TIAGABINE (Systemic)

Some commonly used brand names are:

In the U.S.?

• Gabitril

Category

• Anticonvulsant

Description

Tiagabine (tye-AG-a-been)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 seizuresfor as long as you continue to take it.

Tiagabine is available only with your doctor's prescription, in the followingdosage form:

Oral
• Tablets (U.S.)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For tiagabine, the followingshould be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to tiagabine. Also tell your health care professional ifyou are allergic to any other substances, such as foods, preservatives, ordyes.

Pregnancy?Tiagabine has not been studied in pregnant women.However, studies in pregnant animals have shown that tiagabine may cause harmfuleffects in the fetus when given to the mother in doses greater than the usualhuman dose. Before taking this medicine, make sure your doctor knows if youare pregnant or if you may become pregnant.

Breast-feeding?It is not known whether tiagabine passes into breastmilk. Although most medicines pass into breast milk in small amounts, manyof them may be used safely while breast-feeding. Mothers who are taking thismedicine and who wish to breast-feed should discuss this with their doctor.

Children?Although there is no specific information comparinguse of tiagabine in children younger than 12 years of age with use in otherage groups, this medicine is not expected to cause different side effectsor problems in children than it does in adults.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults. Although there is no specific informationcomparing use of tiagabine in the elderly with use in other age groups, thismedicine is not expected to cause different side effects or problems in olderpeople than it does in younger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingtiagabine, it is especially important that your health care professional knowif you are taking any of the following:

• Carbamazepine (e.g., Tegretol) or
• Phenobarbital or
• Phenytoin (e.g., Dilantin) or
• Primidone (e.g., Mysoline)?Lower blood levels of tiagabinemay occur, so tiagabine may not work properly; your doctor may need to adjustyour dosage

Other medical problems?The presence of other medicalproblems may affect the use of tiagabine. Make sure you tell your doctor ifyou 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 of This Medicine

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

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

Dosing?The dose of tiagabine will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage doses of tiagabine. If your dose is different,do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine.Also, the number of doses you take each day, the timeallowed between doses, and the length of time you take the medicine dependon the medical problem for which you are taking tiagabine.

• For oral dosage form (tablets):
  • For epilepsy:
    • Adults and teenagers 12 years of age and older?At first, 4milligrams (mg) once a day. Your doctor may increase your dose slowly as neededand 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 determinedby the doctor.

Missed dose?If you miss a dose of this medicine, take it assoon as possible. However, if it is almost time for your next dose, skip themissed dose and go back to your regular dosing schedule. Do not double doses.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Tiagabinemay cause dizziness, drowsiness, trouble in thinking, trouble with motor skills,or vision problems. Make sure you know how you reactto this medicine before you drive, use machines, or do anything else thatcould be dangerous if you are not alert, well-coordinated, or able to thinkor 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 depressantsare 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 dentistbefore taking any of the above while you are taking tiagabine.

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

Side Effects of This Medicine

Along with its needed effects, a medicine maycause 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 possibleif any of the following side effects occur:

More common

Blue or purple spots on skin; difficultyin 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 rollingeye 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

Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue or are bothersome:

More common

Chills; diarrhea; dizziness; drowsiness; fever; headache; muscleaches or pain; nervousness; sore throat; tremor; unusualtiredness or weakness; vomiting

Less common

Abdominal pain; flushing; impaired vision; increased appetite; increased cough; mouthulcers; muscle weakness; nausea; pain; trouble insleeping

Other side effectsnot listed above may also occur in some patients. If you notice any othereffects, check with your doctor.