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:

McKesson Contract Packaging

INN (International Name):

BUSPIRONE HYDROCHLORIDE

Composition:

BUSPIRONE HYDROCHLORIDE 5 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET
MCKESSON CONTRACT PACKAGING
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BUSPIRONE HYDROCHLORIDE TABLETS USP
RX ONLY
DESCRIPTION
Buspirone hydrochloride tablets USP are 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. Chemically, buspirone
hydrochloride is
_N_-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-1,1-cyclopentanediacetamide
monohydrochloride, which can be represented by the following
structural formula:
C
H N O •HCl M.W. 421.96
Each tablet, for oral administration, contains 5 mg, 10 mg, 15 mg or
30 mg of buspirone hydrochloride
USP (equivalent to 4.6 mg, 9.1 mg, 13.7 mg and 27.4 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 tablets
are scored such that they may be
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). The 30 mg tablets
are scored such that they may be bisected or trisected. Thus, a single
tablet can provide the following
doses: 30 mg (entire tablet), 20 mg (two-thirds of a tablet), 15 mg
(one-half of a tablet), or 10 mg (one-
third of a tablet). Buspirone hydrochloride tablets USP contain the
following inactive ingredients:
anhydrous lactose, colloidal silicon dioxide, 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 hi