Generic Name: vigabatrin (vye-GA-ba-trin)
Brand Name: Sabril
Vigabatrin 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 vigabatrin 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). Vigabatrin solution should not be used in these patients unless the benefit outweighs the risks.
Use the lowest dose of vigabatrin solution for the shortest time needed. Vigabatrin solution should not be used for longer than 2 to 4 weeks if no improvement is seen in the patient's condition.
Vigabatrin solution is used for:
Treating infantile spasms in children 1 month to 2 years old. It may also be used for other conditions as determined by your doctor.
Vigabatrin 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 vigabatrin solution if:
- you are allergic to any ingredient in vigabatrin solution
Contact your doctor or health care provider right away if any of these apply to you.
Before using vigabatrin solution:
Some medical conditions may interact with vigabatrin 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 vigabatrin 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 vigabatrin solution
This may not be a complete list of all interactions that may occur. Ask your health care provider if vigabatrin 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 vigabatrin solution:
Use vigabatrin solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Vigabatrin solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get vigabatrin solution refilled.
- Take vigabatrin 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 vigabatrin solution. Do not mix vigabatrin 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.
- Vigabatrin 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 vigabatrin 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 vigabatrin solution. There may be an increased risk of side effects (eg, seizures). If you need to stop vigabatrin solution, your doctor will gradually lower your dose.
- Talk with your doctor about what to do if your child vomits or spits up vigabatrin 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 vigabatrin solution.
Important safety information:
- Vigabatrin solution may cause drowsiness, dizziness, or vision problems. These effects may be worse if you take it with alcohol or certain medicines. Use vigabatrin solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- If symptoms do not get better within 2 to 4 weeks or if they get worse, check with your doctor.
- Vigabatrin solution may cause weight gain. If you notice unusual weight gain, contact your doctor.
- Vigabatrin 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 vigabatrin 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 vigabatrin 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.
- Vigabatrin solution may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking vigabatrin solution.
- Lab tests, including eye exams, may be performed while you use vigabatrin 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 vigabatrin solution with caution in the ELDERLY; they may be more sensitive to its effects.
- PREGNANCY and BREAST-FEEDING: It is not known if vigabatrin 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 vigabatrin solution while you are pregnant. Vigabatrin solution is found in breast milk. Do not breast-feed while taking vigabatrin solution.
Possible side effects of vigabatrin 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 upset; stuffy nose; tiredness; trouble sleeping; 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; fever, chills, or persistent sore throat; increased or painful urination; memory or attention problems; mental or mood changes (eg, depression); new or worsening agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; new or worsening seizures;painful menstrual period; suicidal thoughts or actions; symptoms of ear infection (eg, ear pain); 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. Symptoms may include abnormal behavior; coma; confusion; mental or mood changes; new or worsening seizures; severe drowsiness; severe or persistent dizziness or headache; shortness of breath; slow heartbeat; speech problems.Proper storage of vigabatrin solution:
Store vigabatrin 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 vigabatrin solution out of the reach of children and away from pets
- If you have any questions about vigabatrin solution, please talk with your doctor, pharmacist, or other health care provider.
- Vigabatrin 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 vigabatrin 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 vigabatrin solution. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to vigabatrin 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 healthcare provider for complete information about the risks and benefits of using vigabatrin 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.