BUSPIRONE HCL hydrochloride tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Medsource Pharmaceuticals

INN (Mezinárodní Name):

BUSPIRONE HYDROCHLORIDE

Složení:

BUSPIRONE HYDROCHLORIDE 10 mg

Druh předpisu:

PRESCRIPTION DRUG

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

BUSPIRONE HCL- BUSPIRONE HYDROCHLORIDE TABLET
MEDSOURCE PHARMACEUTICALS
----------
BUSPIRONE HCL TABLETS USP
REVISED: NOVEMBER 2013
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
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:
Each tablet for oral administration containing 5 mg, 10 mg, or 15 mg
of buspirone hydrochloride USP
(equivalent to 4.6 mg, 9.1 mg, and 13.7 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 tablet is provided in
a special tablet design. This tablet
is scored so it 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). In addition, each tablet contains the following
inactive ingredients: colloidal silicon
dioxide, lactose monohydrate, 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 buspirone has a high affinity for serotonin (5-HT
) receptors. Buspirone has no significant
affinity for benzodiazepine receptors and does not affect GABA binding
_in vitro_ or _in vivo_ when tested
in preclin