BUSPIRONE- 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 10 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 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 symptoms

Product summary:

Buspirone Hydrochloride Tablets USP are available as white, oval tablets debossed with an hourglass logo, breakline and “5” on one side, “5663” on the reverse side containing 5 mg buspirone hydrochloride, packaged in bottles of 60, 100, 500 and 1000 tablets and unit-dose boxes of 100 tablets. Buspirone Hydrochloride Tablets USP are available as white, oval tablets debossed with an hourglass logo, breakline and “10” on one side, “5664” on the reverse side containing 10 mg buspirone hydrochloride, packaged in bottles of 60, 100, 500 and 1000 tablets and unit-dose boxes of 100 tablets. Buspirone Hydrochloride Tablets USP are available as white, capsule-shaped tablets debossed with “5”, breakline, “5”, breakline, “5” on one side, an hourglass logo, breakline, “56”, breakline, “65” on the reverse side containing 15 mg buspirone hydrochloride, packaged in bottles of 60, 100, 250 and 500 tablets. PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP. Use child-resistant closure (as required). Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from temperatures greater than 86°F (30°C).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUSPIRONE - BUSPIRONE HYDROCHLORIDE TABLET
STAT RX USA LLC
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DESCRIPTION
Buspirone hydrochloride 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
and is chemically designated
as
_N_-[4-[4-(2-Pyrimidinyl)-1-piperazinyl]butyl]-1,1-cyclopentanedi-acetamide
monohydrochloride. It
has the following structural formula:
BUSPIRONE 10MG STRUCTURE IMAGE
C
H N O •HCl M.W. 422.0
Buspirone hydrochloride is supplied as tablets for oral administration
containing 5 mg, 10 mg, or 15 mg
of buspirone hydrochloride (equivalent to 4.6 mg, 9.1 mg, or 13.7 mg
of buspirone free base
respectively). 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 15-mg 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 tablets contain the following inactive ingredients:
colloidal silicon dioxide, lactose
monohydrate, magnesium stearate, microcrystalline cellulose, 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 D -dopamine receptors. Some
studies do suggest that
buspirone may have indirect ef