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:

NuCare Pharmaceuticals,Inc.

INN (International Name):

BUSPIRONE HYDROCHLORIDE

Composition:

BUSPIRONE HYDROCHLORIDE 15 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 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 mont

Product summary:

Buspirone Hydrochloride Tablets USP, 15 mg are white to off-white, capsule-shaped, flat-faced, beveled-edge tablets, bisected on one side and trisected on other side. The trisected side of tablet is debossed with '5' on each trisect segment. The bisected side is debossed with 'ZE', on one bisect and '38' on other bisect segment and are supplied as follows: NDC 66267-875-30 in bottle of 30 tablets Storage: Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Desyrel ® is the registered trademark of Bristol Myers Squibb Company. Synthroid ® is the registered trademark of Abbott Laboratories

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

NuCare Pharmaceuticals,Inc.
----------
Patient Instruction Sheet
Buspirone Hydrochloride Tablets, USP
HOW TO USE
For 15 mg and 30 mg tablets
Response to buspirone varies among individuals. Your physician may
find it necessary to
adjust your dosage to obtain the proper response.
Each tablet is scored and can be broken accurately to provide any of
the following dosages.
To break a tablet accurately and easily, hold the tablet between your
thumbs and index fingers close to the
appropriate tablet score (groove) as shown in the photo. Then, with
the tablet score facing you, apply
pressure and snap the tablet segments apart (segments breaking
incorrectly should not be used).
Call your doctor for medical advice about side effects. You may report
side effects to FDA at 1-800-FDA-
1088.
Revised: 1/2020
Document Id: 9caf8590-f761-c959-e053-2995a90ab836
34391-3
Set id: 46de5018-f04c-4891-e054-00144ff8d46c
Version: 2
Effective Time: 20200121
NuCare Pharmaceuticals,Inc.

Summary of Product characteristics

BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET
NUCARE PHARMACEUTICALS,INC.
----------
BUSPIRONE HYDROCHLORIDE TABLETS, USP
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, USP is a white crystalline powder. It is very
soluble in water; freely soluble
in methanol and in methylene chloride; sparingly soluble in ethanol
and in acetonitrile; very slightly
soluble in ethyl acetate and practically insoluble in hexanes. Its
molecular weight is 422. Chemically,
buspirone hydrochloride is
8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-
dione monohydrochloride. The molecular formula C21H31N5O2•HCl is
represented by the following
structural formula:
Each buspirone hydrochloride tablet intended for oral administration
contains 5 mg or 10 mg or 15 mg
or 30 mg buspirone hydrochloride (equivalent to 4.6 mg, 9.1 mg, 13.7
mg, and 27.4 mg of buspirone
free base, respectively). In addition, each tablet contains the
following inactive ingredients: colloidal
silicon dioxide, lactose monohydrate, magnesium stearate,
microcrystalline cellulose and sodium starch
glycolate. The 5 mg and 10 mg tablets are scored so they can be
bisected. Thus, the 5 mg tablet can also
provide 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The
15 mg and 30 mg 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).
CLINICAL PHARMACOLOGY
The mechanism of action of buspirone is unknown. Buspirone differs
from typical benzodiazepine
anxiolytics in that it does not exert anticonvulsant or