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

  
The Use of Newer Antiepileptic Drugs in Patients With Renal Failure - Clobazam is the first and only 1,5 ... Pharmacokinetics and pharmacodynamic properties of a parent drug and its active or inactive metabolites are greatly affected in patients with kidney disease ...
Sunday October 27, 2024 - medscape.com

Onfi Oral Suspension - Clobazam 2.5mg/mL; berry flavor. Increased risk of drug-related mortality from concomitant use with opioids. Monitor for the emergence or worsening of depression, suicidal thoughts/behavior ...
Friday October 15, 2021 - empr.com

Fighting severe epilepsies: A new era for Dravet syndrome treatment? - Delve into the field of severe epilepsies as new treatments for Dravet syndrome are progressing through the pipeline.
Thursday October 24, 2024 - labiotech.eu

GW Pharma's cannabis-derived epilepsy drug approved in EU - Epidyolex can be used in conjunction with clobazam for patients two years of age and older, following a positive opinion from the CHMP scientific committee in July. The drug is specially ...
Thursday October 31, 2024 - pharmaphorum.com

Esomeprazole Interaction with other Drugs - Esomeprazole is a proton pump inhibitor (PPI), prescribed for gastroesophageal reflux disease (GERD). Esomeprazole can cause an increase in the absorption of Amphetamine resulting in an increased ...
Wednesday August 29, 2018 - medindia.net

Medical cannabis product approved for epilepsy - The drug does not contain any of the psycho-active ... will be used in combination with another epilepsy medication called clobazam. There are many different medical cannabis products.
Friday December 08, 2023 - bbc.com

Pantoprazole Interaction with other Drugs - Pantoprazole is a proton-pump inhibitor, prescribed for gastroesophageal reflux disease (GERD), ulcers, Zollinger-Ellison Syndrome, and erosive esophagitis. Pantoprazole can cause an increase in ...
Wednesday May 19, 2021 - medindia.net

Aquestive Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update - Sublingual Film pre-NDA meeting scheduled for fourth quarter 2024AQST-108 (epinephrine) Topical Gel pre-IND meeting ...
Monday November 04, 2024 - markets.businessinsider.com

Melasma causes: How to get rid of dark spots and pigmentation - An example of an antiseizure drug is clobazam. Contraceptive Therapy: Melasma has been observed in individuals using oral contraceptive pills containing estrogen and progestin. 106352090 ...
Thursday December 28, 2023 - msn.com

What is Hemp Tea? What You Need to Know - CBD may also interact with medications used to manage seizures and electrical activity in the brain, like clobazam ... and is unlikely to cause a positive drug test when consumed in moderation.
Tuesday October 08, 2024 - healthline.com

Overview of Atonic Seizures - Atonic” means loss of muscle tone. This type of seizure is also known as akinetic or drop seizures. Atonic seizures oftentimes begin during childhood and are most common in children, although they may ...
Tuesday October 31, 2023 - msn.com

The Use of Newer Antiepileptic Drugs in Patients With Renal Failure - A bound drug is generally not available to exert a ... the use of perampanel in patients with altered renal function has not been studied. Clobazam: dosage adjustment should not be necessary ...
Saturday November 02, 2024 - medscape.com

  
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