Sabril

Generic Name: vigabatrin (vye GA ba trin)
Brand Names: Sabril

What is Sabril?

Sabril (vigabatrin) is an anti-epileptic medication, also called an anticonvulsant.

Sabril is used in combination with other medications to treat complex partial seizures in adults and adolescents who are at least 16 years old. Sabril is usually given after other anti-epileptic medications have been tried without successful control of seizures.

The powder form is used to treat infantile spasms in babies and children between the ages of 1 month and 2 years.

Sabril may also be used for purposes not listed in this medication guide.

Information about Sabril

Before you take Sabril, tell your doctor if you have any vision problems, such as retinitis or glaucoma. Some people taking Sabril have developed mild to severe vision problems. Vision loss caused by vigabatrin may be permanent, and you must have eye exams on a regular basis while taking this medication.

To be sure Sabril is not causing harmful effects on your vision, you will need a thorough eye exam when you start taking the medication and then every 3 months during treatment. If you ever stop taking Sabril, you may still need to have eye exams every 3 to 6 months after your treatment ends. Do not miss any follow-up visits to your doctor.

Slideshow: Flashback: FDA Drug Approvals 2013

Tell your doctor about all other medications you use.

You may have thoughts about suicide while taking Sabril. Your doctor will need to check your progress at regular visits. Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, or thoughts about suicide or hurting yourself.

Sabril is available only under a special program called SHARE. You must be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication and that you agree to have vision exams on a regular basis while you are taking Sabril.

Before taking this medicine

Some people taking Sabril have developed mild to severe vision problems. Vision problems may occur within weeks to years after you start taking Sabril. Vision loss caused by Sabril may be permanent, and you may notice only mild symptoms of the onset of vision loss. You must have eye exams on a regular basis while taking this medication. Sabril is available only under a special program called SHARE. You must be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication and that you agree to have vision exams every 3 months while you are taking Sabril. Ask your doctor or call the drug maker if you have questions about the program or the written requirements. You should not use Sabril if you are allergic to vigabatrin.

To make sure you can safely take Sabril, tell your doctor if you have any of these other conditions:

  • kidney disease;
  • vision problems, such as retinitis or glaucoma; or

  • if you are pregnant or plan to become pregnant while using Sabril.

You may have thoughts about suicide while taking this medication. Your doctor will need to check your progress at regular visits. Do not miss any scheduled appointments.

FDA pregnancy category C. It is not known whether Sabril will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Although Sabril might harm an unborn baby, having a seizure during pregnancy could harm both mother and baby. If you become pregnant while taking Sabril, do not stop taking it without your doctor's advice. If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Sabril on the baby. Vigabatrin can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using this medicine.

See also: Pregnancy and breastfeeding warnings (in more detail)

How should I take Sabril?

Take Sabril exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose over several weeks or months to make sure you get the best results from this medication.

Sabril may be taken with or without food.

Sabril powder must be mixed with water before you give it to a child. Empty the packet of powder into an empty cup and add 10 milliliters (2 teaspoons) of water that is cold or room temperature. If your doctor has prescribed more than 1 packet per dose, use 2 teaspoons of water for each packet of powder you are mixing.

Do not mix the powder and water until you are ready to give a dose. Stir the mixture until the powder dissolves completely. Give the liquid mixture to your child using the 10 mL oral syringe that comes with the medicine. If your child's dose is more than 1 packet, you will need to fill the syringe once for each packet mixed.

To be sure this medication is not causing harmful effects on your vision, you will need a thorough eye exam when you start taking Sabril and then every 3 months during treatment. If you ever stop taking Sabril, you may still need to have eye exams every 3 to 6 months after your treatment ends. Do not miss any follow-up visits to your doctor.

Do not stop using Sabril without first talking to your doctor, even if you feel fine. You may have increased seizures if you stop using Sabril suddenly. You may need to use less and less before you stop the medication completely. It may take up to 3 months before your seizure control improves. Contact your doctor if your seizures get worse or you have them more often while taking Sabril.

Store Sabril at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe drowsiness or dizziness, confusion, trouble speaking, feeling agitated or irritable, unusual thoughts or behavior, increased seizures, slow heart rate, weak or shallow breathing, or fainting.

What should I avoid?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Sabril side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Sabril: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

  • any change in your vision, no matter how mild;

  • back and forth eye movements you cannot control;

  • tremors;

  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

  • worsening seizures; or

  • confusion, mood or behavior changes, depression, thoughts about suicide or hurting yourself.

Less serious Sabril side effects may include:

  • headache, feeling irritable;

  • dizziness, drowsiness, tired feeling;

  • memory problems;

  • weight gain, swelling anywhere in your body;

  • numbness, burning pain, or tingly feeling in your hands or feet;

  • loss of coordination;

  • joint pain;

  • cold symptoms such as stuffy nose, fever, sneezing, sore throat;

  • nausea, vomiting, diarrhea; or

  • sleep problems (insomnia).

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.

See also: Side effects (in more detail)

What other drugs will affect Sabril?

Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for depression or anxiety can add to sleepiness caused by Sabril. Tell your doctor if you regularly use any of these medicines, or any other seizure medications.

Tell your doctor about all other medications you use, especially:

  • amiodarone (Cordarone, Pacerone);

  • clonazepam (Klonopin);

  • deferoxamine (Desferal);

  • ethambutol (Myambutol);

  • hydroxychloroquine (Plaquenil);

  • phenytoin (Dilantin);

  • tamoxifen (Soltamox); or

  • steroid medicine such as prednisone (Deltasone, Sterapred), budesonide (Pulmicort, Rhinocort, Symbicort), fluticasone (Advair , Flonase, Flovent, Veramyst), mometasone (Asmanex, Nasonex), triamcinolone (Nasacort), and others.

This list is not complete and other drugs may interact with Sabril. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about Sabril.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Sabril only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 4.01. Revision Date: 3/31/2011 1:25:48 PM.

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