Buspar®
The following information is a summary. It is
not intended to replace a doctor's instructions.
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.
HOW DOES BUSPIRONE
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.
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.
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.
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.
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.
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.
|
