What is Sabril?
Sabril can be described as an antiepileptic drug and is also known as an anticonvulsant.Sabril is used with other medicines for treating complex seizures in adults and children who are 10 years old. The powder used for oral solutions can be used for treating infantile spasms in infants and children aged between the ages of one month and two years old.
Sabril may cause severe adverse effects and should only be used by those who are in a position to control seizures with other medications.
Warnings
The use of Sabril could cause permanent loss of vision, even if you cease taking the medication. Inform your doctor about any eye problems like glaucoma or retinitis, and inform your doctor immediately regarding any changes to your vision. It is essential to have regular eye exams prior to, during, and after you take this medication.
To ensure that Sabril does not cause harmful impacts on your eyesight, you'll require an eye examination that is thorough before you start taking the drug and again every 3 months throughout treatments, regardless of whether your vision appears normal. If you quit taking the medication, it is possible that you will require an eye exam at least every three to six months after the treatment is over. Don't miss any follow-up visits with your eye doctor.
Certain babies who are treated with vigabatrin may have abnormal brain growth that was evident in the magnetic resonance imaging (MRI) image. Inform any physician who cares for your child that your child is taking this medication.
There are people who think about suicide while taking seizure medicine. Keep an eye on any changes to your mood or the symptoms. Be sure to report any new or worsening symptoms to your physician.Sabril should be taken only by those who have not been able to manage their seizures using various other medications.
Before you take this drug
Some patients taking Sabril have experienced vision issues in the weeks or years following the beginning of treatment. Vision loss due to Vigabatrin can be permanent, and it is possible to notice minor symptoms initially. Talk to your physician about this possibility.
Sabril is only available from a pharmacy that is certified under an exclusive program. You must sign up for the program and be willing to undergo vision tests prior to, during, and after taking Vigabatrin. Make sure that you know the potential risks and benefits of taking this medication.
It is not recommended to make use of Sabril if you are allergic to Vigabatrin.
To ensure that Sabril is safe for you, inform your doctor that you (or the child who is taking the medication) were ever ill.
- Vision issues;
- Kidney disease;
- Depression is a mental disorder, mental illness, or suicidal thoughts, actions, or behaviors.
Certain people are contemplating suicide when taking Sabril. Your doctor must monitor your progress on a regular basis during appointments. Your family members and other caregivers should be on the lookout for changes in your mood or signs.
Do not begin or stop taking medication for seizures during pregnancy without a physician's guidance. Having a seizure during pregnancy could be harmful to both the baby and the mother. Inform your doctor right away if you find yourself pregnant.
If you're pregnant and you are a registered mother, your name could be included on an OB-gyn registry to track what effects Vigabatrin has on the child.It is not recommended to breastfeed while you're using Sabril.Don't give the medication to children without medical guidance.
Similar/related drugs
Sympazan, gabapentin, Clonazepam, pregabalin, lamotrigine, Lyrica, and diazepam
How to take Sabril?
You should take Sabril exactly as directed by your physician. Follow the directions on the prescription label, and make sure you read the entire medication guide or instruction sheet. Your doctor might occasionally alter the dosage of your medication.You can consume Sabril either with or without food.
Sabril powder should be mixed with water only and should be administered to the child along with meals. Take note of and adhere to any instructions for use that are included in your medication. Talk to your pharmacist or doctor if you don't understand the instructions.Anyone who takes Sabril could develop problems with vision that may get worse even after stopping this medication. The longer you are taking this medication, the more likely you are to experience severe problems with your vision.
It is recommended to have an eye examination that is thorough before you begin to take this medication and every 3 months thereafter while you are taking the treatment, even though your vision appears normal. Eye exams aren't always able to stop vision loss; however, they will assist your doctor in deciding whether to alter your treatment plan. Be aware of the changes that occur in your eyes and inform your doctor as soon as you notice changes.
If you decide to stop taking Sabril You should undergo another eye examination 3 to 6 weeks after the last dose.It is more difficult to determine vision in babies or infants. However, your doctor might still prescribe vigabatrin to your child if the benefits of preventing seizures outweigh the risks. Inform your doctor right away if you suspect that your child's vision could be changing.
Consult your physician if your complex seizures do not improve after three months or more of therapy and if you notice that your infant's infantile spasms don't improve after two to four weeks after treatment.Don't stop using Sabril abruptly, even if you feel well. The abrupt stop can cause seizures. Follow the instructions of your physician when tapering your dose.Place the container back in the original at room temperature, away from heat and moisture.
Dosing information
Usual Adult Dose for Seizure Prophylaxis:
Initial dosage: 1 g daily orally (administered as a 500 mg oral dose 2 times every day) either with or without food
The dose for the entire day could be increased by 500 mg increments in intervals throughout the week, based on the reaction.
Dosage recommended: 3 grams daily, orally (1.5 mg orally two times every day).
A daily dose of 6 grams hasn't been proven to have any additional benefit in comparison to the dose of 3 grams daily and is linked to an increased risk of adverse reactions.
