BUSPIRONE HYDROCHLORIDE- 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:

REMEDYREPACK INC.

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 have 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 continual

Product summary:

Buspirone Hydrochloride Tablets, USP are available containing 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP. The 5 mg tablets are white, oval, scored tablets debossed with M to the left of the score and B1 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-1140-01 bottles of 100 tablets NDC 0378-1140-05 bottles of 500 tablets The 7.5 mg tablets are white to off-white, oval, scored tablets debossed with M to the left of the score and B7 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-1145-01 bottles of 100 tablets The 10 mg tablets are white, oval, scored tablets debossed with M to the left of the score and B2 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-1150-01 bottles of 100 tablets NDC 0378-1150-05 bottles of 500 tablets The 15 mg tablets are white, capsule-shaped, flat-faced tablets scored so that it can be either bisected or trisected. They are debossed with M to the left of the score and B3 to the right of the score on one side of the tablet and 5 on each trisect section on the other side. They are available as follows: NDC 0378-1165-91 bottles of 60 tablets NDC 0378-1165-80 bottles of 180 tablets NDC 0378-1165-05 bottles of 500 tablets The 30 mg tablets are white, capsule-shaped, flat-faced tablets scored so that they can be either bisected or trisected. They are debossed with M to the left of the score and B4 to the right of the score on one side of the tablet and 10 on each trisect section on the other side. They are available as follows: NDC 0378-1175-91 bottles of 60 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Patient Instruction Sheet attached to prescribing information. Additional copies are provided separately.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET
REMEDYREPACK INC.
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(PATIENT INSTRUCTION SHEET INCLUDED.)
DESCRIPTION
Buspirone hydrochloride tablets, USP are an antianxiety agent that are
not chemically or
pharmacologically related to the benzodiazepines, barbiturates, or
other sedative/anxiolytic drugs.
Buspirone hydrochloride, USP 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:
Buspirone hydrochloride tablets are supplied as tablets for oral
administration containing 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 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:
anhydrous lactose, colloidal silicon
dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl
sulfate, and sodium starch
glycolate (potato).
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 effe