BUSPIRONE HYDROCHLORIDE tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

DIRECT RX

INN (mednarodno ime):

BUSPIRONE HYDROCHLORIDE

Sestava:

BUSPIRONE HYDROCHLORIDE 5 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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: Generalized, persistent anxiety (of at least 1 month continual du

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET
DIRECT RX
----------
BUSPIRONE
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 21H 31N 5O 2• HCl is
represented by the following structural formula:
[Buspirone 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 1 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
Note :- Not applicable for divided doses
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