Gabitril

DRUG DESCRIPTION

GABITRIL® (tiagabine hydrochloride) (tiagabine HC1) is an antiepilepsy drug available as 2 mg, 4 mg, 12 mg, and 16 mg tablets for oral administration. Its chemical name is (-)-(R)-l-[4,4-Bis(3-methyl-2-thienyl)-3-butenyljnipecotic acid hydrochloride, its molecular formula is C20H25NO2S2, and its molecular weight is 412.0. Tiagabine HC1 is a white to off-white, odorless, crystalline powder. It is insoluble in heptane, sparingly soluble in water, and soluble in aqueous base. The structural formula is:

GABITRIL®
  (tiagabine hydrochloride) Structural Formula Illustration

Inactive Ingredients

GABITRIL (tiagabine hydrochloride) tablets contain the following inactive ingredients: Ascorbic acid, colloidal silicon dioxide, crospovidone, hydrogenated vegetable oil wax, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, stearic acid, and titanium dioxide.

In addition, individual tablets contain:

2 mg tablets: FD&C Yellow No. 6.
4 mg tablets: D&C Yellow No. 10.
12 mg tablets: D&C Yellow No. 10 and FD&C Blue No. 1.
16 mg tablets: FD&C Blue No. 2.

What are the possible side effects of tiagabine (Gabitril)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; fever; swollen glands; painful sores in or around your eyes or mouth; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these...

Read All Potential Side Effects and See Pictures of Gabitril »

What are the precautions when taking tiagabine hydrochloride (Gabitril)?

Before taking tiagabine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, depression/other mental condition, status epilepticus.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known...

Read All Potential Precautions of Gabitril »


Gabitril Consumer (continued)

SIDE EFFECTS: Inability to concentrate, dizziness, drowsiness, nervousness, irritability, tiredness, or shaking may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: increase in seizure activity, confusion/trouble thinking clearly, difficulty forming sentences, depression, severe weakness.

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

Seek immediate medical attention if you get a seizure that doesn't stop (status epilepticus). This is a very rare but very serious side effect.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking tiagabine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, depression/other mental condition, status epilepticus.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Gabitril Patient Information Including Side Effects

Brand Names: Gabitril

Generic Name: tiagabine (Pronunciation: tye AG a been)

  • What is tiagabine (Gabitril)?
  • What are the possible side effects of tiagabine (Gabitril)?
  • What is the most important information I should know about tiagabine (Gabitril)?
  • What should I discuss with my healthcare provider before taking tiagabine (Gabitril)?
  • How should I take tiagabine (Gabitril)?
  • What happens if I miss a dose (Gabitril)?
  • What happens if I overdose (Gabitril)?
  • What should I avoid while taking tiagabine (Gabitril)?
  • What other drugs will affect tiagabine (Gabitril)?
  • Where can I get more information?

What is tiagabine (Gabitril)?

Tiagabine is an anti-epileptic medication, also called an anticonvulsant.

Tiagabine is used to alone or in combination with other medications to treat partial seizures in adults and children who are at least 12 years old.

Tiagabine may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of tiagabine (Gabitril)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; fever; swollen glands; painful sores in or around your eyes or mouth; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

  • new or worsened seizures;
  • confusion, hallucination;
  • problems with speech or vision;
  • severe blistering, peeling, and red skin rash;
  • tremor;
  • fever, chills, body aches, flu symptoms; or
  • chest pain, fast heart rate.

Less serious side effects may include:

  • dizziness, drowsiness, weakness, tired feeling;
  • feeling restless, irritable, or depressed;
  • nausea, vomiting, stomach pain, diarrhea;
  • trouble concentrating;
  • sleep problems (insomnia);
  • lack of coordination;
  • cough, sore throat; or
  • weight changes.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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

You should not use this medication if you are allergic to tiagabine.

Before taking tiagabine, tell your doctor if you are allergic to any drugs or if you have liver disease.

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Do not stop taking tiagabine without first talking to your doctor, even if you feel better. You may have increased seizures if you stop taking tiagabine suddenly. You will need to use less and less before you stop the medication completely.

Contact your doctor if your seizures get worse or you have them more often while taking tiagabine.

Carry an ID card or wear a medical alert bracelet stating that you are taking tiagabine, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication.

Related Drug Centers
  • Gabitril


Related Drugs Index: