CLOBAZAM

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Created Mar 2019 | Updated Oct 2020

CLOBAZAM

  • [URBADAN]
  • [URBANYL]
  • [FRISIUM]
  • [ONFI]
  • [SYMPAZAN]

DEA CODE 2751: Schedule 4

Clobazam has been used to treat anxiety and epilepsy since 1970s. In the US clobazam was approved for marketing in October of 2011 for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome. It is also approved for adjunctive therapy for epilepsy in patients who have not responded to first-line drugs and in children who are refractory to first-line drugs. The mechanism of action for clobazam is not fully understood but is thought to involve what is known as potentiation of GABAergic neurotransmission resulting from binding at a benzodiazepine site at the GABA(A) receptor. Possible side effects: constipation, fever, drowsiness, sedation, ataxia, aggressive behavior, lethargy, drooling, and irritability. Other side effects include: urinary tract infection, pneumonia, cough, dysphagia, dysarthria, bronchitis, insomnia, fatigue, decreased appetite, and increased appetite.

Clobazam is a benzodiazepine which belongs to the same family of drugs that includes lorazepam (Ativan), diazepam (Valium), midazolam (Versed) and clonazepam (Klonopin). Clobazam is different from the other benzodiazepines because it is utilized for the long-term treatment of epilepsy due to its effectiveness and relatively low tendency to produce sedation.

The medication is indicated for use in patients as an add- on medication for seizures associated with Lennox-Gastaut syndrome. Patients must be 2 years of age or older.


Clobazam
Duration:

A long acting benzodiazepine which focuses primarily on anxiolytic and anticonvulsant properties. It is used medically to treat epilepsy, and this along with its relatively many negative side-effects and contraindications in comparison with other benzodiazepines means it isn't frequently used recreationally.

NOTE: 20mg of Clobazam is approximately equal to 10mg Diazepam.

RouteOnsetDurationAfter Effects
Tripsit Factsheets
All ROAs:20-40 minutes6-12 hours1-12 hours
Clobazam Duration
Avoid:
All other CNS depressants.
Aliases:
  • frisium
Summary:
A long acting half life benzo that focues on Anxiolytic and/or Anticonvulsant.
Effects:
Anxiolytic, Sedative, Muscle Relaxant, Amnesia, Dystaxia.

Breastfeeding:
Summary of Use During 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 and weight gain.

Alternate Drugs to Consider:

  • (Seizure Disorder) Carbamazepine
  • Divalproex
  • Gabapentin
  • Lamotrigine
  • Oxcarbazepine
  • Phenytoin
  • Valproic Acid

EMC PDF Clobazam

Important Information:
Some people have thoughts about suicide while taking clobazam. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Fatal side effects can occur if you use clobazam with opioid medication, alcohol, or other drugs that cause drowsiness or slow your breathing.

Do not stop using clobazam suddenly, or you could have increased seizures or unpleasant withdrawal symptoms.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Do not drink alcohol. Dangerous side effects could occur.

Interactions:

Drug Interactions (471) Alcohol/Food Interactions (1) Disease Interactions (3)


What other drugs will affect Clobazam?

Taking clobazam with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death.

Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures. Other drugs may affect clobazam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

A total of 471 drugs are known to interact with Clobazam.

  • 29 major drug interactions
  • 408 moderate drug interactions
  • 34 minor drug interactions

Medsafe PDF Frisium

IMPORTANT WARNING:
Clobazam may increase the risk of serious or life-threatening breathing problems, sedation, or coma if used along with certain medications. Tell your doctor if you are taking or plan to take: antidepressants; medications for anxiety, mental illness, and seizures; sedatives; sleeping pills; opioids such as codeine, fentanyl (Duragesic, Subsys), morphine (Astramorph, Kadian), or oxycodone (in Percocet, in Roxicet, others); or tranquilizers. Your doctor may need to change the dosages of your medications and will monitor you carefully. If you take clobazam with any of these medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care immediately: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own. Drinking alcohol or using street drugs during your treatment with clobazam also increases the risk that you will experience these serious, life-threatening side effects. Do not drink alcohol or use street drugs during your treatment.

Onfi (clobazam)
Maximum Dosage:
Prescribers Digital Reference
Adults:40 mg/day PO.
Geriatric:40 mg/day PO.
Adolescents:Weighing more than 30 kg: 40 mg/day PO.
Adolescents:Weighing 30 kg or less: 20 mg/day PO.
Children:2 to 12 years weighing more than 30 kg: 40 mg/day PO.
Children:2 to 12 years weighing 30 kg or less: 20 mg/day PO.
Children:1 year: Safety and efficacy have not been established; however, doses up to 2 mg/kg/day PO have been recommended for Dravet syndrome.
Infants:Safety and efficacy have not been established; however, doses up to 2 mg/kg/day PO have been recommended for Dravet syndrome.
Neonates:Safety and efficacy have not been established.

Pediatric:
Appropriate studies have not been performed on the relationship of age to the effects of clobazam in children younger than 2 years of age.

However, safety and efficacy in children with panic disorder have not been established.

