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:

A-S Medication Solutions

INN (Tên quốc tế):

BUSPIRONE HYDROCHLORIDE

Thành phần:

BUSPIRONE HYDROCHLORIDE 10 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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 have 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 d

Tóm tắt sản phẩm:

Product: 50090-2998 NDC: 50090-2998-0 1 TABLET in a BLISTER PACK / 33 in a CARTON

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET
A-S MEDICATION SOLUTIONS
----------
(PATIENT INSTRUCTION SHEET INCLUDED.)
DESCRIPTION
Buspirone hydrochloride tablets, USP are an antianxiety agent that are
not chemically or
pharmacologically related to the benzodiazepines, barbiturates, or
other sedative/anxiolytic drugs.
Buspirone hydrochloride, USP 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 molecular formula
C
H N O •HCl is
represented by the following structural formula:
Buspirone hydrochloride tablets are supplied as tablets for oral
administration containing 5 mg, 7.5 mg,
10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to
4.6 mg, 6.9 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 and 30 mg tablets are provided in a multi-scored
tablet design. These tablets are
scored so they 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). A single 30 mg 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 contain the following inactive ingredients:
anhydrous lactose, colloidal silicon
dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl
sulfate, and sodium starch
glycolate (potato).
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
sedati