Adult Dosing
Adjunctive therapy for treatment of partial seizures (patients who are receiving enzyme-inducing antiepilepsy drugs)
- Initial dose: 4 mg PO qd
- Increase by 4-8 mg/day PO divided bid-qid at weekly intervals until clinical response is achieved or up to 56 mg/day
- Usual maintenance dose: 32-56 mg/day PO divided bid-qid
- Max: 56 mg/day
Note:- Take tiagabine with food; avoid using a loading dose
- Avoid rapid escalation and/or large dose increments of tiagabine
- In case of a missed dose, do not take double doses to make up for the missed one. For missed multiple doses, advise patients to consult a physician for possible re-titration as clinically indicated
- Consider dose adjustment of tiagabine whenever a change in patient's enzyme-inducing status occurs as a result of addition, discontinuation, or dose change of the enzyme-inducing agent
- Following a given dose of tiagabine, plasma concentration in the non-induced patients (patients receiving non-enzyme-inducing AEDs) is more than twice that in induced patients. Thus, non-induced patients require lower doses and a slower titration of tiagabine
Pediatric Dosing
- Safety and effectiveness in pediatric patients <12 yrs of age have not been established
Adjunctive therapy for treatment of partial seizures (patients who are receiving enzyme-inducing antiepilepsy drugs)
Children 
12 yrs
- Initial dose: 4 mg PO qd
- Increase by 4 mg/day PO after 1 week and then by 4-8 mg PO divided bid-qid at weekly intervals until clinical response occurs or up to 32 mg/day
- Max: 32 mg/day
Note:
- Take tiagabine with food; avoid using a loading dose
- Avoid rapid escalation and/or large dose increments of tiagabine
- In case of a missed dose, do not take double doses to make up for the missed one. For missed multiple doses, advise patients to consult a physician for possible re-titration as clinically indicated
- Consider dose adjustment of tiagabine whenever a change in patient's enzyme-inducing status occurs as a result of addition, discontinuation, or dose change of the enzyme-inducing agent
- Following a given dose of tiagabine, plasma concentration in the non-induced patients (patients receiving non-enzyme-inducing AEDs) is more than twice that in induced patients. Thus, non-induced patients require lower doses and a slower titration of tiagabine
[Outline]
See Supplemental Patient Information
- Tiagabine use has been associated with new onset seizures and status epilepticus in patients without epilepsy according to post-marketing reports; dose may be a significant predisposing factor. Discontinue use in nonepileptic patients who develop seizures during treatment and evaluate patients for an underlying seizure disorder
- Safety and efficacy of tiagabine have not been established for any indication other than as adjunctive therapy for partial seizures in patients 12 yrs of age
- Increased risk of suicidal thoughts or behavior has been reported in patients receiving tiagabine. Closely observe patients for the emergence or worsening of depression, suicidality, and/or any unusual changes in mood or behavior
- Anyone considering prescribing tiagabine must balance the risk of suicidal thoughts or behaviors with the risk of untreated illness. If suicidal thoughts or behavior emerge during treatment, the prescriber needs to evaluate whether the emergence of these symptoms may be related to the illness being treated
- Alert families and caregivers of patients being treated with AEDs about the need to monitor patients for the emergence or worsening of depression signs and symptoms, unusual changes in behavior, and also for the emergence of suicidality, and to report such symptoms immediately to health care providers
- Avoid abrupt discontinuation of therapy because of the possibility of increasing seizure frequency
- Impaired concentration, speech or language problems, confusion, somnolence and fatigue have been reported with tiagabine use; some of these events were dose related and occurred usually during initial titration. Exacerbations of EEG abnormalities associated with these cognitive/neuropsychiatric events have been reported in patients with a history of spike and wave discharges on EEG; consider dose modification in these patients
- Moderately severe to incapacitating generalized weakness has been reported with tiagabine use; however, weakness resolved following dose reduction or discontinuation of therapy
- Virtually all experience with tiagabine has been obtained in patients with epilepsy receiving at least one concomitant enzyme-inducing AED, which lowers the plasma levels of tiagabine. Use in non-induced patients requires lower doses of tiagabine. These patients may also require a slower titration of tiagabine compared to that of induced patients
- Tiagabine may bind to melanin-containing tissues. Prolonged use may cause toxicity and ophthalmologic changes
- Dosage reduction may be necessary in patients with liver disease because of the reduced clearance of tiagabine in these patients
- Serious rash may develop with the use of therapy
Caution: Use cautiously in
- Hepatic impairment
- Hx of EEG spike and wave discharges
- Hx of depression
- Non-epileptic patients
- Avoid abrupt withdrawal
- Hx of status epilepticus
- Patients not on enzyme-inducing anticonvulsants
- CNS depressant use
- Alcohol use
Supplemental Patient Information
- Advise patients to refrain from hazardous activities requiring mental alertness such as operating a machinery or driving an automobile until they have gained sufficient experience on tiagabine
- Advise patients to communicate with their physicians if they become pregnant during a course of therapy or intend to become pregnant
- Inform the patients, families and caregivers of the need to be alert for the emergence or worsening of depression symptoms, unusual changes in behavior, and suicidal ideation; instruct them to immediately report such symptoms to the health professional
- Patients should be advised to avoid excessive use of alcohol during therapy
Pregnancy Category:C
Breastfeeding: Monitor the infant for drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants and when using combinations of anticonvulsant or psychotropic drugs. As there is no published experience with tiagabine during breastfeeding, other agents may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 30 May 2011). Manufacturer recommends tiagabine use in nursing mothers only if the benefits clearly outweigh the risks.
Pricing data from www.DrugStore.com in U.S.A.
- Gabitril 4 MG TABS [Bottle] (CEPHALON)
30 mg = $185.48
90 mg = $520.84 - Gabitril 2 MG TABS [Bottle] (CEPHALON)
30 mg = $192.01
90 mg = $542.49 - Gabitril 16 MG TABS [Bottle] (CEPHALON)
30 mg = $300.26
90 mg = $855.78 - Gabitril 12 MG TABS [Bottle] (CEPHALON)
30 mg = $210
90 mg = $599.94
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
