Pronunciation:

vye-GA-ba-trin

Brand Names:

• Sabril

Dosage Forms:

• Powder
• Tablet

Classifications:

Therapeutic—

Anticonvulsant

Pharmacologic—

Gamma Aminobutyric Acid Transaminase Inhibitor

Chemical—

Gamma Aminobutyric Acid (class)

Uses of This Medicine:

Vigabatrin increases the amount of the brain chemical GABA. It is thought that epileptic seizures are the result of low levels of GABA. By increasing the amount of GABA, vigabatrin reduces the likelihood of an epileptic seizure.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

This medicine has been tested in children and, in effective doses, has not been shown to cause different problems than it does in adults.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of vigabatrin in the elderly with use in other age groups.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Carbamazepine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Mental illness—Patients with a history of emotional or behavioral disturbances may be more likely to have an episode following vigabatrin therapy.

• Kidney disease—Vigabatrin is removed from the body by the kidney; slower removal from the body may increase the chance of side effects

Proper Use of This Medicine:

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form ( powder):
  • For epilepsy
    • Adults— To start, 1000 milligrams (mg) a day. The doctor may need to adjust the dose depending on your response to the medicine. However, the dose is usually not more than 4000 mg a day.
    • Children—The dose is based on body weight and will be determined by your doctor. To start, 40 milligrams (mg) per kilogram (kg) (18.2 mg per pound) of body weight per day. Your doctor may increase your dose as needed. However, the dose is usually not more than 100 mg per kg (45.5 mg per pound) of body weight a day, taken in two smaller doses.
  • For infantile spasms
    • Children—The dose is based on body weight and will be determined by your doctor. The usual dose is 50 to 100 mg per kg (22.7 to 45.5 mg per pound) of body weight per day, given in smaller doses twice a day. The doctor may need to adjust the dose based on your response to the medicine.
• For oral dosage form (tablets):
  • For epilepsy
    • Adults—To start, 1000 milligrams (mg) a day. The doctor may need to adjust the dose depending on your response to the medicine. However, the dose is usually not more than 4000 mg a day.
    • Children—The dose is based on body weight and will be determined by your doctor. To start, 40 mg per kg (18.2 mg per pound) of body weight a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 100 mg per kg (45.5 mg per pound) of body weight a day, taken in two smaller doses.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is important that you visit your physician.

If you will be taking this medicine for a long time, it is very important that your eye doctor check you approximately every 3 months for any visual problems.

If your symptoms do not improve or if they become worse, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor.

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy, drowsy, or not alert, .

Do not suddenly stop taking this medicine without first checking with your doctor. Your doctor may want to reduce your dose gradually. Stopping this medicine suddenly may cause seizures.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Amnesia

blurred vision

blue-yellow color blindness

decreased vision or other vision changes

eye pain

increase in seizures

Less common or rare

Uncontrolled rolling eye movements

Symptoms of overdose

Get emergency help immediately if any of the following symptoms of overdose occur:

Mood or mental changes

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abdominal pain

abnormal coordination

agitation

anxiety

clumsiness

confusion

constipation

mental depression

diarrhea

dizziness

drowsiness

double vision or seeing double

fatigue

hyperactivity

increased movement

joint pain

burning, tingling, or prickly sensations

shakiness

sleepiness or unusual drowsiness

trembling

tremor

unsteadiness

Less common

Aggression

concentration impaired

headache

increased saliva

insomnia

muscle weakness

nausea

speech disorder

thinking abnormal

vomiting

weight gain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.