Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
tiagabine hydrochloride (UNII: DQH6T6D8OY) (tiagabine - UNII:Z80I64HMNP)
Wilshire Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Tiagabine hydrochloride tablets are indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures. Tiagabine hydrochloride tablets are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. The abuse and dependence potential of tiagabine hydrochloride have not been evaluated in human studies.
Tiagabine hydrochloride tablets are available in four dosage strengths. Store tablets between 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.
Abbreviated New Drug Application
Wilshire Pharmaceuticals, Inc. ---------- MEDICATION GUIDE Tiagabine Hydrochloride Tablets (tye-AG-a-been HYE-droe-KLOR-ide) Read this Medication Guide before you start taking tiagabine hydrochloride tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about tiagabine hydrochloride tablets? Do not stop taking tiagabine hydrochloride tablets without first talking to your healthcare provider. Stopping tiagabine hydrochloride tablets suddenly can cause serious problems. Tiagabine hydrochloride tablets can cause serious side effects, including: 1. Tiagabine hydrochloride tablets may cause seizures in people who do not have epilepsy. If you do not have a seizure disorder and you take tiagabine hydrochloride tablets, you may have a seizure or seizures that do not stop (status epilepticus). Call your healthcare provider right away if you have a seizure and you are not taking tiagabine hydrochloride tablets for epilepsy. 2. Like other antiepileptic drugs, tiagabine hydrochloride tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • attempts to commit suicide • new or worse depression • new or worse anxiety • feeling agitated or restless • panic attacks • trouble sleeping (insomnia) • new or worse irritability • acting aggressive, being angry, or violent • acting on dangerous impulses • an extreme increase in activity and talking (mania) • other unusual changes in behavior or mood Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. How can I watch for early symptoms of suicidal thoughts and actio Preberite celoten dokument
TIAGABINE HYDROCHLORIDE- TIAGABINE HYDROCHLORIDE TABLET WILSHIRE PHARMACEUTICALS, INC. ---------- TIAGABINE HYDROCHLORIDE TABLETS RX ONLY DESCRIPTION Tiagabine hydrochloride tablets are 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 H NO S HCl, and its molecular weight is 412.0. Tiagabine hydrochloride is a white to off-white, odorless, crystalline powder. It is insoluble in heptane, sparingly soluble in water, and soluble in aqueous base. The structural formula is: INACTIVE INGREDIENTS Tiagabine hydrochloride tablets contain the following inactive ingredients: Anhydrous lactose, microcrystalline cellulose, pregelatinized starch, crospovidone, polyethylene glycol 6000, butylated hydroxyanisole, propyl gallate, colloidal silicon dioxide, magnesium stearate, stearic acid, hydroxypropyl cellulose, hypromellose and titanium dioxide. In addition, individual tablets contain: CLINICAL PHARMACOLOGY MECHANISM OF ACTION The precise mechanism by which tiagabine exerts its antiseizure effect is unknown, although it is believed to be related to its ability, documented in _in vitro_ experiments, to enhance the activity of gamma aminobutyric acid (GABA), the major inhibitory neurotransmitter in the central nervous system. These experiments have shown that tiagabine binds to recognition sites associated with the GABA uptake 20 25 2 2 2 mg tablets: FD&C Yellow No. 6. 4 mg tablets: D&C Yellow No. 10. 12 mg tablets: D&C Yellow No. 10 and FD&C Blue No. 1. 16 mg tablets: FD&C Blue No. 2. carrier. It is thought that, by this action, tiagabine blocks GABA uptake into presynaptic neurons, permitting more GABA to be available for receptor binding on the surfaces of post-synaptic cells. Inhibition of GABA uptake has been shown for synaptosomes, neuronal cell cultures, and glial cell cultures. In rat-derived hippocampal slices, tiagabine has been shown to prolong GA Preberite celoten dokument