pharmacopeia
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/api/v1/drug/tiagabine

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: GABA A Agonists; GABA B Agonists.

GABA AGABA B

Indications

Sourced from openFDA
  • Tiagabine hydrochloride tablet is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.ICD-10: G40.909

Contraindications

Sourced from openFDA
  • Tiagabine hydrochloride is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.contraindicated

Dosage & administration

Sourced from openFDA

General: The blood level of tiagabine obtained after a given dose depends on whether the patient also is receiving a drug that induces the metabolism of tiagabine. The presence of an inducer means that the attained blood level will be substantially reduced. Dosing should take the presence of concomitant medications into account. Tiagabine hydrochloride tablet is recommended as adjunctive therapy for the treatment of partial seizures in patients 12 years and older. The following dosing recommendations apply to all patients taking tiagabine hydrochloride tablets: Tiagabine hydrochloride tablet is given orally and should be taken with food. Do not use a loading dose of tiagabine hydrochloride tablets. Dose titration: Rapid escalation and/or large dose increments of tiagabine hydrochloride tablets should not be used. Missed dose(s): If the patient forgets to take the prescribed dose of tiagabine hydrochloride tablets at the scheduled time, the patient should not attempt to make up for the missed dose by increasing the next dose. If a patient has missed multiple doses, patient should refer back to his or her physician for possible re-titration as clinically indicated. Dosage adjustment of tiagabine hydrochloride tablets should be considered whenever a change in patient’s enzyme-inducing status occurs as a result of the addition, discontinuation, or dose change of the enzyme-inducing agent.

Warnings & precautions

Sourced from openFDA

Seizures in Patients Without Epilepsy: Post-marketing reports have shown that tiagabine hydrochloride use has been associated with new onset seizures and status epilepticus in patients without epilepsy. Dose may be an important predisposing factor in the development of seizures, although seizures have been reported in patients taking daily doses of tiagabine hydrochloride as low as 4 mg/day. In most cases, patients were using concomitant medications (antidepressants, antipsychotics, stimulants, narcotics) that are thought to lower the seizure threshold. Some seizures occurred near the time of a dose increase, even after periods of prior stable dosing. The tiagabine hydrochloride dosing recommendations in current labeling for treatment of epilepsy were based on use in patients with partial seizures 12 years of age and older, most of whom were taking enzyme-inducing antiepileptic drugs (AEDs; e.g., carbamazepine, phenytoin, primidone and phenobarbital) which lower plasma levels of tiagabine hydrochloride by inducing its metabolism. Use of tiagabine hydrochloride without enzyme-inducing antiepileptic drugs results in blood levels about twice those attained in the studies on which current dosing recommendations are based (see DOSAGE AND ADMINISTRATION). Safety and effectiveness of tiagabine hydrochloride have not been established for any indication other than as adjunctive therapy for partial seizures in adults and children 12 years and older.

Adverse reactions

Sourced from openFDA

The most commonly observed adverse events in placebo-controlled, parallel-group, add-on epilepsy trials associated with the use of tiagabine hydrochloride in combination with other antiepilepsy drugs not seen at an equivalent frequency among placebo-treated patients were dizziness/light­-headedness, asthenia/lack of energy, somnolence, nausea, nervousness/irritability, tremor, abdominal pain, and thinking abnormal/difficulty with concentration or attention. Approximately 21% of the 2531 patients who received tiagabine hydrochloride in clinical trials of epilepsy discontinued treatment because of an adverse event. The adverse events most commonly associated with discontinuation were dizziness (1.7%), somnolence (1.6%), depression (1.3%), confusion (1.1%), and asthenia (1.1%). In Studies 1 and 2 (U.S. studies), the double-blind, placebo-controlled, parallel-group, add-on studies, the proportion of patients who discontinued treatment because of adverse events was 11% for the group treated with tiagabine hydrochloride and 6% for the placebo group. The most common adverse events considered the primary reason for discontinuation were confusion (1.2%), somnolence (1.0%), and ataxia (1.0%). Adverse Event Incidence in Controlled Clinical Trials: Table 5 lists treatment-emergent signs and symptoms that occurred in at least 1% of patients treated with tiagabine hydrochloride for epilepsy participating in parallel-group, placebo-controlled trials and were numerically more common in the tiagabine hydrochloride group.

