Gabitril

Generic name: tiagabine
Drug class: Gamma-aminobutyric acid reuptake inhibitors

Medically reviewed by  A Ras MD.

What is Gabitril used for?

Gabitril is a prescription medicine that is used to treat seizures.

Description

GABITRIL® (tiagabine HCl) is an antiepilepsy drug available as 2 mg, 4 mg, 12 mg, and 16 mg tablets for oral administration. Its chemical name is (-)-(R)-1-[4,4-Bis(3-methyl-2-thienyl)-3-butenyl]nipecotic acid hydrochloride, its molecular formula is C20H25NO2S2 HCl, and its molecular weight is 412.0. Tiagabine HCl 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:

structure

 

Inactive Ingredients

GABITRIL 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.

Before taking Gabitril, tell your doctor:

  • If you are allergic to Gabitril; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Gabitril with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Gabitril?

  • Tell all of your health care providers that you take Gabitril. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how Gabitril affects you.
  • Do not stop taking Gabitril all of a sudden without calling your doctor. You may have a greater risk of seizures. If you need to stop Gabitril, you will want to slowly stop it as ordered by your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Have an eye exam as you have been told by your doctor.
  • Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
  • This medicine may cause seizures in people who do not have a seizure disorder. This medicine is only approved to treat certain types of seizures. Call your doctor right away if you have a seizure and you are not taking Gabitril for a seizure disorder.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Gabitril while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Gabitril best taken?

Use Gabitril as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take Gabitril with food.
  • Do not change the dose or stop Gabitril. This could cause seizures. Talk with your doctor.
  • Keep taking Gabitril as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • If you miss 2 doses, call your doctor.

What are the side effects of Gabitril that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • If seizures are worse or not the same after starting Gabitril.
  • Change in balance.
  • Feeling confused.
  • Change in eyesight or in the way you see color.
  • Feeling very tired or weak.
  • Feeling very sleepy.
  • Not able to focus.
  • Trouble speaking.
  • Trouble walking.
  • Patients who take Gabitril may be at a greater risk of having thoughts or actions of suicide. The risk may be greater in people who have had these thoughts or actions in the past. Call the doctor right away if signs like low mood (depression), nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of Gabitril?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Feeling sleepy.
  • Feeling tired or weak.
  • Upset stomach or throwing up.
  • Shakiness.
  • Feeling nervous and excitable.
  • Belly pain.
  • Diarrhea.
  • Not able to sleep.
  • Throat irritation.
  • Flu-like signs.
  • Muscle pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Gabitril?

  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PACKAGE/LABEL DISPLAY PANEL

 

  • NDC 63459-404-30
    30 Tablets
    GABITRIL® (tiagabine hydrochloride) Tablets
    4 mg
    Rx only
    Medication Guide Required: Each time GABITRIL is dispensed, give the patient a Medication Guide

image

Imprint C 404 - Gabitril 4 mg

PACKAGE/LABEL DISPLAY PANEL

  • NDC 63459-412-30
    30 Tablets
    GABITRIL® (tiagabine hydrochloride) Tablets
    1
    2 mg
    Rx only
    Medication Guide Required: Each time GABITRIL is dispensed, give the patient a Medication Guide
image
Imprint 412 C - Gabitril 12 mg

PACKAGE/LABEL DISPLAY PANEL

  • NDC 63459-416-30
    30 Tablets
    GABITRIL® (tiagabine hydrochloride) Tablets
    16 mg
    Rx only
    Medication Guide Required: Each time GABITRIL is dispensed, give the patient a Medication Guide
image
Imprint 416 C - Gabitril 16 mg

SRC: NLM .

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