Gabitril Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Gabitril (tiagabine hydrochloride) is used alone or in combination with other medications to treat partial seizures in adults and children who are at least 12 years old. It is an anti-epileptic medication (anticonvulsant). This medication is available in generic form. Common side effects include inability to concentrate, dizziness, drowsiness, nervousness, irritability, tiredness, or shaking.
The recommended starting dose of Gabitril for adult patients who are already taking enzyme-inducing antiepilepsy drugs (AEDs) is 4 mg once daily. The total daily dose may be increased by 4 to 8 mg at weekly intervals until clinical response is achieved or, up to 56 mg/day. The starting dose in adolescents 12 to 18 years old is 4 mg once daily, which may be increased by 4 to 8 mg at weekly intervals, up to 32 mg/day. Gabitril may interact with cold or allergy medicines, narcotics, sleeping pills, muscle relaxers, medicines for depression or anxiety, medicines to treat a psychiatric disorder, diet pills, stimulants, or ADHD medications, carbamazepine, divalproex, phenobarbital, phenytoin, primidone, or valproic acid. Tell your doctor all medications you use. Gabitril should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Gabitril (tiagabine hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Gabitril in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; fever; swollen glands; painful sores in or around your eyes or mouth; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have any of these serious side effects:
- new or worsened seizures;
- confusion, hallucination;
- problems with speech or vision;
- severe blistering, peeling, and red skin rash;
- tremor;
- fever, chills, body aches, flu symptoms; or
- chest pain, fast heart rate.
Less serious side effects may include:
- dizziness, drowsiness, weakness, tired feeling;
- feeling restless, irritable, or depressed;
- nausea, vomiting, stomach pain, diarrhea;
- trouble concentrating;
- sleep problems (insomnia);
- lack of coordination;
- cough, sore throat; or
- weight changes.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Gabitril (Tiagabine Hydrochloride)
The most commonly observed adverse events in placebo-controlled, parallel-group, add-on epilepsy trials associated with the use of GABITRIL (tiagabine hydrochloride) 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 GABITRIL (tiagabine hydrochloride) 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%).
In Studies 1 and 2 (U.S. studies), the double-blind, placebo-controlled, parallel-group, add-on studies, the proportion of patients who discontinued treatment because of adverse events was 11% for the group treated with GABITRIL (tiagabine hydrochloride) and 6% for the placebo group. The most common adverse events considered the primary reason for discontinuation were confusion (1.2%), somnolence (1.0%), and ataxia (1.0%).
Adverse Event Incidence in Controlled Clinical Trials: Table 5 lists treatment-emergent signs and symptoms that occurred in at least 1% of patients treated with GABITRIL (tiagabine hydrochloride) for epilepsy participating in parallel-group, placebo-controlled trials and were numerically more common in the GABITRIL (tiagabine hydrochloride) group. In these studies, either GABITRIL (tiagabine hydrochloride) or placebo was added to the patient's current antiepilepsy drug therapy. Adverse events were usually mild or moderate in intensity.
The prescriber should be aware that these figures, obtained when GABITRIL (tiagabine hydrochloride) was added to concurrent antiepilepsy drug therapy, cannot be used to predict the frequency of adverse events in the course of usual medical practice when patient characteristics and other factors may differ from those prevailing during clinical studies. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. An inspection of these frequencies, however, does provide the prescribing physician with one basis to estimate the relative contribution of drug and non-drug factors to the adverse event incidences in the population studied.
Table 5: Treatment-Emergent Adverse Event1 Incidence in Parallel-Group, Placebo-Controlled, Add-On Trials (events in at least 1% of patients treated with GABITRIL (tiagabine hydrochloride) and numerically more frequent than in the placebo group)
| BODY SYSTEM/COSTART | GABITRIL (TIAGABINE HYDROCHLORIDE) N=494 % | PLACEBO N=275 % |
| Body as a Whole | ||
| Abdominal Pain | 7 | 3 |
| Pain (unspecified) | 5 | 3 |
| Cardiovascular | ||
| Vasodilation | 2 | 1 |
| Digestive | ||
| Nausea | 11 | 9 |
| Diarrhea | 7 | 3 |
| Vomiting | 7 | 4 |
| Increased Appetite | 2 | 0 |
| Mouth Ulceration | 1 | 0 |
| Musculoskeletal | ||
| Myasthenia | 1 | 0 |
| Nervous System | ||
| Dizziness | 27 | 15 |
| Asthenia | 20 | 14 |
| Somnolence | 18 | 15 |
| Nervousness | 10 | 3 |
| Tremor | 9 | 3 |
| Difficulty with Concentration/Attention* | 6 | 2 |
| Insomnia | 6 | 4 |
| Ataxia | 5 | 3 |
| Confusion | 5 | 3 |
| Speech Disorder | 4 | 2 |
| Difficulty with Memory* | 4 | 3 |
| Paresthesia | 4 | 2 |
| Depression | 3 | 1 |
| Emotional Lability | 3 | 2 |
| Abnormal Gait | 3 | 2 |
| Hostility | 2 | 1 |
| Nystagmus | 2 | 1 |
| Language Problems* | 2 | 0 |
| Agitation | 1 | 0 |
| Respiratory System | ||
| Pharyngitis | 7 | 4 |
| Cough Increased | 4 | 3 |
| Skin and Appendages | ||
| Rash | 5 | 4 |
| Pruritus | 2 | 0 |
| 1 Patients in these add-on studies were receiving one to three concomitant enzyme-inducing antiepilepsy drugs in addition to GABITRIL (tiagabine hydrochloride) or placebo. Patients may have reported multiple adverse experiences; thus, patients may be included in more than one category. *COSTART term substituted with a more clinically descriptive term. | ||
Other events reported by 1% or more of patients treated with GABITRIL (tiagabine hydrochloride) but equally or more frequent in the placebo group were: accidental injury, chest pain, constipation, flu syndrome, rhinitis,anorexia, back pain, dry mouth, flatulence, ecchymosis, twitching, fever,amblyopia, conjunctivitis, urinary tract infection, urinary frequency, infection,dyspepsia, gastroenteritis, nausea and vomiting, myalgia, diplopia, headache, anxiety, acne, sinusitis, and incoordination.
Study 1 was a dose-response study including doses of 32 mg and 56 mg. Table 6 shows adverse events reported at a rate of ≥ 5% in at least one GABITRIL (tiagabine hydrochloride) group and more frequent than in the placebo group. Among these events, depression, tremor, nervousness, difficulty with concentration/attention, and perhaps asthenia exhibited a positive relationship to dose.
Table 6: Treatment-Emergent Adverse Event Incidence in Study l†(events in at least 5% of patients treated with GABITRIL (tiagabine hydrochloride) 32 or 56 mg and numerically more frequent than in the Dlacebo group)
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