Drug Information for Zarontin (Ethosuximide) ORAL SOLUTION (Parke-Davis Div of Pfizer Inc): Medication GuideZARONTIN (Za ron' tin)(ethosuximide)Oral Solution

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  • Read the Medication Guide before you or your family member 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 about ZARONTIN?

    ZARONTIN may cause a serious, even life-threatening blood cell abnormalities such as reduced red or white blood cells; therefore, periodic blood counts should be performed. Contact your healthcare provider right away if you have any of these signs and/or symptoms of infection:

    • Unusual bruising
    • Sore throat
    • Fever

    Like other antiepileptic 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
    • If you have suicidal thoughts or actions, do not stop ZARONTIN without first talking to your healthcare provider.
      • Stopping ZARONTIN suddenly can cause serious problems.
      • 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.
    • 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 as scheduled.
      • Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

    What is ZARONTIN?

    ZARONTIN is a prescription medicine used alone or with other medications to treat certain types of seizures in people. ZARONTIN belongs to a class of prescription medicines called anticonvulsants or anti-seizure medications used to control epilepsy in children and adults. Epilepsy is a condition where you have repeated seizures (fits). There are many different types of seizures, ranging from mild to severe. ZARONTIN is used to control absence (petit mal) seizures. Ask your healthcare provider if you have any questions about why ZARONTIN has been prescribed for you.

    Who should not take ZARONTIN?

    Do not take ZARONTIN if you have had an allergic reaction to other succinimide drugs (e.g., methsuximide) or to any of the inactive ingredients in ZARONTIN. See the end of this guide for a complete list of ingredients.

    What should I tell my healthcare provider before taking ZARONTIN?

    Before taking ZARONTIN, tell your healthcare provider about all of your medical conditions, including if you:

    • Have or had seizures
    • Have or had kidney problems
    • Have or had liver problems
    • Have or had Systematic Lupus Erythematosus
    • Have or had frequent infections such as fever, chills, sore throat or mouth ulcers
    • Have or had a rash or allergic reaction to another antiepileptic drug (AED) medicine
    • Are pregnant or plan to become pregnant. It is not known if ZARONTIN will harm your unborn baby. You and your healthcare provider will have to 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 Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
    • Are breast-feeding or plan to breast-feed. It is not known if ZARONTIN can pass into breast milk and if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take ZARONTIN.

    Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. ZARONTIN and some medicines may interact with each other causing side effects. Especially tell your healthcare provider if you take:

    • Phenytoin and Valproic Acid, which are also used to treat epilepsy.
      • Ethosuximide interacts with phenytoin and valproic acid. Phenytoin may increase their plasma concentrations and valproic acid may both increase or decrease their plasma concentrations therefore periodic blood levels of these drugs may be needed.

    Know the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist each time you get a new medicine. Do not start a new medicine without talking with your healthcare provider.

    How should I take ZARONTIN?

    • Take ZARONTIN exactly as prescribed. Your healthcare provider may need to change (adjust) the dose of ZARONTIN until it is right for you. If you miss a dose of ZARONTIN, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of ZARONTIN at the same time.
    • ZARONTIN oral solution can be taken with or without food.
    • Do not stop taking ZARONTIN without talking to your healthcare provider. If you stop taking ZARONTIN suddenly, you may have seizures more often. If you need to stop taking ZARONTIN, your healthcare provider can tell you how to safely stop taking it.
    • If you take too much ZARONTIN, call your healthcare provider or poison control center, or go to the nearest emergency room right away.
    • If you have epilepsy, tell your healthcare provider if your seizures get worse or if you have new types of seizures.
    • If you do not think you are getting better or have any concerns about your condition while taking ZARONTIN, call your doctor.

    OVERDOSAGE

    If you suspect an overdose, seek medical attention immediately.

    Acute overdoses may produce nausea, vomiting, and can progress to coma with respiratory depression.

    What should I avoid while taking ZARONTIN?

    See the section above called "Who should not take ZARONTIN?"

    Do not drive a car, work with machines, or do other dangerous activities until you know how ZARONTIN affects you.

    What are the possible side effects of ZARONTIN?

    See "What is the most important information I should know about ZARONTIN?"

    ZARONTIN may cause serious side effects, including:

    • Seizures
    • Rash: Tell your healthcare provider right away if you get red itchy wells (hives) or rash on your body, or if you become severely ill and have some or all of these symptoms: swelling of your face oreyes, while taking ZARONTIN.

    The most common side effects of ZARONTIN are:

    • feeling tired or drowsy
    • dizziness or lightheadedness
    • headache
    • weakness, unsteadiness when walking
    • mood changes such feelings of extreme happiness, irritability or excitement
    • hiccups
    • loss of concentration
    • disturbance of sleep
    • frightening dreams
    • abnormally suspicious thoughts
    • increased libido
    • indigestion, stomach pain or discomfort
    • cramps
    • blurred vision
    • nausea (feeling sick or vomiting)
    • swollen gums or tongue
    • diarrhea
    • weight loss
    • loss of appetite
    • itchy red skin rash or hives
    • excessive hairiness, especially in women
    • short sightedness
    • vaginal bleeding
    • allergic reaction
    • blood in urine

    These are not all the possible side effects with ZARONTIN. For more information, ask your healthcare provider or pharmacist.

    Tell your doctor about any side effect that bothers you or that does not go away. 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?

    Keep ZARONTIN and all medicines out of the reach of children.Store ZARONTIN at room temperature, 20°–25°C (68° – 77°F). Preserve in tight containers. Protect from freezing and light.

    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 was written for healthcare professionals.

    What are the ingredients in ZARONTIN?

    Active ingredient: ethosuximide

    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.

    This Medication Guide has been approved by the U.S. Food and Drug Administration.

    LAB-0402-1.0September 2009

  • Drug Information Provided by National Library of Medicine (NLM).
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