tye-A-ga-been

Therapeutic Classification: anticonvulsants

• Adjunctive treatment of partial seizures.

• Enhances the activity of gamma-aminobutyric acid, an inhibitory neurotransmitter.

• Decreased frequency of seizures.

Absorption: 90% absorbed following oral administration.

Distribution: Unknown.

Protein Binding: 96%.

Metabolism/Excretion: Mostly metabolized by the liver; 2% excreted unchanged in urine.

Half-life: Without enzyme-inducing antiepileptic drugs — 7–9 hr; with enzyme-inducing antiepileptic drugs — 4–7 hr.

(blood levels)

Contraindicated in:

• Hypersensitivity.

Use Cautiously in:

• All patients (may ↑ risk of suicidal thoughts/behaviors)
• Hepatic impairment (↓ dose/increased interval may be necessary)
• Patients receiving concurrent non–enzyme-inducing antiepileptic drug therapy such as valproates (may require lower doses and/or slower titration)
• Using tiagabine for off-label uses or other conditions leading to ↑ levels (may ↑ risk of new onset seizures)
• OB: Lactation: Pedi: Pregnancy, lactation, or children <12 yr (safety not established).

CNS: SUICIDAL THOUGHTS, dizziness, drowsiness, nervousness, weakness, cognitive impairment, confusion, difficulty concentrating, hallucinations, headache, mental depression, personality disorder.

EENT: abnormal vision, ear pain, tinnitus.

Resp: dyspnea, epistaxis.

CV: chest pain, edema, hypertension, palpitations, syncope, tachycardia.

GI: abdominal pain, gingivitis, nausea, stomatitis.

GU: dysmenorrhea, dysuria, metrorrhagia, urinary incontinence.

Derm: alopecia, dry skin, rash, sweating.

Metab: weight gain, weight loss.

MS: arthralgia, neck pain.

Neuro: ataxia, tremors.

Misc: allergic reactions, chills, lymphadenopathy.

Drug-Drug:

• Carbamazepine, phenytoin, primidone, and phenobarbital↓ levels.

Drug-Natural Products:

• St. John's wort may ↓ levels.

• PO (Adults >18 yr): 4 mg once daily initially for 1 wk; may ↑ by 4–8 mg/day at weekly intervals, up to 56 mg/day in 2–4 divided doses.
• PO (Children 12–18 yr): 4 mg once daily initially for 1 wk; may ↑ by 4 mg/day after 1 wk, then may ↑ by 4–8 mg/day at weekly intervals, up to 32 mg/day in 2–4 divided doses.

(Generic available)

• Tablets: 2 mg; 4 mg; 12 mg; 16 mg;

• Assess location, duration, and characteristics of seizure activity.
• Assess mental status. May cause impaired concentration, speech or language problems, confusion, fatigue, and drowsiness. Symptoms may decrease with dose reduction or discontinuation.
• Monitor closely for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.

• Therapeutic serum levels have not been determined. However, levels may be monitored prior to and following changes in the therapeutic regimen.

• Do not confuse tiagabine with tizanidine.
• PO: Administer with food.
  • Discontinue tiagabine gradually. Abrupt discontinuation may cause increase in seizure frequency.

• Instruct patient to take medication as directed. Take missed doses as soon as possible unless almost time for next dose. Do not double doses. Do not discontinue abruptly; may cause increase in frequency of seizures. Instruct patient to read the Medication Guide before starting and with each Rx refill, changes may occur.
• Advise patient to notify health care professional immediately if frequency of seizures increases.
• May cause dizziness. Caution patient to avoid driving or activities requiring alertness until response to medication is known. Do not resume driving until physician gives clearance based on control of seizure disorder.
• Advise patient and family to notify health care professional if thoughts about suicide or dying, attempts to commit suicide; new or worse depression; new or worse anxiety; feeling very agitated or restless; panic attacks; trouble sleeping; new or worse irritability; acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking, other unusual changes in behavior or mood occur.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications, especially St. John's wort.
• Instruct patient to notify health care professional of medication regimen prior to treatment or surgery.
• Advise patient to carry identification describing disease process and medication regimen at all times.
• Advise patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.

• Decrease in the frequency or cessation of seizures.

Gabitril

• Risk for injury (Side Effects).

