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:

Northwind Pharmaceuticals, LLC

INN (International Name):

BUSPIRONE HYDROCHLORIDE

Composition:

BUSPIRONE HYDROCHLORIDE 15 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 tablets 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 hydrochloride tablets 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

Product summary:

BusPIRone Hydrochloride Tablets USP, 15 mg are available as white to off-white, rectangular, tablets that can either be bisected or trisected, debossed “TV” and “1003” on bisect segments, and debossed “5” on each trisect segment, and packaged in bottles of 30 (NDC 51655-015-52), bottles of 90 (NDC 51655-015-26). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET
NORTHWIND PHARMACEUTICALS, LLC
----------
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
21
31
5
2
anxiolytics. _In vitro_ preclinical studies have shown that bus