What is Sympazan?
Sympazan, a benzodiazepine-derived drug, is available as an oral film that contains 5 mg, 10mg, or 20mg of Clobazam.
Sympazan can be used with other medications in order to treat seizures in patients 2 years old or older. Lennox-Gastraut syndrome is an extreme form of childhood epilepsy that also causes behavioral and developmental problems. Sympazan may be safe and effective for children younger than 2 years of age.
Warnings
Sympazan may slow or stop breathing, particularly if you've recently taken an opioid medication or alcohol or used other drugs that can slow breathing. Misuse of SYMPAZAN can result in addiction, overdosage and death. Store the medication where others can't get it. Sympazan may prompt suicidal thoughts in some individuals. If you experience sudden changes in mood or behavior that are related to thoughts of suicide, contact your physician immediately.
If you experience severe skin reactions, such as skin pain or skin blisters, seek emergency medical attention. Sympazan should not be stopped without consulting your doctor. If you suddenly stop taking the medication after long-term usage, you may experience increased seizures or withdrawal symptoms that could be life-threatening. Some withdrawal symptoms may last up to one or more years.
Seek medical attention immediately if you experience symptoms after stopping Sympazan, such as abnormal muscle movements, increased activity or talkativeness, sudden and severe mood or behavioral changes, confusion, hallucinations or seizures, or thoughts of suicide.
Before you take this drug
If you have an allergy to clobazam, do not take Sympazan.
Tell your doctor about any of the following to ensure that Sympazan will be safe for you:
- Breathing problems or lung disease
- Depression or mood disorders;
- Drug or alcohol abuse;
- Liver or kidney disease
Suicidal thoughts can arise while taking seizure medicines. Be alert to any changes in mood or symptoms. You and your family members should be on the lookout for any sudden changes in behavior. If you use Sympazan while pregnant, your baby may be born with withdrawal symptoms that are life-threatening and require medical treatment for several months.
You should not stop or start seizure medications during pregnancy without consulting your doctor. A seizure could be harmful to both mother and child. These risks may be outweighed by the benefits of preventing seizures. Inform your doctor immediately if you fall pregnant. Other seizure medications may be safer to take during pregnancy.
Sympazan may reduce the effectiveness of hormonal birth control, such as birth-control pills, and other birth-control methods, such as skin patches, vaginal rings, or injections. You can use barrier birth control as a backup to prevent pregnancy. This could be a condom, diaphragm, or cervical cap. Use birth control for at least 28 days following your last Sympazan dose. Tell your doctor if the baby seems drowsy or has feeding issues if you are nursing. Sympazan should not be used by children under 2 years of age.
Similar/related drugs
Banzel, Epidiolex, Clonazepam, Lamotrigine, Topiramate, Lamictal, and Klonopin
How to take Sympazan?
Follow all instructions on your prescription label and read any accompanying medication guides or instruction sheets. Read all of your Sympazan's labels carefully if there are additional directions included with it, such as taking higher amounts or for longer than prescribed - any time this occurs, consult with a healthcare provider immediately! If there's an urge to increase or extend its use beyond prescribed amounts or duration. If so, seek medical attention immediately.
Sympazan should never be shared with anyone, especially if they have a history of drug abuse. Misuse can lead to addiction, overdose, or death. Store the medication in a place where others cannot reach it. Selling or giving away this medication is illegal.
- For doses above 5 mg/day, take two separate doses.
- Start with 5 mg per day for patients weighing 30 kg or less. Increase as tolerated to 20 mg.
- For patients who weigh more than 30 kg, begin with 10 mg per day and gradually increase to a maximum of 40 mg.
Sympazan can be taken with or without food. Sympazan should not be taken with liquids. Put the oral film over your tongue and let it dissolve. Weight is used to determine the dose for children and adolescents. If your child loses or gains weight, the dose may change.
If you suddenly stop taking Sympazan, seizures may increase. Consult your doctor before stopping Sympazan. If you suddenly stop taking the medication after a long period of use, you may experience life-threatening withdrawal syndromes. Store away from heat and moisture at room temperature. Store your medication in an area where it cannot be misused. You should throw away any oral suspension that is unused 90 days after opening the bottle.
