Clobazam

By Medically reviewed by hellodoktor

Generic Name: Clobazam Brand Name(s): Clobazam.

Uses

What is Clobazam used for?

Clobazam is commonly used with other medications to help control seizures. It belongs to a class of medications called benzodiazepines, which act on the brain and nerves (central nervous system) to produce a calming effect. This drug works by enhancing the effects of a certain natural chemical in the body (GABA).

How should I take Clobazam?

Take this medication by mouth with or without food as directed by your doctor. If unable to swallow tablets, they may be crushed and mixed with applesauce. If you are using the liquid form of this medication, shake the bottle well before each dose. Carefully measure the dose using a special measuring device/syringe. Do not use a household spoon because you may not get the correct dose. Read the Instructions for Use on how to properly use the special measuring device/syringe. If you have any questions, ask your pharmacist.

If you are taking this medication once daily, then take it at bedtime. If you are taking this medication in divided doses, take the largest dose at bedtime.

Dosage is based on your medical condition and response to treatment. In infants, the dosage may also be based on weight.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as headaches, trouble sleeping, restlessness, hallucinations/confusion, nausea, seizures) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Do not increase your dose, take it more often, or use it for a longer time than prescribed. Properly stop the medication when so directed.

When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.

Tell your doctor if your condition persists or worsens.

How do I store Clobazam?

Clobazam is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Clobazam in the bathroom or the freezer. There may be different brands of Clobazam that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Clobazam down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Clobazam?

Before taking clobazam, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines (e.g., diazepam); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: myasthenia gravis, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), kidney disease, liver disease, glaucoma, mental/mood disorders (e.g., depression, psychosis), brain disorders (e.g., head injury, brain damage), breathing problems (e.g., asthma, chronic obstructive pulmonary disease-COPD, sleep apnea), muscle disorders (e.g., weakness, loss of coordination).

Before having surgery, tell your doctor or dentist that you are taking this medication.

This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana. Alcohol may also increase the drug levels.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially drowsiness. This drug may also cause excitement instead of drowsiness in the elderly.

Caution is advised when using this drug in children because they are more sensitive to the effects. This drug can often cause excitement in young children instead of drowsiness.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor about the benefits and risks of using this medication during pregnancy. Since birth control pills, patches, implants, and injections may not work if taken with this medication, discuss reliable forms of birth control with your doctor.

This drug passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Clobazam during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking this Clobazam. This Clobazam is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Clobazam?

Drowsiness, dizziness, tiredness, headache, constipation, weight gain, fever, cough, drooling, trouble sleeping, or nausea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: mental/mood/behavior changes (e.g., agitation, nervousness, confusion, memory loss), muscle weakness, loss of coordination, shaking (tremor) of the fingers, vision changes (e.g., blurred vision, double vision), slurred speech, decrease in sexual interest, painful urination.

A small number of people who take anticonvulsants for any condition may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

Get medical help right away if you have any very serious side effects, including: slow/shallow breathing.

Clobazam may rarely cause very serious (possibly fatal) skin reactions, especially during the first 8 weeks of treatment or when restarting treatment with this medication. Get medical help right away if you develop any of the following symptoms: skin rash/blisters/peeling, itching, or mouth sores. If you have a very serious skin reaction and your doctor says it was caused by clobazam, you should not take the medication again. Ask your doctor or pharmacist for more details.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Clobazam?

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Some products that may interact with this drug include: orlistat, sodium oxybate.

Other medications can affect the removal of clobazam from your body, which may affect how clobazam works. Examples include fluconazole, fluvoxamine, among others.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

Clobazam may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Clobazam?

Clobazam may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Clobazam?

Clobazam may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Clobazam.

What is the dose of Clobazam for an adult?

Usual Adult Dose for 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

Comments:

-A daily dose greater than 5 mg should be administered in divided doses twice a day.

-Doses should be escalated no more rapidly than weekly.

