Generic Name: vigabatrin (vye-GA-ba-trin)
Brand Name: Sabril
Sabril solution may cause permanent vision loss in a high percentage of patients. This effect may occur within weeks or sooner after starting treatment. It may also occur after months or years. The risk may increase with higher doses and prolonged use, but it may occur with any dose or length of use. Vision loss may continue to worsen after stopping Sabril solution.
Vision loss may not be detected until it is severe. Parents or caregivers may not be able to recognize the symptoms of vision loss. Eye exams will be performed at the start of treatment and at least every 3 months during treatment. They will also be performed for 3 to 6 months after treatment stops. Some patients may develop severe vision loss even with monitoring.
Tell the doctor if the patient has or is at risk for developing another type of permanent vision loss. Tell the doctor if the patient uses other medicines that may cause serious vision problems (eg, retinopathy, glaucoma). Sabril solution should not be used in these patients unless the benefit outweighs the risks.
Use the lowest dose of Sabril solution for the shortest time needed. Talk with your doctor about how long you should take Sabril solution.
Sabril solution is used for:
Treating infantile spasms (IS) in children 1 month to 2 years old. It is also used to treat refractory complex partial seizures (CPS) that have not responded to several other treatments. It may also be used for other conditions as determined by your doctor.
Sabril solution is an antiepileptic. Exactly how it works is not known, but it may work by blocking certain enzymes in the brain.
Do NOT use Sabril solution if:
- you are allergic to any ingredient in Sabril solution
Contact your doctor or health care provider right away if any of these apply to you.
Before using Sabril solution:
Some medical conditions may interact with Sabril solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have vision problems, kidney problems, or certain blood problems (eg, anemia, porphyria)
- if you have a history of depression, other mental or mood problems, or suicidal thoughts or actions
Some MEDICINES MAY INTERACT with Sabril solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Hydantoins (eg, phenytoin) because their effectiveness may decreased by Sabril solution
This may not be a complete list of all interactions that may occur. Ask your health care provider if Sabril solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Sabril solution:
Use Sabril solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Sabril solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Sabril solution refilled.
- Take Sabril solution by mouth with or without food.
- Follow your doctor's instructions for how many packets to use per dose.
- Follow the instructions provided for how to mix Sabril solution. Do not mix Sabril solution with food. It can only be mixed with water. You will need to use 10 mL of water (cold or room temperature) for each packet used.
- Sabril solution should be taken right away after it is mixed. Do not store for use at a later time. Throw away any mixture that is left after you use a dose.
- To give Sabril solution, place the tip of the oral syringe into the child's mouth. Point it toward either of the child's cheeks. Push on the plunger slowly, a small amount at a time, until the entire dose is given.
- Wash the oral syringes and mixing cups in warm water. To clean the oral syringes, remove the plunger by gently pulling it straight out of the barrel. Wash the barrel and plunger by hand with soap and water, rinse, and allow to dry. The barrel and plunger may also be washed in the dishwasher utensil rack.
- Do not suddenly stop taking Sabril solution. There may be an increased risk of side effects (eg, seizures). If you need to stop Sabril solution, your doctor will gradually lower your dose.
- Talk with your doctor about what to do if your child vomits or spits up Sabril solution, only takes part of the dose, or misses a dose.
Ask your health care provider any questions you may have about how to use Sabril solution.
Important safety information:
- Sabril solution may cause drowsiness, dizziness, or vision problems. These effects may be worse if you take it with alcohol or certain medicines. Use Sabril solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- If your child is taking Sabril solution for IS and the seizures do not get better within 2 to 4 weeks, talk with the doctor.
- If you are taking Sabril solution for CPS and the seizures do not get better within 3 months, talk with your doctor.
- Sabril solution may cause weight gain. If you notice unusual weight gain, contact your doctor.
- Sabril solution may cause abnormal magnetic resonance imaging (MRI) changes in infants. It is not known if these changes may be harmful. Discuss any questions or concerns with your doctor.
- Patients who take Sabril solution may be at increased risk for suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Sabril solution closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual changes in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
- Sabril solution may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Sabril solution.
- Lab tests, including eye exams, may be performed while you use Sabril solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Sabril solution with caution in the ELDERLY; they may be more sensitive to its effects.
- PREGNANCY and BREAST-FEEDING: It is not known if Sabril solution may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sabril solution while you are pregnant. Sabril solution is found in breast milk. Do not breast-feed while taking Sabril solution.
Possible side effects of Sabril solution:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; cough; decreased appetite; diarrhea; dizziness; drowsiness; headache; irritability; joint pain; nausea; sore throat; stomach pain or upset; stuffy or runny nose; tiredness; trouble sleeping; vomiting; weakness; weight gain.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling of the hands or feet; confusion; decreased coordination; ear pain or discharge; fever, chills, or persistent sore throat; increased or painful urination; memory or attention problems; new or worsening mental, mood, or behavior changes (eg, aggressiveness, agitation, depression, exaggerated feeling of well-being, hostility, impulsiveness, irritability, panic attacks, restlessness, or inability to sit still); new or worsening seizures; painful menstrual period; suicidal thoughts or actions; tremor; trouble walking; uncontrolled eye movements; unusual swelling (eg, of the hands or feet); unusual tiredness or weakness; vision changes (eg, blurred vision, double vision); vision loss (eg, loss of the outer edges of your vision).
This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Sabril solution:
Store Sabril solution at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in the original container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sabril solution out of the reach of children and away from pets
- If you have any questions about Sabril solution, please talk with your doctor, pharmacist, or other health care provider.
- Sabril solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Sabril solution or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Sabril solution. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Sabril solution. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Sabril solution.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.