Tiagabine

Tiagabine is a prescription medication used as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.

• Tiagabine is available under the following different brand names: Gabitril

Common side effects of Tiagabine include:

• inability to concentrate
• dizziness
• drowsiness
• nervousness
• irritability
• tiredness
• shaking
• weakness
• restlessness
• depression
• nausea
• vomiting
• stomach pain
• diarrhea
• sleep problems (insomnia)
• lack of coordination
• cough
• sore throat
• weight changes

Serious side effects of Tiagabine include:

• rash
• sores on the inside of the mouth, nose, eyes, or throat
• flu-like symptoms
• changes in vision
• severe weakness
• uncontrollable shaking of hands
• numbness, pain, burning, or tingling in the hands or feet
• increase in seizure activity
• confusion
• trouble thinking clearly
• difficulty forming sentences
• severe weakness
• seizures, including status epilepticus

Rare side effects of Tiagabine include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet

• 2 mg
• 4 mg
• 12 mg
• 16 mg

Partial seizures (with hepatic enzyme-inducing anticonvulsants)

Adult and geriatric dosage

• Initial: 4 mg/day orally for 1 week
• Titrate weekly by 4-8 mg, not to exceed 56 mg/day divided every 8-12 hours

Pediatric dosage

• Children younger than 12 years
  • Not established
• Children older than 12 years
  • Initial: 4 mg/day orally for one week, then
  • 4 mg orally every 12 hours for one week
  • Titrate weekly by 4-8 mg, not to exceed 32 mg/day divided every 6-12 hours 

Partial seizures (without hepatic enzyme-inducing anticonvulsants)

Adult and geriatric dosage

• 12-22 mg/day orally divided every 8-12 hours

Pediatric dosage

• Children younger than 12 years: Not established
• Children older than 12 years old: Same as adults

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Tiagabine has severe interactions with no other drugs
• Tiagabine has serious interactions with at least 21 other drugs
• Tiagabine has moderate interactions with at least 61 other drugs
• Tiagabine has minor interactions with at least 29 other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Tiagabine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Tiagabine?”

Cautions

• Antiepileptic drugs (AED) increase the risk for suicidal thoughts or behavior in patients taking them for any indication; patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior
• Risk for seizures if used in patients without epilepsy (when used off-label in psychiatric disorder); in nonepileptic patients who develop seizures while on therapy, discontinue therapy and evaluate patients for underlying seizure disorder
• Should not be abruptly discontinued because of the possibility of increasing seizure frequency
• Use without enzyme-inducing AEDs results in about twice the blood levels of Tiagabine than what dosage recommendations are based on
• Because clearance of Tiagabine is reduced in patients with liver disease, dosage reduction may be necessary in these patients
• Adverse events most often associated with therapy were related to the central nervous system; the most significant of these can be classified into two general categories: 1) impaired concentration, speech or language problems, and confusion (effects on thought processes); and 2) somnolence and fatigue (effects on the level of consciousness)
• Moderately severe to incapacitating generalized weakness reported, which resolves after reduction in dose or discontinuation of therapy

Pregnancy and Lactation

• Use with caution if the benefits outweigh the risks during pregnancy
• Lactation
  • Unknown; use caution