Sabril

Sabril Drug Information

• Sabril Overview

  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.

• Sabril Warnings

  Serious vision problems may occur while taking Sabril 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 Sabril, then every 3 months thereafter while you are taking Sabril. You should also have an eye exam 3 to 6 months after stopping Sabril. 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 Sabril. 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.

• How to Use Sabril

  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 with water as directed by the Instructions for Use sheet. Measure the dose using the supplied oral syringe. Do not use a household spoon because you may not get the correct dose. Use the dose right after mixing. Do not mix in advance or store for future use. Discard any unused medication. Take Sabril by mouth with or without food as directed by your doctor, usually twice a day. The Dosage of Sabril is based on your medical condition and response to treatment. For children, the Dosage of Sabril 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 Sabril regularly to get the most benefit from it. To help you remember, take it at the same times each day. Do not increase your dose or take Sabril 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 Sabril without consulting your doctor. Your condition may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased. For infantile spasms, tell the doctor if your infant's spasms worsen or have not improved within 2 to 4 weeks. For seizures, tell your doctor if your seizures worsen or have not improved within 3 months.

• Sabril Precautions

  Before taking vigabatrin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Sabril may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using Sabril, tell your doctor or pharmacist your medical history,eye problems (such as visual field defect, glaucoma, macular degeneration, optic nerve problem), mental/mood problems (such as depression, psychosis), kidney disease, low red blood cell count (anemia). Sabril may make you dizzy or drowsy or cause vision problems. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). 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 Sabril. Older adults may be at greater risk for side effects (such as confusion) while using Sabril. Confusion can increase the risk of falling. Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using vigabatrin. Vigabatrin may harm an unborn baby. Ask about reliable forms of birth control while using Sabril. If you become pregnant, talk to your doctor right away about the risks and benefits of Sabril. Sabril passes into breast milk in small amounts. Consult your doctor before breast-feeding.

• Sabril Misdose

  If you miss a dose of Sabril, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

• Sabril Interactions

  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.drugs that can harm the eye (retinotoxic drugs such as chloroquine, hydroxychloroquine, phenothiazines including thioridazine), orlistat. Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, clonazepam, diazepam, zolpidem), muscle relaxants, and opioid pain relievers (such as codeine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely. Sabril can affect the results of certain lab tests (such as liver function tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use Sabril.

• Sabril Side Effects

  What are Sabril side effects?

  Side effects are physical, mental or emotional symptoms which occur in addition to or outside of the desired effect of a therapeutic treatment such as an over-the-counter or prescribed drug or medication. Side effects from Sabril may occur at the beginning or at the end of treatment and may also depend on the length of time an individual remains on the treatment. Side effects, also known as adverse effects, are generally more likely to occur when starting treatment. Individuals may also experience side effects from Sabril as a result of an interaction with other medications.

  Side Effects of Sabril

  The side effects of Sabril may vary in number and intensity for many different reasons. Factors such as age, weight, gender and ethnicity may influence the side effects of Sabril. Also, an individual’s state of general physical health and seriousness of the disease or illness as well as an increase or decrease in dosage may lead to side effects. Further, side effects from Sabril may also occur as a result of an interaction with certain herbal supplements, foods or drinks.

  Prescription drug side effects can be serious and may cause patients to stop the treatment. However, when side effects from the use of a prescription drug, such as Sabril, do occur a patient should consult their physician. A physician may prescribe an additional treatment in order to control the symptoms or an adjustment in the dosage may be made. In addition, changes to diet, exercise or other lifestyle activities may help to lessen the side effects of Sabril.

  By understanding side effects and the factors which may influence the occurrence of side effects patients are empowered to take an active role in their care. Patients who have specific questions about the side effects of Sabril, or any other medication, should contact their physician. General information about Sabril and the side effects associated with Sabril are described in the following:

  Common Sabril Side Effects

  Severe

  • visual field defect
  • vision loss

  Less Severe

  • drowsy
  • fatigue
  • weight gain
  • tremor
  • blurred vision
  • memory impairment
  • arthralgias
  • ataxia
  • acute confusion
  • dizziness
  • headache disorder
  • upper respiratory infection
  • nausea
  • diarrhea
  • insomnia
  • irritability
  • depression
  • diplopia
  • nystagmus
  • disturbance of attention
  • acute bacterial otitis media

  Less Frequent Sabril Side Effects

  Severe

  • anemia
  • chest pain
  • influenza

  Less Severe

  • edema
  • pharyngitis
  • vertigo
  • acute abdominal pain
  • dyspepsia
  • fever
  • urinary tract infection
  • bronchitis
  • back pain
  • myalgias
  • muscle fasciculation
  • hyporeflexia
  • lethargy
  • asthenopia
  • ocular pain
  • abdominal distension
  • peripheral sensory neuropathy

  Rare or Very Rare Sabril Side Effects

  Severe

  • suicidal ideation
  • suicidal
  • peripheral motor neuropathy
  • dyskinesia
  • angioedema
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • gastrointestinal hemorrhage
  • malignant hyperthermia
  • multiple organ failure
  • cholestasis
  • acquired dystonia
  • encephalopathy
  • myoclonus
  • optic neuritis
  • drug-induced psychosis
  • hypomania
  • laryngeal edema
  • pulmonary thromboembolism
  • acute respiratory insufficiency
  • hearing loss
  • intramyelinic edema

  Less Severe

  • hypesthesia
  • dysmenorrhea
  • erectile dysfunction
  • cough
  • skin rash
  • maculopapular rash
  • aggressive behavior
  • tinnitus
  • acne vulgaris
  • pruritus of skin
  • esophagitis
  • facial edema
  • hypertonia
  • hypotonia
  • muscle spasm
  • indifference
  • delirium
  • stridor
  • alopecia

• Sabril Storage

  Store at room temperature away from light and moisture. Do not open the packets before it is time to prepare the dose. Do not store in the bathroom. 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 Sabril when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.