Drug monograph for the active ingredient in Gabitril

The following information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

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 seizures for as long as you continue to take it.

Tiagabine is available only with your doctor's prescription, in the following dosage 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 will do. This is a decision you and your doctor will make. For tiagabine, the following should be considered:

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

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

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

Children—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.

Older adults—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.

Other medicines—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 tiagabine, it is especially important that your health care professional know if 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 tiagabine may occur, so tiagabine may not work properly; your doctor may need to adjust your dosage

Other medical problems—The presence of other medical problems may affect the use of tiagabine. 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 of This Medicine

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 tiagabine 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 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 time allowed between doses, and the length of time you take the medicine depend on 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, 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—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 other damp 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 sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

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 of This Medicine

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

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

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 above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 09/07/2001

The information contained in the Thomson Healthcare products 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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Copyright © 2004 Thomson Healthcare Inc. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes.

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