VIGABATRIN FOR ORAL SOLUTION USP, 500 MG- vigabatrin for solution
Granules Pharmaceuticals Inc.
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MEDICATION GUIDE Vigabatrin (vye-GA-ba-trin) for Oral Solution, USP |
What is the most important information I should know about Vigabatrin for oral solution? Vigabatrin for oral solution can cause serious side effects, including:
1. Permanent vision loss: Vigabatrin for oral solution can damage the vision of anyone who takes it. Some people can have severe loss particularly to their ability to see to the side when they look straight ahead (peripheral vision). With severe vision loss, you may only be able to see things straight in front of you (sometimes called “tunnel vision”). You may also have blurry vision. If this happens, it will not get better.
Tell your healthcare provider right away if you (or your child): ͦ might not be seeing as well as before starting vigabatrin for oral solution. ͦ start to trip, bump into things, or are more clumsy than usual.
ͦ Parents or caregivers are not likely to recognize the symptoms of vision loss in babies until it is severe. Healthcare providers may not find vision loss in babies until it is severe.
Tell your healthcare provider right away if you think that your baby is: ͦ not seeing as well as before taking Vigabatrin for oral solution
All people who take Vigabatrin for oral solution: • You are at risk for permanent vision loss with any amount of Vigabatrin for oral solution
2. Magnetic resonance imaging (MRI) changes in babies with infantile spasms: Brain pictures taken by magnetic resonance imaging (MRI) show changes in some babies after they are given vigabatrin for oral solution. It is not known if these changes are harmful. 3. Risk of suicidal thoughts or actions: Like other antiepileptic drugs, vigabatrin for oral solution may cause suicidal thoughts or actions in a very small number of people, about 1 in 500 people taking it. Call a healthcare provider right away if you or your child have any of these symptoms, especially if they are new, worse, or worry you: ͦ thoughts about suicide or dying o attempts to commit suicide
Suicidal thoughts or actions can be caused by things other than medicines. If you or your child have suicidal thoughts or actions, your healthcare provider may check for other causes. How can I watch for early symptoms of suicidal thoughts and actions?
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What is vigabatrin for oral solution?
ͦ the CPS do not respond well enough to several other treatments, and
Vigabatrin for oral solution should not be the first medicine used to treat CPS.
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What should I tell my healthcare provider before starting vigabatrin for oral solution? If you or your child has CPS, before taking Vigabatrin for oral solution tell your healthcare provider about all of your medical conditions, including if you or your child:
Pregnancy Registry: If you become pregnant while taking Vigabatrin for oral solution, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. Information on the registry can also be found at the website http://www.aedpregnancy.org/. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. If you are a parent or caregiver whose baby has IS, before giving Vigabatrin to your baby, tell your healthcare provider about all of your baby’s medical conditions, including if your baby has or ever had:
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How should I take Vigabatrin for oral solution?
Vigabatrin for oral solution powder should be mixed with water only.
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What should I avoid while taking vigabatrin? Vigabatrin causes sleepiness and tiredness. Adults taking vigabatrin should not drive, operate machinery, or perform any hazardous task, unless you and your healthcare provider have decided that you can do these things safely |
What are the possible side effects of vigabatrin? Vigabatrin can cause serious side effects, including:
The following serious side effects happen in adults. It is not known if these side effects also happen in babies who take vigabatrin.
If you or your child has CPS, vigabatrin for oral solution may make certain types of seizures worse. Tell your healthcare provider right away if your (or your child's) seizures get worse. The most common side effects of vigabatrin for oral solution in adults include blurred vision, sleepiness, dizziness, problems walking or feeling uncoordinated, shaking (tremor), and tiredness. The most common side effects of vigabatrin for oral solution in children 3 to 16 years of age is weight gain. Also expect side effects like those seen in adults. If you are giving Vigabatrin for oral solution to your baby for IS: Vigabatrin for oral solution may make certain types of seizures worse. You should tell your baby’s healthcare provider right away if your baby’s seizures get worse. Tell your baby’s healthcare provider if you see any changes in your baby’s behavior. The most common side effects of Vigabatrin for oral solution in babies include: o swelling in the bronchial tubes (bronchitis) ͦ sleepiness - Vigabatrin for oral solution may cause your baby to be sleepy. Sleepy babies may have a harder time suckling and feeding, or may be irritable.ͦ ear infection o irritability Tell your healthcare provider if you or your child have any side effect that bothers you or that does not go away. These are not all the possible side effects of Vigabatrin for oral solution. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
How should I store Vigabatrin for oral solution?
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General information about the safe and effective use of Vigabatrin for oral solution? Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about Vigabatrin for oral solution that is written for health professionals. Do not use Vigabatrin for oral solution for a condition for which it was not prescribed. Do not give Vigabatrin for oral solution to other people, even if they have the same symptoms that you have. It may harm them. |
What are the ingredients in Vigabatrin for oral solution? Active Ingredient: vigabatrin, USP Inactive Ingredients: povidone |
This Medication Guide has been approved by the U.S. Food and Drug Administration. Marketed by: Granules Pharmaceuticals Inc., Chantilly, VA 20151 Revised: 11/2021 |