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Nursing Mothers Atomoxetine and/ or its metabolites were excreted in the milk of rats. It is not known if atomoxetine is excreted in human milk. Caution should be exercised if STRATTERA is administered to a nursing woman.
Pediatric Use
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The safety and efficacy of STRATTERA in pediatric patients less than 6 years of age have not been established. The efficacy of STRATTERA beyond 9 weeks and safety of STRATTERA beyond 1 year of treatment have not been systematically evaluated. A study was conducted in young rats to evaluate the effects of atomoxetine on growth and neurobehavioral and sexual development. Rats were treated with 1, 10, or 50 mg/ kg/ day (approximately 0.2, 2, and 8 times, respectively, the maximum human dose on a mg/ m 2 basis) of atomoxetine given by gavage from the early postnatal period (Day 10 of age) through adulthood.
Slight delays in onset of vaginal patency (all doses) and preputial separation (10 and 50 mg/ kg), slight decreases in epididymal weight and sperm number (10 and 50 mg/ kg), and a slight decrease in corpora lutea (50 mg/ kg) were seen, but there were no effects on fertility or reproductive performance. A slight delay in onset of incisor eruption was seen at 50 mg/ kg. A slight increase in motor activity was seen on Day 15 (males at 10 and 50 mg/ kg and females at 50 mg/ kg) and on Day 30 (females at 50 mg/ kg) but not on Day 60 of age. There were no effects on learning and memory tests. The significance of these findings to humans is unknown. Geriatric Use The safety and efficacy of STRATTERA in geriatric patients have not been established. Page: << Prev | 1 | 2 | 3 | 4
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