Gabitril

Gabitril is a prescription medication used in combination with other medications to treat partial seizures. Gabitril belongs to a group of drugs called anticonvulsants, that are thought to work by affecting a brain chemical that slows down the electrical system of the brain.

This medication comes in tablet form and is taken up to 4 times daily with food.

Common side effects of Gabitril include dizziness, lack of energy, and drowsiness. Do not drive a car or operate machinery until you know how this medication affects you.

Gabitril is a prescription medicine used with other medicines to treat partial seizures in adults and children age 12 and older.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Cephalon, Inc.

See “Drug Precautions”.

Gabitril may cause other serious side effects including:

• seizures that can happen more often or become worse
• trouble concentrating, problems with speech and language, feeling confused, feeling sleepy and tired, and problems thinking
• weakness all over your body
• eye and vision problems
• serious rash

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effects of Gabitril include:

• dizziness
• lack of energy
• drowsiness
• nausea
• nervousness
• tremor
• stomach pain
• abnormal thinking
• difficulty with concentration or attention

These are not all the possible side effects of Gabitril. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking Gabitril with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider. Especially tell your healthcare provider if you take:

• alcohol
• benzodiazepines such as alprazolam (Xanax), chlordiazepoxide (Librium, Limbitrol, Librax), clobazam (Onfi), clonazepam (Klonopin), clorazepate (Tranxene), diazepam (Valium), estazolam (Prosom), flurazepam (Dalmane), lorazepam (Ativan), midazolam (Versed), oxazepam (Serax), quazepam (Doral), temazepam (Restoril), triazolam (Halcion).
• carbamazepine (Epitol, Equetro, Tegretol, Tegretol XR)
• phenobarbital (Luminal)
• phenytoin (Dilantin, Phenytek)
• primidone (Mysoline)
• valproic acid (Depakene) and divalproex sodium (Depakote, Depakote ER)

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. Always tell your healthcare provider if there are any changes in any other medicines that you take.

Do not stop taking Gabitril without first talking to your healthcare provider.

Stopping Gabitril suddenly can cause serious problems.

Gabitril can cause serious side effects, including:

1. Gabitril may cause seizures in people who do not have epilepsy. If you do not have a seizure disorder and you take Gabitril, you may have a seizure or seizures that do not stop (status epilepticus). Call your healthcare provider right away if you have a seizure and you are not taking Gabitril for epilepsy.

2. Like other antiepileptic drugs, Gabitril may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

Watch for early symptoms of suicidal thoughts and actions as follows:

• Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled.
• Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop Gabitril without first talking to a healthcare provider.

Stopping Gabitril suddenly can cause serious problems. If you have epilepsy and stop a seizure medicine suddenly, you may have more frequent seizures or seizures that will not stop (status epilepticus).

• Do not take Gabitril if you are allergic to Gabitril hydrochloride or any of the other ingredients in Gabitril. 
• Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking Gabitril without first talking to your healthcare provider. Taking Gabitril with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
• Do not drive, operate heavy machinery, or do other dangerous activities until you know how Gabitril affects you. Gabitril can slow your thinking and motor skills.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Gabitril there are no specific foods that you must exclude from your diet when receiving Gabitril.

Before taking Gabitril, tell your healthcare provider if you:

• have or have had depression, mood problems, or suicidal thoughts or behavior
• have liver problems
• have a history of seizures that do not stop (status epilepticus)
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if Gabitril can harm your unborn baby. 
• are breastfeeding or plan to breastfeed. It is not known if Gabitril passes into breast milk or if it can harm your baby. 

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

If you become pregnant while taking Gabitril, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicines during pregnancy. You can enroll in this registry by calling 1-888-233-2334.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Gabitril passes into breast milk or if it can harm your baby.

• Take Gabitril exactly as your healthcare provider tells you.
• Your healthcare provider may change your dose.
• Gabitril should be taken with food.
• Do not stop taking Gabitril without talking to your healthcare provider. Stopping Gabitril suddenly can increase your chances of having a seizure or cause seizures that will not stop.
• If you miss a dose of Gabitril, do not take 2 doses of Gabitril at the same time. Contact your healthcare provider if you miss more than one dose.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age 
• your liver function

In adolescents 12 to 18 years old who are on enzyme-inducing antiepilepsy drugs (AEDs) such as carbamazepine, phenytoin, primidone, and phenobarbital:

The recommended starting dose is 4mg/day and can be titrated up to a maximum dose of 32 mg/day, and will be given in divided doses.

Adults who are on enzyme-inducing antiepilepsy drugs (AEDs) such as carbamazepine, phenytoin, primidone, and phenobarbital:

The recommended dose range of Gabitril is 32 mg-56 mg/day in divided doses.

Dose will be lower for those patients who are not taking enzyme-inducing antiepilepsy drugs (AEDs).

If you take too much Gabitril, call your healthcare provider or local Poison Control Center right away.

• Store Gabitril between 68°F to 77°F (20°C to 25°C)
• Keep Gabitril away from light and moisture.
• Keep Gabitril and all medicines out of the reach of children.