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:

RedPharm Drug, Inc.

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 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, 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, capsule-shaped, flat- faced, beveled-edge tablets debossed with bisect on one side; one side of bisect is debossed with 'ZE' and another is debossed with '36' and other side is plain and are supplied as follows: NDC 68382-180-01 in bottle of 100 tablets NDC 68382-180-05 in bottle of 500 tablets NDC 68382-180-10 in bottle of 1000 tablets NDC 68382-180-30 in blister pack of 100 unit-dose tablets Buspirone Hydrochloride Tablets USP, 10 mg are white to off-white, capsule-shaped, flat-faced, beveled-edge tablets debossed with bisect on one side; one side of bisect is debossed with 'ZE' and another is debossed with '37' and other side is plain and are supplied as follows: NDC 68382-181-01 in bottle of 100 tablets NDC 68382-181-05 in bottle of 500 tablets NDC 68382-181-10 in bottle of 1000 tablets NDC 68382-181-30 in blister pack of 100 unit-dose tablets 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 68382-182-14 in bottle of 60 tablets NDC 68382-182-01 in bottle of 100 tablets NDC 68382-182-28 in bottle of 180 tablets NDC 68382-182-05 in bottle of 500 tablets NDC 68382-182-10 in bottle of 1000 tablets NDC 68382-182-30 in blister pack of 100 unit-dose tablets Buspirone Hydrochloride Tablets USP, 30 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 '10' on each trisect segment. The bisected side is debossed with 'ZE', on one bisect and '39' on other bisect segment and are supplied as follows: NDC 68382-183-14 in bottle of 60 tablets NDC 68382-183-05 in bottle of 500 tablets NDC 68382-183-10 in bottle of 1000 tablets NDC 68382-183-30 in blister pack of 100 unit-dose tablets Storage: Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. REFERENCE American Psychiatric Association, Ed.: Diagnostic and Statistical Manual of Mental Disorders—III, American Psychiatric Association, May 1980. 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

RedPharm Drug, Inc.
----------
MEDICATION GUIDE
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.
[Figure]
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).
[figure]
Call your doctor for medical advice about side effects. You may report
side effects to FDA at 1-800-FDA-
1088.
Revised: 1/2022
Document Id: d61b948d-1f22-7c00-e053-2a95a90a8802
34391-3
Set id: 5179a29b-e8bf-6677-e054-00144ff88e88
Version: 3
Effective Time: 20220121
RedPharm Drug, Inc.

Summary of Product characteristics

BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET
REDPHARM DRUG, INC.
----------
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:
[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
muscle relaxant
effects