Adderal XR Side Effects & Drug Interactions

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Adderal XR - Side Effects & Drug Interactions [Amphetamine Mixed Salts]

Carcinogenesis/ Mutagenesis and 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 of 30 mg/ day on a mg/ m 2 body surface area basis.

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0 4 8 12 16 24 20

5
10
15
20
25
30

TIME (HOURS)
MEAN
PLASMA

CONCENTRATIONS OF DEXTRO AND LEVOAMPHETAMINE

(ng/ mL) DEXTROAMPHETAMINE
LEVOAMPHETAMINE
ADDERALL XR TM 20 mg qd
ADDERALL Ž 10 mg bid

ADDERALL Ž 10 mg bid
ADDERALL XR TM 20 mg qd

Amphetamine, in the enantiomer ratio present in ADDERALL Ž (immediate-release)( 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 Ž (immediate-release)( 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 5 times the maximum recommended human dose of 30 mg/ day on a mg/ m 2 body surface area basis).

Pregnancy:

Pregnancy Category C.

Amphetamine, in the enantiomer ratio present in ADDERALL Ž (d-to l-ratio of 3: 1), had no apparent effects on embryofetal morphological development or survival when orally administered to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 6 and 16 mg/ kg/ day, respectively. These doses are approximately 1.5 and 8 times, respectively, the maximum recommended human dose of 30 mg/ day on a mg/ m 2 body surface area basis.