BUSPIRONE HCL- 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:

Amneal Pharmaceuticals NY LLC

INN (International Name):

BUSPIRONE HYDROCHLORIDE

Composition:

BUSPIRONE HYDROCHLORIDE 5 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, III1 as follows: Generalized, persistent anxiety (of at least 1 month continual du

Product summary:

Buspirone hydrochloride tablets USP, 5 mg are supplied as white to off-white colored, round, beveled tablets debossed “AA” and “63” bisected on one side with  score and plain on the other side. They are available as follows: Bottle of 100 Tablets:                         NDC 69238-1115-1 Bottle of 500 Tablets:                         NDC 69238-1115-5 Buspirone hydrochloride tablets USP, 7.5 mg are supplied as white to off-white colored, oval shaped, tablet debossed “AA” and “64” bisected on one side with  score and plain on the other side. They are available as follows: Bottle of 100 Tablets:                         NDC 69238-1116-1 Bottle of 500 Tablets:                         NDC 69238-1116-5 Buspirone hydrochloride tablets USP, 10 mg are supplied as white to off-white colored, round, beveled tablets debossed “AA” and “65” bisected on one side with score and plain on the other side. They are available as follows: Bottle of 100 Tablets:                         NDC 69238-1117-1 Bottle of 500 Tablets:                         NDC 69238-1117-5 Buspirone hydrochloride tablets USP, 15 mg are supplied as white to off-white rectangular shaped tablets that can either be bisected or trisected with score, debossed “A” and “0” on bisect segments on one side and debossed “5” on each trisect segments on the other side. They are available as follows: Bottle of 60 Tablets:                           NDC 69238-1118-6 Bottle of 100 Tablets:                         NDC 69238-1118-1 Bottle of 180 Tablets:                         NDC 69238-1118-2 Bottle of 500 Tablets:                         NDC 69238-1118-5 Buspirone hydrochloride tablets USP, 30 mg are supplied as white to off-white rectangular shaped tablets that can either be bisected or trisected with score, debossed “AA” and “67” on bisect segments on one side and debossed “10” on each trisect segment on the other side. They are available as follows: Bottle of 60 Tablets:                           NDC 69238-1119-6 Bottle of 500 Tablets:                         NDC 69238-1119-5 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. Do not take improper broken tablets, if found in the container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUSPIRONE HCL- BUSPIRONE HYDROCHLORIDE TABLET
AMNEAL PHARMACEUTICALS NY LLC
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BUSPIRONE HYDROCHLORIDE TABLETS, USP
(5 MG, 7.5 MG, 10 MG, 15 MG OR 30 MG)
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, USP 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:
Each tablet, for oral administration, contains 5 mg, 7.5 mg, 10 mg, 15
mg or 30 mg of
buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 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: colloidal
silicon dioxide, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, and
sodium starch glycolate.
CLINICAL PHARMACOLOGY
21
31
5
2
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
ass