BUSPIRONE HYDROCHLORIDE tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

BUSPIRONE HYDROCHLORIDE (UNII: 207LT9J9OC) (BUSPIRONE - UNII:TK65WKS8HL)

Saatavilla:

Unichem Pharmaceuticals (USA), Inc.

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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: - Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. - 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. - Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. - 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, 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 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 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 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 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 misuse or abuse (e.g., development of tolerance, incrementation of dose, drug-seeking behavior).

Tuoteyhteenveto:

Buspirone Hydrochloride Tablets, USP, are supplied as follows: Buspirone Hydrochloride Tablets, USP 5 mg: White to off white, round flat faced beveled edge tablet, debossed with "244" on one side and "U" on either side of the break line. Bottle of 100: NDC 29300-244-01 Bottle of 500: NDC 29300-244-05 Buspirone Hydrochloride Tablets, USP 10 mg: White to off white, round flat faced beveled edge tablet, debossed with "245" on one side and "U" on either side of the break line. Bottle of 100: NDC 29300-245-01 Bottle of 500: NDC 29300-245-05 Buspirone Hydrochloride Tablets, USP 15 mg: White to off white, rectangular flat faced beveled edge tablet that can either be bisected or trisected, debossed with "U" and "246" on one side of the trisect segments and plain on other side of the trisect segment. Bottle of 60:   NDC 29300-477-16 Bottle of 100: NDC 29300-477-01 Bottle of 180: NDC 29300-477-18 Bottle of 500: NDC 29300-477-05 Buspirone Hydrochloride Tablets, USP 30 mg: White to off white, rectangular flat faced beveled edge tablet that can either be bisected or trisected, debossed with "U" and "247" on one side of the trisect segments and plain on other side of the trisect segment. Bottle of 60:   NDC 29300-478-16 Bottle of 100: NDC 29300-478-01 Bottle of 500: NDC 29300-478-05 Store at 200 to 250 C (680 to 770 F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep this and all drugs out of reach of children. Additional patient information leaflets can be obtained by calling Unichem at 1-866-562-4616.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET
UNICHEM PHARMACEUTICALS (USA), INC.
----------
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 is a white crystalline, water soluble compound
with a molecular
weight of 421.96. Chemically, buspirone hydrochloride is
N-[4-[4-(2-pyrimidinyl)-1-
piperazinyl]butyl]-1,1-cyclopentanediacetamide monohydrochloride. The
empirical
formula C
H
N O •HCl is represented by the following structural formula:
Each tablet, for oral administration, contains 5 mg, 10 mg, 15 mg or
30 mg of buspirone
hydrochloride, USP (equivalent to 4.6 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 tablets are scored such that they
may be bisected
or trisected. Thus, a single 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). The 30 mg tablets are scored such that they may be bisected
or trisected. Thus,
a single 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, USP contain the following inactive ingredients:
anhydrous lactose,
colloidal silicon dioxide, magnesium stearate, microcrystalline
cellulose, and sodium
starch glycolate.
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 effect that is
associated with more typical
21
31
5
2
anxiolytics. _In vitro_