BUSPIRONE HYDROCHLORIDE tablet
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Summary of Product characteristics
(SPC)
25-11-2010
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Active ingredient:
Buspirone Hydrochloride (UNII: 207LT9J9OC) (Buspirone - UNII:TK65WKS8HL)
Available from:
Dr. Reddy's Laboratories Limited
INN (International Name):
Buspirone Hydrochloride
Composition:
Buspirone Hydrochloride 5 mg
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
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
Product summary:
Buspirone hydrochloride tablets, USP 5 mg are white to off-white, ovoid-rectangular shaped, biconvex, uncoated scored tablet embossed “RïDY” on one side and “472” on the other side and are supplied in bottles of 30, 60, 100, 500 and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-472-30 Bottles of 60 NDC 55111-472-60 Bottles of 100 NDC 55111-472-01 Bottles of 500 NDC 55111-472-05 Unit dose package of 100 (10 x 10) NDC 55111-472-78 Buspirone hydrochloride tablets, USP 10 mg are white to off-white, ovoid-rectangular shaped, biconvex, uncoated scored tablet embossed “RïDY” on one side and “473” on the other side and are supplied in bottles of 30, 60, 100, 500 and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-473-30 Bottles of 60 NDC 55111-473-60 Bottles of 100 NDC 55111-473-01 Bottles of 500 NDC 55111-473-05 Unit dose package of 100 (10 x 10) NDC 55111-473-78 Buspirone hydrochloride tablets, USP 15 mg are white to off-white, flat-rectangular shaped, beveled edged, uncoated scored tablet embossed “RïDY” on one side and “4ï7ï4” on the other side and are supplied in bottles of 30, 60, 100, 180, 500 and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-474-30 Bottles of 60 NDC 55111-474-60 Bottles of 100 NDC 55111-474-01 Bottles of 180 NDC 55111-474-18 Bottles of 500 NDC 55111-474-05 Unit dose package of 100 (10 x 10) NDC 55111-474-78 Buspirone hydrochloride tablets, USP 30 mg are light pink to pink coloured, flat, rectangular shaped, beveled edged, uncoated scored tablet embossed “RïDY” on one side and “4ï7ï5” on the other side and are supplied in bottles of 30, 60, 100, 500 and unit dose package of 100 (10 x 10). Bottles of 30 NDC 55111-475-30 Bottles of 60 NDC 55111-475-60 Bottles of 100 NDC 55111-475-01 Bottles of 500 NDC 55111-475-05 Unit dose package of 100 (10 x 10) NDC 55111-475-78 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 (USP).
Authorization status:
Abbreviated New Drug Application
Summary of Product characteristics
BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET
DR. REDDY'S LABORATORIES LIMITED
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BUSPIRONE HYDROCHLORIDE
(PATIENT INSTRUCTION SHEET INCLUDED)
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, 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 and 30 mg tablets are provided in a multi-scored tablet design.
These tablets are scored so they
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).
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
contain the following inactive ingredients: colloidal silicon dioxide,
lactose monohydrate, magnesium
stearate, microcrystalline cellulose, and sodium starch glycolate. The
30 mg tablet also contains ferric
oxide.
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 prominen
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