Sabril is available as a prescription tablet. It also comes in a powder that turns into a liquid solution when mixed with water. The Food and Drug Administration (FDA) gave this medication a black box warning of possible vision loss. Therefore, Sabril is available only through a Risk Evaluation Mitigation Strategy (REMS) program.
What Is Sabril Used For?
Sabril is used to treat seizures—specifically infantile spasms (IS) and refractory complex partial seizures (CPS).
Brand Name(s): Sabril
Drug Availability: Prescription
Therapeutic Classification: Anticonvulsant (antiepileptic drug)
Available Generically: Yes
Controlled Substance: N/A
Administration Route: Oral (by mouth)
Active Ingredient: Vigabatrin
Dosage Form(s): Tablets and liquid (when the powder is mixed with water)
The FDA approved Sabril to be used by itself for IS in children between 1 month and age 2. Sabril should only be used for IS if the benefits outweigh the risk of vision loss.
Sabril is also an add-on to another anti-seizure treatment for refractory CPS in people 2 years or older. CPS is also known as focal seizure with impaired awareness. People with this medical condition have seizures that start on one side of the brain. These seizures can also cause you to lose awareness or consciousness.
CPS will not get any better for some people after a trial of two to three antiepileptic drugs (AEDs). Therefore, these seizures are called refractory.
In 2015, the Centers for Disease Control and Prevention (CDC) estimated that 3 million adults and nearly 500,000 children had epilepsy in the United States (U.S.). People with epilepsy have a history of at least two seizures.
How to Take Sabril
In general, Sabril is taken by mouth twice daily with or without food.
Compared to Sabril tablets, the liquid dosage form will require more preparation steps before you can take the medication. Specific directions will vary per person. Therefore, take Sabril according to your healthcare provider’s recommendations. The following are some general steps to prepare and take the Sabril liquid solution.
Gather the number of Sabril powder packets recommended by your healthcare provider. Remember that each powder packet contains 500 milligrams (mg) of Sabril. Tap the Sabril packet(s) to settle the powder to the bottom of the packet. Use scissors to cut the Sabril packet(s) along the dotted line to open. Empty the Sabril packet(s) into a clean and clear cup. Fill a second clean and clear cup with cold or room temperature water. Use an oral (by mouth) syringe to transfer water from the second cup to the Sabril cup. For each Sabril packet, you will need to add 10 milliliters (mL) of water. Use a clean spoon to stir the mixture until the solution is clear. Use an oral syringe to measure the Sabril dose in milliliters recommended by your healthcare provider. Place the tip of the syringe in your mouth and point it towards either cheek. Slowly push the plunger until there is no more medication in the syringe. Throw away any leftover mixture. Don’t try to save it for future use. Clean cups and syringes with soap and water.
Storage
When you receive Sabril from the pharmacy, store it at room temperature, which is between 68 degrees to 77 degrees Fahrenheit (F).
To be safe, you may also place Sabril in a locked cabinet or closet to keep your medication out of the reach of children and pets.
If you plan to travel with Sabril, get familiar with your final destination’s regulations. Checking with the U.S. embassy or consulate might be a helpful resource. In general, however, be sure to make a copy of your Sabril prescription. If possible, keep your medication in its original container from your pharmacy with your name on the label. If you have any questions about traveling with your medicine, be sure to ask your pharmacist or healthcare provider.
You can also ask your pharmacist or healthcare provider about the best ways to dispose of your medications. The FDA’s website is a potentially helpful resource to know where and how to discard all unused and expired drugs. You can also find disposal boxes in your area.
Off-Label Uses
Sabril doesn’t currently have any off-label uses.
What Are the Side Effects of Sabril?
This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.
Common Side Effects
Common side effects with Sabril for refractory complex partial seizures (CPS) in adults may include:
Blurred visionDizzinessFatigue (tiredness and low energy)Muscle control problemsSomnolence (drowsiness or sleepiness)Tremors
Children between ages 3 to 16 tend to experience weight gain with Sabril for refractory CPS.
On the other hand, children between 1 month and 2 years tend to have the following common side effects with Sabril for infantile spasms.
Bronchitis (irritated and swollen lung airways) Ear infections Somnolence (sleepiness)
Severe Side Effects
Serious side effects and their symptoms include:
Severe allergic reaction: If you have a severe allergic reaction to Sabril, symptoms may include breathing difficulties, itchiness, and rash. Vision loss: Sabril can raise your risk for tunnel vision, which may vary from mild to severe. Some people, however, have experienced permanent vision loss. Abnormal magnetic resonance imaging (MRI): Children taking Sabril for infantile spasms may have abnormal MRIs. The significance of these MRI changes is unknown. Anemia: Sabril is linked to anemia. Anemia is a condition of low red blood cells (RBCs). You might experience dizziness and pale skin if you have anemia. Antiepileptic drug withdrawal: Abruptly stopping antiepileptic drugs (AEDs)—like Sabril—can cause withdrawal seizures. Fatigue and somnolence (sleepiness): While fatigue and somnolence are common symptoms of Sabril, they can be severe and excessive. Nerve problems: Some people might experience nerve problems with Sabril. Symptoms may include numbness and tingling of your toes and feet. Suicidal thoughts and behaviors: AEDs—like Sabril—may raise your risk of suicidal thoughts. Keep an eye out for concerning changes in mood or behavior. Swelling: Sabril may raise your likelihood of swelling. However, this increased swelling isn’t linked to high blood pressure, heart failure, kidney disease, or worsening liver function. Weight gain: Taking Sabril may lead to weight gain unrelated to the medication’s swelling side effects. The long-term effects of this weight gain are unknown.
