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:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

ИНН (Международная Имя):

BUSPIRONE HYDROCHLORIDE

состав:

BUSPIRONE HYDROCHLORIDE 5 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 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 durat

Обзор продуктов:

Buspirone Hydrochloride Tablets USP, 5 mg are available as round, white to off white tablet, scored, debossed “HP ” above and “23 ” below the score on one side and plain on the reverse side. They are available as follows: Bottles of 100: NDC 23155-023-01 Bottles of 500: NDC 23155-023-05 Bottles of 1000: NDC 23155-023-10 Buspirone Hydrochloride Tablets USP, 10 mg are available as round, white to off white tablet, scored, debossed “HP ” above and “24 ” below the score on one side and plain on the reverse side. They are available as follows: Bottles of 100: NDC 23155-024-01 Bottles of 500: NDC 23155-024-05 Bottles of 1000: NDC 23155-024-10 Buspirone Hydrochloride Tablets USP, 15 mg are available as capsule shaped, white to off white tablet, Debossed “HP ” on one bisect and “25 ” on bisect segment and Debossed “5 ” on each trisect segment on the other side. They are available as follows: Bottles of 60: NDC 23155-025-06 Bottles of 100: NDC 23155-025-01 Bottles of 180: NDC 23155-025-08 Bottles of 500: NDC 23155-025-05 Buspirone Hydrochloride tablets USP, 30 mg are available as capsule shaped, peach color tablet, Debossed “HP ” on one bisect and “97 ” on other bisect segment and, Debossed “10 ” on each trisect segment on other side. They are available as follows: Bottles of 60: NDC 23155-097-06 Bottles of 100: NDC 23155-097-01 Bottles of 500: NDC 23155-097-05 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
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
----------
BUSPIRONE HYDROCHLORIDE TABLETS, USP
RX ONLY
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 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 and 30 mg 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, USP contain the
following inactive
ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium
stearate,
microcrystalline cellulose, and sodium starch glycolate. The 30 mg
tablets also contain
FD&C Yellow No. 6 Aluminum Lake.
CLINICAL PHARMACOLOGY
The mechanism of action of buspirone is unknown. Buspirone differs
from typical
21
31
5
2
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
anxio