BUSPIRONE HCL- buspirone hydrochloride tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

TYA Pharmaceuticals

INN (Nome Internazionale):

BUSPIRONE HYDROCHLORIDE

Composizione:

BUSPIRONE HYDROCHLORIDE 10 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 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 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, lll as follows: 1 Generalized, persistent anxiety (of at least 1 month continual duration), manifes

Dettagli prodotto:

NDC:64725-0658-1 in a BOTTLE of 100 TABLETS

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

BUSPIRONE HCL- BUSPIRONE HYDROCHLORIDE TABLET
TYA PHARMACEUTICALS
----------
REVISED: NOVEMBER 2013 BUSPIRONE HCL 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
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.
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 or when
tested in preclinical models. _In_
_vitro_
_in vitroin