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  • Generic Name: (vigabatrin)
    Other Brands: N/A
  • Last Revised: 08/2016
    • What is this medication and its most common uses?

      Sabril tablets are used along with other medicines to treat certain types of seizures in people who do not respond well enough to several other treatments.

    • What should I know when beginning and continuing on this medication?

      Sabril tablets may only be available under a special restricted distribution program called the Sabril Risk Evaluation and Mitigation Strategy (REMS) program. Sabril may only be used in patients who are enrolled in and meet all conditions of the Sabril REMS program. Your healthcare provider will explain the Sabril REMS program to you. You will likely receive Sabril tablets from a specialty pharmacy.

      How does this medication work?

      A seizure occurs when electrical signals in the brain are out of balance. Sabril tablets are thought to be involved in the production of a chemical that helps to keep electrical signals balanced in the brain.

      What are the beneficial effects of this medication and when should I begin to have results?

      What: When used with your current seizure medicine(s), Sabril tablets may lower the number of monthly seizures you experience.

      When: Everyone responds differently to treatment, so try to be patient and follow your healthcare provider's directions. It is important that you take Sabril tablets exactly as your healthcare provider has prescribed.

      How do I know it is working?

      You may start to notice a reduction in the number of seizures you normally experience. This is a good indicator that your medication is working. Having a record or seizure diary to keep track of when you experienced a seizure (date and under what circumstances) will be helpful to you and your healthcare provider in monitoring your progress.

    • What are the possible side effects of this medication?

      The following is not a full list of side effects. Side effects cannot be anticipated. If any develop or change in intensity, tell your healthcare provider as soon as possible. Only your healthcare provider can determine if it is safe for you to continue taking this medication.

      Sabril tablets can harm or affect your vision. Some people can have severe loss, particularly to their peripheral vision, in which they lose the ability to see to the side when looking straight ahead. If this happens, it may not get better. You may also experience blurry vision. Contact your healthcare provider right away if you think you are not seeing as well as before you started taking Sabril tablets; start to trip, bump into things, or are more clumsy than usual; or if you are surprised by people or things coming in front of you that seem to come out of nowhere.

      Seizures in Adults

      More common side effects may include: permanent vision loss, tiredness, drowsiness, uncontrollable eye movements, shaking, blurred vision, problems with memory or coordination, weight gain, joint pain, confusion.

      Seizures in Children 10-16 Years

      More common side effects may include: weight gain, upper respiratory tract infection, shaking, tiredness, aggression, double vision.

      Less common side effects may include:

      Increased risk of suicidal thoughts or actions, with symptoms such as thoughts about suicide or dying; attempt to commit suicide; new or worse depression, anxiety, or irritability; panic attacks; trouble sleeping; or other unusual changes in behavior or mood.

      Nerve problems with symptoms such as numbness and tingling in your toes or feet.

      Sabril tablets may also cause anemia (low red blood cell counts) and swelling.

    • Who should not take this medication?

      Do not take Sabril tablets if you are allergic to this medicine or any of its ingredients.

    • What should I tell my healthcare provider before I take the first dose of this medication?

      Tell your healthcare provider about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Sabril tablets. Also, talk to your healthcare provider about your complete medical history, especially if you have any nervous or mental illness (such as depression, thoughts of suicide or attempts at suicide), vision or kidney problems, or anemia; are pregnant; plan to become pregnant; or are breastfeeding.

    • What is the usual dosage?

      The information below is based on the dosage guidelines your healthcare provider uses. Depending on your condition and medical history, your healthcare provider may prescribe a different regimen. Do not change the dosage or stop taking your medication without your healthcare provider's approval.

      Adults ≥17 years: The recommended starting dose is 500 milligrams (mg) twice a day.

      Children 10-16 years: Your healthcare provider will prescribe the appropriate dose for your child based on his/her body weight. The usual starting dose is 250 mg twice a day.

      Your healthcare provider may increase your dose as needed, until the desired effect is achieved.

      If you have kidney impairment, your healthcare provider may adjust your dose appropriately.

      It is important that you do not stop taking this medication abruptly. If you need to change or stop taking this medication, it is important that you only do this with the guidance of your healthcare provider.

    • How should I take this medication?

      Take Sabril tablets exactly as prescribed by your healthcare provider. Do not change your dose or stop taking Sabril tablets without first talking to your healthcare provider.

      Take Sabril tablets with or without food.

      If you do not notice an improvement in your condition after 3 months of treatment, notify your healthcare provider.

    • What should I avoid while taking this medication?

      Do not drive, operate machinery, or perform any dangerous tasks until you know how Sabril tablets affect you.

    • What are the possible food and drug interactions associated with this medication?

      If Sabril tablets are taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your healthcare provider before combining Sabril tablets with clonazepam or phenytoin.

    • May I receive this medication if I am pregnant or breastfeeding?

      The effects of Sabril tablets during pregnancy are unknown. The ingredients in Sabril tablets can be found in your breast milk if you take them while breastfeeding. Do not breastfeed while taking Sabril tablets. Tell your healthcare provider immediately if you are pregnant, plan to become pregnant, or are breastfeeding.

      If you become pregnant while taking Sabril tablets, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of seizure medicine during pregnancy.

    • What should I do if I miss a dose of this medication?

      If you miss your scheduled dose of Sabril tablets, contact your healthcare provider or pharmacist for advice.

    • How should I store this medication?

      Store at room temperature.

    • Who should I contact in case of emergency or overdose?
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      In the event of a medical emergency call your doctor or 9-1-1 immediately. In the event of overdose, call your doctor or poison control for further instructions.
      National Poison Control#: Call 1-800-222-1222

      This PDR+ drug information has been developed by the Physicians’ Desk Reference Network (PDRN), a source of medication information trusted by doctors for over 65 years.

      This monograph summarizes the most important information about your medication and does not cover all the information you may need. If you have any questions or concerns or want to learn more about your medication, ask your healthcare provider; he/she will be able to provide answers to your questions. This medication should only be used by the patient for whom it was prescribed and should not be shared with other people.
    • Additional patient resources.
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