Get medical help right away if you develop any of these side effects. Call 911 if your symptoms feel life-threatening.
Long-Term Side Effects
Possible long-term side effects with Sabril may include vision loss and nerve problems.
Dosage: How Much Sabril Should I Take?
Modifications
The following modifications (changes) should be kept in mind when using Sabril:
If you experience a serious side effect, you or your provider may send a report to the FDA’s MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
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): 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): For seizures: Adults and children 17 years of age and weighs more than 60 kilograms (kg)—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 2 to 16 years of age and weighs 10 to 15 kg—Dose is based on body weight and must be determined by your doctor. At first, 175 milligrams (mg) given two times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 1050 mg per day. Children 2 to 16 years of age and weighs 15 to 20 kg—Dose is based on body weight and must be determined by your doctor. At first, 225 milligrams (mg) given two times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 1300 mg per day. Children 2 to 16 years of age and weighs 20 to 25 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 1500 mg per day. Children 2 to 16 years of age and weighs 25 to 60 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 10 kg—Use and dose must be determined by your doctor.
Severe allergic reaction: If you have a severe allergic reaction to Sabril, your healthcare provider wouldn’t recommend this medication.
Pregnancy: In animal studies, Sabril was found to have adverse (negative) effects on the fetus. If taking Sabril during your pregnancy, consider enrolling in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by visiting the registry’s website or calling 1-888-233-2334. Based on currently available information for humans, there are no reports that linked Sabril to negative effects on the unborn fetus.
Discuss with your healthcare provider if you are or plan to become pregnant. They will help you weigh the benefits and risks of taking Sabril during pregnancy.
Breastfeeding: While Sabril is present in human breast milk, the amount is low for daily doses of up to 2000 milligrams (mg). In fact, the Sabril levels in breast milk are less than the typical dosage range given to a 1-month-old child with infantile spasms (IS). As a result, negative effects on the nursing baby are unlikely.
Talk with your healthcare provider if you plan to breastfeed. Your healthcare provider will help you weigh the benefits and harms of taking Sabril while nursing. They can also discuss the different ways available to feed your baby.
Adults over 65: Clinical studies haven’t included a large enough number of people in this age group to see whether they respond differently from younger adults. Since some older adults may have kidney impairment, use Sabril with caution in this population.
Children: Sabril—as an add-on to another seizure treatment option—can be used for refractory complex partial seizures (CPS) in children between 2 and 16 years old. Sabril is also used for IS in children between 1 month and 2 years if the benefits outweigh the risk of vision loss.
Kidney problems: Individuals with kidney problems may not be able to clear Sabril from their bodies as quickly. This means the medicine stays in the body longer and can have increased side effects. For this reason, your healthcare provider will adjust your Sabril dosage based on your kidney function.
Liver problems: Sabril may lower your liver function test levels. Therefore, your healthcare provider isn’t likely to use these tests if they suspect worsening liver function from any cause.
Missed Dose
If you accidentally forgot your Sabril dose, take it as soon as you remember. If it’s already close to your next scheduled dose, however, then skip the missed dose and take the following dose at your next scheduled dosing time. Don’t try to double up to make up for the missed dose.
These suggestions might vary per person. Therefore, make sure to ask for specific recommendations from your healthcare provider.
Try to find ways to help yourself remember to routinely take your medication that works for you. If you miss too many doses, Sabril might be less effective at treating your seizures.
Overdose: What Happens If I Take Too Much Sabril?
There have been reports of overdoses with Sabril at doses between 3 to 90 grams (g)—with most overdoses happening between 7 1/2 to 30 grams of Sabril in combination with other antiepileptic drugs(AEDs).
The symptoms of a suspected overdose with Sabril may include:
Coma Confusion Drowsiness Feelings of dizziness and imbalance Headaches Low blood pressure Low breathing rate Mood and behavior changes Seizures Slow heart rate Speech problems
If you think that you’re experiencing an overdose or life-threatening symptoms, seek immediate medical attention.
Precautions
What Are Reasons I Shouldn’t Take Sabril?
Before taking Sabril, talk with your healthcare provider if any of the following applies to you:
If someone collapses or isn’t breathing after taking Sabril, call 911 immediately.
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.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. Your doctor may want you to join a pregnancy registry for patients taking a seizure medicine.
