Tiagabine Hydrochloride

TIAGABINE HYDROCHLORIDE

Manufacturer: Teva Pharmaceuticals USA, Inc.

Score: 141.0

Quick Summary

Tiagabine Hydrochloride is an antiepilepsy drug used as adjunctive therapy in adults and children 12 years and older for the treatment of partial seizures. It is believed to enhance the activity of gamma aminobutyric acid (GABA), the major inhibitory neurotransmitter in the central nervous system. The drug has been shown to be effective in several animal models of seizures and has a dose-response curve against pentylenetetrazol (PTZ)- and DMCM-induced convulsions. However, it is associated with several warnings, including seizures in patients without epilepsy, suicidal behavior and ideation, withdrawal seizures, cognitive/neuropsychiatric adverse events, and status epilepticus. The recommended dosing regimen varies depending on whether the patient is taking enzyme-inducing antiepilepsy drugs, with typical initial doses ranging from 4 mg once daily to 4 mg twice daily, and titration schedules to achieve optimal therapeutic effects.

Key Clinical Findings and Indications

Adjunctive therapy for partial seizures in adults and children 12 years and older
Enhances GABA activity
Effective in several animal models of seizures
Dose-response curve against PTZ- and DMCM-induced convulsions

Important Safety Information

Warning

Seizures in patients without epilepsy, suicidal behavior and ideation, withdrawal seizures, cognitive/neuropsychiatric adverse events, and status epilepticus

Contraindications

Hypersensitivity to the drug or its ingredients

Adverse Reactions

Dizziness/light-headedness
Asthenia/lack of energy
Somnolence
Nausea
Nervousness/irritability
Tremor
Abdominal pain
Thinking abnormal/difficulty with concentration or attention

Dosing Recommendations

General Guidance

Dose adjustments may be necessary based on concomitant medications and patient response

Partial seizures

Adult Dose

4 mg once daily, titrate by 4-8 mg at weekly intervals

Pediatric Dose

4 mg once daily, titrate by 4 mg at weekly intervals

Special Population Considerations

Pregnancy

Tiagabine has been shown to have adverse effects on embryo-fetal development
Use during pregnancy only if clearly needed

Nursing Mothers

Studies in rats have shown that tiagabine is excreted in milk
Use in nursing mothers only if benefits outweigh risks

Pediatric Use

Safety and effectiveness not established in children under 12 years
Pharmacokinetics evaluated in pediatric patients 3-10 years

Geriatric Use

Limited data available in patients over 65 years
No specific statements about safety or effectiveness in this age group

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