NDC Code^*

• 0093- Teva Pharmaceuticals USA, Inc.
  • 0093-5030- Tiagabine Hydrochloride
    • 0093-5030-56- 30 TABLET, FILM COATED in 1 BOTTLE (0093-5030-56)

• 0093- Teva Pharmaceuticals USA, Inc.
  • 0093-5031- Tiagabine Hydrochloride
    • 0093-5031-56- 30 TABLET, FILM COATED in 1 BOTTLE (0093-5031-56)

• 0093- Teva Pharmaceuticals USA, Inc.
  • 0093-8072- Tiagabine Hydrochloride
    • 0093-8072-56- 30 TABLET, FILM COATED in 1 BOTTLE (0093-8072-56)

• 0093- Teva Pharmaceuticals USA, Inc.
  • 0093-8076- Tiagabine Hydrochloride
    • 0093-8076-56- 30 TABLET, FILM COATED in 1 BOTTLE (0093-8076-56)

• 52536- Wilshire Pharmaceuticals, Inc.
  • 52536-350- tiagabine hydrochloride
    • 52536-350-03- 30 TABLET in 1 BOTTLE (52536-350-03)

• 52536- Wilshire Pharmaceuticals, Inc.
  • 52536-355- tiagabine hydrochloride
    • 52536-355-03- 30 TABLET in 1 BOTTLE (52536-355-03)

• 52536- Wilshire Pharmaceuticals, Inc.
  • 52536-360- tiagabine hydrochloride
    • 52536-360-03- 30 TABLET in 1 BOTTLE (52536-360-03)

• 52536- Wilshire Pharmaceuticals, Inc.
  • 52536-365- tiagabine hydrochloride
    • 52536-365-03- 30 TABLET in 1 BOTTLE (52536-365-03)

• 62756- Sun Pharmaceutical Industries, Inc.
  • 62756-200- TIAGABINE HYDROCHLORIDE
    • 62756-200-18- 1000 TABLET, FILM COATED in 1 BOTTLE (62756-200-18)

• 62756- Sun Pharmaceutical Industries, Inc.
  • 62756-200- TIAGABINE HYDROCHLORIDE
    • 62756-200-83- 30 TABLET, FILM COATED in 1 BOTTLE (62756-200-83)

• 62756- Sun Pharmaceutical Industries, Inc.
  • 62756-224- TIAGABINE HYDROCHLORIDE
    • 62756-224-08- 100 TABLET, FILM COATED in 1 BOTTLE (62756-224-08)

• 62756- Sun Pharmaceutical Industries, Inc.
  • 62756-224- TIAGABINE HYDROCHLORIDE
    • 62756-224-18- 1000 TABLET, FILM COATED in 1 BOTTLE (62756-224-18)

• 62756- Sun Pharmaceutical Industries, Inc.
  • 62756-224- TIAGABINE HYDROCHLORIDE
    • 62756-224-83- 30 TABLET, FILM COATED in 1 BOTTLE (62756-224-83)

• 62756- Sun Pharmaceutical Industries, Inc.
  • 62756-224- TIAGABINE HYDROCHLORIDE
    • 62756-224-88- 100 TABLET, FILM COATED in 1 BOTTLE (62756-224-88)

• 63459- Cephalon, Inc.
  • 63459-402- GABITRIL
    • 63459-402-30- 30 TABLET, FILM COATED in 1 BOTTLE (63459-402-30)

• 63459- Cephalon, Inc.
  • 63459-404- GABITRIL
    • 63459-404-30- 30 TABLET, FILM COATED in 1 BOTTLE (63459-404-30)

• 63459- Cephalon, Inc.
  • 63459-412- GABITRIL
    • 63459-412-30- 30 TABLET, FILM COATED in 1 BOTTLE (63459-412-30)

• 63459- Cephalon, Inc.
  • 63459-416- GABITRIL
    • 63459-416-30- 30 TABLET, FILM COATED in 1 BOTTLE (63459-416-30)

• 69238- Amneal Pharmaceuticals NY LLC
  • 69238-1104- Tiagabine Hydrochloride
    • 69238-1104-3- 30 TABLET in 1 BOTTLE (69238-1104-3)

• 69238- Amneal Pharmaceuticals NY LLC
  • 69238-1105- Tiagabine Hydrochloride
    • 69238-1105-3- 30 TABLET in 1 BOTTLE (69238-1105-3)

• 69238- Amneal Pharmaceuticals NY LLC
  • 69238-1106- Tiagabine Hydrochloride
    • 69238-1106-3- 30 TABLET in 1 BOTTLE (69238-1106-3)

• 69238- Amneal Pharmaceuticals NY LLC
  • 69238-1107- Tiagabine Hydrochloride
    • 69238-1107-3- 30 TABLET in 1 BOTTLE (69238-1107-3)