BUSPIRONE HYDROCHLORIDE tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

BUSPIRONE HYDROCHLORIDE

Sammensætning:

BUSPIRONE HYDROCHLORIDE 10 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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, III 1 as follows: Ge

Produkt oversigt:

BusPIRone Hydrochloride Tablets, USP 10 mg are available as white colored, ovoid rectangular shape, biconvex, uncoated tablet, debossed with “B” and “3” on either side of breakline on one side and another side is plain containing 10 mg buspirone hydrochloride. NDC 43063-785-30 Bottles of 30 NDC 43063-785-90 Bottles of 90 PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 25°C (77°F); excursions permitted between 15° C to 30° C (59° F to 86° F) [see USP controlled room temperature]. KEEP THIS AND ALL OUT OF THE REACH OF CHILDREN.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET
PD-RX PHARMACEUTICALS, INC.
----------
BUSPIRONE HYDROCHLORIDE TABLETS
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 422.0. Chemically, buspirone hydrochloride is
_8_-[4-[4-(2-pyrimidinyl)-1-
piperazinyl]butyl]8-azaspiro[4.5]decane-7,9-dione monohydrochloride.
The empirical
formula C
H
N
O
• HCl is represented by the following structural formula:
Buspirone hydrochloride is supplied as tablets for oral administration
contains 5 mg, 7.5
mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP. The 5 mg,
7.5 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: colloidal silicon dioxide, lactose
monohydrate, magnesium
stearate, microcrystalline cellulose, and sodium starch glycolate
(Type A - potato starch).
1
CLINICAL PHARMACOLOGY
The mechanism of action of buspirone is unknown. Buspirone differs
from typical
21
31
5
2
1
Note :- Not applicable for divided doses
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
an