Generic name: vigabatrin [ vye-GA-ba-trin ]
Known brands: Sabril, Vigadrone
Type of drug: Gamma-aminobutyric acid analogs
What exactly is Sabril?
Sabril is a medicine that is used to stop seizures. It is also called an anticonvulsant.
Sabril is used with other medicines to treat complex partial seizures in adults and children who are at least 10 years old. The powder for oral solution is used to treat infantile spasms in babies and young children between the ages of 1 month and 2 years.
Sabril can cause serious side effects, so it should only be used by people who have tried several other medicines but still can’t stop their seizures.
Taking Sabril can cause you to lose your eyesight for good, even after you stop taking it. Tell your doctor if you have any vision problems, like retinitis or glaucoma. You should also let your doctor know right away if your vision changes. Before, during, and right after taking this medicine, you must have your eyes checked often.
Before you start taking Sabril and then every three months while you are taking it, even if your vision seems fine, you will need a thorough eye exam to make sure it is not hurting your eyes. Even if you stop taking this medicine, your eyes may still need to be checked every 3 to 6 months. Don’t forget to see your doctor for follow-up care.
MRIs have shown that some babies who were given vigabatrin had strange changes in their brains (MRI). Tell any doctor who sees your baby that he or she is taking this medicine.
When taking medicine for seizures, some people think about ending their lives. Keep an eye out for changes in your symptoms or mood. Tell your doctor about any symptoms that are new or getting worse.
Sabril should only be used by people who have had several other medicines fail to stop their seizures.
Before you take this drug
Some people who took Sabril had vision problems a few weeks to a few years after they started taking it. Vision loss from vigabatrin may be permanent, but at first, you may only notice mild symptoms. Discuss this possibility with your doctor.
Sabril can only be bought at certified pharmacies as part of a special program. You have to sign up for the program and agree to get your eyes checked before, during, and soon after you take vigabatrin. Make sure you know the benefits and risks of taking this medicine.
If you are allergic to vigabatrin, you shouldn’t use Sabril.
Tell your doctor if you or the child taking Sabril have ever had:
- Vision problems;
- Kidney disease;
- Low red blood cells (anemia); or
- Depression, a mood disorder, a mental illness, or thoughts or actions that are related to suicide.
While on Sabril, some people think about ending their lives. Your doctor will need to see you often to check on your progress. Changes in your mood or symptoms should also be noticed by your family or other people who care for you.
Do not start or stop taking medicine for seizures without your doctor’s advice while you are pregnant. When a woman is pregnant, having a seizure could hurt both the mother and the baby. If you get pregnant, you should tell your doctor right away.
If you are pregnant, your name might be put on a list to keep track of how vigabatrin affects the baby.
If you are breastfeeding, you shouldn’t take Sabril.
Don’t give this medicine to a child unless a doctor tells you to.
Drugs that are similar
gabapentin, clonazepam, lamotrigine, pregabalin, diazepam, Lyrica, topiramate
What do I do with Sabril?
Take Sabril exactly as your doctor has told you to. Follow all of the directions on the label of your prescription, and read any guides or instruction sheets that come with it. Your doctor may change your dose from time to time.
You can take Sabril with food or on an empty stomach.
Sabril powder only needs to be mixed with water, and the child can take it with a meal. Instructions for Use that come with your medicine should be carefully read and followed. If you don’t understand what to do, talk to your doctor or pharmacist.
People who take Sabril can get vision problems that might get worse even after they stop taking it. The more of this medicine you take, the more likely it is that you will have serious vision problems.
Even if your vision seems fine, you will need a full eye exam before you start taking this medicine and then every 3 months while you are taking it. Even though eye exams may not stop all vision loss, they will help your doctor decide if your treatment plan needs to be changed. Keep an eye out for changes in your vision and tell your doctor about them right away.
If you stop taking Sabril, you should get another eye exam between 3 and 6 months later.
It might be harder to test a baby or young child’s vision. But your doctor may still give the child vigabatrin if preventing seizures is more important than any risk. If you think your child’s vision might be changing, call the doctor right away.
If your complex partial seizures don’t get better after 3 months of treatment or if your baby’s infantile spasms don’t get better after 2 to 4 weeks of treatment, you should call your doctor.
Do not suddenly stop taking Sabril, even if you feel fine. Suddenly stopping may cause more seizures. Follow your doctor’s advice about how to cut down your dose.
Store at room temperature in the original container, away from moisture and heat.
Normal dose for adults to stop seizures:
Initial dose: 1 g by mouth every day (given as 500 mg by mouth twice a day), with or without food.
The total daily dose can be increased by 500 mg every week, depending on how the patient responds.
The recommended daily dose is 3 g. (1.5 g orally 2 times daily)
A daily dose of 6 g has not been shown to be more helpful than a daily dose of 3 g, and it is linked to a higher rate of bad things happening.
