BUSPIRONE HCL tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

BUSPIRONE HYDROCHLORIDE (UNII: 207LT9J9OC) (BUSPIRONE - UNII:TK65WKS8HL)

제공처:

RedPharm Drug, Inc.

INN (International Name):

BUSPIRONE HYDROCHLORIDE

구성:

BUSPIRONE HYDROCHLORIDE 5 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, lll1 as follows: Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of

제품 요약:

Buspirone HCl Tablets USP are supplied as follows: 5 mg tablets: White to off-white, oval, biconvex, scored tablets, debossed WATSON and 657, in bottles of 100, 500, and 1000. 10 mg tablets: White to off-white, oval, biconvex, scored tablets, debossed WATSON and 658, in bottles of 100, 500, and 1000. 15 mg tablets:White to off-white, oval shaped, scored tablets, debossed with the Watson logo and 718, and scoring on both sides so it can be either bisected or trisected, in bottles of 60, 180, 500, and 1000. Store at 20° - 25°C (68°- 77°F). [See USP Controlled Room Temperature]. Protect from temperatures greater than 30°C (86°F). Dispense in a tight, light-resistant container as defined in USP/NF.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

BUSPIRONE HCL- BUSPIRONE HCL TABLET
REDPHARM DRUG, INC.
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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 C21H31N5O2 • HCl is
represented by the following structural formula:
[Buspirone hydrochloride 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-HT1A) receptors.
Buspirone has no significant
affinity for benzodiazepine receptors and does not affect GABA binding
in vitro or in vivo when tested
in preclinical models.
Buspirone has mod