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:

NuCare Pharmaceuticals, Inc.

INN (International Name):

BUSPIRONE HYDROCHLORIDE

Composition:

BUSPIRONE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Buspirone hydrochloride tablets USP 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 USP 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 USP 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, p

Product summary:

BusPIRone Hydrochloride Tablets USP, 5 mg are available as white colored, ovoid rectangular shape, biconvex, uncoated tablet debossed with “B” and “1” on either side of breakline on one side and another side is plain containing 5 mg buspirone hydrochloride packaged in bottles of 20 NDC 68071-3229-2 bottles of 30 NDC 68071-3229-3 bottles of 60 NDC 68071-3229-6 bottles of 90 NDC 68071-3229-9 PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 25°C (77°F);excursions permitted between 15° C to 30° C (59° F to 86° F) [see USP controlled room temperature]. KEEP THIS AND ALL OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET
NUCARE PHARMACEUTICALS, INC.
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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 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, 7.5 mg, 10 mg, 15
mg or 30 mg of buspirone
hydrochloride USP. The 5 mg, 7.5 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: colloidal silicon
dioxide, lactose monohydrate,
magnesium stearate, microcrystalline cellulose, and sodium starch
glycolate (Type A - potato starch).
1
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