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.
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.
Severe allergic reaction: If you have a severe allergic reaction to Sabril or its components (ingredients), you shouldn’t take this medication. Pregnancy: The limited information available from human studies has not linked Sabril to negative effects on the unborn fetus. If you take Sabril during your pregnancy, consider enrolling in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by visiting the registry’s website or calling 1-888-233-2334. Your healthcare provider can also help you weigh the benefits and risks of taking Sabril during pregnancy. Breastfeeding: Limited data show only small amounts of Sabril in human breast milk. These low Sabril levels are less than the typical dosage range for 1-month-old children with infantile spasms. Therefore, Sabril isn’t expected to cause harmful effects on nursing babies. Children: Sabril—combined with another treatment—can be used for refractory complex partial seizures (CPS) in children between 2 and 16 years. If the benefits outweigh the risk of vision loss, Sabril may also be used for infantile spasms (IS) for children between 1 month and 2 years. Adults over 65: There is limited data to compare the differences in responses to Sabril between older and younger adults. Older adults that have kidney issues should use Sabril with caution. People with a high risk of irreversible vision loss: Some people have eye conditions—like age-related macular degeneration (AMD)—that raise the risk for permanent vision loss. Therefore, Sabril isn’t recommended unless the benefits outweigh the risk of vision loss.
What Other Medications Interact With Sabril?
Use caution when taking Sabril with the following medications:
Clonazepam: Clonazepam is a benzodiazepine that has many uses, including seizures. Combining Sabril with clonazepam may lead to higher clonazepam levels in your body and more side effects. Eye-related medications: Sabril is linked to possible vision loss. If you’re currently using medications for your eye condition (e. g. , glaucoma), avoid taking Sabril unless the benefits outweigh the risks. Phenytoin: Phenytoin is an antiepileptic drug (AED). Taking Sabil with phenytoin may lower phenytoin levels and decrease phenytoin’s effectiveness. Therefore, your healthcare provider may need to adjust your medication dose.
For more detailed information about medication interactions with Sabril, talk with your pharmacist or healthcare provider.
And be sure to talk with your healthcare provider about any other medicines that you take or plan to take, including over-the-counter, nonprescription products, vitamins, herbs, or plant-based medicines.
What Medications Are Similar?
Several antiepileptic drugs (AEDs) are available to treat seizures. In general, AEDs are divided into two groups: broad-spectrum and narrow-spectrum AEDs. Broad-spectrum AEDs can typically be used for various seizure types. Narrow-spectrum AEDs are generally only used for specific seizure types.
Sabril is considered a narrow-spectrum AED, and other narrow-spectrum AEDs include:
Dilantin (phenytoin) Lyrica (pregabalin) Neurontin (gabapentin) Phenobarbital Tegretol (carbamazepine) Trileptal (oxcarbazepine) Vimpat (lacosamide)
Compared to all of these narrow-spectrum AEDs, Sabril is the only AED recommended as an initial go-to medication to treat infantile spasms (IS). For refractory complex partial seizures (CPS), however, Sabril isn’t the first-choice option due to its risk of vision loss. While Sabril is available as the generic vigabatrin, it’s a specialty medication. As a result, it might be more expensive than the other narrow-spectrum AEDs.
How Can I Stay Healthy While Taking Sabril?
If you’re taking Sabril, chances are seizures have been negatively affecting your quality of life. You may have tried different approaches or treatments. While living with epilepsy does have its challenges, there are ways to help improve your quality of life. Refer below for some general tips to support your health:
Sabril also has a Risk Evaluation Mitigation Strategy (REMS) program. As a result, your healthcare provider and pharmacy will also need to be REMS-certified.
If cost is a concern, Sabril’s manufacturer may offer a reimbursement support program. For additional information, call Lundbeck at 1-888-457-4273. Other potentially helpful resources may also include RxAssist, NeedyMeds, Rx Outreach, or Simplefill.
As for other AEDs, there is typically little concern about AED interactions with Sabril.
Sabril, however, is typically combined with another antiepileptic drug (AED) for refractory complex partial seizures (CPS). Although Sabril might not be linked to bone problems, the other AED might.
Take antiepileptic drugs (AEDs) as recommended by your healthcare provider. Having seizures is linked to osteoporosis (weak and brittle bones). Eat a healthy diet with adequate amounts of calcium and vitamin D to lower your risk of bone loss. Staying physically active may also lower your risk of osteoporosis. Consider weight-bearing exercises (e. g. , walking, dancing, lifting weights) and balancing activities (e. g. , tai chi, yoga, swimming). Avoid drinking and smoking to limit your osteoporosis risk. People with epilepsy are more likely to get bone fractures (breaks). You can limit your risk for falls and fractures by making your home safer. Consider steps like wearing non-slip shoes and having skid-proof carpets or rugs. Consider support groups or working with a mental health professional to help you find coping strategies that change the way you think, feel, react, or respond to living with seizures.
