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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 oral solution is used in combination with other medicines to treat certain types of seizures in people who do not respond well enough to several other treatments. Sabril oral solution is also used to treat infantile spasms. Sabril oral solution is available as a powder to be mixed with water.

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

      Sabril oral solution may only be available under a special restricted distribution program called the Sabril Risk Evaluation and Mitigation Strategy (REMS) program. Sabril oral solution 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 oral solution from a specialty pharmacy.

      How does this medication work?

      A seizure occurs when electrical signals in the brain are out of balance. Sabril oral solution is 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: Sabril oral solution has been shown to lower the occurrence of seizures.

      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 oral solution exactly as your healthcare provider has prescribed.

      How do I know it is working?

      You may notice a reduction in the number of seizures you normally experience. This is a good indicator that the 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 oral solution 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 starting Sabril oral solution; 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 in adults 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 in children may include: weight gain, upper respiratory infection, shaking, tiredness, aggression, double vision.

      Infantile Spasms

      More common side effects may include: drowsiness, bronchitis (inflammation of the air passages within the lungs), ear infection.

      Less common side effects of Sabril oral solution 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 oral solution may also cause anemia (low red blood cell counts), swelling, or changes in brain pictures taken by MRI in some babies.

    • Who should not take this medication?

      Do not take Sabril oral solution if you are allergic to it 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 oral solution. 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.

      Seizures

      Adults ≥17 years: The recommended starting dose is 500 milligrams (mg) (1 packet) 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.

      Infantile Spasms

      Infants and children 1 month-2 years: Your healthcare provider will prescribe the appropriate dose for your child, based on his/her body weight.

      Your healthcare provider may increase the 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 the healthcare provider.

    • How should I take this medication?

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

      Take Sabril oral solution with or without food. It can be given at the same time as food, but the powder should not be mixed with your food. Sabril oral solution should only be mixed with cold or room temperature water.

      Each dose should be prepared immediately before use and administered cold or at room temperature. Throw away any unused medicine.

      Tell your healthcare provider if your condition does not improve within 3 months of starting treatment with Sabril oral solution.

      Tell your healthcare provider if your child's infantile spasms do not improve within 2-4 weeks of starting treatment with Sabril oral solution.

      Please review the instructions that come with your prescription on how to properly administer Sabril oral solution.

    • What should I avoid while taking this medication?

      Do not drive, operate machinery, or perform any dangerous tasks until you know how Sabril oral solution affects you.

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

      If Sabril oral solution is 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 oral solution with clonazepam or phenytoin.

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

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

      If you become pregnant while taking Sabril oral solution, 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 oral solution, 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.
      back to top Use your PDR® Pharmacy Discount Card when you or a family member fills a prescription and ask for your PDR® Discount every
      time!
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    This discount plan is NOT insurance or a Medicare prescription drug plan. The plan is not intended as a substitute for insurance and does not meet creditable coverage requirements under state or federal law. The plan provides discounts at participating pharmacies on certain pharmaceutical supplies, prescription drugs, or medical equipment and supplies. The range of discounts will vary depending on the products received. Members are obligated to pay the pharmacy the entire amount of the discounted rate for such products at the point of sale. The plan does not pay pharmacies for products provided to members. No enrollment or periodic fees apply. The pharmacy may pay the plan a fee from amounts the pharmacy collects from the member. The discount plan organization is ProCare Pharmacy Benefit Manager, Inc.,1267 Professional Parkway, ProCare Office Park, Gainesville, GA 30507, 1-888-299-5383. Customer service is provided by PDR, LLC., 5 Paragon Drive, Montvale, NJ, 07645, 1-800-232-7379, www.pdr.net/DiscountCard, customerservice@pdr.net.