VIGABATRIN - vigabatrin powder, for solution
Lupin Pharmaceuticals, Inc.
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Vigabatrin (vye-GA-ba-trin) for Oral Solution
Rx only
What is the most important information I should know about vigabatrin for oral solution? Vigabatrin for oral solution can cause serious side effects, including:
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):
Tell your healthcare provider right away if you think that your baby is:
All people who take 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:
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?
What is vigabatrin for oral solution?
Vigabatrin for oral solution should not be the first medicine used to treat CPS.
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:
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.aedpregnancyregistry.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 for oral solution to your baby, tell your healthcare provider about all of your baby's medical conditions, including if your baby has or ever had:
Tell your healthcare provider about all the medicines you or your child take, including prescription and over-the- counter medicines, vitamins, and herbal supplements. Vigabatrin for oral solution and other medicines may affect each other causing side effects.
How should I take vigabatrin for oral solution?
What should I avoid while taking vigabatrin for oral solution?
Vigabatrin for oral solution causes sleepiness and tiredness. Adults taking vigabatrin for oral solution 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 for oral solution?
Vigabatrin for oral solution 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 for oral solution.
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 effect 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:
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. For more information, go to www.lupinpharmaceuticals.com or call 1-800-399-2561.
How should I store vigabatrin for oral solution?
Keep vigabatrin for oral solution and all medicines out of the reach of children.
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
Inactive Ingredient: povidone
For more information, go to www.lupinpharmaceuticals.com or call 1-800-399-2561.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured for:
Lupin Pharmaceuticals, Inc.
Baltimore, Maryland 21202
United States.
Manufactured by:
Lupin Limited,
Goa 403 722
INDIA
Revised: February 2022 ID#: 269608
Vigabatrin (vye-GA-ba-trin) for Oral Solution
Read this Instructions for Use before your child starts taking vigabatrin for oral solution and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your child's medical condition or treatment. Talk to your healthcare provider if you have any questions about the right dose of medicine to give your child or how to mix it.
Important Note:
Supplies you will need to mix 1 dose of vigabatrin for oral solution:
Step 1: Start with 1 of the empty cups and the total number of packets you will need for 1 dose.
Step 2: Before you open the packet, tap it to settle all the powder to the bottom of the packet.
Step 3: Use a pair of scissors to cut open the vigabatrin for oral solution packet along the dotted line.
Step 4: Empty the entire contents of the vigabatrin for oral solution packet into 1 of the clean empty cups (see Figure A).
Step 5: Take the second cup and fill it half way with water (see Figure B).
Do not mix vigabatrin for oral solution with anything other than water.
Step 6: Use the 10 mL oral syringe to draw up 10 mL of water. To do this, put the tip of the oral syringe all the way into the water in your cup. Then pull the plunger up towards you until the white ring at the end of the plunger is at the 10 mL line on the barrel of the oral syringe (see Figure C).
Step 7: Check the oral syringe to make sure it is filled with water up to the 10 mL line (see Figure E).
Step 8: Get the second cup that contains the vigabatrin for oral solution needed for your dose.
Step 9: Hold the 10 mL oral syringe that is filled with water with the tip pointing down over the vigabatrin for oral solution.
Step 10: Slowly push the oral syringe plunger all the way down to empty the water from the oral syringe straight into the cup containing the vigabatrin for oral solution (see Figure F).
Repeat steps 6 through 10 until all of the water that is needed to mix 1 dose of vigabatrin for oral solution has been added to the cup containing the powder.
Step 11: Stir the mixture with the small spoon or other clean utensil until the solution is clear (see Figure G). This means that all of the powder is dissolved and ready for use.
Step 12: Put the tip of the oral syringe all the way into the mixture. Pull the plunger up towards you to draw up the mixture. Stop when the white ring at the end of the plunger lines up with markings on the barrel of the oral syringe that matches the number of mLs of mixture your healthcare provider told you to give (see Figure H).
Step 13: Place the tip of the oral syringe into your child's mouth and point the oral syringe towards either cheek (see Figure J). Push on the plunger slowly, a small amount at a time, until all of the mixture in the oral syringe is given.
Step 14: Throw away any mixture that is left over. Do not save or reuse any leftover mixture.
Step 15: Wash the oral syringes and mixing cups in warm water. To clean the oral syringes, remove the plunger by gently pulling it straight out of the barrel. The barrel and plunger can be hand washed with soap and water, rinsed, and allowed to dry.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured for:
Lupin Pharmaceuticals, Inc.
Baltimore, Maryland 21202
United States.
Manufactured by:
Lupin Limited,
Goa 403 722
INDIA
Revised: February 2022 ID#: 269608