BUSPIRONE HYDROCHLORIDE- 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:

NCS HealthCare of KY, Inc dba Vangard Labs

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 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, III 1 as follows: Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptomsfrom three o

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. Store at controlled room temperature 15°-30°C (59°-86°F) [see USP]. Dispense in tight, light-resistant container (USP).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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BUSPIRONE HYDROCHLORIDE 7-5MG
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
N-[4-[4-(2-Pyrimidinyl)-1-piperazinyl]butyl]-1,1-
cyclopentanediacetamide 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 5 mg, 7.5 mg, 10 mg or
15 mg of buspirone hydrochloride USP. The 5 mg and 10 mg tablets are
scored so they can be bisected.
Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg
tablet can provide a 5 mg dose. The
15 mg tablet is scored so it can be either bisected or trisected.
Thus, a single 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). Buspirone hydrochloride tablets contain
the following inactive ingredients:
lactose monohydrate, magnesium stearate, microcrystalline cellulose,
povidone, sodium starch
glycolate and FD&C yellow #6 aluminum lake. FD&C yellow #6 aluminum
lake is not used in the
manufacturing of 7.5 mg strength.
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-HT1A ) receptors.
Buspirone has no significant
affinity for benzodiazepine receptors and does not affect GABA binding
_in vitro _or _in vivo _when tested
in pr