BUSPIRONE HYDROCHLORIDE tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Par Pharmaceutical, Inc.

INN (International Name):

BUSPIRONE HYDROCHLORIDE

Sammensætning:

BUSPIRONE HYDROCHLORIDE 7.5 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 continual d

Produkt oversigt:

Buspirone Hydrochloride Tablets, USP are available containing 7.5 mg of buspirone hydrochloride, USP. The 7.5 mg tablets are off-white, oval shaped tablets debossed with “Par 725” bisected on one side and “7.5” on the other side. NDC 49884-725-01 bottles of 100 NDC 49884-725-05 bottles of 500 Store at 25° C (77° F); excursions permitted between 15° C to 30° C (59° F to 86° F) [see USP controlled room temperature]. Dispense in tight, light-resistant container (USP).

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET
PAR PHARMACEUTICAL, INC.
----------
BUS PIRONE-ANDA075467
DESCRIPTION
Buspirone hydrochloride tablets, USP are an antianxiety agent that are
not chemically or
pharmacologically related to the benzodiazepines, barbiturates, or
other sedative/anxiolytic drugs.
Buspirone hydrochloride, USP 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 molecular formula
C
H N O •HCl is
represented by the following structural formula:
Buspirone hydrochloride is supplied as tablets for oral administration
containing 7.5 mg of buspirone
hydrochloride. Buspirone hydrochloride tablets contain the following
inactive ingredients: lactose
monohydrate, magnesium stearate, microcrystalline cellulose, povidone,
and sodium starch glycolate
(potato).
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 hydrochloride tablets are 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