Large Description (basic): 

Sabril (SAB-reel) is the brand name used in the United States and some other countries for the seizure medicine vigabatrin (vi-GAB-a-trin). In the United States, the Food and Drug Administration (FDA) first approved vigabatrin in 2009. It has been available in other countries for decades. In the U.S. it is now approved for use for:

  • Treatment of refractory complex partial seizures in children 10 years of age or older and adults. This means that the complex partial seizures have not responded to other seizure medications. It is recommended as an add-on treatment or in addition to another seizure medication.  It is not a drug of first choice for complex partial seizures due to warnings about serious visual loss. 
  • Treatment of infantile spasms in children 1 month old to 2 years old. and children with infantile spasms.

Sabril is marketed in the United States by Lundbeck. Because of the possibility of permanent vision loss, the drug can only be prescribed by physicians who have pre-enrolled in a program to use Sabril. This program, known as the Sabril REMS Program, is being updated as of July 21, 2016 to help health care providers who prescribe the drug. Sabril can be obtained through certain specialty and inpatient pharmacies. 

Information and help for providers prescribing Sabril and for people who may take the medication is available at www.Sabril.net or by cailing Sabril REMS Program at 1-888-457-4273). Any side effects that suggest vision loss should be reported to your doctor and the Sabril REMS Program. If you take a Sabril prescription into a regular pharmacy, it will NOT be filled.

Used to treat: 

How to take and store Vigabatrin?

How to Take:

Follow the directions of your prescribing provider and call if you have any questions. How much and when to take the medicine may vary for each person. 

In adults, usually, the drug is started by taking 500 mg twice a day (1000 mg/day). The dose may be increased at weekly intervals by 500 mg per day to a final daily dose of 1500 mg twice a day (3000 mg daily), based on how well it works and how well you tolerate it.

In children, dosing usually starts at 50 mg per kg each day. The dose may be increased by 25 to 50 mg per kg each week to a maximum dose of 150 mg per kg each day. For example, in children from 10 to 16 years old, the recommended dose starts at 250 mg twice a day. Increase as directed by the prescribing provider to a 1000 mg twice a day. 

Children who weigh more than 60 kg are usually given doses similar to adult recommendations. 

Your provider may suggest starting the medication at a different rate, either faster or slower. Or the daily dose may be different, depending on individual circumstances.  

Sabril is well-absorbed. You can take it with or without food, but it's a good idea to be consistent about how you take it.

Be sure to use only the amount that the provider prescribes. If you think you've used one or two extra tablets, call your doctor for advice.

If an overdose of the medicine has been taken, call your local poison control center or emergency room right away, unless you have special instructions from the doctor.

Don't stop taking Sabril or change the amount you use without talking to the prescribing provider first. Stopping any seizure medicine all at once can cause a serious problem called status epilepticus.

If you have kidney (renal) disease, the dose of Sabril should be adjusted.

For people with mild kidney problems the dose should be decreased by 25%, for people with moderate renal impairment, the dose should be decreased by 50%; and for people with severe renal impairment, the dose should be decreased by 75%.

Use of Powder:

Empty contents of the package into a clean cup. 

Mix the powder with 10 ml or 2 teaspoons of water. Use cold or room temperature water. 

Use the syringe that comes with the powder to draw up the medicine and put it in the child's mouth. 

Prepare and give each dose of medicine immediately. Don't save any unused medicine for a later time. 

How to Store:

All forms of Sabril should be stored at room temperature, away from light and moisture.

 The manufacturer recommends storing Sabril at 20° to 25°C (68° to 77°F), so if you live in a hot climate try to keep it in a cool place. You may take it with you when traveling in temperatures between 15° to 30°C (59° to 86°F). The drug may be stable in colder or hotter temperatures, but information is lacking.

Keep all medicines out of the reach of children.

What if I forget?

-If you forget a dose, take it as soon as you remember. If it is almost time for the next dose, delay that dose for a few hours instead of taking two doses very close together. Then go back to the regular schedule.

-Do your best to follow the prescribing provider's directions. If you forget doses often, get a special pillbox and use an alarm on a watch or cellphone to remind you when to take a dose.  

-Make sure to write down any missed doses and share this with your doctor.

-Taking the right amount of seizure medicine on time every day is the most important step in preventing seizures!

How does Vigabatrin effect the brain?

