BUSPIRONE HYDROCHLORIDE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

DirectRX

DCI (Denominação Comum Internacional):

BUSPIRONE HYDROCHLORIDE

Composição:

BUSPIRONE HYDROCHLORIDE 10 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

- 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 have 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, III1 as follows: Generalized, persistent anxiety (of at least 1 month continua

Status de autorização:

Abbreviated New Drug Application

Características técnicas

BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET
DIRECTRX
----------
BUSPIRONE HYDROCHLORIDE
DESCRIPTION SECTION
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, USP is a white crystalline powder. It is very
soluble in water; freely soluble
in methanol and in methylene chloride; sparingly soluble in ethanol
and in acetonitrile; very slightly
soluble in ethyl acetate and practically insoluble in hexanes. Its
molecular weight is 422. Chemically,
buspirone hydrochloride is
8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-
dione monohydrochloride. The molecular formula C21H31N5O2•HCl is
represented by the following
structural formula:
Structural formula
Each buspirone hydrochloride tablet intended for oral administration
contains 5 mg or 10 mg or 15 mg
or 30 mg buspirone hydrochloride (equivalent to 4.6 mg, 9.1 mg, 13.7
mg, and 27.4 mg of buspirone
free base, respectively). In addition, each tablet contains the
following inactive ingredients: colloidal
silicon dioxide, lactose monohydrate, magnesium stearate,
microcrystalline cellulose and sodium starch
glycolate. The 5 mg and 10 mg tablets are scored so they can be
bisected. Thus, the 5 mg tablet can also
provide 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).
CLINICAL PHARMACOLOGY SECTION
The mechanism of action of buspirone is unknown. Buspirone differs
from typical benzodiazepine
anxiolytics in that it does not exert anticonvulsant