Approved indication: For adults and children older than 10 years old who have not responded well to other treatments for refractory complex partial seizures (CPS) and for whom the potential benefits outweigh the risk of losing their sight. Sabril is not recommended as a first-line treatment for complex partial seizures.
Normal dose for epilepsy in children:
Spasms in babies:
From 1 month to 2 years:
The first dose is 50 mg/kg/day of vigabatrin oral solution, which can be given with or without food. Up to a maximum of 150 mg/kg/day, the dose can be changed by 25 to 50 mg/kg/day every three days.
The powder should be dumped out of the right number of packets (500 mg per packet) into an empty cup and mixed with 10 mL of cold or room temperature water per packet using the 10 mL oral syringe that comes with the medicine. The final solution has a strength of 50 mg/mL.
Each dose should be made right before it is used and given either cold or at room temperature.
Authorized sign: As a single treatment for children ages 1 month to 2 years old who have infantile spasms (IS) and for whom the possible benefits are more important than the possible risk of vision loss.
Usual dose for preventing seizures in children:
10–16 years old and between 25 and 60 kg:
-The first dose is 500 mg a day by mouth (given as 250 mg twice a day by mouth), with or without food.
-Maintenance dose: The total daily dose can be increased by 2 gm every seven days (1 g orally 2 times daily).
-Patients who weigh more than 60 kg should be given the same amount as an adult.
Approved indication: For children 10 to 16 years old who have not responded well to other treatments for refractory complex partial seizures (CPS) and for whom the potential benefits are greater than the risk of vision loss. For complex partial seizures, vigabatrin is not a first-line treatment.
What will happen if I don’t take a dose?
Take the medicine as soon as you can, but skip the dose you missed if your next dose is almost due. Take only one dose at a time.
If your baby is taking Sabril and misses a dose, only takes part of a dose, or throws up or spits up after taking it, call your doctor for instructions.
What happens if I overdose?
Get help from a doctor right away or call 1-800-222-1222 to reach the Poison Help line.
Symptoms of an overdose can include being very sleepy or dizzy, confused, having trouble speaking, feeling angry or irritable, having strange thoughts or acting in strange ways, having more seizures, a slow heart rate, weak or shallow breathing, or passing out.
What not to do
Don’t drive or do anything else dangerous until you know how this medicine will make you feel. Your responses could be slowed down.
Sabril side effects
Get medical help right away if you have hives, trouble breathing, swelling in your face or throat, or other signs of an allergic reaction to Sabril (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Taking vigabatrin can cause you to lose your eyesight for good. Tell your doctor right away if you see anything different. If your child is taking Sabril, you should tell the doctor right away if he or she is bumping into things or easily startled or surprised.
Tell your doctor about any new or worsening symptoms, like mood or behavior changes, anxiety, panic attacks, trouble sleeping, or feeling impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or having thoughts about suicide or hurting yourself.
Call your doctor right away if:
- More seizures or seizures that get worse;
- Any change, no matter how small, in the way you see;
- Strange or uncontrollable eye movements;
- Vigabatrin causes a baby to be very sleepy, fussy, or have trouble eating;
- Tingling, numbness, or pain that feels like it’s on fire in your hands or feet;
- Gaining weight with or without swollen limbs;
- Fever, pain or fullness in the ear, trouble hearing, drainage from the ear, or fussiness in a child are signs of an ear infection; or
- Low red blood cells (anemia): pale skin, unusual tiredness, feeling lightheaded or short of breath, and cold hands and feet.
MRI scans have shown that some babies who were given Sabril had abnormal brain changes (MRI). It is not known if these changes are caused by vigabatrin or if they are bad. Tell any doctor who sees your baby that he or she is taking this medicine.
Some common side effects of Sabril could be:
- Blurry vision or other problems with the eyes;
- Feeling sleepy, dizzy, or tired;
- Trouble walking or coordinating yourself;
- Shaking or tremors;
- Aggressive behavior;
- Confusion, trouble thinking or remembering things;
- Weight gain;
- Joint pain;
- Signs of a cold, like a runny nose, sneezing, or a sore throat; or
- Fussiness, ear infection, cough, and trouble breathing in babies.
This isn’t a full list of all possible side effects, and there may be others. You should talk to your doctor about any side effects. You can call 1-800-FDA-1088 to tell the FDA about side effects.
What effects will other drugs have on Sabril?
Other drugs, like prescription and over-the-counter medicines, vitamins, and herbal products, may interact with vigabatrin. Tell your doctor about all the medicines you are taking now, as well as any you start or stop taking.
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Remember to keep this and all other medicines out of reach of children, to never give your medicines to other people, and to only use this medicine for what it was prescribed for.
Talk to your doctor or other healthcare provider to make sure that the information on this page applies to your situation.