BUSPAR- buspirone hydrochloride tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

BUSPIRONE HYDROCHLORIDE (UNII: 207LT9J9OC) (BUSPIRONE - UNII:TK65WKS8HL)

Tilgængelig fra:

DIRECT RX

INN (International Name):

BUSPIRONE HYDROCHLORIDE

Sammensætning:

BUSPIRONE HYDROCHLORIDE 5 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 have 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

Produkt oversigt:

Buspirone Hydrochloride Tablets USP, 5 mg are white to off-white, capsule-shaped, flat- faced, beveled-edge tablets debossed with bisect on one side; one side of bisect is debossed with 'ZE' and another is debossed with '36' and other side is plain

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

DIRECT RX
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Patient Instruction Sheet
Buspirone Hydrochloride Tablets, USP
HOW TO USE
For 15 mg and 30 mg tablets
Response to buspirone varies among individuals. Your physician may
find it necessary to
adjust your dosage to obtain the proper response.
Each tablet is scored and can be broken accurately to provide any of
the following dosages.
Figure
To break a tablet accurately and easily, hold the tablet between your
thumbs and index fingers close to the
appropriate tablet score (groove) as shown in the photo. Then, with
the tablet score facing you, apply
pressure and snap the tablet segments apart (segments breaking
incorrectly should not be used).
figure
Call your doctor for medical advice about side effects. You may report
side effects to FDA at 1-800-
FDA-1088.
Revised: 5/2016
Document Id: 33accd6b-10a7-5bd3-e054-00144ff88e88
Set id: 33accd6b-10a6-5bd3-e054-00144ff88e88
Version: 1
Effective Time: 20160525
DIRECT RX

Produktets egenskaber

BUSPAR- BUSPIRONE HYDROCHLORIDE TABLET
DIRECT RX
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BUSPIRONE HYDROCHLORIDE
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 powder. It is very
soluble in water; freely soluble
in methanol and in methylene chloride; sparingly soluble in ethanol
and in acetonitrile; very slightly
soluble in ethyl acetate and practically insoluble in hexanes. Its
molecular weight is 422. Chemically,
buspirone hydrochloride is
8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-
dione monohydrochloride. The molecular formula C21H31N5O2•HCl is
represented by the following
structural formula:
Structural formula
Each buspirone hydrochloride tablet intended for oral administration
contains 5 mg or 10 mg or 15 mg
or 30 mg buspirone hydrochloride (equivalent to 4.6 mg, 9.1 mg, 13.7
mg, and 27.4 mg of buspirone
free base, respectively). In addition, each tablet contains the
following inactive ingredients: colloidal
silicon dioxide, lactose monohydrate, magnesium stearate,
microcrystalline cellulose and sodium starch
glycolate. The 5 mg and 10 mg tablets are scored so they can be
bisected. Thus, the 5 mg tablet can also
provide 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The
15 mg and 30 mg 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).
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