Generic Name: vigabatrin (vye GA ba trin)Brand Names: Sabril
Vigabatrin is an anti-epileptic medication, also called an anticonvulsant.
Vigabatrin is used in combination with other medications to treat complex partial seizures in adults and adolescents who are at least 16 years old. Vigabatrin is usually given after other anti-epileptic medications have been tried without successful control of seizures.
The powder form of vigabatrin is used to treat infantile spasms in babies and children between the ages of 1 month and 2 years.
Vigabatrin may also be used for other purposes not listed in this medication guide.
To be sure vigabatrin 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 vigabatrin, 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.
You may have thoughts about suicide while taking vigabatrin. 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.
Vigabatrin is available only under a special program called SHARE. You must be enrolled in the program and sign documents stating that you understand the dangers of this medication and that you agree to have vision exams on a regular basis while you are taking vigabatrin.
Vigabatrin is available only under a special program called SHARE. You must be enrolled in the program and sign documents stating that you understand the dangers of this medication and that you agree to have vision exams every 3 months while you are taking vigabatrin. Ask your doctor or call the drug maker if you have questions about the program or the written requirements.You should not use this medication if you are allergic to vigabatrin.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:
vision problems, such as retinitis or glaucoma.
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 vigabatrin is harmful to an unborn baby, but having a seizure during pregnancy could harm both the mother and the baby. Do not start taking vigabatrin during pregnancy without telling your doctor you are pregnant.
If you become pregnant while taking vigabatrin for seizures, do not stop taking it without your doctor's advice. Seizure control is very important during pregnancy and the benefits of preventing seizures may outweigh any risks posed by taking vigabatrin.
Your name may need to be listed on a pregnancy registry if you become pregnant while using this medication. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether vigabatrin had any effect on the baby.Vigabatrin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.
Vigabatrin may be taken with or without food.
Vigabatrin powder must be mixed with water before you give it to your 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.
Your doctor may occasionally change your dose over several weeks or months to make sure you get the best results from this medication.
To be sure this medication is not causing harmful effects on your vision, you will need a thorough eye exam when you start taking vigabatrin and then every 3 months during treatment. If you ever stop taking vigabatrin, 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 vigabatrin without first talking to your doctor, even if you feel better. You may have increased seizures if you stop using vigabatrin suddenly. You will 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 vigabatrin. Store vigabatrin at room temperature away from moisture and heat.
See also: Vigabatrin dosage in more detail
Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.
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.
any change in your vision, no matter how mild;
back and forth eye movements you cannot control;
confusion, mood or behavior changes, depression, thoughts about suicide or hurting yourself;
pale skin, easy bruising; or
Less serious side effects may include:
drowsiness, dizziness; tired feeling;
numbness or tingly feeling in your toes or feet;
runny or stuffy nose, fever, sore throat, cough;
nausea, vomiting, diarrhea, constipation;
headache, sleep problems (insomnia);
joint pain; or
loss of coordination.
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.
Usual Adult Dose for Seizure Prophylaxis:
Initial dose: 1 g/day (administered as one 500 mg tablet orally twice daily) with or without foodThe total daily dose may be increased in 500 mg increments at weekly intervals depending on response.Recommended dose: 3 g/day (1.5 g twice daily)A 6 g/day dose has not been shown to confer additional benefit compared to the 3 g/day dose and is associated with an increased incidence of adverse events.
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.
Tell your doctor about all other medications you use, especially:
steroids such as prednisone and others (especially if taken daily over a long period of time); or
aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), naproxen (Aleve, Naprosyn), meloxicam (Mobic), piroxicam (Feldene), and others.
This list is not complete and there may be other drugs that can interact with vigabatrin. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.