BUSPIRONE HCL- buspirone hydrochloride tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

Buspirone hydrochloride (UNII: 207LT9J9OC) (Buspirone - UNII:TK65WKS8HL)

Mevcut itibaren:

Rebel Distributors Corp.

INN (International Adı):

Buspirone hydrochloride

Kompozisyon:

Buspirone hydrochloride 5 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 symptoms from three of

Ürün özeti:

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. Store at 20° - 25°C (68°- 77°F). [See USP controlled room temperature]. Protect from temperatures greater than 30°C (86°F). Dispense in a tight, light-resistant container as defined in USP/NF.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

BUSPIRONE HCL- BUSPIRONE HYDROCHLORIDE TABLET
REBEL DISTRIBUTORS CORP.
----------
BUSPIRONE HCL TABLETS USP
REVISED: OCTOBER 2007
RX ONLY
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
preclinical