Product Details
CLOBAZAM 10 MG
Introduction : Clobazam 10mg tablet 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 10mg tablet 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 doctors prescription.
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.
Indication : Clobazam 10mg tablet is 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
Administration : Clobazam 10mg tablet 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.
Storage : Store in a cool and dry place away from sunlight, undeer 30 degree celcius
Mechanism of Action : The mechanism of clobazam, a 1,5-benzodiazepine, is not fully understood, however, it may bind to the benzodiazepine site of the GABA(A) receptor and potentiate neurotransmission.
Therapeutic : Anticonvulsant
Side Effects : Side effects may include constipation, fever, lethargy, somnolence, sedation, or drooling
Contraindications : Avoid use of this drug during pregnancy and prescribe an alternative. Evidence has demonstrated fetal abnormalities or risks when used during pregnancy.
Safety Advice / Warnings : 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. Birth control pills may not work as well while you are using this medicine.
This medicine will add to the effects of alcohol, 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.
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,
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,
References : Product Information: SYMPAZAN(TM) oral film, clobazam oral film. Aquestive Therapeutics (per FDA), Warren, NJ, 2018.
Product Information: ONFI(R) oral tablets, oral suspension, clobazam oral tablets, oral suspension. Lundbeck (per FDA), Deerfield, IL, 2013.
US Food & Drug Administration (FDA): Orphan Drug Designation Database. US Food & Drug Administration (FDA). Silver Spring, MD. 2022.
Jawad S, Richens A, & Oxley J: Single dose pharmacokinetic study of clobazam in normal volunteers and epileptic patients. Br J Clin Pharmacol 1984; 18:873-877.