BUSPIRONE HYDROCHLORIDE- buspirone hydrochloride tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Lake Erie Medical DBA Quality Care Products LLC

INN (Tarptautinis Pavadinimas):

BUSPIRONE HYDROCHLORIDE

Sudėtis:

BUSPIRONE HYDROCHLORIDE 10 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

INDICATIONS AND USAGE 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, lll1 as follows:  Generalized, persistent anxiety (of at least 1 month continual duration), manifested by

Produkto santrauka:

HOW SUPPLIED Buspirone HCl Tablets USP are supplied as follows: 5 mg tablets: White, oval, biconvex, scored tablets, debossed WATSON and 657, in bottles of 100, 500, and 1000. 10 mg tablets: White, oval, biconvex, scored tablets, debossed WATSON and 658, in bottles of 100, 500, and 1000. 15 mg tablets: White, oval shaped, scored tablets, debossed with the Watson logo and 718, and scoring on both sides so it can be either bisected or trisected, in bottles of 60, 180, 500, and 1000.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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BUSPIRONE HYDROCHLORIDE 10 MG
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, or 15 mg of
buspirone hydrochloride USP
(equivalent to 4.6 mg, 9.1 mg, and 13.7 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 tablet is provided in
a special tablet design. This tablet
is scored so it 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). In addition, each tablet contains 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 associated with more typical anxiolytics. In
vitro preclinical studies have shown
that buspirone has a high affinity for serotonin (5-HT
) receptors. Buspirone has no significant affinity
for benzodiazepine receptors and does not affect GABA binding _in
vitro_ or _in vivo_ when tested in
precli