Vigadrone

Vigadrone is used with other medications to treat refractory complex partial seizures in adults and children who are at least 2 years old. This medicine is given when other treatments have not worked or have stopped working.

Vigadrone is also used to treat infantile spasms in babies and children between 1 month and 2 years old. Some brand forms of vigabatrin are only for treating infantile spasms.

Vigadrone is available only through a special program. You must be registered in the program and understand the risks and benefits of Vigadrone.

Vigadrone may also be used for reasons not listed in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Your dose needs may change if you switch to a different brand, strength, or form of Vigadrone. Avoid medication errors by using it exactly as directed on the label, or as prescribed by your doctor.

Vigadrone is usually taken twice per day. You may take this medicine with or without food.

Read and carefully follow any Instructions for Use provided with your medicine. Be sure you understand how to properly use Vigadrone before using the first dose and how to store it. Ask your doctor or pharmacist if you do not understand these instructions.

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

Doses are based on weight in children and teenagers. Your child's dose may change if the child gains or loses weight.

Vigadrone may cause vision problems that could get worse or become permanent, even after you stop using this medicine. You are more likely to develop severe vision problems the more you take this medicine and the longer you take it.

You may need frequent vision exams before starting, during, and after you stop taking Vigadrone. This can help your doctor determine how long you should use this medicine.

It may be more difficult to test vision in a baby or young child. However, your doctor may still prescribe Vigadrone for the child if the benefit of preventing seizures outweighs any risk. Tell the doctor right away if you think your child's vision may be changing.

Call your doctor if your symptoms do not improve, or if they get worse.

Seizures may increase if you stop using Vigadrone suddenly. Ask your doctor before stopping the medicine. Follow your doctor's instructions about tapering your dose.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Vigadrone.

Store Vigadrone in the original container at room temperature away from moisture and heat.

The oral solution may also be stored in the refrigerator. Throw away any used oral solution 90 days after opening the bottle, even if there is still medicine left inside.

Vigadrone can cause vision issues that might result in permanent vision loss, even after you stop taking Vigadrone. Contact your doctor immediately if you notice any changes in your vision.

Some babies who have been treated with Vigadrone have shown brain changes on magnetic resonance imaging (MRI). Inform any doctor treating your baby that they are using this medicine.

Some individuals may have thoughts of suicide while using seizure medicine. Notify your doctor right away if you experience sudden changes in mood or behavior, or have thoughts of suicide.

Using Vigadrone may increase the risk of vision problems. Vision loss from this medicine may be permanent, and you might notice only mild symptoms at first. Ask your doctor about your personal risk.

You should not use Vigadrone if you are allergic to it.

Tell your doctor if you have or have ever had:

• anemia (low red blood cells);
• current or potential vision problems (caused by a disease or by certain medicines);
• depression, a mood disorder, mental illness, or suicidal thoughts or actions; or
• kidney disease.

Some people may have thoughts about suicide while taking seizure medicine. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

Some babies treated with Vigadrone have had brain changes seen on magnetic resonance imaging (MRI). It is not known if these changes are harmful. Inform any doctor treating your baby that the child is taking this medicine.

Do not start or stop seizure medication during pregnancy without your doctor's advice. Vigadrone may harm an unborn baby, but having a seizure during pregnancy could harm both mother and baby. Preventing seizures may outweigh these risks. Tell your doctor right away if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of vigabatrin on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Vigadrone can cause permanent vision loss. Tell your doctor right away about any changes in your vision. If a child is taking this medicine, tell the doctor right away if the child shows signs of vision changes, such as bumping into things or being easily startled or surprised.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Vigadrone may cause serious side effects. Call your doctor at once if you have:

• increased or worsening seizures;
• severe drowsiness, fussiness, or feeding problems (in a baby taking Vigadrone);
• numbness, tingling, or burning pain in your hands or feet;
• weight gain or swelling; or
• low red blood cells (anemia)--pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects of Vigadrone may include:

• blurred vision or other eye problems;
• drowsiness, dizziness, feeling tired;
• problems with walking or coordination;
• tremors or shaking;
• weight gain;
• bronchitis, cold symptoms such as stuffy nose, sneezing, sore throat; or
• (in babies) fussiness, ear infection, cough, breathing problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Call your doctor for instructions if you miss a dose, take only part of a dose, or spit up or vomit after taking the medicine.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Do not drive or do anything dangerous until you know how Vigadrone will affect you. Your reactions may be impaired.

Other drugs may affect Vigadrone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.