BUSPIRONE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

APNAR PHARMA LP

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Buspirone hydrochloride tablets are indicated for the management of anxiety disorder 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, III 1 as follows: Generalized, persistent anxiety (of at least 1 month

Product summary:

Buspirone Hydrochloride Tablets, USP 5 mg are available as white to off white, flat faced, capsule shaped tablet, functionally-scored on one side and debossed with "098" on other side, packaged in bottles of 60 tablets (NDC 24689-781-06),100 tablets (NDC 24689-781-01), 500 tablets (NDC 24689-781-05) and 1000 tablets (NDC 24689-781-10) and carton of 100 (10 x 10) unit-dose tablets (NDC 24689-781-00). Buspirone Hydrochloride Tablets, USP 7.5 mg are available as white to off white, flat faced, capsule shaped tablet, scored on one side and debossed with "107" on other side, packaged in bottles of 60 tablets (NDC 24689-785-06),100 tablets (NDC 24689-785-01), 500 tablets (NDC 24689-785-05) and 1000 tablets (NDC 24689-785-10) and carton of 100 (10 x 10) unit-dose tablets (NDC 24689-785-00). Buspirone Hydrochloride Tablets, USP 10 mg are available as white to off white, flat faced, capsule shaped tablet, functionally-scored on one side and debossed with "099" on other side, packaged in bottles of 60 tablets (NDC 24689-907-06),100 tablets (NDC 24689-907-01), 500 tablets (NDC 24689-907-05) and 1000 tablets (NDC 24689-907-10) and carton of 100 (10 x 10) unit-dose tablets (NDC 24689-907-00). Buspirone Hydrochloride Tablets, USP 15 mg are available as white to off white, flat faced, capsule shaped, functionally-scored tablet that can be bisected or trisected, debossed with “1” and “00” on bisect segments, and debossed "5" on each trisect segment, packaged in bottles of 60 tablets (NDC 24689-921-06),100 tablets (NDC 24689-921-01), 500 tablets (NDC 24689-921-05) and 1000 tablets (NDC 24689-921-10) and carton of 100 (10 x 10) unit-dose tablets (NDC 24689-921-00). Buspirone Hydrochloride Tablets, USP 30 mg are available as white to off white, flat faced, capsule shaped, functionally-scored tablet that can be bisected or trisected, debossed with “1” and “01” on bisect segments, and debossed "10" on each trisect segment, packaged in bottles of 60 tablets (NDC 24689-933-06),100 tablets (NDC 24689-933-01), 500 tablets (NDC 24689-933-05) and 1000 tablets (NDC 24689-933-10) and carton of 100 (10 x 10) unit-dose tablets (NDC 24689-933-00). Store at 20 o to 25 o C (68 o to 77 o F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET
APNAR PHARMA LP
----------
BUSPIRONE HYDROCHLORIDE TABLETS USP
(PATIENT INSTRUCTION SHEET INCLUDED)
RX ONLY
DESCRIPTION
Buspirone hydrochloride tablets, USP are 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)-1piperazinyl]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 are 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
functionally-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 functionally-scored such that they may be
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). The 30 mg
tablets are functionally-scored such
that they may be bisected or trisected. Thus, a single 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: anhydrous
lactose, colloidal silicon dioxide, 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