BUSPIRONE HYDROCHLORIDE tablet

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Rebel Distributors Corp

ИНН (Международная Имя):

BUSPIRONE HYDROCHLORIDE

состав:

BUSPIRONE HYDROCHLORIDE 15 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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

Обзор продуктов:

BusPIRone Hydrochloride Tablets USP, 15 mg are available as white to off-white, rectangular, tablets that can either be bisected or trisected, debossed “TV” and “1003” on bisect segments, and debossed “5” on each trisect segment, and packaged in bottles of 100 and 500 tablets. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET
REBEL DISTRIBUTORS CORP
----------
BUSPIRONE HYDROCHLORIDE TABLETS USP
0053
0054
1003
5200
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 bu