Approved indication: for adults and children of 10 years old or older as a treatment for patients with refractory complex partial seizures (CPS) that have not been treated with other treatment options and for whom benefits are greater than the risk of losing vision. Sabril is not suggested as a primary treatment for patients with complex partial seizures.
Usual Pediatric Dose for Epilepsy:
Infantile Spasms:
From 1 month to 2 years old:
The initial dose is 50 mg/kg/day of vigabatrin oral solution in two equal doses, without or with food. The dosage can be adjusted in 25–50 mg/kg/day increments each day for three days, up to 150 mg/kg/day.
The whole contents of the correct quantity of packs (500 mg/packet) of powder need to be removed from an empty cup and then dissolved in 10 ml of cold or warm water for each packet, using the 10 ml oral syringe that comes with the drug. The final concentration of the solution should be at least 50 mg/ml.
Each dose should be prepared promptly prior to use and then given cold or at room temperature.
The indication for approval is monotherapy for children that are between 1 month and 2 years old with infantile spasms (IS) and whose potential benefits are greater than the danger of losing vision.
Usual Pediatric Dose for Seizure Prophylaxis:
Between 10 and 16 years of age and weighing between 25 and 60 kg:
Initial dose: 500 mg taken orally every day (administered in a single dose of 250 mg oral dose 2 times every day) either with or without food.
Maintenance dose: The daily dose can be increased every week up to 2 gm daily orally (1 2 g taken orally every day).
Patients weighing over 60 kilograms should be treated in accordance with adult guidelines.
Accepted indication: For children aged 10–16 years old as a supplement therapy for patients suffering from refractory, severe part seizures (CPS) who have not been treated with other treatments and for whom the possible benefits are greater than the potential risk of losing vision. Vigabatrin is not suggested as a primary treatment for complex seizures.
Do I be concerned if I miss a dose?
Do not take the medicine for as long as you are able, but avoid your missed dosage if it's nearing the time to take the next dose. Don't take two doses at a time.
Contact your doctor for advice for your child if he or she takes Sabril and is unable to take the dose, only takes one portion of a dose, or vomits or spits after taking the medication.
What will happen if I take excessively?
Get medical attention in an emergency or contact the Poison Help Line toll-free at 1-800-222-1222.
Overdose symptoms can include extreme sleepiness as well as dizziness and confusion, difficulty speaking, feeling angry or angry, strange thoughts or behaviors, increased seizures, low heart rates, and weak or shallow breathing or fainting.
What should be avoided?
Avoid driving or engaging in hazardous activities until you are aware of the effects this medication will have on your body. The way you react could be impaired.
Side effects of Sabril
Contact a medical professional immediately. If you are experiencing indications that you are experiencing an allergic reaction to Sabril (hives and breathing difficulties and swelling of your throat or face) or a severe reaction to your skin (fever and sore throat, eye burning, irritation, the skin is red or purple and blisters and peels).
The use of vigabatrin could cause permanent loss of vision. Talk to your doctor right away about any changes to your vision. If your kid is on Sabril, tell the doctor immediately if the child exhibits indications of vision changes, including hitting objects or being frequently shocked or awed.
Inform your doctor about any new or deteriorating symptoms for treatment, including changes in your behavior or mood, anxiety, panic attacks, trouble sleeping, or if you are feeling uncontrollably angry, irritable, aggressive, active, restless (mentally and physically), or depressed. It is possible that you are considering the risk of suicide or inflicting harm on you.
Contact your doctor immediately. If you are suffering from:
- Seizures that are getting worse or more frequent;
- Any changes to your eyesight, regardless of how slight;
- Eye movements that are unusual or irregular;
- Extreme drowsiness, fussiness, or problems with feeding (in the case of a baby who is taking Vigabatrin);
- Tingling, numbness, and burning sensations in your feet or hands
- Weight gain, with or without swelling;
- Symptoms for an infection in the ear (fever, hearing pain or fullness, difficulty hearing, earache discharge from the ears, or a fussiness in children;
- Low red blood cells (anemia): pale skin, unusual fatigue, feeling lightheaded or breathless, cold feet and hands
Some children who are treated with Sabril have been diagnosed with abnormal brain changes that were detected by magnetic resonance imaging (MRI). It is not clear whether these changes are due to vigabatrin or whether they cause harm. Inform any doctor treating your baby that he or she is taking this medication.
Common side effects of Sabril include:
- Blurred vision or eye issues;
- Drowsiness, dizziness, feeling tired;
- Issues with walking or coordination;
- Shakes or tremors;
- Aggressive behavior;
- Issues with memory or thinking;
- Weight gain
- Joint pain;
- Cold symptoms like nasal stuffiness, sneezing, sore throats,
- (in infants): ear infections, fussiness (in infants) ear infections, cough, breathing issues.
This isn't a complete list of all the side effects. Other side effects could occur. Contact your physician for advice regarding medical adverse effects. You can report any adverse reactions to the FDA at 1-800-FDA-1088.
Interaction with other drugs
Other drugs can interfere with vigabatrin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Inform your physician about the medicines you are currently taking as well as any medications you are about to start or stop taking.
