BUSPIRONE HYDROCHLORIDE tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Accord Healthcare Inc.

INN (Tarptautinis Pavadinimas):

BUSPIRONE HYDROCHLORIDE

Sudėtis:

BUSPIRONE HYDROCHLORIDE 5 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 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 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: - 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 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 ADMINISTRATIONAND 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 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).

Produkto santrauka:

BusPIRone Hydrochloride Tablets, USP 5 mg are available as white colored, ovoid rectangular shape, biconvex, uncoated tablets, debossed with “B” and “1” on either side of breakline on one side and another side is plain containing 5 mg buspirone hydrochloride (NDC 16729-200), packaged in bottles of 100 tablets (NDC 16729-200-01), 500 tablets (NDC 16729- 200-16) and 1,000 tablets (NDC 16729-200-17). BusPIRone Hydrochloride Tablets, USP 7.5 mg are available as white colored, ovoid rectangular shape, biconvex, uncoated tablets, debossed with “B” and “2” on either side of breakline on one side and another side is plain containing 7.5 mg buspirone hydrochloride (NDC 16729- 201), packaged in bottles of 100 tablets (NDC 16729-201-01), 500 tablets(NDC 16729- 201-16) and 1,000 tablets (NDC 16729-201-17). BusPIRone Hydrochloride Tablets, USP 10 mg are available as white colored, ovoid rectangular shape, biconvex, uncoated tablet, debossed with “B” and “3” on either side of breakline on one side and another side is plain containing 10 mg buspirone hydrochloride (NDC 16729-202), packaged in bottles of 100 tablets (NDC 16729-202-01), 500 tablets (NDC 16729-202- 16) and 1,000 tablets (NDC 16729-202-17). BusPIRone Hydrochloride Tablets, USP 15 mg are available as white colored, rectangle shape, beveled edge, uncoated tablets, debossed with two breaklines in between “B” and “4” on one side, another side is plain with two breaklines and having one breakline on side surface containing 15 mg buspirone hydrochloride (NDC 16729-203). These tablets are scored to provide 15 mg (entire tablet), 10 mg (two- third of a tablet), 7.5 mg (one-half of a tablet) or 5 mg (one third of a tablet) are packaged in bottles of 60 tablets (NDC 16729-203-12), 100 tablets (NDC 16729-203-01), 180 tablets (NDC 16729-203-59), 500 tablets (NDC 16729-203-16) and 1,000 tablets (NDC 16729-203-17). BusPIRone Hydrochloride Tablets, USP 30 mg are available as white colored, rectangle shape, beveled edge, uncoated tablets, debossed with two breaklines in between “B” & “8” on one side, another side is plain with two breaklines and having one breakline on side surface containing 30 mg buspirone hydrochloride (NDC 16729-289), these tablets are scored to provide 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) are packaged in bottles of 60 tablets (NDC 16729- 289-12), 100 tablets (NDC 16729-289-01), 180 tablets (NDC 16729-289-59), 500 tablets (NDC 16729-289-16) and 1,000 tablets (NDC 16729-289-17). PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 25°C (77°F); excursions permitted between 15° C to 30° C (59° F to 86° F) [see USP controlled room temperature]. KEEP THIS AND ALL OUT OF THE REACH OF CHILDREN.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET
ACCORD HEALTHCARE INC.
----------
BUSPIRONE HYDROCHLORIDE TABLETS
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 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
O
• HCl is represented by the following structural formula:
Buspirone hydrochloride is supplied as tablets for oral administration
contains 5 mg, 7.5
mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP. The 5 mg,
7.5 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: colloidal silicon dioxide, lactose
monohydrate, magnesium
stearate, microcrystalline cellulose, and sodium starch glycolate
(Type A - potato starch).
1
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
1
Note :- Not applicable for divided doses
anxioly