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Sabril

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

What is Sabril?

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

Sabril is used in combination with other medications to treat complex partial seizures in adults and children who are at least 10 years old. The powder form is used to treat infantile spasms in babies and children between the ages of 1 month and 2 years.

Sabril can cause serious side effects and should be used only by people who have been unable to control their seizures with several other medications.

Important information

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.

Anyone taking Sabril can develop vision problems that could get worse, even after you stop using this medicine. The more you take Sabril, the more likely you are to develop severe vision problems.

Some people have thoughts about suicide while taking seizure medication. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Before taking this medicine

Sabril is available only from a certified pharmacy under a special program called SHARE. You must be registered in the program and agree to have vision exams every 3 months while taking Sabril. Be sure you understand the risks and benefits of taking this medicine.

Some people taking vigabatrin have developed vision problems within weeks to years after starting treatment. Vision loss caused by vigabatrin may be permanent, and you may notice only mild symptoms at first. Talk to your doctor about this possibility.

You should not use Sabril if you are allergic to vigabatrin.

To make sure Sabril is safe for you, tell your doctor if you have:

  • vision problems;

  • kidney disease;

  • anemia (low red blood cells); or

  • a history of depression, mood disorder, mental illness, or suicidal thoughts or actions.

Some people have thoughts about suicide while taking seizure medication. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Follow your doctor's instructions about taking seizure medication if you are pregnant. Seizure control is very important during pregnancy, and having a seizure could harm both mother and baby. Do not start or stop taking this medicine without your doctor's advice, and tell your doctor right away if you become pregnant.

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 Sabril.

How should I take Sabril?

Take Sabril exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

You may take Sabril with or without food.

Sabril powder must be mixed only with water. Carefully follow your doctor's dosing instructions if you are giving Sabril to a child or infant.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Anyone taking Sabril can develop vision problems that could get worse, even after you stop using this medicine. The more you take Sabril, the more likely you are to develop severe vision problems.

You will need a thorough eye exam when you start taking Sabril and then every 3 months during treatment. Eye exams may not fully prevent vision damage, but they will help your doctor decide whether to change your treatment plan. Stay alert to any changes in your vision and report them to your doctor right away. If you ever stop taking Sabril, you may still need continued eye exams.

Call your doctor if your complex partial seizures do not improve after 3 months of treatment, or if your baby's infantile spasms do not improve after 2 to 4 weeks of treatment.

Do not stop using Sabril suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor's instructions about tapering your dose.

Store Sabril in the original container at room temperature away from moisture and heat.

Sabril dosing information

Usual Adult Dose for Seizure Prophylaxis:

Initial dose: 1 g orally daily (administered as one 500 mg orally 2 times daily) with or without food

The total daily dose may be increased in 500 mg increments at weekly intervals depending on response.

Recommended dose: 3 g orally daily (1.5 g orally 2 times daily)

A 6 g daily dose has not been shown to confer additional benefit compared to the 3 g daily dose and is associated with an increased incidence of adverse events.

Approved indication: For adults and children 10 years of age and older as adjunctive therapy for refractory complex partial seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. Vigabatrin is not indicated as a first line agent for complex partial seizures.

Usual Pediatric Dose for Epilepsy:

Infantile Spasms:
1 month to 2 years of age:
Initial dose: 50 mg/kg/day of vigabatrin oral solution given in two divided doses with or without food. The dose may be titrated by 25 to 50 mg/kg/day increments every 3 days up to a maximum of 150 mg/kg/day.

The entire contents of the appropriate number of packets (500 mg/packet) of powder should be emptied into an empty cup, and should be dissolved in 10 mL of cold or room temperature water per packet using the 10 mL oral syringe supplied with the medication. The concentration of the final solution is 50 mg/mL.

Each individual dose should be prepared immediately before use and administered cold or at room temperature.

Approved indication: As monotherapy for pediatric patients who are 1 month to 2 years of age with infantile spasms (IS) and for whom the potential benefits outweigh the potential risk of vision loss.

Usual Pediatric Dose for Seizure Prophylaxis:

10 to 16 years of age and 25 to 60 kg:
-Initial dose: 500 mg orally daily (administered as one 250 mg orally 2 times daily) with or without food
-Maintenance dose: Total daily dose may be increased at weekly intervals to 2 gm orally daily (1 g orally 2 times daily).
-Patients weighing more than 60 kg should be dosed according to adult guidelines.

Approved indication: For children 10 to 16 years of age as adjunctive therapy for refractory complex partial seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. Vigabatrin is not indicated as a first line agent for complex partial seizures.

See also: Dosage Information (in more detail)

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.

Call your doctor for instructions if your baby is taking Sabril and misses a dose, takes only part of a dose, or spits up or vomits after taking the medicine.

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 while taking Sabril?

This medicine 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 signs of an allergic reaction to Sabril: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Taking Sabril can cause permanent vision loss. Tell your doctor right away about any changes in your vision. If a child is taking Sabril: Tell the doctor right away if the child shows signs of vision changes, such as bumping into things or being easily startled or surprised.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

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

  • back and forth eye movements you cannot control;

  • severe drowsiness, fussiness, or feeding problems (in a baby taking Sabril);

  • numbness, tingling, or burning pain in your hands or feet;

  • weight gain with or without swelling;

  • signs of an ear infection - fever, ear pain or full feeling, trouble hearing, drainage from the ear, fussiness in a child; or

  • low red blood cells (anemia) - pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating.

Some babies treated with Sabril have had abnormal brain changes seen on magnetic resonance imaging (MRI). It is not known if these changes are caused by Sabril or if they are harmful. Tell any doctor who treats your baby that the child is taking Sabril.

Common Sabril side effects may include:

  • drowsiness, dizziness, feeling tired;

  • problems with walking or coordination;

  • tremors or shaking;

  • aggressive behavior;

  • problems with thinking or memory;

  • joint pain; or

  • cold symptoms such as stuffy nose, sneezing, sore throat.

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?

Other drugs may interact with vigabatrin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

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 1996-2016 Cerner Multum, Inc. Version: 5.01. Revision Date: 2015-11-16, 8:17:34 AM.

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