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Generic Name: Vigabatrin (vye GA-batrin)
Brand names: Sabril and Vigadrone

What is Vigadrone?

Anticonvulsant medicine Vigadrone, or antiepileptic medication, is also known as an anticonvulsant.In combination with other medications, Vegadrone can be used to treat partial complex seizures that occur in adults and children over the age of 10. This powder for oral solution can be used to treat infantile spasms among babies and children aged between 1 month and 2 years.

Vegadrone may cause serious side effects and should only be taken by those who are unable to control seizures using other medications.This medication guide does not list all possible uses of Vigadrone.

Side effects of Vigadrone

If you experience symptoms of an allergic reaction, such as hives, difficulty breathing, swelling on your face or in your throat, or a severe reaction to the skin (fever or sore throat with burning eyes, skin pain or blistering, or a red or purple rash), seek emergency medical attention.

Taking Vigadrone can cause permanent vision loss. Inform your doctor immediately if you notice any changes in vision. If you are taking this medication, tell your doctor if you notice any changes in vision.

You should tell your doctor if any symptoms worsen or change, including changes in mood or behavior, anxiety, panic attacks, or trouble sleeping. Also, you may experience sudden impulses of hyperactivity or aggression; feeling hostile towards others; restlessness or hyperactivity; depression; or thinking about harming yourself or even taking your life.

Vegadrone may cause serious side effects. If you experience:

  • Seizures that are worsening or increasing in frequency;
  • Any change in your vision
  • Unusual or involuntary movements of the eye
  • Severe drowsiness or problems with feeding (in a child taking Vigadrone);
  • You may experience numbness or burning in your feet or hands.
  • Weight gain without or with swelling
  • Signs of an ear infection: fever, ear pain, fullness, difficulty hearing, drainage in the ear, or
  • Low red blood cells (anemia)--pale or unusually tired skin, feeling lightheaded or short-of-breath, cold hands and/or feet

On magnetic resonance imaging, some babies treated with Vigadrone showed abnormal brain changes. However, it is unknown if the changes were caused by the medicine or if there was any harm. Inform any doctor treating your child that the baby is taking this medication.

Vegadrone can cause the following side effects:

  • Blurred vision or other eye disorders
  • Drowsiness, feeling of fatigue, dizziness
  • Problems with coordination or walking
  • Tremors or shaking
  • Aggressive behavior;
  • Confusion is a problem with memory or thinking.
  • Weight gain
  • Joint pain
  • Cold symptoms like a stuffy nose, sneezing, or sore throat.
  • In babies, fussiness, ear infections, coughing, and breathing problems

There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.

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Vegadrone may cause permanent loss of vision, even if you stop taking it.Notice any sudden changes in vision as soon as they arise and contact your physician immediately. You should have regular eye examinations before, during, and soon after taking this medication.Magnetic resonance imaging (MRI) has revealed abnormal brain changes in some babies treated with Vigadrone. Inform any doctor treating your child that the child is on this medication.

While taking seizure medications, some people experience suicidal thoughts. Be alert if you notice any changes in your mood or symptomatology. Inform your doctor if you experience any new symptoms or if they worsen.

Before you take this drug

Some people who take Vegadrone develop vision problems weeks or years after beginning treatment. The vision loss that may result from this medication may not be temporary. You may only notice mild symptoms initially.

Only a pharmacy certified under a special programme can provide Vegadrone. You must register in the programme, and you agree to undergo vision tests before, during, and soon after taking this medication. Make sure you know the risks and benefits before taking this medication.

If you have an allergy to vigadrone, it is best not to use it.

Tell your doctor whether you or the child taking the medicine has ever:

  • Vision problems
  • Kidney disease
  • Anaemia (low blood red cells)
  • Depression is a mental illness or a mood disorder.

Vigadrone can cause suicidal thoughts in some people. You will be required to visit your doctor regularly in order to monitor your progress. You or your family members should be aware of any changes in mood or symptoms.

You should not stop or start taking seizure medications during pregnancy without consulting your doctor. A seizure could be harmful to both mother and child. Inform your doctor immediately if you fall pregnant.You may find your name on a registry for pregnant women to monitor the effects of Vigabatrin.If you use Vigadrone, it is not recommended that you breastfeed.Do not administer this medicine to an infant without consulting a doctor.

How To Take Vegadrone?

Read all the instructions or guides that come with your medication and follow the directions. Sometimes, your doctor will change the dose. You must take the medication exactly as prescribed.Vegadrone can be taken with or without food.The powder should only be mixed with water and given to your child along with food. Please read and follow the instructions for use that come with your medicine. If you don't understand the instructions, ask your doctor or pharmacist.Even after stopping Vigadrone, anyone taking Vigadrone may develop severe vision problems. The longer you use this medication, the greater your risk of developing severe vision problems.

Even if you think your vision is normal, you will still need to have a thorough exam done before starting Vigadrone. You should also get an eye examination every three months while on treatment. Although eye exams do not prevent all vision damage, they can help your doctor determine if your treatment plan needs to be changed. Report any changes to your doctor as soon as you notice them.

You should schedule a follow-up eye examination 3–6 months after stopping Vigadrone.A baby or young child may have a more difficult time being tested for vision. Your doctor may prescribe Vigadrone to your child if the benefits of preventing seizures are greater than any risks. If you notice that your child's eyesight is changing, tell the doctor immediately.

If your infantile spasms don't improve within 2 to 4 weeks, call your doctor.Even if you are feeling fine, do not suddenly stop taking Vigadrone. Sudden stopping can cause seizures to increase. You should follow your doctor's advice about reducing your dosage.Vegadrone should be stored in its original container at room temperature and away from moisture.

What happens if I miss the dose?

If you are almost due for your next dose, skip the missed one. Never take two doses of the same medicine at once.

If your baby misses or takes only a part of the dose or vomits or spits after taking Vigadrone, call your doctor to get instructions.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

Overdose symptoms include extreme drowsiness, dizziness or confusion, difficulty speaking, agitation or irritability, uncharacteristic thoughts or behaviors, increased seizures, a slow heartbeat or weak or shallow breaths, or fainting.

What should be avoided?

Vegadrone can affect your reaction time. Avoid driving and other hazardous activities until you are sure of their effects. You may be unable to react.

Interaction with other drug

Vegadrone may interact with other drugs, such as vitamins and herbal remedies. Inform your doctor of all the medicines you are taking and those that you stop or start using.



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