Description and Brand NamesBefore UsingProper UsePrecautionsSide Effects Brand Name : Frisium Descriptions 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 Suspension 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. Pregnancy Information about this clobazam-oral-route Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breastfeeding Studies in women suggest that this medication poses minimal risk to the infant when used during 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. • 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. • Alfentanil • Amobarbital • Anileridine • Aprobarbital • Butabarbital • Butalbital • Carbinoxamine • Carisoprodol • Chloral Hydrate • Chlorzoxazone • Clozapine • Cobicistat • Codeine • Dabrafenib • Dantrolene • Eslicarbazepine Acetate • Ethchlorvynol • Fentanyl • Hydrocodone • Hydromorphone • Levorphanol • Meperidine • Mephenesin • Mephobarbital • Meprobamate • Metaxalone • Methocarbamol • Methohexital • Morphine • Morphine Sulfate Liposome • Nifedipine • Orlistat • Oxycodone • Oxymorphone • Pentobarbital • Phenobarbital • Piperaquine • Primidone • Propoxyphene • Remifentanil • Secobarbital • Sodium Oxybate • Sufentanil • Tamoxifen • Thiopental • Tramadol 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. • Dextromethorphan • Etravirine • Felbamate • Fosphenytoin • Ginkgo • Ketoconazole • Phenytoin • 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: • Depression, history of or • Mood or behavior disorder, history of—Use with caution. May make these conditions worse. • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body. 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. This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions. 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. Take the tablet with or without food. 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 (suspension or tablets): For seizures: Adults, teenagers, 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, teenagers, 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. 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. It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. 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, including some dental anesthetics. 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. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to think well. Do not suddenly stop taking this medicine without checking first 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 headache, nausea, irritability, tremors, or trouble sleeping. 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. Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills with this medicine. 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. 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 troubled breathing • holding false beliefs that cannot be changed by fact • irregular, fast or slow, or shallow breathing • itching • joint or muscle pain • lack of feeling or emotion • painful or difficult urination • pale or blue lips, fingernails, or skin • pinpoint red spots on the skin • red skin lesions, often 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 • troubled breathing with exertion • unusual bleeding or bruising • unusual excitement, nervousness, or restlessness • unusual tiredness or weakness 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 (stool) • drooling • ear congestion • irritability • loss of voice • nasal congestion • runny nose • sleepiness or unusual drowsiness • 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 • rash, hives, or welts • 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.