Dosing information
Adult dose for Lennox Gastaut Syndrome:
Initial total daily dose:
Body Weight: 30 kg or Less: 5 mg per day orally
Weight 30 kg over: Orally 10 mg per day
Day 7 total daily dose:
Weight 30 kg and less: Orally 10 mg per day
Body Weight over 30 kg: Orally 20 mg per day
Day 14 total daily dose:
Body Weight: 30 kg or Less: 20 mg per day orally
Bodyweight over 30 kg: oral 40 mg per day
Usual Geriatric Dose of Lennox Gastaut Syndrome:
Initial dose: 5 mg per day orally
Day 7 total daily dose:
Body Weight: 30 kg or Less: 5 mg per day orally
Body Weight over 30 kg: Orally 10 mg per day
Day 14 total daily dose:
Weight 30 kg and less: Orally 10 mg per day
Body Weight over 30 kg: Orally 20 mg per day
Maximum dose:
Body Weight: 30 kg or Less: 20 mg/day
Bodyweight over 30 kg: 20 mg/day
Usual pediatric dose for Lennox Gastaut Syndrome:
Two years old or older
Initial daily dose
Body Weight: 30 kg or Less: 5 mg per day orally
Body Weight over 30 kg: Orally 10 mg per day
Day 7 total daily dose:
Weight 30 kg and less: Orally 10 mg per day
Body weight over 30 kg: 20 mg per day orally
Day 14 total daily dose:
Body Weight: 30 kg or Less: 20 mg per day orally
Body Weight over 30 kg: Orally 40 mg per day
Comments:
A daily dose exceeding 5 mg must be divided into 2 doses and administered twice a day.
Doses should not be increased more than once a week.
The doses should be tapered weekly, reducing the daily total by 5–10 mg.
Adjunctive treatment for seizures associated with Lennox Gastaut Syndrome
What happens if I miss the dose?
If you are almost due for your next dose, skip the missed one. Never take two doses of the same medicine at once.
What happens if I overdose?
Call the Poison Help Line at 1-800-222-1222 or seek emergency medical care. Clobazam overdoses can be deadly if taken with alcohol, opioid medicines, or other drugs that cause drowsiness and slow breathing. Overdose symptoms include extreme drowsiness, weakness, confusion, breathing problems, and loss of consciousness.
What should be avoided?
Don't drink alcohol. Side effects and death can occur. Sympazan can cause you to feel dizzy or drowsy. Avoid driving and other hazardous activities until you are sure how they will affect you. Drowsiness or dizziness can lead to accidents or serious injuries.
Side effects of Sympazan
If you experience any of the following symptoms: an allergic reaction to Sympazan( hives; difficulty breathing; swelling on your face or in your throat); a severe skin response (fever or burning eyes; sore neck; skin pain or blistering; or a red or purple rash with blistering or peeling).
Sympazan may slow or stop breathing, particularly if you've recently consumed alcohol or opioid medications. If your breathing pauses are becoming irregular or blue lips appear, or if you cannot wake up, someone caring for you should immediately seek medical assistance.
You should tell your doctor if any symptoms worsen or change, including changes in mood or behavior, anxiety, panic attacks, or trouble sleeping. Also, you may feel more impulsive, agitated, hostile, aggressive, or restless.
If you experience:
- Weak or shallow breathing
- Severe drowsiness, feeling like you might pass out;
- Problems with muscle or balance movement.
Older adults may experience drowsiness and dizziness for a longer period of time. Avoid falling or causing an accident.
Common Sympazan side effects may include:
- Drowsiness, tiredness, trouble sleeping;
- Slurred speech
- Anger, aggression;
- Constipation;
- Painful urination
- Fever, coughing, breathing problems,
- Drooling.
There may be other side effects. For medical advice related to side effects, consult with your healthcare provider or reach out to the FDA at 1-800-FDA-1088 - reporting side effects can also be done through them.
Interaction with other drug
Asking your doctor about opioid medications, sleeping pills, muscle relaxers, anxiety medication, or seizure medicine can lead to dangerous side effects. Clobazam may interact with other drugs, such as prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor of all the other medications you take.