Brain cells need to work (fire) at a certain rate to function normally. During a seizure, brain cells are forced to work much more rapidly than normal. Sabril makes chemical changes in the brain that slow down brain cell firing during a seizure.

How does the body digest Vigabatrin?

-After taking Sabril tablets, peak blood levels are reached in 1-2.5 hours and effects probably last several days.

-Sabril is usually taken two times a day to lessen side effects from a large single dose.

-People with poor kidney function usually need to take less Sabril and may take it less often, because it stays in their body longer.

How well does the Vigabatrin work?

Sabil was approved in the US based on two studies for complex partial seizures and two for infantile spasms. All of the studies showed more improvement in seizures in the group of patients taking Sabil compared to a placebo sugar pill. But Sabril only reduced seizures, and did not eliminate them or cure the underlying epilepsy.

What are the most common side effects of Vigabatrin?

Sabril can have serious side effects, and so it should only be used after other medicines have been tried, and after careful consideration of possible benefits versus the risks.

Vision 

-The side effect of greatest concern is a potential for loss of peripheral vision. This means that people may not see well to the sides or high up and low down. According to the manufacturer, the risk increases with total dose and how long it is used. There is no amount of Sabril that is known to be free of the risk for potential vision loss.  

-Vision loss may occur in up to 30% of people taking Sabril. Risk of new and worsening vision loss continues as long as Sabril is used, and possibly after stopping the drug. Periodic vision testing (recommended to be every 3 months) is required for patients on Sabril, but cannot reliably prevent vision damage.

Changes in brain myelin

-Vigabatrin occasionally can produce changes in brain myelin, which is the coating of nerve cells. These changes can be seen with a brain MRI, but their clinical significance is unknown. The most common disease of myelin is multiple sclerosis, but there is no evidence that vigabatrin produces multiple sclerosis. MRI changes usually resolve with discontinuation of vigabatrin.

Changes in mood, behavior, suicidal thinking

All seizure medicines, including Sabril, carry warnings about suicidal thinking and tendencies. In a pooled analysis of 11 studies, the FDA noted 4 suicides among 27,863 patients. Epilepsy itself is associated with a higher risk for depression and suicide. You and your family should be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to your healthcare providers.

Other side effects

This table shows potential side effects that occurred in people taking Sabril when compared to people taking a placebo or inactive drug. 

Side Effect Sabril Placebo
Fatigue 27% 16%
Sleepiness 22% 13%
Dizziness 21% 17%
Tremor 14% 8%
Nasopharyngitis 13% 10%
Blurry vision 11% 5%
Memory impairment 10% 3%
Stomach upset, constipation or diarrhea 10% 8%
Upper respiratory tract infection 9% 5%
Coordination abnormal 9% 2%
Weight gain 8% 3%
Joint pains 8% 3%
Urinary tract infection 4% 0%
Headache 4% 1%
Fluid retention 2% 1%

Many other side effects were seen, but it is not known whether they were caused by Sabril, other medicines or non-drug reasons.

Laboratory abnormalities

Anemia (low red blood counts) were seen in 6% of patients taking Sabril vs. 2% of those on placebo. Sabril decreases liver enzyme markers AST and ALT. While not a sign of a problem, the decrease could make it harder to detect other problems.

What are the most serious side effects of Vigabatrin?

Vision:

Vigabatrin has serious potential adverse effects and carries an FDA black box warning about the potential for causing loss of peripheral vision. This means that the drug may cause permanent, changes in visual fields that may range from mild to severe.

- The terms used to describe the visual field problem are bilateral concentric visual field constriction that can occur in 30% or more of patients taking the medication. This vision problem can also include 'tunnel vision' to within 10 degrees of visual fixation which can be disabling. 

-In some cases, vigabatrin may damage the central retina of the eye and decrease visual acuity.

-The onset of visual loss is unpredictable. It can occur anytime during treatment with vigabatrin, for example within weeks of starting it, sooner, or even after months or years.

-The risk of visual loss increases with increasing doses and cumulative exposure (for example at higher doses or longer periods of time the drug is used).  There is no dose or length of time on the drug known to be free of risk of visual loss.

-Adults are required to have a formal opthalmologic or eye exam every 3 months during therapy.  Visual or eye assessments should also be done about 3 to 6 months after the therapy is stopped.  Some patients may be exempted from periodic ophthalmologic (eye) exams; information about this is documented in a special post-marketing program ("Share Program") to tightly assess the adverse effects related to this drug.  

