BUSPIRONE HYDROCHLORIDE tablet

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Mylan Institutional Inc.

INN (Alþjóðlegt nafn):

BUSPIRONE HYDROCHLORIDE

Samsetning:

BUSPIRONE HYDROCHLORIDE 5 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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: - 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 tablets are 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).

Vörulýsing:

Buspirone Hydrochloride Tablets, USP are available containing 5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP. The 5 mg tablets are white, oval, scored tablets debossed with M to the left of the score and B1 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-985-20 – Unit dose blister packages of 100 (10 cards of 10 tablets). The 10 mg tablets are white, oval, scored tablets debossed with M to the left of the score and B2 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-986-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 15 mg tablets are white, capsule-shaped, flat-faced tablets scored so that it can be either bisected or trisected. They are debossed with M to the left of the score and B3 to the right of the score on one side of the tablet and 5 on each trisect section on the other side. They are available as follows: NDC 51079-960-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 30 mg tablets are white, capsule-shaped, flat-faced tablets scored so that they can be either bisected or trisected. They are debossed with M to the left of the score and B4 to the right of the score on one side of the tablet and 10 on each trisect section on the other side. They are available as follows: NDC 51079-994-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. PHARMACIST: Patient Instruction Sheet attached to prescribing information.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

BUSPIRONE HYDROCHLORIDE- BUSPIRONE HYDROCHLORIDE TABLET
MYLAN INSTITUTIONAL INC.
----------
(PATIENT INSTRUCTION SHEET INCLUDED.)
DESCRIPTION
Buspirone hydrochloride tablets, USP are an antianxiety agent that are
not chemically or
pharmacologically related to the benzodiazepines, barbiturates, or
other
sedative/anxiolytic drugs.
Buspirone hydrochloride, USP 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 molecular
formula C
H
N
O
•HCl is represented by the following structural formula:
Buspirone hydrochloride tablets are supplied as tablets for oral
administration containing
5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP
(equivalent to
4.6 mg, 6.9 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 and 30 mg tablets are provided in a multi-scored 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 tablets contain the
following inactive ingredients: anhydrous lactose, colloidal silicon
dioxide, magnesium
stearate, microcrystalline cellulose, sodium lauryl sulfate, and
sodium starch glycolate
(potato).
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 sedati