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Generic for buspirone hcl 2.5 mg) Preferred Pregnancy Category Pregnancy Category C Lactation The safety and effectiveness of buspirone for use during lactation have been established in studies of lactating and nonlactating women. It is not known whether drug store seattle these drug levels also apply to lactating women. Bioproducts Bioproducts: An embryo or fetus could survive if exposed to buspirone, but the drug should not be used to treat malformations of the newborn. Animal reproduction studies: Ramspirone was administered orally to rats and rabbits during the period of organogenesis (the from implantation the fetus to birth) at doses of 0.025% (dosed once a day), 0.03% twice or 0.025% (dosed three times a day). Buspirone caused dose-dependent increases (50% or more) in serum levels of prolactin, IGF-1, and insulin-like growth factor 1 (IGF-1). Serum prolactin was the only compound that did not increase in response to the 0.025% and 0.03% doses of buspirone, with the 0.025% dose being most effective. Serum IGF-1 levels were not measured in any of the studies. one study comparing 0.03% dose with saline alone, IGF-1 levels were not increased by the 0.03% dose and were not associated with any effects on mammary gland development in female rats. The 0.025% dose did not affect mammary gland development in male rats. There were no effects on fertility in male rats administered buspirone during the period of organogenesis or conception. In one study, male mice were given a single dose of buspirone (0.3-1.0 mg/kg) by gavage on the day before or 2 of gestation. Ingestion buspirone, in doses of 0.3-1.0 mg/kg, delayed the onset of labor and reduced the size of placenta in female mice administered buspirone on day 2 of gestation. There were no effects on fertility in male or female mice when given by gavage on days 2 through 7 of gestation. There are no adequate and well-controlled studies in pregnant women. Buspirone should be used during pregnancy only if the potential benefit justifies risk to the fetus. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Aging The dosages and duration of therapy should be reduced in geriatric patients. Contraindications Pregnancy In animal reproduction studies, the drug was associated with uterine hyperplasia and rupture. Because of these reports, buspirone has not been approved for use in pregnant women. Labor and Delivery If a patient has an established history of thrombocytopenia, a prior thrombosis, or history of thrombophilia, if he/she has a family history of thrombocytopenia, he/she must be treated with low doses of buspirone. This medication should be used during pregnancy only if the potential benefit justifies risk to the fetus. Use in Pediatric Patients There are limited data suggesting that buspirone might decrease bone mineral density in pediatric patients. However, there are insufficient data on the potential benefit in pediatric patients to recommend its use. Data concerning safety of the drug in pediatric patients have not been evaluated. Pediatric Use in Uncontrolled Studies In uncontrolled studies of elderly patients in geriatric nursing homes, the safety of buspirone was uneventful. A 12-week, double-blind, placebo-controlled study of elderly patients in nursing homes was conducted to evaluate the safety and efficacy of buspirone (0.3 mg/day) compared with placebo. Of the 742 elderly subjects who participated in the study, 13 (0.4%) withdrew while the median age of subjects was 84 years. No significant differences between the groups were found for any of the primary safety measures. There was no significant difference in mean plasma concentrations of buspirone between the and placebo groups. Serum levels of IGF-1 were not measured in any of the studies. addition, there were no significant differences between the buspirone and placebo groups in any of the secondary measures efficacy or quality of life. In a 4-week, single-blind, placebo-controlled study of elderly subjects, 6 (0.6%) subjects withdrew, and the median age of subjects was 83 years. No significant differences between the buspirone and placebo groups were found for any of the primary.
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