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 HOW
DOES BUSPAR WORK?
The mechanism of action of BUSPAR is not clearly known.
BUSPAR differs from typical benzodiazepines like Vallium
or Xanax anti-anxiety medication in that it does not
exert anti-seizure or muscle relaxant effects. It also
lacks the prominent sedative effect that is associated
with benzodiazepines.
In vitro studies have shown that BUSPAR has a high affinity
for serotonin receptors (receptors in the brain that
mediate arousal). BUSPAR has no significant affinity
for benzodiazepine receptors in the brain.
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HOW
EFFECTIVE IS BUSPAR?
The excellent efficacy of BUSPAR has been demonstrated
in controlled clinical trials of outpatients with a
diagnosis of Generalized Anxiety Disorder (GAD).
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, persistent anxiety (of at least
one 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: Hyper-attentiveness resulting
in distractibility, difficulty in concentrating, insomnia,
feeling "on edge", irritability, impatience.
The effectiveness of BUSPAR 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 BUSPAR for 1 year
without ill effect. Therefore, the physician who elects
to use BUSPAR for extended periods should periodically
reassess the usefulness of the drug for the individual
patient.
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DOSAGE
AND ADMINISTRATION:
The recommended initial dose is 15 mg daily (5 mg 3
times a day). To achieve an optimal therapeutic response,
at intervals of 2 to 3 days the dosage may be increased
5 mg per day, as needed. The maximum daily dosage should
not exceed 60 mg per day. In clinical trials allowing
dose titration, divided doses of 20 to 30 mg per day
were commonly employed.
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ADVERSE
REACTIONS:
The more commonly observed untoward events associated
with the use of BUSPAR not seen at an equivalent incidence
among placebo-treated patients include dizziness, nausea,
headache, nervousness, lightheadedness, and excitement.
Other common adverse events included: central nervous
system disturbances (3.4%), primarily dizziness, insomnia,
nervousness, drowsiness, and lightheaded feeling; gastrointestinal
disturbances (1.2%), primarily nausea; and miscellaneous
disturbances (1.1%), primarily headache and fatigue.
Interference with cognitive and motor performance: Studies
indicate that BUSPAR is less sedating than other anti-anxiety
medications and that it does not produce significant
functional impairment. However, its CNS effects in any
individual patient may not be predictable.
Therefore, patients should be cautioned about operating
an automobile or using complex machinery until they
are reasonably certain that BUSPAR treatment does not
affect them adversely.
While formal studies of the interaction of BUSPAR with
alcohol indicate that BUSPAR does not increase alcohol-induced
impairment in motor and mental performance, it is prudent
to avoid concomitant use of alcohol and BUSPAR.
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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 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 BUSPAR and placebo. In addition,
studies 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 is
difficult to predict from experiments the extent to
which a CNS-active drug will be misused.
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BE
SURE TO INCLUDE IN YOUR PHYSCIAL EXAMINATION/MEDICAL
QUESTIONAIRRE FORM THE FOLLOWING INFORMATION:
Include any medications, prescription or non-prescription,
alcohol, or drugs that you are now taking or plan to
take during your treatment with BUSPAR.
Note if you are pregnant, or if you are planning to
become pregnant while you are taking BUSPAR.
Note if you are breast-feeding an infant.
ORDER
NOW!
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