BUSPIRONE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvKARE

INN (International Name):

BUSPIRONE HYDROCHLORIDE

Composition:

BUSPIRONE HYDROCHLORIDE 7.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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, III 1 as follows: Generalized, persistent anxiety (of at least 1 mont

Product summary:

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 42291-176-90 bottles of 90 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).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET
AVKARE
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BUSPIRONE HCI TABLETS, USP
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 levels of 1 n