Sabril

Sabril is a medicine that reduces seizures. Sabril (Vagabatrin) is used alone or with other medicines to treat complex partial seizures in adults and children 10 years of age and older, and infantile spasms in children. It is used in patients who have already been treated with other medicines that did not work well.

Vigabatrin is an anticonvulsant. It increases the amount of the chemical called gamma amino butyric acid (GABA) in the brain. Some seizures are caused by low levels of GABA. When vigabatrin increases GABA, it reduces the likelihood of a seizure.

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

This product is available in the following dosage forms:

• Tablet
• Powder for Solution
• Powder

Here are the important things you must know before using the drug Sabril. In deciding to use any 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 Sabril, the following should be considered:

1. 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.

2. Pediatric Population:

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of vigabatrin oral solution to treat infantile spasms in children 1 month to 2 years of age.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of vigabatrin to treat complex partial seizures in children 10 to 16 years of age. However, safety and efficacy have not been established in children younger than 10 years of age.

3. Geriatric Population:

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vigabatrin in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving vigabatrin.

4. Pregnancy:

All Trimesters: Category C: Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

5. Breastfeeding:

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.

6. Drug Interactions:

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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
• Orlistat

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
• Phenytoin

7. 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.

8. 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:

• Anemia or
• Depression, history of or
• Eye or vision problems or
• Mental illness, history of—Use with caution. May make these conditions worse.
• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Always take Sabril as directed by your doctor. When taking Sabril, do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Doing so may increase the chance of side effects.

Sabril is only available through a restricted program called the SHARE program. It is very important that you understand the SHARE program and become familiar with the Medication Guide. Talk to your doctor about the SHARE program before starting treatment with Sabril.

You may take this medicine with or without food.

To use the oral liquid:

• Open the packet and empty the contents into an empty cup.
• Dissolve it with 10 milliliters (mL) of cold or room temperature water.
• Do not use the liquid if it is not clear (or free of particles) and colorless.
• Measure the dose with the oral syringe in the package.
• Throw away any unused liquid after the dose is given.

Vigabatrin may be used together with other seizure medicines. Keep using all of your medicines unless your doctor tells you to stop.

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 (solution):

        o For infantile spasms:

              Children 1 month to 2 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 50 milligrams (mg) per kilogram (kg) of body weight per day, divided and given 2 times a day. Your doctor may adjust the dose as needed. However, the dose is usually not more than 150 mg per kg per day.
              Children younger than 1 month of age—Use and dose must be determined by your doctor.

• For oral dosage forms (solution or tablets):

        o For seizures:

              Adults—At first, 500 milligrams (mg) two times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
              Children 10 to 16 years of age—At first, 250 milligrams (mg) two times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 2000 mg per day.
              Children younger than 10 years of age—Use and dose must be determined by your doctor.

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.

Always observe proper precautions when taking Sabril. It is very important that your doctor check your or your child's progress at regular visits to allow for changes in the dose and to check for any unwanted effects.

This medicine may cause permanent vision loss. Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. It is very important that your ophthalmologist (eye doctor) check your child's or your eyes approximately every 3 months for any visual problems.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests (eg, magnetic resonance imaging or MRI).

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause some people to become drowsy, sleepy, or weak 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 drowsy or not alert.

Check with your doctor right away if you or your child are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

Tell your doctor if you or your child have increased weight or swelling in the hands, ankles, or feet while taking this medicine.

Do not suddenly stop taking this medicine without checking first with your doctor. Your doctor may want to gradually reduce the amount you are using before stopping it completely. Stopping this medicine suddenly may cause seizures.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Sabril may cause side effects, and you must watch out for them while using the drug. 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:

• Blue-yellow color blindness
• Blurred vision
• Decreased vision or other vision changes
• Eye pain
• Increase in seizures
• Loss of memory
• Problems with memory

Less common or rare:

• Uncontrolled rolling eye movements

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 or stomach pain
• Abnormal coordination
• Agitation
• Burning, tingling, or prickly sensations
• Clumsiness
• Confusion
• Constipation
• Diarrhea
• Dizziness
• Double vision or seeing double
• Drowsiness
• Increased movement
• Joint pain
• Mental depression
• Sleepiness or unusual drowsiness
• Trembling
• Tremor
• Trouble sitting still
• Unsteadiness

Less common:

• Aggression
• Headache
• Increased saliva
• Muscle weakness
• Nausea
• Poor concentration
• Speech disorder
• Thinking abnormal
• Trouble sleeping
• 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.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.