Vigabatrin
The following information is an educational aid only. It is not intended as a medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

Vigabatrin
(vye GA ba trin)

U.S. Brand Names
Sabril®

Canadian Brand Names
Sabril®

Dosage Forms
• This medicine is available as a powder to prepare a liquid and a tablet.

Pharmacologic Category
Anticonvulsant, Miscellaneous

What key warnings should I know about before giving this medicine to my child?
This medicine may cause permanent vision loss.

This medicine is only available to U.S. patients enrolled in the SHARE Program.

Please read the medication guide.

Is it safe for my child to take this medicine?
• Not if your child has an allergy to vigabatrin or any other part of this medicine.

• Be sure to let healthcare provider know if your child has any allergies or reactions to medicine, food preservatives, or dyes. Make sure to tell about the allergy and how it affected your child. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved.

Why does my child need this medicine?
• This medicine is used to prevent or control seizures.

How does this medicine work?
• Vagabatrin calms the brain.

How is this medicine given?
• Give this medicine with or without food. Give with food if it causes an upset stomach.

• Dissolve powder in 2 teaspoonfuls of water and have your child drink right away.

How long does this medicine take to work?
• Your child may start feeling better several days after starting this medicine.

What do I do if my child misses a dose? (does not apply to patients in the hospital)
• Give a missed dose as soon as possible.

• If it is almost time for the next dose, skip the missed dose and return to your child's regular schedule.

• Do not give a double dose or extra doses.

• Do not change dose or stop your child's medicine. Talk with healthcare provider.

What safety measures should I take while my child is using this medicine?
• If your child has been taking this medicine for several weeks, talk with healthcare provider before stopping. You may want to gradually withdraw this medicine.

• If your child has anemia, talk with healthcare provider.

• If your child has kidney disease, talk with healthcare provider.

• If your child has a mental health disorder, talk with healthcare provider.

• If your child has vision problems, talk with healthcare provider.

• Have your child wear a disease medical alert identification.

• Check your child's medicines with healthcare provider. This medicine may not mix well with other medicines.

• This medicine may cause your child to be less alert. Have your child avoid tasks or activities that require alertness. These include playing (for example, riding a bicycle, rollerblading, contact sports) or using items that require concentration or coordination (for example, scissors, lawnmower, electric scooters, or toy cars). Your child's activities should be closely monitored until you see how this medicine affects him/her. School work may be more difficult for your child to focus on and complete.

What are some possible side effects of this medicine?
• Feeling lightheaded, sleepy, having blurred vision, or a change in thinking clearly. Have your child avoid tasks or activities that require alertness or clear vision until you see how this medicine affects him/her.

• Feeling dizzy. Rising slowly over several minutes from sitting or lying position is recommended. Children should be extra careful climbing stairs.

• Nervous and excitable.

• Change in balance.

• Weight gain.

• Headache.

• Shakiness.

• Emotional ups and downs.

• Diarrhea.

• Nausea or vomiting. Small frequent meals and frequent mouth care may help. Older children may suck hard, sugar-free candy.

What should I monitor?
• Change in condition being treated. Is it better, worse, or about the same?

• Your child should have an eye exam every 3 months.

• Follow up with healthcare provider.

When should I call my child's healthcare provider?
• If any of this information causes you to be concerned, any of the common side effects occur, or if your child's symptoms do not improve after taking this medicine.

• If you suspect an overdose, call your local poison control center or emergency department immediately.

• If your child shows signs of a life-threatening reaction, call healthcare provider or emergency department immediately. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; fits; swelling of face, lips, tongue, or throat; or if your child exhibits any other unusual behavior.

• If your child shows signs or symptoms of depression, suicidal thoughts, nervousness, emotional ups and downs, abnormal thinking, anxiety, or lack of interest in life.

• If your child shows signs of severe dizziness or passes out.

• If your child has significant change in thinking clearly and logically.

• If your child is feeling extremely nervous and excitable.

• If your child is feeling extremely tired or weak.

• If your child's seizures are worse or different after starting this medicine.

• If your child has a sudden change in vision.

• If your child has severe muscle pain or weakness.

• If your child has swelling.

• If your child develops a rash.

• No improvement in condition or if you believe your child's condition is worse.

How should I store and/or dispose of this medicine?
• Store at room temperature.

• Protect from moisture. Do not store in a bathroom or kitchen.

General statements
• If your child has a life-threatening allergy, he/she should wear allergy identification at all times.

• This medicine is available by prescription only. If there are refills, contact your pharmacy. If no refills remain, you may need to contact your child's healthcare provider.

• This medicine should be thrown out when your child no longer needs it or if the medicine becomes outdated.

• Do not share your child's medicine with others and do not give anyone else's medicine to your child.

• Keep all medicine out of the reach of children and pets.

• Many medications interact with other medications. Keep a list of all your child's medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to your child's healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant).

• Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or in Canada to Health Canada's Canada Vigilance Program at 1-866-234-2345.

• Talk with your child's healthcare provider before giving him/her any new medicine, including over-the-counter, natural products, or vitamins.

• Medicine can be dangerous if used incorrectly. Follow directions given by healthcare provider.

Created: 2007-09-14 13:48:48.0

Modified: 2009-09-16 12:13:36.0

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