fulfillment Sabril (Oral) Generic Name: vigabatrin (Oral route) vye-GA-ba-trin Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings Breastfeeding Warnings User Reviews Support Group Q & A Pricing & Coupons Oral route(Powder for Solution;Tablet) Vigabatrin can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, vigabatrin may also decrease visual acuity.Risk increases with increasing dose and cumulative exposure, but there is no dose or exposure to vigabatrin known to be free of risk of vision loss.Risk of new and worsening vision loss continues as long as vigabatrin is used, and possibly after discontinuing vigabatrin.Baseline and periodic vision assessment is recommended for patients on vigabatrin. However, this assessment cannot always prevent vision damage.Vigabatrin is available only through a restricted program called the Vigabatrin REMS Program. Further information is available at www.vigabatrinREMS.com or 1-866-244-8175 . Commonly used brand name(s) In the U.S. Sabril Available Dosage Forms: Tablet Powder for Solution Powder Therapeutic Class: Anticonvulsant Pharmacologic Class: Gamma Aminobutyric Acid Transaminase Inhibitor Chemical Class: Gamma Aminobutyric Acid (class) Slideshow Epilepsy in Adults: A Healthcare Professional's Guide Uses For Sabril Vigabatrin is used alone or together with other medicines to treat complex partial seizures in adults and children 10 years of age and older, and infantile spasms in children. It is used in patients who have already been treated with other medicines that did not work well. Vigabatrin is an anticonvulsant. It increases the amount of the chemical called gamma amino butyric acid (GABA) in the brain. Some seizures are caused by low levels of GABA. When vigabatrin increases GABA, it reduces the likelihood of a seizure. This medicine is available only with your doctor's prescription. Before Using Sabril In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Allergies Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Pediatric Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of vigabatrin oral liquid to treat infantile spasms in children 1 month to 2 years of age. Safety and efficacy have been established. Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of vigabatrin oral liquid and tablets to treat complex partial seizures in children 10 to 16 years of age. However, safety and efficacy have not been established in children younger than 10 years of age. Geriatric Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vigabatrin in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving vigabatrin. Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Interactions with Medicines Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Calcifediol Carbamazepine Orlistat Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Fosphenytoin Ginkgo Phenytoin Interactions with Food/Tobacco/Alcohol Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. Other Medical Problems The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: Anemia or Depression, history of or Eye or vision problems or Mental illness, history of Use with caution. May make these conditions worse. Kidney disease Use with caution. The effects may be increased because of slower removal of the medicine from the body. Proper Use of Sabril Take this medicine only as directed by your doctor . Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. Vigabatrin is only available through a restricted program called the Vigabatrin REMS program. It is very important that you understand the Vigabatrin REMS program and become familiar with the Medication Guide. Talk to your doctor about the program before starting treatment with vigabatrin. You may take this medicine with or without food. To use the oral liquid : Open the packet and empty the contents into a clean cup. Dissolve it with 10 milliliters (mL) of cold or room temperature water. Do not use the liquid if it is not clear (or free of particles) and colorless. Measure the dose with the oral syringe in the package. Throw away any unused liquid after the dose is given. Vigabatrin may be used together with other seizure medicines. Keep using all of your medicines unless your doctor tells you to stop. Dosing The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. For oral dosage form (solution): For infantile spasms: Children 1 month to 2 years of age Dose is based on body weight and must be determined by your doctor. The starting dose is 50 milligrams (mg) per kilogram (kg) of body weight per day, divided and given 2 times a day. Your doctor may adjust the dose as needed. However, the dose is usually not more than 150 mg per kg per day. Children younger than 1 month of age Use and dose must be determined by your doctor. For oral dosage forms (solution or tablets): For seizures: Adults At first, 500 milligrams (mg) two times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day. Children 10 to 16 years of age and weighs 25 to 60 kilograms (kg) Dose is based on body weight and must be determined by your doctor. At first, 250 milligrams (mg) given two times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 2000 mg per day. Children younger than 10 years of age and weighs less than 25 kg Use and dose must be determined by your doctor. Missed Dose If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Storage Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. Precautions While Using Sabril It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects. This medicine may cause permanent vision loss. Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. It is very important that your ophthalmologist (eye doctor) check your child's or your eyes within 4 weeks after starting treatment, every 3 months during treatment, and about 3 to 6 months after stopping treatment with this medicine. Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine (eg, magnetic resonance imaging or MRI). This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you, your child, or your caregiver notice any of these side effects, tell your doctor right away. This medicine may cause some people to become drowsy, sleepy, tired, or weak than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are drowsy or not alert . Check with your doctor right away if you or your child are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy. This medicine may increase your weight and cause swelling in your hands, ankles, or feet. Your doctor may need to check your weight on a regular basis while you are using this medicine. Talk to your doctor about ways to prevent weight gain. Do not suddenly stop taking this medicine without checking first with your doctor . Your doctor may want to gradually reduce the amount you are using before stopping it completely. Stopping this medicine suddenly may cause seizures. Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Sabril Side Effects Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: More common Blue-yellow color blindness blurred vision decreased vision or other vision changes eye pain increase in seizures loss of memory problems with memory Less common or rare Uncontrolled rolling eye movements Get emergency help immediately if any of the following symptoms of overdose occur: Symptoms of overdose Change in or loss of consciousness Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: More common Agitation burning, tingling, or prickly sensations clumsiness or unsteadiness confusion constipation diarrhea dizziness double vision or seeing double increased movement joint pain mental depression sleepiness or unusual drowsiness stomach pain trembling tremor trouble sitting still Less common Aggression headache increased saliva muscle weakness nausea poor concentration speech disorder trouble sleeping unusual thoughts vomiting weight gain Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Side Effects (complete list) The information contained in the Truven Health Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you. The use of the Truven Health products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. 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Next Side Effects Print this page Add to My Med List More about Sabril (vigabatrin) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Generic Availability Drug class: gamma-aminobutyric acid analogs Consumer resources Sabril Sabril (Vigabatrin Oral Solution) Sabril (Vigabatrin Tablets) Professional resources Sabril (AHFS Monograph) Sabril (FDA) Related treatment guides Seizure Prevention Epilepsy Seizures} Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug 8 years Approval History FDA approved 2009 Manufacturer Lundbeck Inc. Drug Class Gamma-aminobutyric acid analogs Related Drugs Epilepsy gabapentin , Lyrica , Neurontin , lamotrigine , levetiracetam , Lamictal , Keppra , Depakote , More... Seizures diazepam , levetiracetam , topiramate , Valium , Topamax , Keppra , primidone , Dilantin , More... Seizure Prevention clonazepam , diazepam , Klonopin , lamotrigine , topiramate , Valium , Topamax , Lamictal , More... Sabril Rating No Reviews - Be the first! 4.0 /10 No Reviews - Be the first! 4.0 Rate it! Related Questions & Answers Vigabatrin - does anyone have any experience with sabril for cocaine addiction? Read more questions} } with politeness
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