Frisium 10 mg 5 Tab

What is Frisium ( clobazam )?

Clobazam is a benzodiazepine (ben-zoe-dye-AZE-eh-peen). Clobazam affects chemicals in the brain that may become unbalanced and cause anxiety.

Clobazam is used in combination with other medications to treat seizures caused by Lennox-Gastaut syndrome, a severe form of childhood epilepsy that also causes developmental and behavior problems.

Clobazam may also be used for purposes not listed in this medication guide.

What is the most important information I should know about clobazam?

You should not use clobazam if you are allergic to it.

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits.

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.

What should I discuss with my healthcare provider before taking clobazam?

You should not take clobazam if you are allergic to it.

To make sure you can safely take clobazam, tell your doctor if you have any of these other conditions:

• liver or kidney disease;

• any type of breathing problem or lung disease;

• a history of depression or suicidal thoughts or behavior; or

• a history of drug or alcohol addiction.

Some young people have thoughts about suicide when first taking clobazam. Your doctor will need to check your progress at regular visits while you are using this medicine. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Clobazam may be habit forming. Never share clobazam with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether clobazam will harm an unborn baby.Clobazam may cause breathing problems, feeding problems, low body temperature, and withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Clobazam can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking clobazam.

Clobazam can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Clobazam should not be given to a child younger than 2 years old.

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 clobazam.

How should I take clobazam?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may crush the clobazam tablet and mix the medicine into a spoonful of applesauce to make swallowing easier. Swallow right away without chewing. Do not save the mixture for later use.

Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not stop using clobazam 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.

Use clobazam regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. Contact your doctor if your seizures get worse or you have them more often while taking clobazam.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Clobazam is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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.

What should I avoid while taking clobazam?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Do not drink alcohol while taking clobazam.

Clobazam side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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.

In rare cases, clobazam may cause a severe skin reaction, especially during the first 8 weeks of taking this medicine. Call your doctor right away if you have a hives, mouth sores, or a skin rash that spreads and causes blistering and peeling.

Call your doctor at once if you have:

• confusion, hallucinations;

• fever, chills, cough with yellow or green mucus, feeling short of breath;

• a light-headed feeling, like you might pass out;

• weak or shallow breathing;

• pain or burning when you urinate;

• urinating less than usual or not at all; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• drowsiness, tired feeling;

• slurred speech, drooling;

• sleep problems (insomnia);

• dry cough; or

• constipation.

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.

See also: Side effects (in more detail)

Clobazam dosing information

Usual Adult Dose for Lennox-Gastaut Syndrome:

Clobazam should be administered in divided doses twice daily (the 5 mg dose can be administered as a single daily dose). Dose escalation should not proceed more rapidly than every 7 days and dosing within each body weight group should be individualized.

Initial total daily dose: 
Body weight 30 kg or less: 5 mg orally daily 
Body weight 30 kg or more: 10 mg orally daily 
Starting day 7 total daily dose: 
Body weight 30 kg or less: 10 mg orally daily
Body weight 30 kg or more: 20 mg orally daily
Starting day 14 total daily dose: 
Body weight 30 kg or less: 20 mg orally daily 
Body weight 30 kg or more: 40 mg orally daily

Usual Geriatric Dose for Lennox-Gastaut Syndrome:

Initial dose: 5 mg orally daily
Maintenance dose: Dose should be initially titrated to 10 to 20 mg orally daily
Maximum dose: After the initial titration to 10 to 20 mg orally daily, the patient may be further titrated to the maximum dose (20 to 40 mg orally daily based on weight) may be started on day 21.

Usual Pediatric Dose for Lennox-Gastaut Syndrome:

Pediatric patients 2 years and greater:

Clobazam should be administered in divided doses twice daily (the 5 mg dose can be administered as a single daily dose). Dose escalation should not proceed more rapidly than every 7 days and dosing within each body weight group should be individualized.

Initial total daily dose: 
Body weight 30 kg or less: 5 mg orally daily 
Body weight 30 kg or more: 10 mg orally daily 
Starting day 7 total daily dose: 
Body weight 30 kg or less: 10 mg orally daily
Body weight 30 kg or more: 20 mg orally daily
Starting day 14 total daily dose: 
Body weight 30 kg or less: 20 mg orally daily 
Body weight 30 kg or more: 40 mg orally daily

What other drugs will affect clobazam?

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking clobazam with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with clobazam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.