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:

Clinical Solutions Wholesale, LLC

INN (International Name):

BUSPIRONE HYDROCHLORIDE

Composition:

BUSPIRONE HYDROCHLORIDE 15 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET
CLINICAL SOLUTIONS WHOLESALE, LLC
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BUSPIRONE HYDROCHLORIDE TABLETS, USP
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, USP is a white crystalline powder. It is very
soluble in water; freely soluble
in methanol and in methylene chloride; sparingly soluble in ethanol
and in acetonitrile; very slightly
soluble in ethyl acetate and practically insoluble in hexanes. Its
molecular weight is 422. Chemically,
buspirone hydrochloride is
8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-
dione monohydrochloride. The molecular formula C21H31N5O2•HCl is
represented by the following
structural formula:
Each buspirone hydrochloride tablet intended for oral administration
contains 10 mg or 15 mg buspirone
hydrochloride (equivalent to 9.1 mg and 13.7 mg of buspirone free
base, respectively). In addition, each
tablet contains the following inactive ingredients: colloidal silicon
dioxide, lactose monohydrate,
magnesium stearate, microcrystalline cellulose and sodium starch
glycolate. The 10 mg tablets are
scored so they can be bisected. Thus, the 10 mg tablet can provide a 5
mg dose. The 15 mg tablets are
scored so they 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).
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