국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
BUSPIRONE HYDROCHLORIDE (UNII: 207LT9J9OC) (BUSPIRONE - UNII:TK65WKS8HL)
Medsource Pharmaceuticals
BUSPIRONE HYDROCHLORIDE
BUSPIRONE HYDROCHLORIDE 10 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
BUSPIRONE HCL- BUSPIRONE HYDROCHLORIDE TABLET MEDSOURCE PHARMACEUTICALS ---------- BUSPIRONE HCL TABLETS USP REVISED: NOVEMBER 2013 RX ONLY DESCRIPTION Buspirone hydrochloride is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]-butyl]-8- azaspiro[4.5]decane-7,9- dione monohydrochloride. The empirical formula C H N O • HCl is represented by the following structural formula: Each tablet for oral administration containing 5 mg, 10 mg, or 15 mg of buspirone hydrochloride USP (equivalent to 4.6 mg, 9.1 mg, and 13.7 mg of buspirone free base respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg tablet is provided in a special tablet design. This tablet is scored so it can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. CLINICAL PHARMACOLOGY The mechanism of action of buspirone is unknown. Buspirone differs from typical benzodiazepine anxiolytics in that it does not exert anticonvulsant or muscle relaxant effects. It also lacks the prominent sedative effect that is associated with more typical anxiolytics. _In vitro_ preclinical studies have shown that buspirone has a high affinity for serotonin (5-HT ) receptors. Buspirone has no significant affinity for benzodiazepine receptors and does not affect GABA binding _in vitro_ or _in vivo_ when tested in preclin 전체 문서 읽기