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:

STAT RX USA LLC

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 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, III1 as follows: Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptom

Product summary:

Buspirone hydrochloride Tablets, USP, 7.5 mg (off-white, oval shaped tablet debossed with “Par 725” bisected on one side and “7.5” on the other side. 7.5 mg tablets      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).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUSPIRONE HYDROCHLORIDE - BUSPIRONE HYDROCHLORIDE TABLET
STAT RX USA LLC
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DESCRIPTION
Buspirone hydrochloride, USP 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 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 USP. Buspirone hydrochloride tablets contain the
following inactive ingredients: lactose
monohydrate, magnesium stearate, microcrystalline cellulose, povidone,
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. _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 is rapidly absorbed in man and undergoes
extensive first-pass metabolism. In a
radio-labeled 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 1ng/mL to 6 ng/mL have
been observed 40 to 90 m