BUSPIRONE HCL- 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:

Blenheim Pharmacal, Inc.

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 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 1 as follows: Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms

Resumo do produto:

Buspirone HCl Tablets USP are supplied as follows: 5 mg tablets: White to off-white, oval, biconvex, scored tablets, debossed WATSON and 657, in bottles of 100, 500, and 1000. 10 mg tablets: White to off-white, oval, biconvex, scored tablets, debossed WATSON and 658, in bottles of 100, 500, and 1000. 15 mg tablets:White to off-white, oval shaped, scored tablets, debossed with the Watson logo and 718, and scoring on both sides so it can be either bisected or trisected, in bottles of 60, 180, 500, and 1000. Store at 20° - 25°C (68°- 77°F). [See USP Controlled Room Temperature]. Protect from temperatures greater than 30°C (86°F). Dispense in a tight, light-resistant container as defined in USP/NF.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

BUSPIRONE HCL- BUSPIRONE HYDROCHLORIDE TABLET
BLENHEIM PHARMACAL, INC.
----------
BUSPIRONE HCL TABLETS USP
REVISED: NOVEMBER 2013
RX ONLY
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 preclinical models.
Buspirone has moderate affinity for brain D2-dopamine receptors. Some
studies do suggest that
buspirone may have indirect effects on other neurotransmitter systems.
Buspirone is rapidly absorbed in man and undergoes extensive
first-pass metabolism. In a radiolabeled
study, unchanged buspirone in the plasma accounted for only about 1%
of the radioactivity in the plasma.
Following oral administration, plasma concentrations of unchanged
buspirone are very low and variable
between subjects. Peak plasma levels of 1 to 6 ng/mL have been
observed 40 to 90 minutes after single
oral doses of 20 mg. The single-dose bioavailability of unchanged
buspirone when taken as a tablet is
on the average about 90% of an equivalent dose of solution, but there
is large variability.
The effects of food upon the bioavailability of buspirone have been
studied in eight subjects. They
were given a 20 mg dose with and without food; the area under the
plasma concentration-time curve
(AUC) and peak plasma concentration (C
) of unchanged buspirone increased by 84% and 116%,
respectively, but the total amount of buspirone immunoreactive
material did not change. This suggests
that food may decrease the extent of presystemic clearance of
buspirone (See DOSAGE AND
ADMINISTRATION).
A multiple-dose study conducted in 15 subjects suggests that buspirone
has nonline