Vigabatrin, Oral

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KEY POINTS

• This medicine is taken by mouth to treat certain types of seizures and to treat infantile spasms. Take it exactly as directed.
• This medicine can cause permanent vision loss.
• This medicine may increase suicidal thoughts or actions in some people.
• This medicine may cause permanent vision loss or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antiseizure

Generic and brand names: vigabatrin, oral; Sabril

What is this medicine used for?

This medicine is taken by mouth to treat certain types of seizures in adults and children 10 years of age and older. It may also be used to treat infantile spasms. This medicine is available only through a special program.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Anemia (low red blood cell counts)
• Depression or thoughts of suicide
• Kidney disease
• Vision problems

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Contact your healthcare provider right away if you become pregnant while taking this medicine. You and your healthcare provider should decide if you should continue taking this medicine while you are pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Take this medicine exactly as directed by your healthcare provider. Take this medicine regularly to control your condition. Do not stop taking it without your healthcare provider's approval. Your seizures may get worse if you suddenly stop taking this medicine. You may have to gradually reduce your dosage to prevent side effects.

Check the label on the medicine for directions about your specific dose. Follow your healthcare provider's instructions carefully.

Check with your healthcare provider before using this medicine in children ages 2 to 10.

This medicine may be taken with or without food.

This medicine comes in the form of tablets or a powder. If you have the powder form, mix it with water only. Use the oral syringe that comes with the medicine to measure the amount of water you need. Give the medicine immediately after mixing it. Closely follow the instructions provided in the medicine package. Ask your healthcare provider or pharmacist about anything you do not understand.

If you are taking other medicines for seizures, follow your healthcare provider's instructions carefully for taking these medicines.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: double vision, drowsiness, slow heartbeat, restlessness, confusion, slurred speech, diarrhea, lack of coordination, trouble breathing.

What should I watch out for?

This medicine may cause permanent vision loss. You need to have eye exams before starting treatment, at least every 3 months during treatment, and for several months after treatment is stopped. If you notice any eye problems or changes in your vision, contact your healthcare provider right away. Talk with your healthcare provider about this.

This kind of medicine may increase suicidal thoughts or actions in some people. Contact your healthcare provider right away if you have

• More outgoing or aggressive behavior than normal
• Confusion
• Restlessness
• Panic attacks
• New or worsening depression
• Thoughts of suicide

This medicine may affect your vision, or make you drowsy or dizzy. Do not drive or operate machinery unless you are fully alert and can see clearly.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, an MRI, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. Carry some form of identification or a Medic Alert bracelet stating that you have seizures and are taking an antiseizure medicine. If you become unconscious, the ID tells emergency healthcare providers that you may need special care.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Double vision, blurred vision, eye movements that you cannot control, or any other eye problems; trouble walking; memory problems or confusion; numbness or tingling in your hands or feet; unusual tiredness or weakness; sudden changes in mood, behaviors, thoughts, or feelings; suicidal thoughts; swelling in your hands, ankles, or feet; ear pain or ringing in the ears; severe dizziness or fainting; chest pain; tremors or shaking; severe muscle pain or weakness; unusual weight gain; severe drowsiness; skin rash, blistering, or peeling.

Other: Mild dizziness; joint pain; sleepiness; sore throat; cough; runny or stuffy nose; mild weight gain; constipation; diarrhea; mild nausea or vomiting; headache; irritability in infants.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antianxiety medicines such as alprazolam (Xanax), clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antidepressants such as amitriptyline, duloxetine (Cymbalta), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), and venlafaxine (Effexor)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), and hydroxyzine (Vistaril)
• Antipsychotic medicines such as aripiprazole (Abilify), chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), olanzapine (Zyprexa), perphenazine, pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Doxepin (Silenor)
• Mefloquine
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Natural remedies such as evening primrose oil, gotu kola, kava, and valerian
• Orlistat (alli, Xenical)
• Other antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), clobazam (Onfi), eslicarbazepine (Aptiom), ethosuximide (Zarontin), felbamate (Felbatol), fosphenytoin (Cerebyx), lamotrigine (Lamictal), levetiracetam (Keppra), phenytoin (Dilantin, Phenytek), primidone (Mysoline), rufinamide (Banzel), tiagabine (Gabitril), topiramate (Qudexy, Topamax, Trokendi), vigabatrin (Sabril), and zonisamide (Zonegran)
• Pain medicines such as buprenorphine (Buprenex, Butrans), fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), methadone (Dolophine, Methadose), oxycodone (OxyContin, Roxicodone), and tramadol (ConZip, Ultram)
• Parkinson’s disease medicines such as entacapone (Comtan), pramipexole (Mirapex), ropinirole (Requip), and rotigotine (Neupro)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Sleeping pills such as eszopiclone (Lunesta), flurazepam, suvorexant (Belsomra), temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)

Do not drink alcohol while taking this medicine without your healthcare provider’s approval.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store the medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.