BUSPIRONE HYDROCHLORIDE tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Bryant Ranch Prepack

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Buspirone hydrochloride tablets, USP 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, USP 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, USP 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 mon

Tóm tắt sản phẩm:

NDC: 71335-1749-1: 60 Tablets in a BOTTLE NDC: 71335-1749-2: 30 Tablets in a BOTTLE NDC: 71335-1749-3: 56 Tablets in a BOTTLE NDC: 71335-1749-4: 90 Tablets in a BOTTLE NDC: 71335-1749-5: 180 Tablets in a BOTTLE NDC: 71335-1749-6: 15 Tablets in a BOTTLE NDC: 71335-1749-7: 120 Tablets in a BOTTLE

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET
BRYANT RANCH PREPACK
----------
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
with a molecular
weight of 421.96. Chemically, buspirone hydrochloride is
N-[4-[4-(2-pyrimidinyl)-1-
piperazinyl]butyl]-1,1-cyclopentanediacetamide monohydrochloride. The
empirical
formula C
H
N O •HCl is represented by the following structural formula:
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