Gabitril

Generic name: Tiagabine hydrochloride

What is Gabitril?

Gabatril is indicated as add-on therapy in adults and children 12 years and older for the treatment of partial seizures.

What is the most important information I should know about Gabitril?

Gabitril is approved as add-on therapy for the management of partial seizure disorders. In patients not diagnosed with epilepsy, seizures have occurred in patients taking Gabitril.

Most seizures in patients without epilepsy occurred soon after starting Gabitril, after a dose increase, or after several months of treatment. Seizures have occurred at very low doses of Gabitril.

Safety and effectivenss of Gabitril have not been established for any indications other than as add-on therapy for partial seizures in adults and children 12 years and older.

Do not abruptly stop taking Gabitril because of the possibility of increasing seizure frequency. If you are having problems, talk to your doctor before stopping any medications.

Although rare, a very serious and possibly fatal rash may occur with the use of Gabitril.

Who should not take Gabitril?

Gabitril is contraindicated in patients who have demonstrated an allergic reaction to this drug or any of its ingredients.

What should I tell my doctor before I take the first dose of Gabitril?

Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Gabitril. Also, talk to your doctor about your complete medical history, especially if you have liver problems, are pregnant or plan to become pregnant, breastfeeding or plan to breastfeed, have a mental condition, or status epilepticus.

What is the usual dosage?

The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

Patients who are taking enzyme-inducing antiepilepsy drugs (carbamazapine, phenytoin, primidone, and phenobarbital)

Adolescents 12 to 18 years old: Gabitril should be initiated at 4 mg once daily. Modification of concomitant antiepilepsy drugs is not necessary, unless clinically indicated. The total daily dose of Gabitril may be increased by 4 mg at the beginning of Week 2. Thereafter, the total daily dose may be increased by 4 to 8 mg at weekly intervals until clinical response is achieved, or up to 32 mg/day. The total daily dose should be given in divided doses two to four times daily.

Adults: Gabitril should be initiated at 4 mg once daily. Modification of concomitant antiepilepsy drugs is not necessary, unless clinically indicated. The total daily dose of Gabitril may be increased by 4 to 8 mg at weekly intervals until clinical response is achieved, or up to 56 mg/day. The total daily dose should be given in divided doses two to four times daily. Doses above 56 mg/day have not been systematically evaluated in adequate and well-controlled clinical trials.

Patients who are only taking non-enzyme-inducing AEDS require lower doses of Gabitril than the patients receiving enzyme-inducing agents.

How should I take Gabitril?

Gabitril should be taken with food after a meal or snack.

What should I avoid while taking Gabitril?

This drug may make you dizzy or drowsy; use caution when engaging in activities requiring alertness such as driving or using machinery. Avoid alcoholic beverages.

What are possible food and drug interactions associated with Gabitril?

If Gabitril is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Gabitril with the following: carbamazepine, phenobarbital, phenytoin, and valproate.

What are the possible side effects of Gabitril?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

Side effects may include: dizziness, lack of energy, drowsiness, nausea, nervousness, tremor, abdominal pain, difficulty concentrating

Can I receive Gabitril if I am pregnant or breastfeeding?

If you are a woman of childbearing age, be sure to notify your doctor if you become pregnant or intend to become pregnant while taking Gabitril. Also tell your doctor if you are breastfeeding or plan to breastfeed. Gabitril should be used in women who are pregnant or nursing only if the benefits clearly outweigh the risks.

What should I do if I miss a dose of Gabitril?

If you forget to take Gabitril at your scheduled time, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose of Gabitril. Do not attempt to make up a missed dose by increasing the next dose.

How should I store Gabitril?

Store Gabitril at room temperature. Protect from light and moisture.