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:

AvPAK

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 duration), manifested by symptoms from three of the four following categories: 1.      Motor tension: Shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. 2.      Autonomic hyperactivity: Sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. 3.      Apprehensive expectation: Anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4.      Vigilance and scanning: Hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience. 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 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 for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient. Buspirone hydrochloride tablets 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 ) Controlled Substance Class: Buspirone hydrochloride is not a controlled substance. Physical and Psychological Dependence: 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 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 causes 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 misuse or abuse (e.g., development of tolerance, incrementation of dose, drug-seeking behavior). To report SUSPECTED ADVERSE REACTIONS contact AvKARE at 1-855-361-3993; email [e-mail]; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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. 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. 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 50268-135-15 (10 tablets per card, 5 cards per carton). 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. Dispensed in Unit Dose Package. For Institutional Use Only. 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

AvPAK
----------
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: 1/2024
Document Id: 0e85a5c9-76a6-f621-e063-6394a90a8782
34391-3
Set id: b230197c-3d50-7874-e053-2a95a90af50f
Version: 4
Effective Time: 20240109
AvPAK

Summary of Product characteristics

BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET
AVPAK
----------
BUSPIRONE HYDROCHLORIDE TABLETS, USP
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, 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
muscle relaxa