Generic name: zonisamide (zoe NIS a mide)
Brand name: Zonegran
Drug class: Carbonic anhydrase inhibitor anticonvulsants
Zonegran (zonisamide) is a sulfa drug with anti-convulsant effects.
Zonegran is a prescription medicine used together with other medicines to treat partial partial seizures in adults with epilepsy.
It is not known if Zonegran is safe or effective in children under 16 years of age.
Warnings
You should not use Zonegran if you are allergic to zonisamide, or to other sulfa drugs such as sulfamethoxazole (Gantanol), sulfisoxazole (Gantrisin), or sulfamethoxazole-trimethoprim (Bactrim, Septra, Sulfatrim, SMX-TMP, and others). A sulfa drug allergic reaction can be fatal.
Taking Zonegran can cause permanent vision loss. Tell your doctor right away if you have any eye pain or redness or any changes in your vision.
Some people have thoughts about suicide while taking zonisamide. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.
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.
Zonegran may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Do not stop using this medicine without first talking to your doctor, even if you feel fine. You may have increased seizures if you stop using Zonegran suddenly. You may need to use less and less before you stop the medication completely.
If you need surgery, tell the surgeon ahead of time that you are using Zonegran. You may need to stop using the medicine for a short time.
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
Before taking this medicine
You may not be able to take Zonegran if you have ever had a severe allergic to a sulfa drug.
To make sure Zonegran is safe for you, tell your doctor if you have ever had:
- liver disease;
- kidney disease;
- high levels of ammonia;
- stomach flu or illness causing diarrhea;
- a growth disorder;
- a bone disorder that causes soft or weak bones or low bone mineral density;
- depression, or suicidal thoughts or actions;
- if you have ever had metabolic acidosis (too much acid in your blood); or
- if you have been on a ketogenic diet (high-fat, high-protein, low-carb).
Some people have thoughts about suicide while taking Zonegran. 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.
Zonisamide may harm an unborn baby. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of zonisamide on the baby.
You should not breastfeed while using Zonegran.
Zonegran is not approved for use by anyone younger than 16 years old.
How should I take Zonegran?
Take Zonegran exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
Zonegran can be taken with or without food.
Swallow the capsule whole and do not crush, chew, break, or open it.
While using Zonegran, you may need frequent blood tests.
Do not stop using Zonegran suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor's instructions about tapering your dose.
Do not share this medicine with another person, even if they have the same symptoms you have.
Store at room temperature away from moisture, heat, and light.
Dosing information
Usual Adult Dose for Seizures:
16 years of age and older:
-Initial dose: 100 mg orally once a day
-Titration: After 2 weeks at 100 mg/day, the dose may be increased to 200 mg/day as either a single or divided dose (100 mg orally 2 times a day) for at least 2 weeks; it can then be increased to 300 mg/day, then 400 mg/day either as a single daily dose or divided into 2 daily doses, with the dose stable for at least 2 weeks to achieve steady state at each level
-Maintenance dose: 400 mg/day
-Maximum dose: 600 mg/day
Comments:
-This drug may be taken with or without food.
-Capsules should be swallowed whole.
-Because of the long half-life of this drug, up to 2 weeks may be required to achieve steady state levels upon reaching a stable dose or following dosage adjustment.
-The prescriber may wish to prolong the duration of treatment at the lower doses in order to fully assess the effects of this drug at steady state (noting that many of the side effects are more frequent at doses of 300 mg per day and above). Although there is some evidence of greater response at doses above 100 to 200 mg/day, the increase appears small and formal dose response studies have not been conducted.
Use: As adjunctive therapy in the treatment of partial seizures
Usual Pediatric Dose for Seizures:
Less than 16 years of age: Not recommended
16 years of age and older: See adult dosing
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.
Overdose symptoms may include slow heart rate, feeling light-headed, fainting, and slow or shallow breathing.
What to avoid
Avoid driving or hazardous activity until you know how Zonegran will affect you. Your reactions could be impaired.
Drinking alcohol with this medicine can cause side effects.
Zonegran side effects
Get emergency medical help if you have signs of an allergic reaction to Zonegran: any form of skin rash, hives; fever, swollen glands, feeling weak or tired, severe muscle pain, unusual bruising or bleeding; yellowing of your skin or eyes; difficult breathing; swelling of your face, lips, tongue, or throat.
Report any new or worsening symptoms to your doctor, such as: sudden mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have:
- eye pain or redness or any changes in your vision;
- decreased sweating, feeling very hot;
- signs of metabolic acidosis - confusion, vomiting, lack of energy, irregular heartbeats;
- symptoms of a blood cell disorder - fever, chills, body aches, flu symptoms, sores in your mouth and throat;
- symptoms of a kidney stone - severe pain in your stomach or lower back, blood in your urine;
- increased or worsening seizures;
- the first sign of any skin rash, no matter how mild; 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 Zonegran side effects may include:
- drowsiness, dizziness;
- problems with memory or concentration;
- feeling agitated or irritable;
- loss of coordination, trouble walking; or
- loss of appetite.
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 Zonegran?
Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking Zonegran with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety or depression.
Other drugs may interact with zonisamide, 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.