Sabril

The active ingredient in Sabril is vigabatrin. Vigabatrin (Sabril) is an anti-epileptic drug. The mechanism of action is not quite apparent in how it works to treat seizures. However, it is thought to increase the levels of gamma-aminobutyric acid (GABA), a chemical in the brain that soothes nerves. This helps to control seizures.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Sabril. However, the following is a synopsis of the general guidelines for the use of Sabril:

• You can take Sabril with or without food.
• Sabril powder should be combined just with water and administered to the child with a meal. Read and carefully follow any instructions for use that come with your medicine.
• Anyone on Sabril may experience vision difficulties that worsen even after stopping the medication.
• Even if your vision appears normal, you will need a comprehensive eye exam before beginning therapy with this medication and then every three months thereafter. Eye exams may not completely prevent vision deterioration, but they can help your doctor decide whether to adjust your treatment plan. Stay watchful for any changes in your vision and notify your doctor straight away.
• It may be more challenging to assess vision in a baby or young child. Your doctor may still give vigabatrin to the child if the benefit of preventing seizures outweighs the danger. If you suspect your child's vision is changing, contact the doctor right away.
• Contact your doctor if your complex partial seizures do not improve after 3 months of treatment, or if your baby's infantile spasms do not improve after 2 to 4 weeks of treatment. Do not miss any follow-up visits to your doctor.

The most common side effects of Sabril seen in clinical trials as compared to placebo include:

• Dizziness.
• Tiredness.
• Ear infection.
• Blurred vision.
• Weight gain.
• Visual field defects.
• Drowsiness.
• Sleepiness.
• Retinal disorders.

Some individuals may experience serious side effects while using Sabril. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Allergic reaction to the medication.
• Suicidal thoughts or actions.
• Risk of permanent vision loss.
• Edema.
• Peripheral neuropathy in adult patients.

These are not all of the possible side effects of Sabril. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Sabril, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Vision problems.
• Kidney problems.
• Anemia (low red blood cells).
• Depression, or a mood disorder.
• Pediatric patients with infantile spasms aged 1 month to 2 years for whom the potential benefits outweigh the potential risk of vision loss.

Boxed Warning

Can produce permanent bilateral concentric visual field constriction, including tunnel vision, which can lead to impairment; in some circumstances, can damage the central retina and reduce visual acuity.

There are no contraindications with Sabril.

It may take many days or weeks for the drug to begin working for you. It will most likely depend on several things, including why you require Sabril, your dosage, the severity of your seizures, and any other seizure medications you are taking. According to one study, infantile spasms in children take an average of 5 days to resolve entirely. The length of time it takes for medicine to work for complex partial seizures in adults varies, ranging from around 2 weeks to 3 months.

When Sabril is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Phenytoin.
• Clonazepam.

The dosage for tablets and powders is the same as for oral solutions.

Complex Partial Seizures (mg/kg/day)

For those 17 years of age and up, take 500 mg to 1,500 mg orally twice a day.

Age 2 to less than 17 years: The recommended dose is determined by your child's body weight.

22 to 33 pounds: take 175 mg to 525 mg by mouth twice a day.

33 to 44 pounds: 225 mg to 650 mg orally twice daily.

44 to 55 pounds: 250 mg to 750 mg taken orally twice a day.

For weights ranging from 55 to 132 pounds, take 250 mg to 1,000 mg orally twice a day.

More than 132 pounds: 500 mg to 1,500 mg orally twice daily.

Treatment of infantile spasms: The dosage is calculated based on your child's weight. The beginning dose is 25 mg/kg orally twice each day. The maximum dose is 75 mg/kg, twice per day.

Store your Sabril at room temperature and keep it out of reach of children.

Lundbeck is the pharmaceutical company that manufactures Sabril.

There are several lower-cost generic name versions available of Sabril.

Even if you feel fine, do not suddenly stop taking Sabril. Stopping quickly may result in more seizures. Follow your doctor's recommendations for tapering your dosage.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

If you are pregnant, your name may be added to a pregnancy registry to monitor the effects of vigabatrin on the baby.

If you are breastfeeding or plan to breastfeed, Sabril can pass into breast milk and may harm your baby. Breastfeeding is not recommended.