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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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Adverse Effects
Endocrine:
Infrequently, decreased and increased libido, weight gain, weight loss, menstrual irregularity/breakthrough bleeding. Rarely, delayed ejaculation, impotence, galactorrhea, amenorrhea, t
hyroid abnormality.
Allergic or Toxic:
Skin rash, sore throat. Infrequently, edema/facial edema, pruritus, chills/fever. Rarely, photophobia, erythema, flu-like symptoms.
Clinical Laborato
ry:
Infrequently, increases in liver enzymes. Rarely, eosinophilia, leukopenia, thrombocytopenia.
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How to Use
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 maxim
um 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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Overdose
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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What is this Drug
Buspirone (byoo-SPYE-rone) is used to treat certain anxiety disorders or to relieve the symptoms of anxiety. However, buspirone usually is not used for anxiety or tension caused by the stress of every
day life.
It is not known exactly how buspirone works to relieve the symptoms of anxiety. Buspirone is thought to work by decreasing the amount and actions of a chemical known as serotonin in
certain parts of the brain.
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Drug Interactions
In vitro, buspirone does not displace tightly bound drugs like phenytoin, propranolol and warfarin from serum proteins. However, there has been 1 report of prolonged prothrombin time when buspirone wa
s added to the regimen of a patient treated with warfarin. The patient was also chronically receiving phenytoin, phenobarbital, digoxin and Synthroid. In vitro, buspirone may displace less firmly boun
d drugs like digoxin. The clinical significance of this property is unknown.
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