-Once detected, visual loss is irreversible. It is expected that even with frequent monitoring, some patients could develop severe visual loss. It is possible that visual loss could worsen despite stopping the drug.

-Because of this risk of permanent visual loss, the drug is available only through a restricted distribution program with a central pharmacy. Physicians who prescribe the drug need to take special educational classes in order to appropriately handle these issues and counsel patients.

-Because of the risk for visual problems and because vigabatrin, when it is effective, provides an observable symptomatic benefit, a patient who does not show substantial benefit within 3 months of starting treatment should be withdrawn from the drug. If, in the clinical judgment of the prescriber, evidence of treatment failure becomes obvious earlier than 3 months, treatment should be stopped at that time. Patient response to and continued need for treatment should be periodically assessed. This is true for both children and adults.

-The diagnostic approach to assess and monitor vision has been outlined by the pharmaceutical company. Perimetry is recommended, preferably by automated threshold visual field testing. Additional testing may also include electroretinography, retinal imaging, and other methods, depending on the physician’s choice. In patients exempted from visual testing, the treatment may continue according to clinical judgment with appropriate patient counseling.

Other side effects

-Somnolence (sleepiness) and fatigue, symptoms of peripheral neuropathy, edema and weigt gain. The average weight gained is 3.5 kilograms and this has been reported in 17% of patients.

Who should not take Vigabatrin?

People whose vision cannot be monitored should not take Sabril. People known to be allergic to Sabril should not take it.

Impact of Vigabatrin on bone health

See package insert.

Can Vigabatrin be taken with other medicines?

-Any time a doctor suggests a new prescription, be sure to talk about what other medicines, supplements, herbs, and vitamins are already being taken. Sometimes one kind of medicine changes the way another kind of medicine works in the body. If two kinds of medicine affect each other, the doctor may prescribe something else or change the amount to be taken.

-In clinical trials, Sabril lowered phenytoin (Dilantin) levels about 20%, but had little or no effect on other antiseizure drug levels.

-Other antiseizure drugs have little effect on Sabril.

-The manufacturer’s package insert says that Sabril is unlikely to affect steroid oral contraceptives or hormonal birth control. 

What are the effects of Vigabatrin on Children?

Sabril has been tested in children and can be used in children with refractory complex partial seizures and infantile spasms. Side effects (discussed elsewhere) can be severe, so Sabril should only be used in children with careful consideration of the possible risks versus benefits.

If a woman takes Vigabatrin during pregnancy will it hurt the baby?

The U.S. Food and Drug Administration (FDA) lists Sabril in Pregnancy Category C, known to cause birth defects in animals, and suspected to be able to produce birth defects in people. Talk to your doctor or another health professional if you are pregnant or plan to become pregnant. We don't yet have enough information to be able to estimate the risk of various types of birth defects that might occur if Sabril is taken during pregnancy. We also don't know enough to compare the risk with Sabril to the risk with other seizure medicines. The risk of birth defects is generally higher for women who take more than one AED and for women with a family history of birth defects.

Women who are capable of becoming pregnant should take at least 400 micrograms (0.4 mg) of folic acid (folate) daily to help prevent a type of birth defect called a neural tube defect. (The best-known of these is spina bifida, in which the spinal cord is not completely enclosed.) Women at high risk, such as those with a history of this kind of defect in a previous pregnancy, should take 4000 mcg (4 mg) daily, beginning before they become pregnant. Pregnant patients taking SABRIL are encouraged to call the North American Antiepileptic Drug (NAAED) Pregnancy Registry at 1-888-233-2334, or visit online at www.aedpregnancyregistry.org.

Sabril is excreted in breast milk and could cause toxicity in the baby. If you want to breast-feed your baby, check with your doctor about what seizure medicine would be best for you. Women who are capable of becoming pregnant should take at least 400 micrograms (0.4 mg) of folic acid (folate) daily to help prevent a type of birth defect called a neural tube defect. (The best-known of these is spina bifida, in which the spinal cord is not completely enclosed.) Women at high risk, such as those with a history of this kind of defect in a previous pregnancy, should take 4000 mcg (4 mg) daily, beginning before they become pregnant.

What are the effects of Vigabatrin on Seniors

Studies of elderly patients taking Sabril are few, but seniors are prone to have more confusion, sedation and side effects because their kidneys do not clear the drug as well as in younger patients.

What are the dose ranges for Vigabatrin?

