Generic Name: vigabatrin (Oral route)
Medically reviewed by Drugs.com. Last updated on Dec 16, 2019.
Vigabatrin can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, vigabatrin may also decrease visual acuity.Risk increases with increasing dose and cumulative exposure, but there is no dose or exposure to vigabatrin known to be free of risk of vision loss.Risk of new and worsening vision loss continues as long as vigabatrin is used, and possibly after discontinuing vigabatrin.Baseline and periodic vision assessment is recommended for patients on vigabatrin. However, this assessment cannot always prevent vision damage.Vigabatrin is available only through a restricted program called the Vigabatrin REMS Program. Further information is available at www.vigabatrinREMS.com or 1-866-244-8175 .
Commonly used brand name(s)
In the U.S.
Available Dosage Forms:
- Powder for Solution
Therapeutic Class: Anticonvulsant
Pharmacologic Class: Gamma Aminobutyric Acid Transaminase Inhibitor
Chemical Class: Gamma Aminobutyric Acid (class)
Uses for Sabril
Vigabatrin is used alone or together 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.
Before using Sabril
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of vigabatrin oral liquid to treat infantile spasms in children 1 month to 2 years of age. Safety and efficacy have been established.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of vigabatrin oral liquid and tablets 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.
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 caution and an adjustment in the dose for patients receiving vigabatrin.
|All Trimesters||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.|
Interactions with medicines
Interactions with food/tobacco/alcohol
Other medical problems
- 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.
Proper use of Sabril
This section provides information on the proper use of a number of products that contain vigabatrin. It may not be specific to Sabril. Please read with care.
Take this medicine only as directed by your doctor. 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. To do so may increase the chance of side effects.
Vigabatrin is only available through a restricted program called the Vigabatrin REMS program. It is very important that you understand the Vigabatrin REMS program and become familiar with the Medication Guide. Talk to your doctor about the program before starting treatment with vigabatrin.
You may take this medicine with or without food.
To use the oral liquid:
- Open the packet and empty the contents into a clean 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.
- For oral dosage form (solution):
- 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 infantile spasms:
- For oral dosage forms (solution or tablets):
- 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 and weighs 25 to 60 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. At first, 250 milligrams (mg) given 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 and weighs less than 25 kg—Use and dose must be determined by your doctor.
- For seizures:
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 very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for 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 within 4 weeks after starting treatment, every 3 months during treatment, and about 3 to 6 months after stopping treatment with this medicine.
Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine (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. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. 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, tired, 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.
This medicine may increase your weight and cause swelling in your hands, ankles, or feet. Your doctor may need to check your weight on a regular basis while you are using this medicine. Talk to your doctor about ways to prevent weight gain.
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.
Sabril side effects
Check with your doctor immediately if any of the following side effects occur:
- 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
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Change in or loss of consciousness
- burning, tingling, or prickly sensations
- clumsiness or unsteadiness
- double vision or seeing double
- increased movement
- joint pain
- mental depression
- sleepiness or unusual drowsiness
- stomach pain
- trouble sitting still
- increased saliva
- muscle weakness
- poor concentration
- speech disorder
- trouble sleeping
- unusual thoughts
- weight gain
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More about Sabril (vigabatrin)
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Images
- Drug Interactions
- Pricing & Coupons
- En Español
- Generic Availability
- Drug class: gamma-aminobutyric acid analogs
- FDA Approval History
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