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Drugs reference index «Sabril»

Sabril
Sabril


Sabril

Generic Name: vigabatrin (Oral route)

vye-GA-ba-trin

Oral routeTablet

Vision loss:

Vigabatrin causes permanent bilateral concentric visual field constriction in 30 percent or more of patients that ranges in severity from mild to severe, including tunnel vision to within 10 degrees of visual fixation, and can result in disability. In some cases, vigabatrin also can damage the central retina and may decrease visual acuity.

The onset of vision loss from vigabatrin is unpredictable, and can occur within weeks of starting treatment or sooner, or at any time during treatment, even after months or years.

The risk of vision loss increases with increasing dose and cumulative exposure, but there is no dose or exposure known to be free of risk of vision loss.

Vision testing at baseline (no later than 4 weeks after starting vigabatrin) and at least every 3 months during therapy is required for adults on vigabatrin. Vision testing is also required about 3 to 6 months after the discontinuation of vigabatrin therapy. Once detected, vision loss due to vigabatrin is not reversible. It is expected that, even with frequent monitoring, some patients will develop severe vision loss.

It is possible that vision loss can worsen despite discontinuation of vigabatrin.

Because of the risk of vision loss, vigabatrin should be withdrawn from patients who fail to show substantial clinical benefit within 3 months of initiation, or sooner if treatment failure becomes obvious. Patient response to and continued need for vigabatrin should be periodically reassessed.

Symptoms of vision loss from vigabatrin are unlikely to be recognized by patients or caregivers before vision loss is severe. Vision loss of milder severity, while often unrecognized by the patient, can still adversely affect function.

Vigabatrin should not be used in patients with, or at high risk of, other types of irreversible vision loss unless the benefits of treatment clearly outweigh the risks. The interaction of other types of irreversible vision damage with vision damage from vigabatrin has not been well-characterized, but is likely adverse.

Vigabatrin should not be used with other drugs associated with serious adverse ophthalmic effects such as retinopathy or glaucoma unless the benefits clearly outweigh the risks.

The lowest dose and shortest exposure to vigabatrin should be used that is consistent with clinical objectives.

Because of the risk of permanent vision loss, vigabatrin is available only through a special restricted distribution program called SHARE, by calling 1-888-45-SHARE. Only prescribers and pharmacies registered with SHARE may prescribe and distribute vigabatrin. In addition, vigabatrin may be dispensed only to patients who are enrolled in and meet all conditions of SHARE .

Vigabatrin causes permanent vision loss which may occur at any time during therapy and the risk increases with total dose and duration of use. Periodic vision testing is required for patients receiving vigabatrin therapy. Vigabatrin should not be used concomitantly with other drugs associated with adverse ophthalmic effects or in patients at high risk for other types of irreversible vision damage. Vigabatrin is only available through a special restricted distribution program .

Oral routeSolution

Vision loss:

Vigabatrin causes permanent vision loss in infants, children and adults. Because assessing vision loss is difficult in children, the frequency and extent of vision loss in infants and children is poorly characterized. For this reason, the data described below is primarily based on the adult experience.

In adults, vigabatrin causes permanent bilateral concentric visual field constriction in 30 percent or more of patients that ranges in severity from mild to severe, including tunnel vision to within 10 degrees of visual fixation, and can result in disability. In some cases, vigabatrin also can damage the central retina and may decrease visual acuity.

The onset of vision loss from vigabatrin is unpredictable, and can occur within weeks of starting treatment or sooner, or at any time during treatment, even after months or years.

The risk of vision loss increases with increasing dose and cumulative exposure, but there is no dose or exposure known to be free of risk of vision loss.

It is possible that vision loss can worsen despite discontinuing vigabatrin.

Because of the risk of vision loss, vigabatrin should be withdrawn from patients with infantile spasms who fail to show substantial clinical benefit within 2 to 4 weeks of initiation, or sooner if treatment failure becomes obvious. Patient response to and continued need for vigabatrin should be periodically reassessed.

In infants and children, vision loss may not be detected until it is severe. Nonetheless, vision should be assessed to the extent possible at baseline (no later than 4 weeks after starting vigabatrin) and at least every 3 months during therapy. Once detected, vision loss due to vigabatrin is not reversible. Vision testing is also required about 3 to 6 months after the discontinuation of vigabatrin therapy.

