BUSPIRONE HYDROCHLORIDE- 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.

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 continual d

Product summary:

BusPIRone Hydrochloride Tablets, USP 15 mg are available as white colored, rectangle shape, beveled edge, uncoated tablets, debossed with two breaklines in between “B” and “4” on one side. NDC 68071-3240-3 BOTTLES OF 30 NDC 68071-3240-9 BOTTLES OF 90 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
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
with a molecular weight of
422.0. Chemically, buspirone hydrochloride is
_8_-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]8-
azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical formula
C
H
N
O
• HCl is
represented by the following structural formula:
Buspirone hydrochloride is supplied as tablets 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
21
31
5
2
1
Note :- Not applicable for divided doses
sedative effect that is associated with more typical a