilitated patients
    Reduce dose in elderly
    Avoid long term use
    Patient should avoid alcohol as effect may be potentiated
    Female: Ensure adequate contraception during treatment
    Advise patient of increased risk of falls
    Advise patient/carers to report signs of suicide ideation or behaviour

    Patients should be closely monitored for signs or symptoms of Stevens-Johnson syndrome and toxic epidermal necrolysis, especially during the first 8 weeks of treatment. If signs or symptoms suggest Steven-Johnson syndrome or toxic epidermal necrolysis, clobazam should not be resumed and alternative therapy should be considered.

    Pregnancy and Lactation

    Pregnancy

    Clobazam is contraindicated during the first trimester of pregnancy but may be used with caution during the second and third trimester.

    The manufacturer does not recommend using clobazam during the first trimester of pregnancy, and advises caution if clobazam is used during the second and third trimesters.

    Benzodiazepines cross the placenta. There is conflicting information about whether there may be a small increased risk of congenital malformation (such as oral cleft) if benzodiazepines are used during the first trimester of pregnancy. Although a considerable number of exposed pregnancies have been documented, there is still insufficient information about clobazam in pregnancy for clarity but it is thought likely that the risks are similar to those posed by other benzodiazepines.

    Benzodiazepines administered during the late stages of pregnancy may cause functional disturbances in the newborn due to persisting presence of the drug, also physical dependence in the neonate, and withdrawal symptoms in the postnatal period. Withdrawal symptoms such as restlessness, tremors, hypertonia, vomiting, diarrhoea and convulsions may be seen in the neonatal period. A 'floppy infant syndrome' lasting up to several months has been observed following maternal treatment with some benzodiazepines manifested as: muscle flaccidity, lethargy, disturbances of temperature regulation, respiratory depression and difficulties in feeding in the neonate.

    Adjusting or stopping any anti-epileptic medication during pregnancy should not be done without specialist advice, and the relative benefits and risks should be discussed carefully first. The risk of inadequate seizure control may be more detrimental to the foetus than the use of antiepileptic drugs. Pregnancy in epileptic women is associated with a higher risk of congenital abnormalities, which are mainly associated with the use of anti-epileptic drugs rather than the disease itself. This risk is increased when multiple drugs are used. Routine monitoring of antiepileptic drugs is not recommended, but may be useful in cases where seizures have increased or are likely to, in order to plan the extent of dose adjustment needed.

    Lactation

    Clobazam is contraindicated during breastfeeding.

    Use of clobazam when breastfeeding is contraindicated by the manufacturer.

    Benzodiazepines are excreted in breast milk. LactMed (2020) state that due to the low quantity excreted into the breast milk no effect is expected on the infant during short term exposure especially if the infant is older than two months. During long term treatment the infant should be monitored for possible sedation and poor suckling and weight gain (LactMed 2020).

    Effects on Ability to Drive and Operate Machinery

    This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988 (England and Wales).
    When prescribing this medicine: Advise patient the medicine can affect cognitive function and is likely to affect ability to drive. Advise patient not to drive until they know how the medicine affects them.

    Counselling

    Patients should be advised to swallow the tablets without chewing with at least half a glass of water.

    Patients should be advised to consult their doctor or pharmacist before taking over the counter medications as some products may increase the sedative effects of clobazam e.g preparations containing codeine, antihistamines and cimetidine.

    Patients should avoid alcohol.

    Patients should be advised of increased risk of falls.

    Patients should be advised of possible changes in both mood and behaviour.

    Women of child bearing potential should be advised to discuss their therapy and possible withdrawal of clobazam if they should wish to become, or discover they are, pregnant.

    Patients should be advised that clobazam may cause drowsiness which may affect their ability to drive and operate machinery.

    Side Effects

    Aggression
    Agitation
    Amnesia
    Anger
    Anterograde amnesia
    Anxiety
    Ataxia
    Attention disturbances
    Behavioural disturbances
    Cognitive impairment
    Confusion
    Constipation
    Decreased appetite
    Delayed reactions
    Delusions
    Dependence
    Depression
    Diplopia
    Dizziness
    Drowsiness
    Dry mouth
    Falls
    Fatigue
    Fine tremor (usually hands)
    Hallucinations
    Headache
    Hypothermia
    Impaired concentration
    Impaired consciousness
    Irritability
    Memory disturbances
    Mood changes
    Motor disturbances
    Muscle spasm
    Muscle weakness
    Nausea
    Nightmares
    Numbed emotions
    Nystagmus
    Paradoxical reactions
    Photosensitivity
    Psychotic reactions
    Rages
    Rash
    Reduced libido
    Respiratory depression
    Restlessness
    Sedation
    Sleep disturbances
    Sleepiness
    Somnolence
    Speech disturbances
    Stevens-Johnson syndrome
    Suicidal tendencies
    Tolerance
    Toxic epidermal necrolysis
    Unsteady gait
    Urticaria
    Visual disturbances
    Weight gain
    Withdrawal symptoms

    Overdosage

    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Further Information

    Last Full Review Date: March 2021

    Reference Sources

    Summary of Product Characteristics: Clobazam 1mg/1ml oral suspension. Wockhardt UK Ltd. Revised June 2020.

    Summary of Product Characteristics: Clobazam 2mg/ml oral suspension. Wockhardt UK Ltd. Revised June 2020.

    Summary of Product Characteristics: Frisium tablets 10 mg. Sanofi. Revised March 2020.

    Summary of Product Characteristics: Perizam 1mg/ml oral suspension. Rosemont Pharmaceuticals Ltd. Revised December 2020.

    Summary of Product Characteristics: Perizam 2mg/ml oral suspension. Rosemont Pharmaceuticals Ltd. Revised December 2020.

    Summary of Product Characteristics: Tapclob 5mg/5ml oral suspension. Martindale Pharmaceuticals Ltd. February 2020.

    Summary of Product Characteristics: Tapclob 10mg/5ml oral suspension. Martindale Pharmaceuticals Ltd. February 2020.

    Summary of Product Characteristics: Zacco 5mg/5ml oral suspension. Thame Laboratories Ltd. June 2020.

    Summary of Product Characteristics: Zacco 10mg/5ml oral suspension. Thame Laboratories Ltd. June 2020.

    Gov.uk. Government departments. Department for Transport. Publications. Drug driving and medicine: advice for healthcare professionals. Drug driving: Guidance for healthcare professionals on drug driving. Available at: https://www.gov.uk Last accessed: 6 January 2015.
    New drug driving offence implications for medicines packaging. Medicines Regulatory News. 10 December 2013. Available at: https://www.mhra.gov.uk Last accessed: 6 January 2015.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 25 March 2021

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
    Clobazam Last revised: 21 September 2020
    Last accessed: 25 March 2021

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