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:

STAT Rx USA LLC

INN (International Name):

BUSPIRONE HYDROCHLORIDE

Composition:

BUSPIRONE HYDROCHLORIDE 30 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 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 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 duration), manifested by symptom

Product summary:

Buspirone Hydrochloride Tablets, USP are available containing 30 mg of buspirone hydrochloride, USP. Bottles of 30  -  NDC # 16590-375-30 Bottles of 60  -  NDC # 16590-375-60 Bottles of 90  -  NDC # 16590-375-90 Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Patient Instruction Sheet attached to prescribing information. Additional copies are provided separately. Relabeling and Repackaging by: STAT Rx USA LLC Gainesville, GA  30501

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUSPIRONE HYDROCHLORIDE - BUSPIRONE HYDROCHLORIDE TABLET
STAT RX USA LLC
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BUSPIRONE HYDROCHLORIDE TABLET
(Patient Instruction Sheet Attached. Additional copies are provided
separately.)
DESCRIPTION
Buspirone hydrochloride is 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 molecular formula
C
H N O •HCl is
represented by the following structural formula:
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 and 30
mg tablets are provided in a
multi-scored tablet design. These 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). A
single 30 mg 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 contain
the following inactive ingredients:
anhydrous lactose, colloidal silicon dioxide, magnesium stearate,
microcrystalline cellulose, sodium
lauryl sulfate, 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 associ