For adults, Sabril is usually started at 500 milligrams (mg) twice daily. The dosage can be increased to 1000 mg twice a day after two weeks, then 1500 mg twice a day two weeks later. Dosage usually would be continued at 1500 mg twice a day (3000 mg per day total). For people who are particularly prone to medication side effects, the initiation may start more slowly. On the other hand, some patients with an urgent need to control seizures quickly might increase dosage faster than usual. You should plan the medication schedule with your doctor.

Read the package insert of Vigabatrin

"In the United States, companies that manufacture medicines are required to publish certain kinds of information about each product. This document is commonly known as a “package insert” because it is usually included with each package of the medicine. You can also read these documents (also called ""prescribing information"") online. The U.S. package insert for Sabril is found at:

To learn how to read and understand a package insert, see "How to read a package insert"

Small Description (adv): 

Sabril (SAB-reel) is the brand name used in the United States and some other countries for the seizure medicine vigabatrin (vi-GAB-a-trin). In the United States, the Food and Drug Administration (FDA) approved vigabatrin in 2009 to be used as a seizure medicine in adults and children with uncontrolled complex partial seizures and children with infantile spasms. In 2013, it was approved or use in children 10 years of age or older with refractory complex partial seizures. Sabril has been available in many countries for decades. The medicine carries warnings about serious visual loss, so it is not a drug of first choice for complex partial seizures.

Large Description (adv): 

Vigabatrin has been available around the world for nearly 2 decades. It was approved by the U.S. Federal Drug Administration in 2009 for the specific indications of infantile spasms in children as well as refractory partial epilepsy in adults where all other options have failed. Vigabatrin’s exact mechanism of action is unknown; however, it is believed that it exerts its anti-seizure effect as a result of its action as an irreversible inhibitor of g-aminobutyric acid transaminase (GABA-T), the enzyme responsible for the metabolism of the inhibitory neurotransmitter GABA. This action results in increased levels of GABA in the central nervous system. There is no direct correlation between the serum concentration of the drug and the effectiveness of the drug. The duration of the drug effect is unique because it is actually dependent on the rate of the individual’s enzyme resynthesis rather than on the rate of elimination of the drug from the systemic circulation. This makes the drug quite different from other agents in that monitoring serum levels are rendered almost obsolete, because the drug is individually tailored to the patient’s physiology based on one’s GABA receptors.

Indications (adv): 

Sabril (vigabatrin) tablets are indicated as adjunctive (add-on) therapy in the treatment of complex partial seizures (previously called temporal lobe seizures, psychomotor seizures or limbic seizures) in adults, generally taken as 18 years old or older. The medication may be used in complex partial seizures with or without secondary generalization to tonic-clonic seizures. In should only be used after other safer medicines have been found not to work. Usually, Sabril is added when another seizure medicine is not controlling seizures, rather than being used by itself; however, an experienced physician may choose to try Sabril as a single agent in some circumstances. Sabril (vigabatrin) oral solution (mixed from the powder and water) is indicated for children with infantile spasms. Infantile spasms are a type of seizure disorder beginning between 1 month and 2 years of life. The babies have spasms of the limb and neck muscles resulting in sudden flexion or extension of the arms or legs. The seizures are brief, but may cluster. Some episodes are so subtle as to not be recognized as seizures; others are stronger and more obvious. Infantile spasms can be associated with developmental delay (previously called mental retardation) and a characteristic EEG (brainwave) abnormality called hypsarrhythmia. When these three go together, the condition is known as West’s syndrome. Infantile spasms can be of unknown cause or they can be a symptom of another neurological condition, for example, tuberous sclerosis.  Infantile spasms are difficult to treat. Another FDA approved therapy is ACTH ( adrenocorticotropic hormone). This injection has considerable side effects if used for more than a few weeks, and it is increasingly hard to obtain. Other medications have been tried, but evidence of benefit is strongest for vigabatrin, especially when infantile spasms result from tuberous sclerosis.

Forms (adv): 

Sabril is available in 2 forms: A 500 milligram tablet or a powder meant to be dissolved to create an oral solution.

Sabril is marketed in the United States by Lundbeck. Because of the possibility of sometimes permanent vision loss, the drug can only be prescribed by physicians who have pre-enrolled in a program to use Sabril. The drug can only be obtained through a central pharmacy, which can be contacted at the SHARE Call Center at 1-888-45-SHARE (1-888-457-4273). If you take a Sabril prescription into a regular pharmacy, it will NOT be filled.