Geriatric:
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of clobazam in the elderly. However, elderly patients are more likely to have age-related liver problems, which may require caution and an adjustment in the dose for patients receiving clobazam.

Other Interactions:

  • Ethanol

Other Medical Problems:
Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol abuse, or history of
  • Depression, history of
  • Drug abuse or dependence, or history of
  • Lung or breathing problems (eg, respiratory depression)
  • Mood or behavior disorder, history of - Use with caution. May make these conditions worse
  • Liver disease, mild to moderate - Use with caution. The effects may be increased because of slower removal of the medicine from the body

Onfi (clobazam tablets and oral suspension)
Side Effects:
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
RxList
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have:
  • confusion, hallucinations
  • fever, chills, cough with yellow or green mucus, feeling short of breath
  • severe drowsiness, feeling like you might pass out
  • weak or shallow breathing
  • pain or burning when you urinate
  • urinating less than usual or not at all
The sedative effects of clobazam may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury while you are taking clobazam.
Common side effects may include:
  • aggressive behavior
  • drowsiness, feeling tired
  • fever, cough, breathing problems
  • slurred speech, drooling
  • sleep problems (insomnia)
  • constipation, painful urination
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

ONFI, Sympazan (clobazam) (Rx)
Black Box Warnings:
Concomitant use of benzodiazepines and opioids may result in profound respiratory depression, coma, and death; administer concomitantly when there are no alternative options; limit dosages and durations to minimum required; monitor for signs and symptoms of respiratory depression and sedation

Addiction, abuse, and misuse

  • On September 2020, FDA addressed serious risks of benzodiazepine addiction, abuse, and misuse, which can lead to overdose and death
  • Physical dependence can occur when taken steadily for several days to weeks, even as prescribed
  • Stopping abruptly or reducing dosage too quickly can result in withdrawal reactions, including seizures, which can be life-threatening
  • Assess each patient's risk prior to prescribing and monitor regularly for the development of these behaviors or conditions

Liver:
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.

Clobazam Hepatotoxicity:
Limited data are available on the hepatotoxicity of clobazam. In clinical trials, clobazam was not associated with an increased frequency of serum aminotransferase elevations as compared to placebo treatment, and there were no instances of clinically apparent liver injury. No individual case reports of clobazam hepatotoxicity have been published since its wide spread clinical availability. Liver injury from benzodiazepines is quite rare, but isolated instances of hepatotoxicity have been reported for clorazepate and clonazepam, two other benzodiazepines used predominantly in the therapy of epilepsy. Thus, clinically apparent liver injury due to clobazam must be rare, if it occurs at all.

E Likelihood score: E (unlikely cause of clinically apparent liver injury).


Clobazam:
  • A benzodiazepine
  • Used for its anxiolytic effect, and as an adjunctive therapy in epilepsy
  • First synthesized in 1966
  • Patented in 1968
  • First published in 1969
  • Marketed in 1970
  • Originally marketed as an anxioselective anxiolytic and an anticonvulsant since 1984

    The primary drug-development goal was to provide greater anxiolytic, anti-obsessive efficacy with fewer benzodiazepine-related side effects.

  • Common side effects include fever, lethargy, sleepiness, drooling, and constipation

  
Hormonal Contraceptive Agents/Clobazam Interactions - Consult your healthcare professional before taking or discontinuing any drug or commencing any course ... becoming pregnant while you are taking clobazam. Clobazam may harm your baby.
Monday April 08, 2019 - webmd.com

The Use of Newer Antiepileptic Drugs in Patients With Renal Failure - Clobazam is the first and only 1,5-benzodiazepine in clinical use as an anticonvulsant. Clobazam exerts it anticonvulsant effects via its selective affinity for the ω 2 site of the GABA-A ...
Thursday February 02, 2023 - medscape.com

Clobazam Market size (New Report 2023-2029) is Going to Boom in near Future| 113 Pages Report - Jan 25, 2023 (The Expresswire) -- The Global "Clobazam Market" [Latest report 2023] thoroughly explores several important elements that are important to the market and its sectors. The report ...
Tuesday January 24, 2023 - marketwatch.com

NICE recommends cannabinoid med for severe epilepsy - Epilepsy is one of the most common neurological features of TSC and can severely impact patients’ lives. TSC can be diagnosed in infancy, but many aren’t diagnosed until later in childhood, when ...
Tuesday January 31, 2023 - pharmaphorum.com

Clobazam Market Size 2023 with Factor Outlook, Deployment Viewpoint, Society Size Outlook, - Jan 15, 2023 (The Expresswire) -- The Clobazam market is expected to witness significant growth due to growing device usage and high-volume demand. This company is uncertain and is expected to ...
Saturday January 14, 2023 - marketwatch.com

A Possible Mechanism Underlying the Effectiveness of Acupuncture in the Treatment of Drug Addiction - Clinical trials are currently underway to determine the effectiveness of acupuncture in the treatment of drug addiction. While there are still many unanswered questions about the basic mechanisms ...
Wednesday February 01, 2023 - medscape.com

Hormonal Contraceptive Agents/Clobazam Interactions - Clobazam may harm your baby ... The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate ...
Wednesday November 15, 2017 - webmd.com

  
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