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GABA reuptake inhibitor (antiepileptic) Pregnancy: Clinical experience in pregnant women is limited; animal experiments have not shown a teratogenic effect but have revealed peri- and post-natal toxicity at very high doses. No information is available on use during breast-feeding. As a precautionary measure it is preferable not to use tiagabine during pregnancy or breast-feeding unless, in the physician's opinion, the potential benefits outweigh the potential risks (§4.6).

Tiagabine

Brand names: Gabitril

Tiagabine is an antiseizure medicine used as adjunctive therapy for partial (focal) seizures with or without secondary generalisation.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Adults and children over 12 years: initial daily dose 5–10 mg, followed by weekly increments of 5–10 mg/day. Usual maintenance dose in patients taking enzyme-inducing drugs is 30–45 mg/day; in patients not taking enzyme-inducing drugs the maintenance dose should initially be reduced to 15–30 mg/day
Route: Oral — taken with meals
Frequency: The initial daily dose should be taken as a single dose or divided into two doses; the daily maintenance dose should be divided into two or three single doses
Licensed as adjunctive therapy for partial seizures in adults and adolescents over 12 years; safety and effectiveness have not been established for any other indication. Dosing schemes may need to be individualised based on the patient's characteristics such as age and concomitant medicines. Concomitant CYP3A4/5 inducers: as CYP3A4/5 is involved in tiagabine metabolism, adjust the dose when combined with CYP3A4/5 inducers — the estimated plasma concentration in non-induced patients is more than twice that in patients receiving enzyme-inducing agents, so non-induced patients require lower and less frequent doses and may need slower titration; reconsider the dose whenever the patient's enzyme-inducing status changes. Rapid titration and/or large dose increments may not be well tolerated and should be avoided. Children under 12 years: there is no experience in this age group and tiagabine should not be used. Elderly: pharmacokinetics do not appear significantly modified, but only limited information is available — use with caution. Hepatic impairment: reduce the individual doses and/or prolong the dose intervals in mild to moderate impairment and monitor closely for dizziness and tiredness; contraindicated in severely impaired hepatic function. Withdrawal: although there is no evidence of withdrawal seizures, taper off treatment over 2–3 weeks. Post-marketing reports of new onset seizures and status epilepticus in patients without epilepsy — contributing factors include high dosage and fast titration rate.

Dose adjustments

Renal

Renal insufficiency does not affect the pharmacokinetics of tiagabine, therefore the dosage does not need to be modified in these patients (§4.2).

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients
  • Severely impaired liver function
  • Combination with St John's Wort (Hypericum perforatum)

Side effects

  • Dizziness and tremor (very common)
  • Nervousness, non-specific (very common)
  • Tiredness (very common)
  • Nausea (very common); diarrhoea, vomiting and abdominal pain (common)
  • Concentration difficulties, depressed mood, emotional lability, confusion, insomnia and hostility/aggression (common); visual field defects reported rarely

Interactions

  • St John's Wort (Hypericum perforatum) — combination is contraindicated (§4.3)
  • Enzyme-inducing antiepileptic agents (phenytoin, carbamazepine, phenobarbital, primidone) — enhance the metabolism of tiagabine; patients taking enzyme-inducing drugs may require doses above the usual dose range (§4.4)
  • CYP3A4/5 inducers generally — dose adjustment of tiagabine recommended; reconsider the dose whenever an enzyme-inducing agent is added, discontinued or dose-changed (§4.2)
  • Triazolam — tiagabine may slightly prolong its CNS depressant effect, although this interaction is unlikely to be clinically relevant (§4.4)
  • Valproate — tiagabine causes a slight decrease (about 10%) in steady-state valproate concentrations; no effect on steady-state phenytoin or carbamazepine concentrations (US label, Drug Interactions)

Clinical monograph

How it works

It selectively inhibits the GAT-1 GABA transporter, reducing reuptake of GABA into neurones and glia and thereby prolonging inhibitory GABAergic neurotransmission.

Prescribing in practice

  • It has been associated with new-onset seizures and status epilepticus in people without epilepsy when used off-licence, so it should be reserved for adjunctive treatment of epilepsy and titrated gradually.
  • Dizziness, tremor, difficulty concentrating and tiredness are common, particularly during titration.
  • Clearance is increased by enzyme-inducing antiseizure drugs, which may affect the regimen.

Monitoring

Monitor seizure frequency, alertness and central nervous system tolerability, and remain alert to mood changes during treatment.

Counselling the patient

  • Do not stop the medicine abruptly, as this may trigger seizures.
  • Report new or worsening seizures, marked drowsiness or low mood.

Evidence & guidelines

Its adjunctive efficacy in focal epilepsy is supported by randomised placebo-controlled trials.

Reference: NICE NG217; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.