Generic name: clobazam (KLOE ba zam)
Brand name: Sympazan
Drug class: Benzodiazepine anticonvulsants
Sympazan is a benzodiazepine derivative and is supplied as an oral film containing 5 mg, 10 mg, or 20 mg of clobazam.
Sympazan is used in combination with other medications to treat seizures caused by Lennox-Gastaut syndrome in people 2 years of age or older. Lennox-Gastaut syndrome is a severe form of childhood epilepsy that also causes developmental and behavior problems.
It is not known if Sympazan is safe and effective in children less than 2 years old.
Warnings
Sympazan can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing.
MISUSE OF SYMPAZAN CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.
Some people have thoughts about suicide while taking Sympazan. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.
Do not stop using Sympazan suddenly, or you could have increased seizures or unpleasant withdrawal symptoms.
Before taking this medicine
You should not take Sympazan if you are allergic to clobazam.
To make sure Sympazan is safe for you, tell your doctor if you have ever had:
- breathing problems or lung disease;
- depression, mood problems, or suicidal thoughts or behavior;
- a drug or alcohol addiction; or
- liver or kidney disease.
Some people have thoughts about suicide while taking Sympazan. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.
If you use Sympazan while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.
Do not start or stop taking seizure medication during pregnancy without your doctor's advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of clobazam on the baby.
Sympazan can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using this medicine, use a back-up barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge. Keep using birth control for at least 28 days after your last dose of Sympazan.
If you are breastfeeding, tell your doctor if you notice drowsiness or feeding problems in the nursing baby.
Sympazan should not be given to a child younger than 2 years old.
How should I take Sympazan?
Take Sympazan exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides. Your doctor may occasionally change your dose. Never use Sympazan in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of Sympazan.
Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.
You may take Sympazan with or without food.
To use the oral film, place it on the top of your tongue. Swallow several times as the film dissolves, without drinking liquid.
Clobazam doses are based on weight in children. Your child's dose needs may change if the child gains or loses weight.
Do not stop using Sympazan suddenly, even if you feel fine. Stopping suddenly may cause increased seizures or unpleasant withdrawal symptoms. Follow your doctor's instructions about tapering your dose.
Tell your doctor if your seizures get worse or you have them more often while taking Sympazan.
Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.
Dosing information
Usual Adult Dose of Sympazan for Lennox-Gastaut Syndrome:
Initial daily dose:
-Body weight 30 kg or less: 5 mg orally per day
-Body weight 30 kg or more: 10 mg orally per day
Day 7 total daily dose:
-Body weight 30 kg or less: 10 mg orally per day
-Body weight 30 kg or more: 20 mg orally per day
Day 14 daily dose:
-Body weight 30 kg or less: 20 mg orally per day
-Body weight 30 kg or more: 40 mg orally per day
Usual Geriatric Dose of Sympazan for Lennox-Gastaut Syndrome:
Initial dose: 5 mg orally per day
Day 7 total daily dose:
-Body weight 30 kg or less: 5 mg orally per day
-Body weight 30 kg or more: 10 mg orally per day
Day 14 daily dose:
-Body weight 30 kg or less: 10 mg orally per day
-Body weight 30 kg or more: 20 mg orally per day
Maximum dose:
-Body weight 30 kg or less: 20 mg/day
-Body weight 30 kg or more: 40 mg/day
Usual Pediatric Dose of Sympazan for Lennox-Gastaut Syndrome:
2 years or older:
Initial daily dose:
-Body weight 30 kg or less: 5 mg orally per day
-Body weight 30 kg or more: 10 mg orally per day
Day 7 total daily dose:
-Body weight 30 kg or less: 10 mg orally per day
-Body weight 30 kg or more: 20 mg orally per day
Day 14 daily dose:
-Body weight 30 kg or less: 20 mg orally per day
-Body weight 30 kg or more: 40 mg orally per day
Comments:
-A daily dose greater than 5 mg should be administered in divided doses twice a day.
-Doses should be escalated no more rapidly than weekly.
-Doses should be withdrawn gradually by tapering the total daily dose by 5 to 10 mg on a weekly basis until discontinued.
Use: Adjunctive treatment of seizures associated with Lennox-Gastaut syndrome.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of clobazam can be fatal if you take it with alcohol, opioid medicine, or other drugs that cause drowsiness or slow your breathing.
Overdose symptoms may include extreme drowsiness or weakness, confusion, slow breathing, or loss of consciousness.
What should I avoid while taking Sympazan?
Do not drink alcohol. Dangerous side effects or death could occur.
Avoid driving or hazardous activity until you know how Sympazan will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.
Sympazan side effects
Get emergency medical help if you have signs of an allergic reaction to Sympazan (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
Sympazan can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing. A person caring for you should seek emergency medical attention if you have weak or shallow breathing, if you are hard to wake up, or if you stop breathing.
Call your doctor at once if you have:
- severe drowsiness, feeling like you might pass out;
- unusual changes in mood or behavior;
- aggression, thoughts of hurting yourself; or
- problems with balance or muscle movement.
The sedative effects of clobazam may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury while you are taking Sympazan.
Common Sympazan side effects may include:
- constipation;
- drowsiness, lack of energy;
- fever; or
- drooling.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Sympazan?
Taking Sympazan with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.
Tell your doctor about all your other medicines, especially:
- cold or cough medicine that contains dextromethorphan;
- antifungal medicine; or
- a stomach acid reducer (such as Nexium or Prilosec).
This list is not complete. Other drugs may interact with clobazam, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.