Advanced Consumer Information

Sabril

Generic Name: vigabatrin (Oral route)

vye-GA-ba-trin

Commonly used brand name(s):

In Canada

Sabril

Available Dosage Forms:

Powder
Tablet

Therapeutic Class: Anticonvulsant

Pharmacologic Class: Gamma Aminobutyric Acid Transaminase Inhibitor

Chemical Class: Gamma Aminobutyric Acid (class)

Uses For Sabril

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 Sabril

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.

Pediatric

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

Geriatric

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.

Interactions with 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

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Fosphenytoin
Ginkgo

Interactions with Food/Tobacco/Alcohol

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.

Proper Use of Sabril

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 Sabril

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.

Sabril Side Effects

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.

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