Use in specific populations

Sourced from openFDA

Pregnancy: Tiagabine has been shown to have adverse effects on embryo-fetal development, including teratogenic effects, when administered to pregnant rats and rabbits at doses greater than the human therapeutic dose. An increased incidence of malformed fetuses (various craniofacial, appendicular, and visceral defects) and decreased fetal weights were observed following oral administration of 100 mg/kg/day to pregnant rats during the period of organogenesis. This dose is approximately 16 times the maximum recommended human dose (MRHD) of 56 mg/day, based on body surface area (mg/m 2 ). Maternal toxicity (transient weight loss/reduced maternal weight gain during gestation) was associated with this dose, but there is no evidence to suggest that the teratogenic effects were secondary to the maternal effects. No adverse maternal or embryo-fetal effects were seen at a dose of 20 mg/kg/day (3 times the MRHD on a mg/m 2 basis). Decreased maternal weight gain, increased resorption of embryos and increased incidences of fetal variations, but not malformations, were observed when pregnant rabbits were given 25 mg/kg/day (8 times the MRHD on a mg/m 2 basis) during organogenesis. The no effect level for maternal and embryo-fetal toxicity in rabbits was 5 mg/kg/day (equivalent to the MRHD on a mg/m 2 basis).

Overdosage

Sourced from openFDA

Human Overdose Experience: Human experience of acute overdose with tiagabine hydrochloride is limited. Eleven patients in clinical trials took single doses of tiagabine hydrochloride up to 800 mg. All patients fully recovered, usually within one day. The most common symptoms reported after overdose included somnolence, impaired consciousness, agitation, confusion, speech difficulty, hostility, depression, weakness, and myoclonus. One patient who ingested a single dose of 400 mg experienced generalized tonic-clonic status epilepticus, which responded to intravenous phenobarbital. From post-marketing experience, reports of overdose involving tiagabine hydrochloride alone have included cases in which patients required intubation and ventilatory support as part of the management of their status epilepticus. Overdoses involving multiple drugs, including tiagabine hydrochloride, have resulted in fatal outcomes.

Approval history

Sourced from openFDA
  • Sep 30, 1997NDANDA020646Cephalon
  • Nov 4, 2011ANDAANDA077555Sun Pharm Inds
  • Nov 16, 2021ANDAANDA214816Msn

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
82 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Encephalopathy1620%
  2. 2Myoclonus1417%
  3. 3Off Label Use1316%
  4. 4Drug Ineffective1012%
  5. 5Dizziness67.3%
  6. 6Feeling Abnormal56.1%
  7. 7Seizure56.1%
  8. 8Product Use In Unapproved Indication44.9%
  9. 9Serotonin Syndrome44.9%
  10. 10Toxicity To Various Agents44.9%
  11. 11Tremor44.9%
  12. 12Abnormal Behaviour33.7%
  13. 13Completed Suicide33.7%
  14. 14Drug Interaction33.7%
  15. 15Dyskinesia33.7%

Literature

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Recent PubMed references pinned to Tiagabine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 21 ClinicalTrials.gov registrations naming Tiagabine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Tiagabine work?
Mechanism-of-action classes: GABA A Agonists; GABA B Agonists.
What is Tiagabine used for?
According to FDA labeling, Tiagabine carries indications including: Tiagabine hydrochloride tablet is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Tiagabine?
Tiagabine is classified as Fatty acid derivatives, Anti-epileptic Agent, GABA A Agonists, GABA B Agonists, Decreased Central Nervous System Disorganized Electrical Activity, Increased GABA Activity.
What are the brand names for Tiagabine?
Tiagabine is marketed under brand names including Gabitril.
What are the contraindications for Tiagabine?
Tiagabine labeling lists contraindications including: Tiagabine hydrochloride is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.. Always consult the full prescribing information and a clinician.
Note. Data for tiagabine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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