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ADDERALL-XR (AMPHETAMINE, DEXTROAMPHETAMINE): NONCLINICAL TOXICOLOGY

Carcinogenesis, Mutagenesis, Impairment of Fertility

No evidence of carcinogenicity was found in studies in which D,L-Amphetamine (enantiomer ratio of 1:1) was administered to mice and rats in the diet for 2 years at doses of up to 30 mg/kg/day in male mice, 19 mg/kg/day in female mice, and 5 mg/kg/day in male and female rats. These doses are approximately 2.4, 1.5, and 0.8 times, respectively, the maximum recommended human dose for children of 30 mg/day, on a mg/m2 body surface area basis.

Amphetamine, in the enantiomer ratio present in Adderall-XR (D- to L- ratio of 3:1), was not clastogenic in the mouse bone marrow micronucleus test in vivo and was negative when tested in the E. coli component of the Ames test in vitro. D,L-Amphetamine (1:1 enantiomer ratio) has been reported to produce a positive response in the mouse bone marrow micronucleus test, an equivocal response in the Ames test, and negative responses in the in vitro sister chromatid exchange and chromosomal aberration assays.

Amphetamine, in the enantiomer ratio present in Adderall-XR (D- to L- ratio of 3:1), did not adversely affect fertility or early embryonic development in the rat at doses of up to 20 mg/kg/day (approximately 8 times the maximum recommended human dose for adolescents of 20 mg/day, on a mg/m2 body surface area basis).

Animal Toxicology and/or Pharmacology

Acute administration of high doses of amphetamine (D- or D,L-) has been shown to produce long-lasting neurotoxic effects, including irreversible nerve fiber damage, in rodents. The significance of these findings to humans is unknown.



Adderall-XR related pharmaceutical drugs and medications

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Strattera nonclinical toxicology - Atomoxetine Hydrochloride
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  • Eli Lilly
  • DKSH
  • Y.C. Woo
  • Balamol - Bromazepam
  • Tablets; Oral; Bromazepam 3 mg
  • Tablets; Oral; Bromazepam 6 mg
  • Fada Pharma


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