(ethosuximide) Capsules, Oral Solution
Read this Medication Guide before you start taking
ZARONTIN and each time you get a refill. There may be new information. This
information does not take the place of talking to your healthcare provider
about your medical condition or treatment. If you have any questions about
ZARONTIN, ask your healthcare provider or pharmacist.
What is the most important information I should know
Do not stop taking ZARONTIN without first talking to
your healthcare provider.
Stopping ZARONTIN suddenly can cause serious problems.
ZARONTIN can cause serious side effects, including:
1. Rare but serious blood problems that may be
life-threatening. Call your healthcare provider right away if you have:
- fever, swollen glands, or sore throat that come and go or
do not go away
- frequent infections or an infection that does not go away
- easy bruising
- red or purple spots on your body
- bleeding gums or nose bleeds
- severe fatigue or weakness
2. Systematic Lupus Erythematosus. Call your
healthcare provider right away if you have any of these symptoms:
- joint pain and swelling
- muscle pain
- low-grade fever
- pain in the chest that is worse with breathing
- unexplained skin rash
3. Like other antiepiieptic drugs, ZARONTIN may cause
suicidal thoughts or actions in a very small number of people, about 1 in 500.
Call a healthcare provider right away if you have any
of these symptoms, especially if they are new, worse, or worry you:
- thoughts about suicide or dying
- attempts to commit suicide
- new or worse depression
- new or worse anxiety
- feeling agitated or restless
- panic attacks
- trouble sleeping (insomnia)
- new or worse irritability
- acting aggressive, being angry, or violent
- acting on dangerous impulses
- an extreme increase activity and talking (mania)
- other unusual changes in behavior or mood
How can I watch for early symptoms of suicidal
thoughts and actions?
- Pay attention to any changes, especially sudden changes,
in mood, behaviors, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider
Call your healthcare provider between visits as needed,
especially if you are worried about symptoms.
Do not stop ZARONTIN without first talking to a
- Stopping ZARONTIN suddenly can cause serious problems.
- Stopping a seizure medicine suddenly in a patient who has
epilepsy can cause seizures that will not stop (status epilepticus).
Suicidal thoughts or actions can be caused by things
other than medicines. If you have suicidal thoughts or actions, your healthcare
provider may check for other causes.
What is ZARONTIN?
ZARONTIN is a prescription medicine used to treat absence
(petit mal) seizures.
Who should not take ZARONTIN?
Do not take ZARONTIN if you are allergic to succinimides
(methsuximide or ethosuximide), or any of the ingredients in ZARONTIN. See the
end of this Medication Guide for a complete list of ingredients in ZARONTIN.
What should I tell my healthcare provider before
Before you take ZARONTIN, tell your healthcare provider
- have or had liver problems
- have or have had depression, mood problems or suicidal thoughts
- have any other medical conditions
- are pregnant or plan to become pregnant. It is not known
if ZARONTIN can harm your unborn baby. Tell your healthcare provider right away
if you become pregnant while taking ZARONTIN. You and your healthcare provider
should decide if you should take ZARONTIN while you are pregnant.
- If you become pregnant while taking ZARONTIN, talk to
your healthcare provider about registering with the North American
Antiepiieptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is
to collect information about the safety of antiepiieptic drugs during
pregnancy. You can enroll in this registry by calling 1-888-233-2334.
- are breast-feeding or plan to breast-feed. It is not
known if ZARONTIN can pass into breast milk. You and your healthcare provider
should decide how you will feed your baby while you take ZARONTIN.
Tell your healthcare provider about all the medicines you
take, including prescription and non-prescription medicines, vitamins, and
herbal supplements. Taking ZARONTIN with certain other medicines can cause side
effects or affect how well they work. Do not start or stop other medicines
without talking to your healthcare provider.
Know the medicines you take. Keep a list of them with you
to show your healthcare provider and pharmacist when you get a new medicine.
How should I take ZARONTIN?
- Take ZARONTIN exactly as prescribed. Your healthcare
provider will tell you how much ZARONTIN to take.
- Your healthcare provider may change your dose. Do not
change your dose of ZARONTIN without talking to your healthcare provider.
- If you take too much ZARONTIN, call your healthcare
provider or your local Poison Control Center right away.
What should I avoid while taking ZARONTIN?
- Do not drink alcohol or take other medicines that make
you sleepy or dizzy while taking ZARONTIN without first talking to your healthcare
provider. ZARONTIN taken with alcohol or medicines that cause sleepiness or
dizziness may make your sleepiness or dizziness worse.
- Do not drive, operate heavy machinery, or do other
dangerous activities until you know how ZARONTIN affects you. ZARONTIN can
slowyour thinking and motor skills.
What are the possible side effects of ZARONTIN?
- See “What is the most important information I should
know about ZARONTIN?”
ZARONTIN may cause other serious side effects, including:
- Serious allergic reactions. Call your healthcare provider
right away if you have any of these symptoms:
- skin rash
- sores in your mouth
- blistering or peeling skin
- Changes in thinking, mood, or behavior. Some patients may
get abnormally suspicious thoughts, hallucinations (seeing or hearing things
that are not there), or delusions (false thoughts or beliefs).
- Grand mal seizures can happen more often or become worse
Call your healthcare provider right away, if you have
any of the symptoms listed above.
The most common side effects of ZARONTIN include
- nausea or vomiting
- indigestion, stomach pain
- weight loss
- loss of appetite
- dizziness or lightheadedness
- unsteadiness when walking
- loss of concentration
Tell your healthcare provider about any side effect that
bothers you or that does not go away.
These are not all the possible side effects with
ZARONTIN. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.
How should I store ZARONTIN?
- Store ZARONTIN capsules at room temperature, between 59°F
to 86°F (15°C to 30°C).
- Store ZARONTIN syrup (oral solution) at 20°-25°C (68°- 77°F).
Preserve in tight containers. Protect from freezing and light.
Keep ZARONTIN and all medicines out of the reach of
General information about ZARONTIN
Medicines are sometimes prescribed for purposes other
than those listed in a Medication Guide. Do not use ZARONTIN for a condition
for which it was not prescribed. Do not give ZARONTIN to other people, even if they
have the same condition. It may harm them.
This Medication Guide summarizes the most important
information about ZARONTIN. If you would like more information, talk with your
healthcare provider. You can ask your healthcare provider or pharmacist for
information about ZARONTIN that is written for healthcare professionals.
For more information, go to www. pfizer.com or call 1
What are the ingredients in ZARONTIN?
Active ingredient: ethosuximide Capsules
Inactive ingredients: Polyethylene glycol 400, NF;
D&C yellow No. 10; FD&C red No.3; gelatin, NF; glycerin, USP; and
Inactive ingredients: Each 5 ml (teaspoonful) of
oral solution contains 250 mg ethosuximide in a raspberry flavored base. Also
contains citric acid, anhydrous, USP; FD&C red No. 40; FD&C yellow No.
6; flavor; glycerin, USP; purified water, USP; saccharin sodium, USP; sodium
benzoate, NF; Sodium Citrate, USP; sucrose, NF.