buspirone hydrochloride- Buspirone Hydrochloride tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

ETHEX

INN (Mezinárodní Name):

Buspirone Hydrochloride

Léková forma:

TABLET

Složení:

5 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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

Přehled produktů:

Buspirone Hydrochloride Tablets, USP. 5 mg and 10 mg tablets are available in bottles of 100 and 500. The 5 mg tablet is yellow, oval shaped, debossed "ETHEX" and "264" on one side, and debossed "5", bisect, "mg" on the other side. The 10 mg tablets are yellow, oval shaped, debossed "ETHEX" and "265" on one side, and debossed "10", bisect, "mg" on the other side. 5 mg tablets NDC 58177-264-04   Bottles of 100 NDC 58177-264-08   Bottles of 500 10 mg tablets NDC 58177-265-04   Bottles of 100 NDC 58177-265-08   Bottles of 500 15 mg tablets yellow, capsule shaped in a bi/trisegmented tablet design, are available in bottles of 100 and 500. The 15 mg tablet is scored so that it can be either bisected or trisected. It is debossed " ETH", bisect, "309" on one side and on the reverse side, the number 5 is debossed on each trisect segment. 15 mg tablets NDC 58177-309-04   Bottles of 100 NDC 58177-309-08   Bottles of 500 Store at controlled room temperature, 15-30°C (59-86°F). Protect from temperatures greater than 86°F (30°C). Dispense in a tight, light-resistant container (USP).

Charakteristika produktu

BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET
ETHEX
----------
DESCRIPTION
Buspirone hydrochloride, USP 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 is supplied as tablets for oral administration
containing 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 bi/tri-segmented tablet design. This tablet is scored so it can
be either 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). Buspirone
hydrochloride tablets contain the
following inactive ingredients: alumina hydrate, colloidal silicon
dioxide, lactose monohydrate,
magnesium stearate, microcrystalline cellulose, sodium starch
glycolate, and D&C yellow no.10 lake.
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_