Vigabatrin (vye-GA-ba-trin)

Treats seizures and infantile spasms. This is an anticonvulsant.

Brand Name(s):

Sabril, Vigadrone, Vigpoder

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid, Powder, Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Sabril® powder for oral liquid:
  • Open the packet and empty the powder into a clean cup.
  • Mix the powder with cold or room temperature water. Use an oral syringe to measure the right amount of water. You will need 10 milliliters (mL) of water for each packet.
  • Do not use the mixed medicine if you see particles in it. The mixed medicine should be clear and colorless.
  • Throw away any unused liquid after the dose is given.
• Vigafyde™ oral liquid:
  • Press and turn the child-resistant cap counterclockwise. Insert the bottle adapter. While holding the bottle firmly on a flat surface, push the ribbed end of the bottle adapter all the way into the neck of the bottle. Make sure that the bottle adapter is fully inserted.
  • Use the oral syringe to draw the prescribed dose. Push the plunger all the way up towards the tip of the syringe to remove air. Place the bottle on a flat surface, insert the tip of the syringe into the opening of the bottle adapter and push down gently.
  • While holding the oral syringe firmly into the bottle, turn the bottle upside down. Slowly pull back the plunger of the syringe until you reach the prescribed dose. Hold the plunger to keep it from moving.
  • If there are large air bubbles, slowly push up on the plunger until the bubbles are removed.
  • Remove the syringe from the bottle adapter by gently pulling it straight up.
  • Make sure your child is sitting upright when giving this medicine. Place the tip of the syringe into your child's mouth and point the syringe towards either cheek. Push on the plunger slowly.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• You may store opened Vigafyde™ oral liquid in the refrigerator. Throw away unused medicine 90 days after opening the bottle.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how vigabatrin works. Tell your doctor if you are using clonazepam or phenytoin.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Do not breastfeed while you are using this medicine.
• Tell your doctor if you have kidney disease, anemia, eye or vision problems, or a history of depression or mental illness.
• This medicine may cause the following problems:
  • Permanent vision loss
  • Increased risk of suicidal thoughts or behavior
  • Anemia
  • Peripheral neuropathy (nerve problem)
• This medicine may make you sleepy or tired. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments. It is very important that your eye doctor check your eyes during and after treatment with this medicine.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, changes in vision
• Feeling confused, depressed, anxious, or irritable
• Fever, chills, cough, sore throat, runny or stuffy nose, body aches
• Hearing problems, ear pain
• Muscle twitching, problems with balance or walking
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Rapid weight gain, swelling in your hands, ankles, or feet
• Unusual moods or behavior, thoughts of hurting yourself or others
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea, nausea, vomiting
• Dizziness, sleepiness, tiredness
• Joint, muscle, or back pain
• Weight gain

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088