Serious vision problems may occur while taking this medication and may be permanent even after you stop taking the medication. To prevent vision problems from getting worse, your doctor must find any eye problems as early as possible. Also, tell your doctor if you have a history of vision problems. It is very important that you have an eye exam before or within 4 weeks of starting this medication, then every 3 months thereafter while you are taking this medication. You should also have an eye exam 3 to 6 months after stopping this medication. Follow your doctor's directions carefully and keep all medical/eye/lab appointments. Tell your doctor right away if you have any changes in vision (such as loss of vision, blurred vision, double vision, sensitivity to light, eye pain).
Only patients who have signed an informed consent and agree to the requirements of the REMS program may obtain and use vigabatrin. Only physicians enrolled in REMS may prescribe vigabatrin, and only pharmacies enrolled in the program may dispense it. Consult your doctor or pharmacist for more details about the REMS program and for more information about the risk and benefits of using this medication. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.
Vigabatrin is used to treat babies, one month to 2 years old who have a condition known as infantile spasms. Vigabatrin has also been used in combination with other medications to treat seizure disorders (epilepsy). Vigabatrin decreases the number of seizures in adults and children who have not been able to control their seizures with other treatment. Vigabatrin is an anticonvulsant. It is thought to work by stopping the breakdown of a natural calming substance (GABA) in the brain.
Read the Medication Guide and Instructions for Use sheet provided by your pharmacist before you start taking vigabatrin and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.
Mix the contents of the packet in a glass of water, and drink immediately after mixing. Do not mix in advance or store for future use. If the dose is less than a full packet, mix the entire contents of the packet in 10 milliliters of liquid. Mix well and measure the dose using a special measuring device. Do not use a household spoon because you may not get the correct dose. Discard any unused medication. If you are using two packets, then mix the contents in 20 milliliters of liquid. If you are using three packets, then mix the contents in 30 milliliters of liquid. Each packet should have 500 milligrams of vigabatrin. If the packets you receive have more than 500 milligrams of vigabatrin, consult your pharmacist for how to mix this product.
Take this medication by mouth with or without food, usually twice a day or as directed by your doctor.
The dosage is based on your medical condition and response to treatment. For children, the dosage is also based on their weight. Your doctor may direct you to take a low dose at first, gradually increasing the dose to lower the chance of side effects such as drowsiness and confusion. Your doctor will adjust your dose to find the best dose for you. Follow your doctor's directions carefully.
Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Continue to take your other seizure medications unless otherwise directed by your doctor. Vigabatrin is not usually used alone except in the treatment of spasms in infants.
Take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased. Do not stop taking this medication without consulting your doctor. Your seizures may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.
Tell your doctor if your infant's spasms worsen or have not improved within 2 to 4 weeks.
See also Warning section.
Drowsiness, dizziness, and difficulty concentrating may occur, especially during the first few days as your body adjusts to the medication. Children may become restless or excited. Nausea, vomiting, headache, weight gain, and tiredness may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if any of these unlikely but serious side effects occur: shakiness (tremor), increase in seizures, tingling/numbness.
A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.
Seek immediate medical attention if any of these rare but very serious side effects occur: severe drowsiness/difficulty waking up, severe mental/mood changes (e.g., confusion, hallucinations).
Vigabatrin has rarely caused very serious liver disease. Tell your doctor right away if you develop symptoms of liver disease, including persistent nausea, stomach/abdominal pain, dark urine, yellowing eyes/skin.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking vigabatrin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye problems (e.g., visual field defect, glaucoma, macular degeneration, optic nerve problem), mental/mood problems (e.g., depression, psychosis), kidney disease, liver disease.
This drug may make you dizzy or drowsy or cause vision problems. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.
MRI tests of the brain in infants have shown changes after they are given vigabatrin. It is not known if these changes are harmful. Consult your doctor for more details. If your infant is going to have an MRI test, notify testing personnel that your infant is using this medication.
Older adults may be at greater risk for side effects (e.g., confusion) while using this drug. Confusion can increase the risk of falling.
During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away. Talk with your doctor about effective forms of birth control.
This medication passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, clonazepam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine).
This product can affect the results of certain lab tests (e.g., liver function tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow/shallow breathing, loss of consciousness.
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip themissed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised September 2016. Copyright(c) 2016 First Databank, Inc.
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