Description
Clobazam is used to help control seizures (convulsions) that occur with Lennox-Gastaut syndrome (LGS). It works in the brain to prevent seizures. This medicine will not cure LGS and will only control seizures for as long as you continue to take it.
Clobazam is a benzodiazepine. Benzodiazepines belong to the group of medicines called central nervous system (CNS) depressants, which are medicines that slow down the nervous system.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
- Film
- Suspension
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
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. Safety and efficacy 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.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Flumazenil
- Thioridazine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acepromazine
- Alfentanil
- Alprazolam
- Amphetamine
- Anileridine
- Aripiprazole
- Asenapine
- Baclofen
- Benperidol
- Benzhydrocodone
- Benzphetamine
- Bromazepam
- Buprenorphine
- Butalbital
- Butorphanol
- Calcifediol
- Calcium Oxybate
- Cannabidiol
- Cannabis
- Carbamazepine
- Carbinoxamine
- Carisoprodol
- Carphenazine
- Cetirizine
- Chloral Hydrate
- Chlordiazepoxide
- Chlorpromazine
- Chlorzoxazone
- Clonazepam
- Clorazepate
- Clozapine
- Codeine
- Cyclobenzaprine
- Dabrafenib
- Dantrolene
- Daridorexant
- Desogestrel
- Dexmedetomidine
- Dextroamphetamine
- Diacetylmorphine
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Etravirine
- Felbamate
- Fosphenytoin
- Ginkgo
- Ketoconazole
- Phenytoin
- Rifapentine
- St John's Wort
- Theophylline
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol abuse, or history of or
- Depression, history of or
- Drug abuse or dependence, or history of or
- Lung or breathing problems (eg, respiratory depression) or
- 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.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much of this medicine is used for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose.
This medicine comes with a Medication Guide and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.
You may take the medicine with or without food.
Place the whole film on top of your tongue. Do not take any liquid when using this medicine. Do not chew, spit, or talk while the film dissolves. If you need a second film, wait until the first film dissolves before using a second film.
You may swallow the tablet whole or break it in half along the score. If you are unable to swallow the tablet, it may be crushed and mixed in applesauce.
Shake the oral liquid before each dose. Use the bottle adapter and dosing syringe in the package to measure the right dose. Wash the syringe after each use and air dry. Do not put the syringe in the dishwasher.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage forms (film, suspension, or tablets):
- For seizures:
- Adults and children 2 years of age and older weighing more than 30 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 10 milligrams (mg) per day, given as 2 divided doses per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg per day.
- Adults and children 2 years of age and older weighing 30 kg or less—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 5 mg as a single dose per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 20 mg per day.
- Older adults—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 5 mg as a single dose per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg per day.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For seizures:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Throw away any unused oral liquid 90 days after the bottle is opened for the first time.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.
Tell your doctor if you are pregnant or planning to become pregnant. Using this medicine during the later pregnancy may cause problems in your newborn baby (eg, sedation or withdrawal symptoms). Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, feeding problems, a high-pitched cry, irritability, low muscle tone, restlessness, shakiness or tremors, sluggishness, trouble breathing, weight loss, vomiting, or fails to gain weight. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, and colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your doctor or dentist before taking any of these medicines with clobazam.
This medicine may cause some people to be dizzy, drowsy, or less alert than normal.
This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a possible worsening of your seizures and reduce the possibility of withdrawal symptoms such as changes in behavior, discouragement, feeling sad or empty, irritability, lack of appetite, loss of interest or pleasure, trouble concentrating, seeing or hearing things that others do not see or hear, thoughts of killing oneself, trouble sleeping, unusual movements, responses, or expressions.
Symptoms of an overdose include: blurred vision, change or loss of consciousness, changes in patterns and rhythms of speech, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, hallucinations, loss of strength or energy, muscle pain or weakness, nightmares, pale or blue lips, fingernails, or skin, shakiness, unsteadiness, trembling, or other problems with muscle control or coordination, slurred speech, trouble in speaking, sweating, trouble breathing, trouble sleeping, unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness, unusual excitement, nervousness, restlessness, or irritability, or unusual weak feeling. Call your doctor right away if you notice these symptoms.
Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis can occur with this medicine. Check with your doctor right away if you have Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips.
Check with your doctor right away if you have black, tarry stools, chest pain, chills, cough, fever, painful or difficult urination, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness. These may be symptoms of serious skin reaction called drug reaction with eosinophilia and systemic symptoms (DRESS).
If you or your child develop any unusual or strange thoughts and behavior while taking this medicine, be sure to discuss it with your doctor. Some of the changes that have occurred in people taking this medicine are like those seen in people who drink too much alcohol. Clobazam may cause confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.
Birth control pills may not work as well while you are using this medicine. To keep from getting pregnant, use another form of birth control together with your birth control pills during therapy and for 28 days after you take the last dose.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Difficulty with swallowing
- fever
- shakiness and unsteady walk
- unsteadiness, trembling, or other problems with muscle control or coordination
Less common
- Change in speech pattern
- restlessness
- slurred speech
- trouble sitting still
- trouble speaking
Incidence not known
- Agitation
- black, tarry stools
- bleeding gums
- blistering, peeling, or loosening of the skin
- blood in the urine or stools
- chest pain
- chills
- confusion as to time, place, or person
- cough
- diarrhea
- difficult or trouble breathing
- holding false beliefs that cannot be changed by fact
- irregular, fast or slow, or shallow breathing
- itching, rash, hives, or welts
- joint or muscle pain
- lack of feeling or emotion
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- painful or difficult urination
- pale or blue lips, fingernails, or skin
- pinpoint red spots on the skin
- red skin lesions, of ten with a purple center
- red, irritated eyes
- seeing, hearing, or feeling things that are not there
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- swollen glands
- unusual bleeding or bruising
- unusual excitement, nervousness, or restlessness
- unusual tiredness or weakness
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Agitation
- blurred vision
- change or loss of consciousness
- changes in patterns and rhythms of speech
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- loss of strength or energy
- nightmares
- shakiness and unsteady walk
- slurred speech
- sweating
- talkativeness
- trouble speaking
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- unusual excitement, nervousness, restlessness, or irritability
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Aggressive
- body aches or pain
- decreased appetite
- difficulty having a bowel movement
- drooling
- ear congestion
- irritability
- loss of voice
- runny or stuffy nose
- sneezing
- vomiting
Less common
- Bladder pain
- cloudy urine
- cough with mucus
- frequent urge to urinate
- increased appetite
- lower back or side pain
Incidence not known
- Double vision
- full or bloated feeling
- headache
- muscle spasms
- pressure in the stomach
- red skin
- swelling of the stomach area
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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