"The U.S. Food and Drug Administration today approved Aptiom (eslicarbazepine acetate) as an add-on medication to treat seizures associated with epilepsy.
Epilepsy is a brain disorder caused by abnormal or excessive activity in the brain"...
- Clinician Information:
Sabril Patient Information including How Should I Take
In this Article
- What is vigabatrin (Sabril)?
- What are the possible side effects of vigabatrin (Sabril)?
- What is the most important information I should know about vigabatrin (Sabril)?
- What should I discuss with my health care provider before taking vigabatrin (Sabril)?
- How should I take vigabatrin (Sabril)?
- What happens if I miss a dose (Sabril)?
- What happens if I overdose (Sabril)?
- What should I avoid while taking vigabatrin (Sabril)?
- What other drugs will affect vigabatrin (Sabril)?
- Where can I get more information?
What should I discuss with my health care provider before taking vigabatrin (Sabril)?
Some people taking vigabatrin have developed mild to severe vision problems. Vision problems may occur within weeks to years after you start taking vigabatrin. Vision loss caused by vigabatrin may be permanent, and you may notice only mild symptoms of the onset of vision loss. You must have eye exams on a regular basis while taking this medication.
Vigabatrin is available only under a special program called SHARE. You must be registered in the program and sign documents stating that you understand the risks and benefits of taking 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.
To make sure you can safely take vigabatrin, tell your doctor if you have any of these other conditions:
- kidney disease;
- vision problems, such as retinitis or glaucoma; or
- if you are pregnant or plan to become pregnant while using vigabatrin.
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 will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
Although vigabatrin might harm an unborn baby, having a seizure during pregnancy could harm both mother and baby. If you become pregnant while taking vigabatrin, do not stop taking it without your doctor's advice.
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 vigabatrin on the baby.
Vigabatrin can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using vigabatrin.
How should I take vigabatrin (Sabril)?
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Your doctor may occasionally change your dose over several weeks or months to make sure you get the best results from this medication.
Vigabatrin may be taken with or without food.
Vigabatrin powder must be mixed with water before you give it to a 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.
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 fine. You may have increased seizures if you stop using vigabatrin suddenly. You may 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 at room temperature away from moisture and heat.
Additional Sabril Information
- Sabril Drug Interactions Center: vigabatrin oral
- Sabril Side Effects Center
- Sabril FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find tips and treatments to control seizures.