Sabril

Generic name: vigabatrin [ vye-GA-ba-trin ]
Brand names: Sabril, Vigadrone, Vigpoder
Drug class: Gamma-aminobutyric acid analogs

Medically reviewed by Philip Thornton, DipPharm. Last updated on May 13, 2024.

What is Sabril?

Sabril is an anticonvulsant used for refractory complex partial seizures in specific patients 2 years and older and to treat infantile spasms 1 month to 2 years old. It can cause serious side effects, including vision loss, and should only be used if the potential benefits outweigh the potential risks.

Sabril (vigabatrin) is thought to work by stabilizing the electrical activity in your brain and calming it. It does this by increasing the amount of an inhibitory neurotransmitter (chemical messenger) called GABA (gamma aminobutyric acid).

What is Sabril used for?

Sabril is FDA-approved to treat refractory complex partial seizures in patients 2 years and older who have not responded to other medicines. It is used together with another anticonvulsant, and only if the potential benefits outweigh the risk of any loss of vision. It is not used as a first-line treatment for complex partial seizures.

Sabril is also FDA-approved to treat infantile spasms in babies and children between the ages of 1 month and 2 years. It should be used if the potential benefits outweigh the potential risk of vision loss. It can be used as a single therapy for infantile spasms.

Warnings

Taking Sabril can cause permanent vision loss, even after you stop using this medicine. Tell your doctor if you have any vision problems, such as retinitis or glaucoma and advise your doctor right away about any changes in your vision. You must have frequent eye exams before, during, and shortly after taking this medicine.

To be sure Sabril is not causing harmful effects on your vision, you will need a thorough eye exam before you start taking the medication and then every 3 months during treatment, even if your vision seems normal. If you ever stop taking this medicine, 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.

Some babies treated with vigabatrin have had abnormal brain changes seen on magnetic resonance imaging (MRI). Tell any doctor who treats your baby that the child is taking this medicine.

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

Some people taking Sabril 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.

Sabril is available only from a certified pharmacy under a special program. You must be registered in the program and agree to have vision exams before, during, and shortly after taking vigabatrin. Be sure you understand the risks and benefits of taking this medicine.

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

To make sure Sabril is safe for you, tell your doctor if you (or the child taking this medicine) have ever had:

• vision problems;

• kidney disease;

• anemia (low red blood cells); or

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

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

Do not start or stop taking seizure medication during pregnancy without your doctor's advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of vigabatrin on the baby.

You should not breastfeed while you are using Sabril.

Do not give this medicine to a child without medical advice.

How should I take Sabril?

Take Sabril exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

You may take Sabril with or without food.

Sabril powder must be mixed only with water, and can be given to the child with a meal. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

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

You will need a thorough eye exam before you start taking this medicine and then every 3 months during treatment, even if your vision seems normal. 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 stop taking Sabril, you should have another eye exam about 3 to 6 months after your last dose.

It may be more difficult to test vision in a baby or young child. However, your doctor may still prescribe vigabatrin for the child if the benefit of preventing seizures outweighs any risk. Tell the doctor right away if you think your child's vision may be changing.

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

Dosing information

Usual Sabril Adult Dose for Refractory Complex Partial Seizures (17 years of age and older)

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 2 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. Sabril is not indicated as a first line agent for complex partial seizures.

Usual Sabril Pediatric Dose for Refractory Complex Partial Seizures (2 to 16 years of age)

The recommended dosage is based on body weight and administered as two divided doses. The dosage may be increased in weekly intervals, depending on response. Dose patients weighing more than 60 kg according to adult recommendations.

Usual Pediatric Dose for Infantile Spasms (1 month to 2 years of age)

Initial dose: 50 mg/kg (25 mg/kg twice daily); increase total daily dose every 3 days, in increments of 25 mg/kg/day to 50 mg/kg/day, up to a maximum daily dose of 150 mg/kg (75 mg/kg twice daily).
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.

Comments

• Renal Impairment: Dose adjustment is recommended.
• Sabril is available as tablets (500 mg), for oral solution 500 mg per packet
• What happens if I miss a dose?

Related/similar drugs

gabapentin, clonazepam, lamotrigine, pregabalin, lorazepam, diazepam, topiramate, Lamictal, prednisolone, Klonopin

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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 to avoid

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Sabril side effects

Get emergency medical help if you have signs of an allergic reaction to Sabril (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Taking vigabatrin 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:

• increased or worsening seizures;

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

• unusual or involuntary eye movements;

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

• 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, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

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 vigabatrin or if they are harmful. Tell any doctor who treats your baby that the child is taking this medicine.

Common Sabril side effects may include:

• blurred vision or other eye problems;

• drowsiness, dizziness, feeling tired;

• problems with walking or coordination;

• tremors or shaking;

• aggressive behavior;

• confusion, problems with thinking or memory;

• weight gain;

• joint pain;

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

• (in babies) fussiness, ear infection, cough, breathing problems.

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.

What other drugs will affect Sabril?

Other drugs may interact with vigabatrin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Popular FAQ

Further information

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.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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