Dosing (adv): 

Adults with refractory complex partial seizures- the typical starting dose is 500 milligram tablet taken twice a day. The typical recommended dose to stop seizures is 1500 milligrams taken twice a day.

In kids ( ages 10- 16 years of age) with refractory complex partial seizures, the typical starting dose is 250 milligrams twice day. The typical recommended dose is 1000 milligrams twice a day. Treatment dose will depend on the child's weight.

In babies with Infantile spasms, treatment is started at 50 milligrams per kilogram of weight  and the totla daily dose is divided in 2. The total daily dose can be increased to a maximum of 150 milligrams per kilogram per day divided in 2 doses in a day.

How to take and store Vigabatrin?
Missed Doses

See package insert.

Mechanisms of actions of Vigabatrin

See package insert.

Clinical Pharmacology of Vigabatrin

See package insert.

Efficacy of Vigabatrin

VGB is approved for use for 2 particular indications in the United States; complex partial seizures in adults and infantile spasms in children.

Infantile Spasms

The effectiveness of vigabatrin in monotherapy for infantile spasms has been established in 2 multi-centered, controlled studies. Both studies were similar in terms of the population studied and seizure characteristics of enrolled patients. In the first study, a multi-centered, randomized, low-dose, high-dose, parallel group, partially blinded, caregivers knew the actual dose, but not whether their child was classified as high- or low-dose; the EEG reader was blinded, but investigators were not blinded; study to evaluate the safety and efficacy of vigabatrin in patients less than 2 years of age with new onset infantile spasms. The total number of children studied was 221. The primary efficacy endpoint of the study was to proportion the patients who were spasm free for 7 consecutive days, beginning within the first 14 days of vigabatrin therapy. Patients with both symptomatic and cryptogenic etiologies were studied with infantile spasms. The study comprised of 2 phases. The first phase was a 14-21 day partially blind phase in which patients were randomized to either receive a low dose, 18-36 mg/kg/day, or a high dose, 100-148 mg/kg/day, of vigabatrin. The study drug was titrated over 7 days followed by a constant dose for 7 days. If the patient became spasm free on or before day 14, another 7 days of constant dose was administered. Seventeen patients in the high-dose group achieved spasm freedom compared to 8 patients in the low-dose group, which was statistically significant at p=0.0375.

The second study was a multi-centered, randomized, double-blind, placebo-controlled, parallel group study consisting of a pre-treatment baseline period of 2 to 3 days followed by a 5-day, double-blind, treatment phase during which patients were treated with vigabatrin initial dose of 15 mg/kg/day with a titration allowed to 150 mg/kg/day. The total number of children studied was 40. In the second study, no statistically significant differences were observed in the average frequency of spasms using a 2-hour evaluation window; however, a post-hoc alternative efficacy analysis using a 24-hour clinical evaluation window found a statistically significant difference in the overall percentage of reductions in spasms between the vigabatrin group of 68.9% and the placebo group of 17% (p=0.030). Based on these 2 studies, the drug was approved for the indication of infantile spasms.

Complex Partial Seizures in Adults

The effectiveness of several as add-on therapy in adult patients with complex partial seizures was established in 2 U.S. multi-centered, double-blind, placebo-controlled, parallel-group clinical studies. A total of 357 adults, age 18 to 60 years, with complex partial seizures with or without secondary generalization were enrolled. Patients were required to be on an adequate and stable dose of an anticonvulsant and have a history of failure on an adequate regimen of either carbamazepine or phenytoin. Patients had a history of about 8 seizures per month for about 20 years prior to entrance into the study.

In the first study, a randomized, double-blind, placebo-controlled dose response study consisting of an 8-week baseline followed by an 18-week treatment period, patients were randomized to receive placebo or 1, 3, or 6 g of vigabatrin per day administered twice daily. During the first 6 weeks following randomization, the dose was titrated upward beginning with 1 g/day and increasing by 0.5 g/day on days 1 and 5 of each subsequent week in the 3 g/day group and 6 g/day group until the assigned dose was reached. The 3 g/day and 6 g/day dose groups were statistically significantly superior to placebo, but the 6 g/day was not superior to the 3 g/day group. The proportion of patients achieving any particular level of reduction in complex partial seizures was consistently higher for the sample of 3 and 6 g/day group compared to the placebo group. For example, 51% of patients randomized in the sample 3 g/day and 53% of patients randomized in sample 6 g/day experienced a 50% or greater reduction in seizure frequency compared to 9% of patients randomized to placebo.