Symptoms of vision loss from vigabatrin are unlikely to be recognized by the parent or caregiver before vision loss is severe. Vision loss of milder severity, although unrecognized by the caregiver, may still adversely affect function.

Vigabatrin should not be used in patients with, or at high risk of, other types of irreversible vision loss unless the benefits of treatment clearly outweigh the risks. The interaction of other types of irreversible vision damage with vision damage from vigabatrin has not been well-characterized, but is likely adverse.

Vigabatrin should not be used with other drugs associated with serious adverse ophthalmic effects such as retinopathy or glaucoma unless the benefits clearly outweigh the risks.

The lowest dose and shortest exposure to vigabatrin should be used that is consistent with clinical objectives.

The possibility that vision loss from vigabatrin may be more common, more severe or have more severe functional consequences in infants and children than in adults cannot be excluded.

Because of the risk of permanent vision loss, vigabatrin is available only through a special restricted distribution program called SHARE, by calling 1-888-45-SHARE. Only prescribers and pharmacies registered with SHARE may prescribe and distribute vigabatrin. In addition, vigabatrin may be dispensed only to patients who are enrolled in and meet all conditions of SHARE .

Vigabatrin causes permanent vision loss which may occur at any time during therapy and the risk increases with total dose and duration of use. Periodic vision testing is required for patients receiving vigabatrin therapy. Vigabatrin should not be used concomitantly with other drugs associated with adverse ophthalmic effects or in patients at high risk for other types of irreversible vision damage. Vigabatrin is only available through a special restricted distribution program .

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)

Uses For Sabril

Vigabatrin is used alone or together with other medicines to control certain types of seizures (convulsions) in the treatment of epilepsy. This medicine is used in patients with seizures 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. It is thought that epileptic seizures are the result of low levels of GABA. By increasing the amount of GABA, vigabatrin reduces the likelihood of an epileptic 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 solution to treat infantile spasms in children and infants 1 month to 2 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of vigabatrin tablets in children and teenagers younger than 16 years of age with complex partial seizures. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of valproate sodium injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving vigabatrin.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal 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

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.

  • Carbamazepine

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. Effects may be increased because of slower removal of the medicine from the body.

Proper Use of Sabril

Take this medicine exactly 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.

It is very important that you understand the requirements of the SHARE program, and become familiar with Sabril® Medication Guide. Ask your doctor or pharmacist before starting treatment with vigabatrin.

You may take this medicine with or without food.

To use the oral solution:

  • Open the packet and empty the contents into an empty cup.
  • Dissolve it with 10 milliliters (mL) of cold or room temperature water.
  • Measure the dose with an oral syringe that comes with the package.

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 and infants 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, given in smaller doses two times a day. Your doctor may adjust the dose as needed up to a maximum dose of 150 mg per kg of body weight per day.
      • Infants up to 1 month—Use and dose must be determined by your doctor.
  • For oral dosage form (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 a day.
      • Children—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 allow for changes in the dose and to check for any unwanted effects.

It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients taking a seizure medicine.

This medicine may increase your risk of 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 approximately every 3 months for any visual problems.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests (e.g., 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. 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, 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.

Tell your doctor if you or your child have increased weight or swelling in the hands, ankles, or feet while taking this medicine.

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.

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
  • Mood or mental changes

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
  • Abdominal or stomach pain
  • abnormal coordination
  • agitation
  • anxiety
  • burning, tingling, or prickly sensations
  • clumsiness
  • confusion
  • constipation
  • diarrhea
  • dizziness
  • double vision or seeing double
  • drowsiness
  • increased movement
  • joint pain
  • mental depression
  • restlessness
  • shakiness
  • sleepiness or unusual drowsiness
  • trembling
  • tremor
  • trouble sitting still
  • unsteadiness
Less common
  • Aggression
  • headache
  • increased saliva
  • muscle weakness
  • nausea
  • poor concentration
  • sleeplessness
  • speech disorder
  • thinking abnormal
  • trouble sleeping
  • unable to sleep
  • 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.

The information contained in the Thomson Healthcare (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.

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  • Sabril Consumer Overview
  • Sabril MedFacts Consumer Leaflet (Wolters Kluwer)
  • Vigabatrin Professional Patient Advice (Wolters Kluwer)

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