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Special Wanring
Post Introduction Clinical Experience:
Post-marketing experience in the US has shown an adverse experience profile similar to that given above. Additional reports have included rare occurrences of
allergic reaction, cogwheel rigidity, dystonic reaction, ecchymosis, emotional lability and tunnel vision. Because of the uncontrolled nature of these spontaneous reports, a causal relationship to bu
spirone treatment has not been determined.
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Possible food and drug interactions when taking this medication
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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What is this Drug
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 BUS
PAR for extended periods should periodically reassess the usefulness of the drug for the individual patient.
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Proper Use of This Medicine
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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What side effects can this medication cause?
More common side effects may include:
- Dizziness, dry mouth, fatigue, headache, light-headedness, nausea, nervousness, unusual excitement
Less common or rare side effects may include:
- Anger/hostility, blurred vision, bone aches/pain, confusion, constipation, decreased concentration, depression, diarrhea, fast, fluttery heartbeat, incoordination, muscle pain/aches, numbness,
pain or weakness in hands or feet, rapid heartbeat, rash, restlessness, stomach and abdominal upset, sweating/clamminess, tingling or pins and needles, tremor, urinary incontinence, vomiting, weakness
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Symptoms of overdose
There is no specific antidote for buspirone. Management should, therefore, be symptomatic and supportive. Any patient suspected of having taken an overdose should be admitted to a hospital as soon as
possible, and the stomach emptied by gastric lavage. Respiration, pulse and blood pressure should be monitored, as in all cases of drug overdosage. As with the management of intentional overdosage wit
h any drug, the ingestion of multiple agents should be suspected. In 6 anuric patients, hemodialysis either had no effect on the pharmacokinetics of buspirone or decreased its clearance.
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