DRUGS AND SUPPLEMENTS

Clobazam

March 21, 2017

Clobazam Oral suspension

What is this medicine?

CLOBAZAM (KLOH bay zam) is a benzodiazepine. It is used to treat seizures due to Lennox-Gastaut syndrome in combination with other anti-seizure medicines.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • drug abuse or addiction

  • kidney disease

  • liver disease

  • lung or breathing disease

  • mental illness

  • suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

  • an unusual or allergic reaction to clobazam, other benzodiazepines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Shake well before each use. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Use the oral syringe provided with your medicine to measure your dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Each carton contains 2 syringes. Use only 1 for your dose. The second syringe should be used only if you lose the other syringe or if it becomes damaged. Inside the carton is an adapter for the syringe. Insert the provided adapter firmly into the neck of the bottle before first use and keep the adapter in place for the duration of the usage of the bottle. To withdraw the dose, insert the dosing syringe into the adapter, turn the bottle upside down, and then slowly pull back the plunger of the syringe to prescribed dose. After removing the syringe from the bottle adapter, slowly squirt the dose into the corner of the patient’s mouth. Replace the cap after each use; it will fit over the adapter only when the adapter is properly placed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years of age for selected conditions, precautions do apply.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

This medicine may interact with the following medications:

  • alcohol

  • certain antihistamines such as diphenhydramine, doxylamine, and chlorpheniramine

  • dextromethorphan

  • female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections

  • fluconazole

  • fluvoxamine

  • ketoconazole

  • medicines for sleep

  • narcotic medicines for pain

  • omeprazole

  • other benzodiazepines (i.e., alprazolam, chlordiazepoxide, clonazepam, clorazepate, diazepam, estazolam, flurazepam, lorazepam, midazolam, oxazepam, quazepam, temazepam, triazolam)

  • ticlopidine

  • tricyclic antidepressants (i.e., amitriptyline, clomipramine, desipramine, doxepin, imipramine, nortriptyline, protriptyline, trimipramine)

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. Visit your doctor or health care professional for regular checks on your progress. Your body may become dependent on this medicine. Do not stop taking except on your doctor's advice. You may develop a severe reaction. Your doctor will tell you how much medicine to take.

Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medicine and dosage times.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Do not treat yourself for coughs, colds, or allergies without asking your doctor or health care professional for advice. Some ingredients can increase possible side effects.

The use of this medicine may increase the chance of suicidal thoughts or actions. Pay special attention to how you are responding while on this medicine. Any worsening of mood, or thoughts of suicide or dying should be reported to your health care professional right away.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control.

Women who become pregnant while using this medicine may enroll in the North American Antiepileptic Drug Pregnancy Registry by calling 1-888-233-2334. This registry collects information about the safety of antiepileptic drug use during pregnancy.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • breathing problems

  • depressed mood

  • fever

  • hallucination, loss of contact with reality

  • redness, blistering, peeling or loosening of the skin, including inside the mouth

  • suicidal thoughts or other mood changes

  • unusual bleeding or bruising

  • unusually weak or tired

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

  • constipation

  • dizziness

  • drooling

  • drowsiness

  • restlessness

  • tiredness

  • trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

This medicine may cause accidental overdose and death if it taken by other adults, children, or pets. Mix any unused medicine with a substance like cat litter or coffee grounds. Then throw the medicine away in a sealed container like a sealed bag or a coffee can with a lid. Do not use the medicine after the expiration date.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F).

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Clobazam Oral tablet

What is this medicine?

CLOBAZAM (KLOH bay zam) is a benzodiazepine. It is used to treat seizures due to Lennox-Gastaut syndrome in combination with other anti-seizure medicines.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • drug abuse or addiction

  • kidney disease

  • liver disease

  • lung or breathing disease

  • mental illness

  • suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

  • an unusual or allergic reaction to clobazam, other benzodiazepines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. The tablets may be swallowed whole, split in half along the score line, or crushed and mixed in applesauce. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years of age for selected conditions, precautions do apply.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

This medicine may interact with the following medications:

  • alcohol

  • certain antihistamines such as diphenhydramine, doxylamine, and chlorpheniramine

  • dextromethorphan

  • female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections

  • fluconazole

  • fluvoxamine

  • ketoconazole

  • medicines for sleep

  • narcotic medicines for pain

  • omeprazole

  • other benzodiazepines (i.e., alprazolam, chlordiazepoxide, clonazepam, clorazepate, diazepam, estazolam, flurazepam, lorazepam, midazolam, oxazepam, quazepam, temazepam, triazolam)

  • ticlopidine

  • tricyclic antidepressants (i.e., amitriptyline, clomipramine, desipramine, doxepin, imipramine, nortriptyline, protriptyline, trimipramine)

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. Visit your doctor or health care professional for regular checks on your progress. Your body may become dependent on this medicine. Do not stop taking except on your doctor's advice. You may develop a severe reaction. Your doctor will tell you how much medicine to take.

Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medicine and dosage times.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Do not treat yourself for coughs, colds, or allergies without asking your doctor or health care professional for advice. Some ingredients can increase possible side effects.

The use of this medicine may increase the chance of suicidal thoughts or actions. Pay special attention to how you are responding while on this medicine. Any worsening of mood, or thoughts of suicide or dying should be reported to your health care professional right away.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control.

Women who become pregnant while using this medicine may enroll in the North American Antiepileptic Drug Pregnancy Registry by calling 1-888-233-2334. This registry collects information about the safety of antiepileptic drug use during pregnancy.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • breathing problems

  • depressed mood

  • fever

  • hallucination, loss of contact with reality

  • redness, blistering, peeling or loosening of the skin, including inside the mouth

  • suicidal thoughts or other mood changes

  • unusual bleeding or bruising

  • unusually weak or tired

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

  • constipation

  • dizziness

  • drooling

  • drowsiness

  • restlessness

  • tiredness

  • trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

This medicine may cause accidental overdose and death if it taken by other adults, children, or pets. Mix any unused medicine with a substance like cat litter or coffee grounds. Then throw the medicine away in a sealed container like a sealed bag or a coffee can with a lid. Do not use the medicine after the expiration date.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F).

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Updated:  

March 21, 2017

Sources:  

U.S. FDA-approved Package Insert