Brand Name

    US Brand Name

    Gabitril


    Description

    Tiagabine is used to help control some types of seizures in the treatment of epilepsy. This medicine cannot cure epilepsy and will only work to control seizures for as long as you continue to take it.

    Tiagabine is available only with your doctor's prescription.

    This product is available in the following dosage forms:

    • Tablet

    Before Using

    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

    Although there is no specific information comparing use of tiagabine in children younger than 12 years of age with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

    Geriatric

    Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of tiagabine in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

    Breastfeeding

    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.

    Drug Interactions

    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
    • 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.

    • Carbamazepine
    • Fosphenytoin
    • Ginkgo
    • Phenobarbital
    • Phenytoin
    • Primidone

    Other Interactions

    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:

    • Liver problems—Higher blood levels of tiagabine may result, leading to an increase in the chance of side effects
    • Status epilepticus—Tiagabine may cause the condition to recur

    Proper Use

    Take this medicine only as directed by your doctor, to help your condition as much as possible. Do not take more or less of it, and do not take it more or less often than your doctor ordered.

    Tiagabine should be taken with food or on a full stomach.

    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 (tablets):
      • For epilepsy:
        • Adults and teenagers 12 years of age and older—At first, 4 milligrams (mg) once a day. Your doctor may increase your dose slowly as needed and tolerated. However, the dose usually is not greater than 56 mg a day.
        • Children up to 12 years of age—Use and dose must be determined by the 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.


    Precautions

    Tiagabine may cause dizziness, drowsiness, trouble in thinking, trouble with motor skills, or vision problems. 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 not alert, well-coordinated, or able to think or see well.

    This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; other medicines for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking tiagabine.

    Do not stop taking tiagabine without first checking with your doctor. Stopping the medicine suddenly may cause your seizures to return or to occur more often. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.


    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 as soon as possible if any of the following side effects occur:

    More common

    • Blue or purple spots on skin
    • difficulty in concentrating or paying attention

    Less common

    • Burning, numbness, or tingling sensations
    • clumsiness or unsteadiness
    • confusion
    • itching
    • mental depression
    • speech or language problems

    Rare

    • Agitation
    • bloody or cloudy urine
    • burning, pain, or difficulty in urinating
    • frequent urge to urinate
    • generalized weakness
    • hostility
    • memory problems
    • quick to react or overreact emotionally
    • rash
    • uncontrolled back-and-forth and/or rolling eye movements
    • walking in unusual manner

    Symptoms of overdose

    • Agitation (severe)
    • clumsiness or unsteadiness (severe)
    • coma
    • confusion (severe)
    • drowsiness (severe)
    • increase in seizures
    • mental depression
    • severe muscle twitching or jerking
    • sluggishness
    • speech problems (severe)
    • weakness

    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

    • Chills
    • diarrhea
    • dizziness
    • drowsiness
    • fever
    • headache
    • muscle aches or pain
    • nervousness
    • sore throat
    • tremor
    • unusual tiredness or weakness
    • vomiting

    Less common

    • Abdominal pain
    • flushing
    • impaired vision
    • increased appetite
    • increased cough
    • mouth ulcers
    • muscle weakness
    • nausea
    • pain
    • trouble in sleeping

    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.






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