Clobazam

The recommended adult dose of clobazam ranges from 5 mg to 80 mg daily, as directed by your doctor, taken in 1 or 2 doses with or without food. Doses up to 30 mg daily may be taken as a single daily dose. Higher doses must be split into 2 daily doses. If the dose is divided, the higher portion of the dose should be taken at night. The dose is usually started at 5 mg to 15 mg daily and increased gradually as needed. For children 2 to 16 years, the starting dose should be 5 mg daily, increased gradually to a maximum of 40 mg per day. For children younger than 2 years, the starting dose is based on body weight. If you have reduced liver or kidney function, your doctor may recommend a lower dose.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Clobazam exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Clobazam at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause memory loss; it may cause headaches; it may cause confusion; it may cause dizziness - use caution when getting up from a lying or sitting position and use caution if driving; it may cause a general feeling of weakness; it may cause unusual tiredness; it may cause drowsiness that lasts until the next day - use caution until you know how you will react. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Each white-to-off-white, uncoated, round tablet, with a “P” logo debossed on one side and “10” score “CL” on the other, contains 10 mg of clobazam. Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose, magnesium stearate, starch (corn) and talc.

Do not take Clobazam if you:

• are allergic to clobazam or any ingredients of the medication
• are allergic to other benzodiazepines (e.g., Diazepam, Lorazepam)
• are breast-feeding
• are in the first 3 months of pregnancy
• have a history of drug or alcohol dependence
• have acute narrow-angle (closed-angle) Glaucoma
• have Myasthenia Gravis
• have severe breathing problems or Sleep Apnea
• have severe liver impairment

There may be an interaction between clobazam and any of the following:

• Abiraterone
• alcohol
• anesthetics (e.g., halothane, nitrous oxide)
• antihistamines (e.g,. cetirizine, doxylamine, Diphenhydramine, Hydroxyzine, Loratadine)
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Atomoxetine
• azelastine
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• Baclofen
• barbiturates (e.g., butalbital, pentobarbital Phenobarbital)
• benzodiazepines (e.g., Alprazolam, diazepam, lorazepam)
• birth control pills
• brimonidine
• Bortezomib
• Buprenorphine
• Buspirone
• Captopril
• Carvedilol
• chloral hydrate
• chloroquine
• Cimetidine
• Dabrafenib
• Dextromethorphan
• Doxorubicin
• dronabinol
• droperidol
• Duloxetine
• Esomeprazole
• Flecainide
• Gefitinib
• Gemfibrozil
• grapefruit juice
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; delaviridine, efavirenz, etravirine only)
• isoniazid
• kava kava
• lithium
• lopinavir
• Maprotiline
• Methadone
• methamphetamine
• Metoprolol

• Mexiletine
• Mirtazapine
• Moclobemide
• Modafinil
• muscle relaxants (e.g., Cyclobenzaprine, methocarbamol, orphenadrine)
• narcotic analgesics (e.g., Codeine, Morphine, Hydrocodone, Fentanyl)
• nefazodone
• nicardipine
• Olopatadine
• Omeprazole
• Perampanel
• Pramipexole
• procainamide
• Propafenone
• Propranolol
• rifampin
• Ropinirole
• Rotigotine
• Rufinamide
• Saxagliptin
• scopolamine
• other seizure medications (e.g., Carbamazepine, clobazam, Ethosuximide, felbamate, Levetiracetam, phenobarbital, Phenytoin, primidone, Topiramate, Valproic acid, zonisamide)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, duloxetine, Fluoxetine, Paroxetine, Sertraline)
• Tamoxifen
• Tapentadol
• Tetrabenazine
• theophyllines (e.g., Aminophylline, Oxtriphylline, Theophylline)
• Ticlopidine;
• Timolol
• Tolterodine
• Tramadol
• tricyclic antidepressants (e.g., Amitriptyline, Desipramine, Imipramine, Nortriptyline)
• Tranylcypromine
• Zolpidem
• Zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Clobazam. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Clobazam.

HEALTH CANADA ADVISORY

October 30, 2020

Health Canada has issued new restrictions concerning the use of benzodiazepines and benzodiazepine-like prescription drugs. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Asthma and breathing disorders: Clobazam can suppress breathing. If you have asthma, or another lung disease that increases your risk for breathing difficulties, discuss with your doctor how Clobazam may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Clobazam, and whether any special monitoring is needed.

Drowsiness and reduced alertness: Clobazam causes drowsiness and slows down reaction time. Determine how clobazam affects you before performing potentially hazardous activities requiring mental alertness and physical coordination (such as driving or operating dangerous machinery).

Kidney function: Kidney Disease or reduced kidney function may cause Clobazam to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how Clobazam may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Clobazam, and whether any special monitoring is needed. People with severely reduced kidney function should not use Clobazam.

Liver function: Liver disease or reduced liver function may cause Clobazam to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Clobazam may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Clobazam, and whether any special monitoring is needed. People with severely reduced liver function should not take Clobazam.

Mental and emotional disorders: Medications to treat seizures have been known to contribute to mood swings, symptoms of Depression, aggravation of psychosis and other behavioural changes. If you have depression or a history of depression, discuss with your doctor how Clobazam may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Clobazam, and whether any special monitoring is needed. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking Clobazam, contact your doctor as soon as possible.

Myasthenia gravis: Myasthenia gravis is a condition that causes specific muscle weakness. Clobazam can make symptoms of this illness worse. People with myasthenia gravis should discuss with their doctor how Clobazam may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Suicidal thoughts and behaviour: Some people taking anti-seizure medications may have suicidal thoughts or behaviour. If this happens to you or you notice this in a family member who is taking Clobazam, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking Clobazam.

Tolerance: Clobazam may lead to tolerance when used for a long period of time. Tolerance means that your body gets used to the medication so that more medication may be needed to produce the same effect. Your doctor will recommend the dose of clobazam that is most appropriate for you. Do not change your dose or the way you are using the medication on your own. If you find that a dose of clobazam is not providing the same amount of seizure control as before, contact your doctor.

Withdrawal: Clobazam can become habit-forming. Withdrawal symptoms similar to those occurring with other medications of this class have been observed when clobazam was stopped suddenly after it was taken regularly over a period of time. Withdrawal symptoms include:

• abdominal cramps
• agitation
• confusion
• Diarrhea
• extreme anxiety
• headache
• hypersensitivity to light
• irritability
• memory impairment

• mood changes
• muscle pain
• nervousness
• seizures
• sleep problems
• sweating
• tension, restlessness
• tremors
• vomiting

Reducing the dose gradually can help prevent or decrease these withdrawal symptoms. Do not try to stop the medication or reduce the dose on your own – consult your doctor for help.

Pregnancy: Clobazam is not recommended during the first 3 months of pregnancy as it may harm the development of the unborn baby. In later stages of pregnancy, it should not be used unless the benefits outweigh the risks. If you become pregnant while taking Clobazam, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking clobazam, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding, however it is generally recommended that women do not breast-feed while they are taking Clobazam.

Seniors: The drowsiness caused by clobazam may affect seniors even more than others. Ask your doctor what you can do to reduce your risk of falls.

This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Take it regularly and continuously to maintain its beneficial effects. It is not advisable to stop using this product suddenly, particularly if you have been on it for several weeks. If you are considering stopping the medication, talk to your pharmacist first. If you forget a dose, take it as soon as you remember -- unless it is almost time for your next dose. In that case, skip the missed dose. Do not double the next dose to catch up. This medication may be taken with or without food. Consuming alcohol may intensify the effect of this product. Limit alcohol consumption to occasional small quantities.