-Doses should be withdrawn gradually by tapering the total daily dose by 5 to 10 mg on a weekly basis until discontinued.

Use: Adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS)

Usual Geriatric Dose for 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

Maximum dose:

-Body weight 30 kg or less: 20 mg/day

-Body weight 30 kg or more: 40 mg/day

Comments:

-A daily dose greater than 5 mg should be administered in divided doses twice a day.

-Doses should be escalated no more rapidly than weekly.

-Based on clinical response, maximum doses may be started after 21 days.

-Doses should be withdrawn gradually by tapering the total daily dose by 5 to 10 mg on a weekly basis until discontinued.

Use: Adjunctive treatment of seizures associated with LGS

Renal Dose Adjustments

Mild to moderate renal dysfunction (30 to 80 mL/min): No adjustment recommended.

Severe renal dysfunction (less than 30 mL/min) or ESRD: Data not available

Liver Dose Adjustments

Mild to moderate liver dysfunction (Child-Pugh score 5 to 9):

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

Maximum dose:

-Body weight 30 kg or less: 20 mg/day

-Body weight 30 kg or more: 40 mg/day

Comment: Based on clinical response, maximum doses may be started after 21 days.

Severe liver dysfunction: Dose adjustments may be required; however, no specific guidelines have been suggested.

Dose Adjustments

CYP450 2C19 poor metabolizers:

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

Maximum dose:

-Body weight 30 kg or less: 20 mg/day

-Body weight 30 kg or more: 40 mg/day

Comment: Based on clinical response, maximum doses may be started after 21 days.

Treatment Discontinuation:

-Abrupt discontinuation should be avoided.

-The dose should be reduced by 5 to 10 mg every week until discontinuation.

Other Comments

Administration advice:

-Once titrated to an effective dose, patients should remain on their treatment and care should be exercised when changing between different formulations.

-Tablets can be administered whole, broken in half along the score, or crushed and mixed in applesauce.

-This drug can be administered without regard to meals.

-Oral suspension: The manufacturer product information should be consulted.

Storage requirements:

-Oral suspension: Store upright in the original bottle and protect from light.

General:

-Limitation of use: Treatment of short-term, mild anxiety may be inappropriate and/or unsuitable.

-Patients with schizophrenia or other psychotic illnesses should limit benzodiazepines to adjunctive treatment; primary treatment with benzodiazepines should be avoided in this patient population.

Monitoring:

-Hematologic: Periodic blood counts

-Hepatic: Regular liver function tests, especially in patients with liver or renal dysfunction receiving long-term treatment

-Nervous system: Signs/symptoms of sedation

-Other: Signs/symptoms of paradoxical reactions

-Psychiatric: Signs/symptoms of anxiety, emergence/worsening of depression, suicidal thoughts or behavior, any unusual changes in mood or behavior, withdrawal side effects

-Renal: Regular renal function tests, especially in patients with liver or renal dysfunction receiving long-term treatment

-Respiratory: Respiratory function

Patient advice:

-This medicine may increase the risk of suicidal thoughts and behavior. Be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Report any behavior of concern to your healthcare provider as soon as possible.

-This drug may cause drowsiness and dizziness and reduce alertness. Do not drive a car or operate dangerous machinery until you know how this drug affects you.

-Do not drink alcohol or take other drugs that may cause sleepiness or dizziness while taking this drug until you talk to your healthcare provider.

-Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.

What is the dose of Clobazam for a child?

Usual Pediatric Dose for 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

Comments:

-A daily dose greater than 5 mg should be administered in divided doses twice a day.

-Doses should be escalated no more rapidly than weekly.

-Doses should be withdrawn gradually by tapering the total daily dose by 5 to 10 mg on a weekly basis until discontinued.

Use: Adjunctive treatment of seizures associated with LGS

How is Clobazam available?

Clobazam is available in the following dosage forms and strengths:

  • Tablet
  • Oral Suspension

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Clobazam, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: January 17, 2018 | Last Modified: September 12, 2019

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