BUSPIRONE HYDROCHLORIDE tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Strides Pharma Science Limited

INN (Medzinárodný Name):

BUSPIRONE HYDROCHLORIDE

Zloženie:

BUSPIRONE HYDROCHLORIDE 5 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 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 symptoms from three o

Prehľad produktov:

Buspirone Hydrochloride Tablets, USP are available as: Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C to 30 °C (59 °F to 86 °F) [See USP controlled room temperature]. Dispense in a tight, light-resistant container (USP).

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

BUSPIRONE HYDROCHLORIDE - BUSPIRONE HYDROCHLORIDE TABLET
STRIDES PHARMA SCIENCE LIMITED
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BUSPIRONE HYDROCHLORIDE TABLETS, USP
(PATIENT INSTRUCTION SHEET INCLUDED)
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 empirical
formula C
H
N O .HCl is represented by the following structural formula:
Buspirone hydrochloride tablets, USP 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 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). The 30 mg tablets are
scored such that they
may be bisected or trisected. 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, USP contain
the following
inactive ingredients: colloidal silicon dioxide, lactose monohydrate,
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
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