Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Cephalon UK Limited, Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX, United Kingdom
Gabitril is an anti-epileptic drug indicated as add-on therapy for partial seizures with or without secondary generalisation where control is not achieved by optimal doses of at least one other anti-epileptic drug.
Gabitril should be taken orally with meals.
Dosing schemes may need to be individualised based upon a patient’s particular characteristics such as age and concomitant medications.
As CYP3A4/5 is involved in the metabolism of tiagabine, it is recommended that the dose of tiagabine is adjusted when it is taken in combination with CYP3A4/5 inducers (see section 4.5 Interactions with other medicinal products and other forms of interactions).
Following a given dose of tiagabine, the estimated plasma concentration in non-induced patients is more than twice that in patients receiving enzyme-inducing agents. To achieve similar systemic exposures of tiagabine, non-induced patients require lower and less frequent doses of tiagabine than induced patients. These patients may also require a slower titration of tiagabine compared to that of induced patients. Dosage adjustment of tiagabine should be considered whenever a change in patient’s metabolic enzyme-inducing status occurs as a result of the addition, discontinuation, or dose change of the enzyme-inducing agent.
The initial daily dose is 5-10 mg tiagabine, followed by weekly increments of 5-10 mg/day. The 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. 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.
There is no experience with Gabitril in children under 12 years of age and as such Gabitril should not be used in this age group.
The pharmacokinetic properties of tiagabine do not seem to be significantly modified in the elderly. However, only limited information is available on the use of tiagabine in elderly patients. It is therefore recommended to use tiagabine with caution in this age group.
Renal insufficiency does not affect the pharmacokinetics of tiagabine, therefore the dosage does not need to be modified in these types of patients.
Tiagabine is metabolised in the liver and since the pharmacokinetics of tiagabine in patients with mild to moderate impaired liver function is modified (see Section 5.2), the Gabitril dosage should be adjusted by reducing the individual doses and/or prolonging the dose intervals.
Gabitril should not be used in patients with severely impaired hepatic function (see Section 4.3).
Symptoms most often accompanying Gabitril overdose, alone or in combination with other drugs, have included seizures, including status epilepticus, in patients with and without underlying seizure disorders, respiratory depression, respiratory arrest, coma, loss of consciousness, spike wave stupor, encephalopathy, amnesia, confusion, disorientation, somnolence, dyskinesia, myoclonus, tremors, ataxia or incoordination, dizziness, nystagmus, impaired speech, headache, psychotic disorder, hallucinations, hostility, aggression, agitation, vomiting, hypersalivation, bradycardia, tachycardia, ST wave changes, hypertension, hypotension and urinary incontinence. In more severe instances, mute and withdrawn appearance of the patient and risk of convulsion have been reported.
From post-marketing experience, there have been no reports of fatal overdoses involving Gabitril alone (doses up to 720 mg), although a number of patients required intubation and ventilatory support as part of the management of their status epilepticus.
In case of overdose, standard symptomatic treatment and medical observation with supportive care is recommended. Hospitalisation can be recommended in cases of severe overdoses. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of more than 2 mg/kg.
4 years.
Do not store above 25°C.
Store in the original package.
Child resistant, white polyethylene bottles with white polypropylene screw closures with an embedded desiccant agent.
Packs containing 50 and 100 tablets. Not all pack sizes may be marketed.
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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