BUSPIRONE HYDROCHLORIDE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Carilion Materials Management

INN (Διεθνής Όνομα):

BUSPIRONE HYDROCHLORIDE

Σύνθεση:

BUSPIRONE HYDROCHLORIDE 5 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Product: 68151-1437 NDC: 68151-1437-0 1 TABLET in a PACKAGE

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET
CARILION MATERIALS MANAGEMENT
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BUSPIRONE HYDROCHLORIDE TABLETS USP
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. 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, 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 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:
anhydrous lactose, colloidal silicon dioxide, magnesium stearate,
microcrystalline cellulose, 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 associated with more typical anxiolytics. _In
vitro_ preclinical studies have shown
that buspirone has