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:

Oxford Pharmaceuticals, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Buspirone hydrochloride tablets, USP 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, USP 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, USP 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 duration), manifested by symptoms from three of the four following categories: The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride tablets, USP in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride tablets, USP for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets, USP for extended periods should periodically reassess the usefulness of the drug for the individual patient. Buspirone hydrochloride tablets, USP are contraindicated in patients hypersensitive to buspirone hydrochloride. The use of monoamine oxidase inhibitors (MAOIs) intended to treat depression with buspirone or within 14 days of stopping treatment with buspirone is contraindicated because of an increased risk of serotonin syndrome and/or elevated blood pressure. The use of buspirone within 14 days of stopping an MAOI intended to treat depression is also contraindicated. Starting buspirone in a patient who is being treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome. (see WARNINGS, DOSAGE AND ADMINISTRATION AND DRUG INTERACTIONS). Buspirone hydrochloride, USP is not a controlled substance. In human and animal studies, buspirone has shown no potential for abuse or diversion and there is no evidence that it causes tolerance, or either physical or psychological dependence. Human volunteers with a history of recreational drug or alcohol usage were studied in two double-blind clinical investigations. None of the subjects were able to distinguish between buspirone hydrochloride tablets, USP and placebo. By contrast, subjects showed a statistically significant preference for methaqualone and diazepam. Studies in monkeys, mice, and rats have indicated that buspirone lacks potential for abuse. Following chronic administration in the rat, abrupt withdrawal of buspirone did not result in the loss of body weight commonly observed with substances that cause physical dependency. Although there is no direct evidence that buspirone hydrochloride tablets, USP cause physical dependence or drug-seeking behavior, it is difficult to predict from experiments the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of buspirone hydrochloride tablets, USP misuse or abuse (e.g., development of tolerance, incrementation of dose, drug-seeking behavior).

Product summary:

Buspirone Hydrochloride Tablets, USP 5 mg are white to off-white, round, flat-faced, beveled edge bisected tablets debossed “091” above the bisect on one side and "O" logo on the other side. Supplied in bottles of 100’s (NDC 69584-091-10) and 500’s (NDC 69584-091-50). Buspirone Hydrochloride Tablets, USP 10 mg are white to off-white, round, flat-faced, beveled edge bisected tablets debossed “092” above the bisect on one side and "O" logo on the other side. Supplied in bottles of 100’s (NDC 69584-092-10) and 500’s (NDC 69584-092-50). Buspirone Hydrochloride Tablets, USP 15 mg are white rectangle, flat faced, beveled edge tablets double-scored and debossed with "0|9|3" on one side and double-scored and debossed "|O|" logo on the other side. Supplied in bottles of 100’s (NDC 69584-093-10) and 500’s (NDC 69584-093-50). Buspirone Hydrochloride Tablets, USP 30 mg are white to off-white, capsule shape, flat face, beveled edge tablets, scored and debossed “094 O” on one side and double-scored and debossed “10 10 10” on the other side. Supplied in bottles of 60’s (NDC 69584-094-06), 180’s (NDC 69584-094-18) and 500’s (NDC 69584-094-50). Dispense 15 mg and 30 mg with Patient Information Sheet available at: https://www.oxford-rx.com/med-guides Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°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
OXFORD PHARMACEUTICALS, LLC
----------
BUSPIRONE HYDROCHLORIDE TABLETS USP
(PATIENT INFORMATION SHEET INCLUDED)
RX ONLY
DESCRIPTION
Buspirone hydrochloride tablets, 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 0 • HCl is represented by the following structural formula:
Buspirone hydrochloride, USP 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, and 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 the adjustable dosage 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, USP tablets
contain the
following inactive ingredients: colloidal silicon dioxide, lactose
anhydrous, magnesium
stearate, microcrystalline cellulose, and sodium starch glycolate
(Type A).
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 pr