Tiagabine Hydrochloride
Generic Name: tiagabine hydrochloride
Brand Names:
Tiagabine Hydrochloride
DESCRIPTION Tiagabine hydrochloride is an antiepilepsy drug available as 2 mg, 4 mg, 12 mg and 16 mg tablets for oral administration. Its chemical name is (-)-(R)-1-[4,4-Bis(3-methyl-2-thienyl)-3-butenyl]nipecotic acid hydrochloride, its molecular formula is C 20 H 25 NO 2 S 2 HCl, and its molecular weight is 412.0. Tiagabine HCl is a white to off-white, odorless, crystalline powder. It is insoluble in heptane, sparingly soluble in water, and soluble in aqueous base.
Overview
DESCRIPTION Tiagabine hydrochloride is an antiepilepsy drug available as 2 mg, 4 mg, 12 mg and 16 mg tablets for oral administration. Its chemical name is (-)-(R)-1-[4,4-Bis(3-methyl-2-thienyl)-3-butenyl]nipecotic acid hydrochloride, its molecular formula is C 20 H 25 NO 2 S 2 HCl, and its molecular weight is 412.0. Tiagabine HCl is a white to off-white, odorless, crystalline powder. It is insoluble in heptane, sparingly soluble in water, and soluble in aqueous base.
Uses
INDICATIONS AND USAGE Tiagabine HCl is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.
Dosage
DOSAGE AND ADMINISTRATION 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 HCl 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 HCl: Tiagabine HCl is given orally and should be taken with food. Do not use a loading dose of tiagabine HCl. Dose titration: Rapid escalation and/or large dose increments of tiagabine HCl should not be used.
Side Effects
ADVERSE REACTIONS The most commonly observed adverse events in placebo-controlled, parallel-group, add-on epilepsy trials associated with the use of tiagabine HCl 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 HCl 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%).
Interactions
Drug Interactions In evaluating the potential for interactions among co-administered antiepilepsy drugs (AEDs), whether or not an AED induces or does not induce metabolic enzymes is an important consideration. Carbamazepine, phenytoin, primidone, and phenobarbital are generally classified as enzyme inducers; valproate and gabapentin are not. Tiagabine HCl is considered to be a non-enzyme inducing AED (see PRECAUTIONS, General, Use in Non-Induced Patients ). The drug interaction data described in this section were obtained from studies involving either healthy subjects or patients with epilepsy. Effects of Tiagabine HCl on other Antiepilepsy Drugs (AEDs): Phenytoin : Tiagabine had no effect on the steady-state plasma concentrations of phenytoin in patients with epilepsy.
Warnings
WARNINGS Seizures in Patients Without Epilepsy: Post-marketing reports have shown that tiagabine HCl 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 HCl 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. CONTRAINDICATIONS Tiagabine HCl is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
Pregnancy
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 ).
Storage
HOW SUPPLIED Tiagabine HCl tablets are available in four dosage strengths. 2 mg orange-peach, round tablets, debossed with on one side and 402 on the opposite side, are available in bottles of 30 ( NDC 0093-5030-56). 4 mg yellow, round tablets, debossed with on one side and 404 on the opposite side, are available in bottles of 30 ( NDC 0093-5031-56).
Frequently Asked Questions
What is Tiagabine Hydrochloride used for?▼
INDICATIONS AND USAGE Tiagabine HCl is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.
What are the side effects of Tiagabine Hydrochloride?▼
ADVERSE REACTIONS The most commonly observed adverse events in placebo-controlled, parallel-group, add-on epilepsy trials associated with the use of tiagabine HCl 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 HCl 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%).
Can I take Tiagabine Hydrochloride during pregnancy?▼
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 ).
What are the important warnings for Tiagabine Hydrochloride?▼
WARNINGS Seizures in Patients Without Epilepsy: Post-marketing reports have shown that tiagabine HCl 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 HCl 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. CONTRAINDICATIONS Tiagabine HCl is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
Related Medications
Coffea Cruda
coffea cruda
Non-Standardized Food Allergenic Extract [EPC]
For sleeplessness with mental hyperactivity*
Europium Metallicum
europium metallicum
Jateorhiza Palmata, Boldo Leaf, Rhamnus Frangula, Scabiosa Succisa Underground Parts, Valeriana Officinalis, Dulcamara, Rumex Crispus, Argentum Metallicum
jateorhiza palmata, boldo leaf, rhamnus frangula, scabiosa succisa underground parts, valeriana officinalis, dulcamara, rumex crispus, argentum metallicum
Uses For the temporary relief of symptoms associated with mild skin irritation poor digestion
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.