Vigafyde 100 mg/mL oral solution

Generic name:
Vigabatrin solution - oral

Pronunciation
(vye-GA-ba-trin)

Brand name(s)
Vigafyde

Serious vision problems may occur while taking this medication and may be permanent even after your child stops taking the medication. To prevent vision problems from getting worse, the doctor must find any eye problems as early as possible. Also, tell the doctor if your child has a history of vision problems. It is very important that your child has an eye exam before or within 4 weeks of starting this medication, then every 3 months after that while taking this medication. Your child should also have an eye exam 3 to 6 months after stopping this medication. Follow the doctor's directions carefully and keep all medical/eye/lab appointments. Tell the doctor right away if your child is acting differently than normal or if you notice any changes in vision (such as loss of vision, sensitivity to light, eye pain).

To receive vigabatrin in the United States, you must understand, agree to, and carefully follow the requirements of the REMS Program for this medication. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

This medication is used to treat a certain type of seizure in children (infantile spasms). 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 the pharmacist before your child starts taking vigabatrin and each time you get a refill. If there are any questions, ask the doctor or pharmacist.

Give this medication by mouth with or without food as directed by the doctor, usually twice daily. Do not mix with water or other liquids when measuring the dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because your child may not get the correct dose. The dosage is based on your child's medical condition, weight, and response to treatment.

To reduce your child's risk of side effects, the doctor may direct your child to start this medication at a low dose and gradually increase the dose. Follow the doctor's instructions carefully.

Give this medication regularly to get the most benefit from it. To help remember, give it at the same times each day.

Do not increase your child's dose or use this drug more often or for longer than prescribed. The condition will not improve any faster, and your child's risk of side effects will increase.

Do not stop giving this medication without consulting the doctor. Some conditions may become worse when this drug is suddenly stopped. The dose may need to be gradually decreased.

Tell the doctor if your child's seizures get worse or do not get better within 2 to 4 weeks.

See also Warning section.

Drowsiness, difficulty feeding, or restlessness may occur. Nausea, vomiting, stomach upset, diarrhea, or weight gain may also occur. If any of these effects last or get worse, tell the doctor or pharmacist promptly.

Remember that this medication has been prescribed because the doctor has judged that the benefit to your child is greater than the risk of side effects. Many people using this medication do not have serious side effects.

In adults, this medication may cause low red blood cell count (anemia) or swelling. Tell the doctor right away if you notice rapid breathing, pale skin, fast heartbeat, or swelling of the ankles/feet in your child.

In adults, 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. Talk to your doctor for more details.

A very serious allergic reaction to this drug is rare. However, get medical help right away 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 the doctor or pharmacist.

In the US -

Call the 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 the doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before giving vigabatrin, tell the doctor or pharmacist if your child is allergic to it; or if they have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to the pharmacist for more details.

Before using this medication, tell the doctor or pharmacist your child's medical history, especially of:

• eye problems (such as visual field defect, glaucoma, macular degeneration, optic nerve problem)
• kidney disease

MRI tests of the brain in children have shown changes after they are given vigabatrin. It is not known if these changes are harmful. Consult the doctor for more details. If your child is going to have an MRI test, tell testing personnel that your child is using this medication.

Before having surgery, tell the doctor or dentist about all the products your child uses (including prescription drugs, nonprescription drugs, and herbal products).

This medication is not usually used by adults. It is unlikely to be used during pregnancy or breastfeeding. Consult the doctor if you have any questions about this medication.

Drug interactions may change how your child's medications work or increase your child's risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products your child uses (including prescription/nonprescription drugs and herbal products) and share it with the doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without the doctor's approval.

Some products that may interact with this drug are:

• drugs that can harm the eye (retinotoxic drugs such as chloroquine, hydroxychloroquine, phenothiazines including thioridazine)
• orlistat

Tell the doctor or pharmacist if your child is taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your child's medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask the pharmacist about using those products safely.

This medication may interfere with certain lab tests (such as liver function tests), possibly causing false test results. Make sure lab personnel and all the doctors know your child uses 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 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: slow/shallow breathing, loss of consciousness.

Do not share this medication with others.

Lab and/or medical tests (such as eye exams, kidney function, complete blood count) should be done while your child is taking this medication. Keep all medical and lab appointments. Consult the doctor for more details.

If your child misses a dose, give it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Give the next dose at the regular time. Do not double the dose to catch up.

Store unopened bottle at room temperature. Once the bottle is opened, this medication may be stored at room temperature or in the refrigerator and expires after 90 days. Keep all medications away from children and pets.

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 the pharmacist or local waste disposal company.

Your child's condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.