BUSPIRONE HYDROCHLORIDE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

RPK Pharmaceuticals, Inc.

INN (International Name):

BUSPIRONE HYDROCHLORIDE

구성:

BUSPIRONE HYDROCHLORIDE 10 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 hydrochloride tablets 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 hydrochloride tablets 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, III1 as follows: Generalized, persistent anxiety (of at least 1 month continual du

제품 요약:

Product: 53002-1017 NDC: 53002-1017-3 30 TABLET in a BOTTLE NDC: 53002-1017-6 60 TABLET in a BOTTLE NDC: 53002-1017-0 100 TABLET in a BOTTLE

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET
RPK PHARMACEUTICALS, INC.
----------
BUSPIRONE HYDROCHLORIDE TABLETS USP
RX ONLY
DESCRIPTION
Buspirone hydrochloride tablets USP are 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. Chemically,
buspirone hydrochloride is
_N_-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-1,1-
cyclopentanediacetamide monohydrochloride, which can be represented by
the following
structural formula:
C
H
N O •HCl M.W. 421.96
Each tablet, for oral administration, contains 5 mg, 10 mg, 15 mg or
30 mg of buspirone
hydrochloride, USP (equivalent to 4.6 mg, 9.1 mg, 13.7 mg, and 27.4 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 tablets are scored such that they
may be bisected
or trisected. Thus, a single 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). The 30 mg tablets are scored such that they may be bisected
or trisected. Thus,
a single tablet can provide the following doses: 30 mg (entire
tablet), 20 mg (two-thirds
of a tablet), 15 mg (one-half of a tablet), or 10 mg (one-third of a
tablet). Buspirone
hydrochloride tablets USP contain the following inactive ingredients:
anhydrous lactose,
colloidal silicon dioxide, 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 hi