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Description
Buspirone Hydrochloride is indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. It is an agent that is not chemically or pharmacologically related to
the benzodiazepines (e.g. Valium, Xanax) barbituates, or other sedative/anti-anxiety drugs.
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Overdosage
In clinical pharmacology trials, buspirone up to 400 mg/day was administered to healthy male volunteers. As this dose was approached, the following symptoms were observed in descending order of freque
ncy: drowsiness, ataxia, nausea and vomiting, dizziness, clammy feeling, difficulty thinking, feeling high, rushing sensation, gastric distress, headache, itching, miosis, hypotension, tremor, incoord
ination, insomnia and hallucinations. In a dose ranging study in acute psychotic patients, up to 2400 mg/day was administered. Dizziness, nausea and vomiting were the most common adverse effects. One
patient developed extrapyramidal symptoms at 600 mg/day.
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DRUG ABUSE AND DEPENDENCE :
In human and animal studies, BUSPAR 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 wi
th 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 BUSPAR and placebo. In addition, stud
ies in monkeys, mice, and rats have indicated that BUSPAR lacks potential for abuse.
Although there is no direct evidence that BUSPAR causes physical dependence or drug-seeking behavior, it i
s difficult to predict from experiments the extent to which a CNS-active drug will be misused.
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Other Medicines
In laboratory studies in healthy volunteers, buspirone in doses up to 20 mg did not potentiate the psychomotor impairment produced by relatively modest doses of alcohol. However, decreased contentedne
ss or dysphoria was observed with a combination of alcohol and a 20 mg single dose of buspirone. Since no data are available on concomitant use of higher doses of buspirone and alcohol, it is prudent
to advise patients to avoid alcohol during buspirone therapy.
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Before Using This Medicine
Possible Concerns Related to Buspirone's Binding to Dopamine Receptors:
Because buspirone can bind to central dopamine receptors, a question has been raised about its potential to cause acute and
chronic changes in dopamine mediated neurological function (e.g., dystonia, pseudoparkinsonism, akathisia, and tardive dyskinesia). Clinical experience in controlled trials has failed to identify any
significant neuroleptic-like activity; however, a syndrome of restlessness, appearing shortly after initiation of treatment, has been reported in some small fraction of buspirone treated patients. The
syndrome may be explained in several ways.
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Special Wanring
Miscellaneous:
Tinnitus, muscle aches/pains. Infrequently, redness/itching of eyes, altered taste/smell, roaring sensation in head, malaise, easy bruising, dry skin, arthralgia, blisters, hair los
s. Rarely, acne, thinning of nails, sore eyes, inner ear abnormality, pressure on eyes, nocturia, enuresis, hiccups, voice loss, alcohol abuse.
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