It should be started slowly in a divided dose twice daily, and it should be done according to body weight. Serum levels of clobazam and its metabolites require days to reach a steady state level. Onfi, produced by Lundbeck , is available in the United States as 10 mg and 20 mg scored tablets, as well as 2. The dose of Onfi depends on patient's weight. The total daily dose should be divided into 2 daily doses.
For patients at or less than 30 kilograms of body weight, start Onfi at 5 milligrams daily and slowly increase the medication up to 20 milligrams a day as tolerated by the patient. For patients more than 30 kilograms of body weight, start Onfi at 10 milligrams daily and increase the dose up to 40 milligrams a day as tolerated by the patient.
You need to adjust the dose in older patients, patients who are known to slowly metabolize medications through the liver known CYP2C19 metabolizers and individuals with liver disease or problems.
It's OK to take clobazam either with food or without food. To give it to small children or others who cannot swallow tablets, you can crush it and mix it with a spoonful of soft food such as applesauce, yogurt, or ice cream or use the suspension.
Measure your dose of Onfi oral suspension using the bottle adapter and dosing syringes that are given with the suspension. Use Onfi oral suspension within 90 days of first opening the bottle. Throw away any unused Onfi suspension after this time.
In general, a forgotten dose should be taken right away. If it is almost time for the next dose, just take one dose, not a double dose, and call the doctor's office for more advice. Do your best to follow the doctor's directions. If you forget doses often, it may be a good idea to get a special pillbox or watch with an alarm to remind you.
Taking the right amount of seizure medicine on time every single day is the most important step in preventing seizures! The mechanism of action for clobazam is not fully understood but is thought to involve what is known as potentiation of GABAergic neurotransmission resulting from binding at a benzodiazepine site at the GABA A receptor. It is bioavailable. Food does not affect absorption. It can be easily crushed in items such as apple sauce or other foods.
The main metabolite of the drug is the major circulating metabolite in humans, and at therapeutic doses, plasma concentrations of this can be 3 times higher than its parent compound.
There is no specific recommendation from the company as to what should be done with people who have kidney or renal problems. Clobazam is being marketed in the United States under the trade name of Onfi. The FDA indication for clobazam is strictly for add-on therapy for treatment of seizures associated with Lennox-Gastaut syndrome in children from age 2 and older. Both studies were similar in terms of the patient populations that were studied.
The first study was a randomized, double-blind, placebo-controlled study that looked at patients who were aged 2 to 54 years with a current or prior diagnosis of Lennox-Gastaut syndrome. The patients were divided into 2 groups by weight, those who were less than 30 kg and those who were greater than 30 kg, and then they were randomized to 1 of 3 maintenance doses of the medication 5 mg- Low, 10 mg Medium and 20 mg High doses. The primary measure for the study was the percent seizure reduction and weekly frequency of various seizures that typify the syndrome, primarily drop, tonic, or myoclonic seizures over a 4-week baseline to a week period of observation on the medication.
In the low-dose group, there was a In the medium-dose group, there was a The placebo group showed only a Because this is a drug in the benzodiazepine family, they also looked at the issue of tolerance which is common to this drug group. Tolerance is defined as whether a drug maintains its effectiveness over time at a given dose.
In other benzodiazepines, one often needs to take more of a given drug in order to maintain effectiveness. There was no significant development of tolerance over a 3-month period of observation.
In the high dose group, the target daily dose of 20 mg for less than 30 kg body weight vs. Based on these analyses, the drug was approved. However, excitement over these findings has been tempered by the fact that the benefits can often be short-lived. The most commonly reported side effect with this drug includes tiredness and sedation.
In general, these tend to be dose related with the higher doses resulting in higher reports of adverse effects. Because it is a benzodiazepine, abrupt discontinuation should be avoided. 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, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, pale or blue lips, fingernails, or skin, shakiness, unsteadiness, trembling, or other problems with muscle control or coordination, sweating, trouble breathing, or unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness.
Call your doctor right away if you notice these symptoms. Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the 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. 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:. 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. All rights reserved.
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Drugs and Supplements Clobazam Oral Route. Legal Conditions and Terms Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below.
Advertising Mayo Clinic is a nonprofit organization and proceeds from Web advertising help support our mission. Advertising and sponsorship policy Advertising and sponsorship opportunities. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies. Clobazam pronounced as kloe' ba zam.
Why is this medication prescribed? How should this medicine be used? Other uses for this medicine What special precautions should I follow? What special dietary instructions should I follow? What should I do if I forget a dose? What side effects can this medication cause? What should I know about storage and disposal of this medication?
Brand names. To take the liquid, follow these steps: Before the first use, uncap the bottle and firmly insert the adapter into the neck of the bottle until the adapter top is even with the bottle top. Do not remove the adapter during the period of time you are using this bottle. Shake the liquid well before each use to mix the medication evenly. To measure your dose, push the plunger of the syringe all the way down and insert the syringe into the adapter of the upright bottle.
Then turn the bottle upside down and slowly pull the plunger back until the black ring is in line with your prescribed dose. Remove the syringe from the bottle adapter and slowly squirt the liquid from the syringe into the corner of your mouth. Place the bottle cap over the adapter after each use. Wash the oral syringe after each use.
To wash the syringe, remove the plunger completely, wash the barrel and plunger with soap and water, rinse, and allow to dry. Do not place the syringe parts in the dishwasher. To take the film, follow these steps: Open the foil pouch and remove the film.
Be sure that your hands are dry and clean. Place the film on the top of your tongue. Close your mouth and swallow your saliva normally. Do not chew, spit, or talk while the film dissolves. Do not take with liquids.
Wash your hands. Other uses for this medicine. What special precautions should I follow? Before taking clobazam, tell your doctor and pharmacist if you are allergic to clobazam, any other medications, or any of the ingredients in clobazam tablets, suspension, or film. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with clobazam, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
If you take clobazam regularly during the last few months of your pregnancy, your baby may experience withdrawal symptoms after birth. Tell your baby's doctor right away if your baby experiences any of the following symptoms: irritability, hyperactivity, abnormal sleep, high-pitched cry, uncontrollable shaking of a part of the body, vomiting, or diarrhea. If you become pregnant while taking clobazam, call your doctor.
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