Vigabatrin can cause permanent vision damage, including loss of peripheral vision and having blurry vision. Although vision loss is possible with any amount of vigabatrin, your risk may be greater with the more vigabatrin that you take daily and the longer you take it. Vision loss can happen at any time during treatment with vigabatrin. Vision loss is not likely to be noticed before it is severe. Tell your doctor if you have or have ever had any vision problems. If you experience any of the following symptoms, call your doctor immediately: think you are not seeing as well as before taking vigabatrin; start to trip, bump into things, or are more clumsy than usual; are surprised by people or things coming in front of you that seem to come out of nowhere; blurry vision; double vision; eye movements you can't control; eye pain; and headache.
Because of the risk of permanent vision loss with this medication, vigabatrin is only available through a special program called Sabril REMS® . You, your doctor, and your pharmacist must be enrolled in this program before you can receive vigabatrin. All people who are prescribed vigabatrin must have a vigabatrin prescription from a doctor who is registered with Sabril REMS ® and have the prescription filled at a pharmacy that is registered with Sabril REMS® in order to receive this medication. Ask your doctor for more information about this program and how you will receive your medication.
An eye doctor will test your vision within 4 weeks of starting vigabatrin, at least every 3 months during treatment, and 3-6 months after stopping treatment. Vision testing is difficult in infants and may not find vision loss before it is severe. Be sure to call your doctor immediately if you think your baby is not seeing as well as before taking vigabatrin or is acting differently than normal. Vision tests cannot prevent vision damage but they are important to decrease further damage from occurring by stopping vigabatrin if vision changes are found. Once detected, vision loss is not reversible. It is possible that further damage can occur after stopping vigabatrin.
Your doctor will assess your response to and continued need for vigabatrin. This is done within 2-4 weeks of starting treatment in infants and children, within 3 months of starting treatment in adults, and then on a regular basis as needed for all patients. If your doctor determines that vigabatrin is not working for you, then your treatment should be stopped.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with vigabatrin and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( Web Site) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risks of taking vigabatrin.
Vigabatrin tablets are used in combination with other medications to control certain types of seizures in adults and children 10 years of age or older whose seizures were not controlled by several other medications. Vigabatrin powder is used to control infantile spasms (a type of seizure that babies and children can have) in babies 1 month to 2 years of age. Vigabatrin is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.
Vigabatrin comes as a powder to be mixed with water and as a tablet to take by mouth. It is usually taken twice a day with or without food. Take vigabatrin at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take vigabatrin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor will probably start you on a low dose of vigabatrin and gradually increase your dose, not more often than once every 3 days for babies receiving the powder mixed with water and once a week for adults taking tablets.
Vigabatrin may help control your condition but will not cure it. Continue to take vigabatrin even if you feel well. Do not stop taking vigabatrin without talking to your doctor. If you suddenly stop taking vigabatrin, your seizures may happen more often. Your doctor will probably decrease your dose gradually, not more often than once every 3-4 days for babies receiving the powder mixed with water and once a week for adults taking tablets. Tell your doctor immediately if your seizures happen more often while you are stopping vigabatrin.
If you are taking the powder, you must mix it with cold or room temperature water immediately before taking it. Do not mix the powder with any other liquid or food. The doctor will tell you how many packets of vigabatrin powder to use and how much water to mix it with. The doctor will also tell you how much of the mixture to take for each dose. Do not use a household spoon to measure your dose. Use the oral syringe that came with the medication. Carefully read the manufacturer's instructions that describe how to mix and take a dose of vigabatrin. Be sure to ask your pharmacist or doctor if you have any questions about how to mix or take this medication.
Talk to the doctor about what to do if your baby vomits, spits up, or only takes part of the dose of vigabatrin.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before taking vigabatrin,
Unless your doctor tells you otherwise, continue your normal diet.
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Vigabatrin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately:
Vigabatrin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( Web Site) or by phone (1-800-332-1088).
Keep vigabatrin tablets and vigabatrin powder in the container they came in, tightly closed, and out of reach of children. Store them at room temperature and away from excess heat and moisture (not in the bathroom).
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website ( Web Site) for more information if you do not have access to a take-back program.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. Web Site
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at Web Site. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include the following:
Keep all appointments with your doctor and eye doctor.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking vigabatrin.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.