The second study consisted of 183 randomized patients who were placed in a randomized, double-blind, placebo-controlled, parallel study consisting of an 8-week baseline period and a 16-week treatment period. During the first 4 weeks following randomization, the dose of vigabatrin was titrated upward beginning with 1 g/day and increased by 0.5 g/day on a weekly basis to the maintenance dose of 3 g/day. The proportion of patients achieving any particular level of reduction in seizure frequency was consistently higher for the sample 3 g/day group compared to the placebo group. For example, 39% of patients randomized in sample 3 g/day (50%) had a greater reduction in complex partial seizures compared to 21% of patients randomized to placebo.

Common side effects of Vigabatrin

See package insert.

Serious Side effects of Vigabatrin

VGB has serious potential adverse effects and carries an FDA black box warning. The drug may cause permanent, bilateral concentric visual field constriction in 30% or more of patients that ranges in severity from mild to severe, including tunnel vision to within 10 degrees of visual fixation and can result in disability. In some cases, VGB may damage the central retina decreasing visual acuity. The onset of visual loss is unpredictable and can occur within weeks of starting treatment or sooner or anytime during treatment, even after months or years. The risk of visual loss increases with increasing dose and cumulative exposure, but there is no dose or exposure known to be free of risk of visual loss. Unless the patient is formally exempted from periodic ophthalmologic assessment as documented in a special post-marketing program to tightly assess the adverse effects related to this drug entitled “Share Program,” a formal ophthalmologic assessment every 3 months during therapy is required for adults. Visual assessment is also required about 3-6 months after the discontinuation of therapy. Once detected, visual loss is irreversible. It is expected that even with frequent monitoring, some patients could develop severe visual loss. It is possible that visual loss could worsen despite discontinuation of the drug. Because of this risk of permanent visual loss, the drug is available only through a restricted distribution program with a central pharmacy. Physicians who prescribe the drug need to take special educational classes in order to appropriately handle these issues and counsel patients. As a result, because of this risk and because vigabatrin, when it is effective, provides an observable symptomatic benefit, a patient who fails to show substantial benefit within 3 months of initiation of treatment should be withdrawn from the drug. If it is in the clinical judgment of the prescriber, evidence of treatment failure becomes obvious earlier than 3 months, treatment should be discontinued at that time. Patient response to and continued need for treatment should be periodically assessed. This is true for both children and adults. The diagnostic approach to assess and monitor vision has been outlined by the pharmaceutical company. Perimetry is recommended, preferably by automated threshold visual field testing. Additional testing may also include electroretinography, retinal imaging, and other methods, depending on the physician’s choice. In patients exempted from visual testing, the treatment may continue according to clinical judgment with appropriate patient counseling.

Outside of the visual adverse effects, other important adverse effects that need to be considered include the presence of somnolence and fatigue, symptoms of peripheral neuropathy, edema and weigt gain. The average weight gained is 3.5 kilograms and this has been reported in 17% of patients.

Vigabatrin Contraindications

See package insert.

Impact of Vigabatrin on bone health

See package insert.

Vigabatrin Interactions with other medications

See package insert.

Vigabatrin effects on Children

See package insert.

Vigabatrin and Pregnancy

See package insert.

Vigabatrin effects on Seniors

See package insert.

Vigabatrin Dosing and titration

With regards to dosing, for refractory partial epilepsy, 500 mg of the drug is started as twice-daily oral administration with or without food. The total daily dose may be increased in 500 mg increments at weekly intervals depending on the response. The recommended daily dose of vigabatrin is 3 g/day. It is not approved for higher doses.

In children 1 month to 2 years of age with infantile spasms, the drug can be given as a twice-daily oral administration. The initial daily dose of 15 mg/kg/day given in 2 divided doses and can be titrated by 25-50 mg/kg/day in increments every 3 days up to a maximum of 150 mg/day.

Vigabatrin Package insert

"In the United States, companies that manufacture medicines are required to publish certain kinds of information about each product. This document is commonly known as a “package insert” because it is usually included with each package of the medicine. You can also read these documents (also called ""prescribing information"") online. The U.S. package insert for Sabril is found at:

To learn how to read and understand a package insert, see "How to read a package insert"

Vigabatrin References for Professionals