Buspirone Contraindications and Precautions
- breast-feeding
- MAOI therapy
- benzodiazepine dependence
- children
- driving or operating machinery
- elderly
- ethanol intoxication
- hepatic disease
- pregnancy
- renal disease
- renal failure
- renal impairment
Buspirone Contraindications and Precautions
Buspirone is absolutely contraindicated in patients with a known hypersensitivity to the drug.
Buspirone has a slow onset of action; buspirone does not exhibit cross-tolerance with benzodiazepines and other common sedative/hypnotic drugs. Buspirone will not block the withdrawal syndrome often seen with cessation of therapy in those with benzodiazepine dependence. Therefore, before starting therapy with buspirone, it is advisable to withdraw patients gradually from the benzodiazepine or other prior CNS-active treatment. Patients who are being converted from a benzodiazepine to buspirone therapy may need to overlap buspirone initiation with the downward titration of the benzodiazepine. The onset of anxiolytic effect of buspirone may take 2 weeks; maximal effects occur at 3 - 6 weeks.
Buspirone is contraindicated for concomitant use in patients receiving MAOI therapy (buspirone-interactions/">see Drug Interactions).
Caution should be used when administering buspirone to patients with renal disease that leads to renal impairment because the drug and its metabolites are eliminated mainly through the kidneys; decreased renal function or renal failure could result in decreased excretion and possible accumulation of the drug and its metabolites.
Caution should be used when administering buspirone to patients with hepatic disease because the drug is metabolized by the liver. Decreased hepatic function results in decreased clearance of the drug and a longer half-life; administration to those with severe hepatic disease is not recommended.
Safe and effective use in children < 18 years old has not been established. The safety and effectiveness of buspirone in 559 pediatric patients of 6 - 17 years of age were evaluated in two placebo-controlled 6-week trials for generalized anxiety disorder (GAD). Safety and effectiveness were not established in these children at doses recommended for use in adults. No unexpected safety findings were associated with buspirone in these trials. There are no long-term safety or efficacy data in children.
There were no effects of age on the pharmacokinetics of buspirone. The safety and efficacy profiles of buspirone in 605 anxious, elderly patients (mean age = 70.8 years) were similar to those in a younger adult population.
Studies indicate that buspirone is less sedating than other anxiolytics 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 driving or operating machinery until they are reasonably certain that buspirone treatment does not affect them adversely. While formal studies of the interaction of the drug with alcohol indicate that buspirone does not increase alcohol-induced impairment in motor and mental performance, it is prudent to avoid concomitant ethanol intoxication while taking buspirone.
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, pseudo-parkinsonism, 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.
Buspirone is classified in FDA pregnancy risk category B. No fertility impairment or fetal damage was observed in reproduction studies performed in rats and rabbits at doses of approximately 30 times the maximum recommended human dose. In humans, however, adequate, well-controlled studies during pregnancy have not been performed. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
The extent of the excretion in human milk of buspirone or its metabolites is not known. Buspirone and its metabolites are excreted in the milk of lactating rats. Buspirone administration during breast-feeding should be avoided if clinically possible.
[ Last revised: 2/12/2002 ]
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