Adderal XR - Side Effects & Drug Interactions

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Haloperidol

Haloperidol blocks dopamine receptors, thus inhibiting the central stimulant effects of amphetamines.

Lithium carbonate

The anorectic and stimulatory effects of amphetamines may be inhibited by

lithium carbonate.

Meperidine

Amphetamines potentiate the analgesic effect of meperidine.

Methenamine therapy

Urinary excretion of amphetamines is increased, and efficacy is reduced, by acidifying agents used in methenamine therapy.

Norepinephrine

Amphetamines enhance the adrenergic effect of norepinephrine.

Phenobarbital

Amphetamines may delay intestinal absorption of phenobarbital; co-administration of phenobarbital may produce a synergistic anticonvulsant action.

Phenytoin

Amphetamines may delay intestinal absorption of phenytoin; co-administration of phenytoin may produce a synergistic anticonvulsant action.

Propoxyphene

In cases of propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur.

Veratrum alkaloids

Amphetamines inhibit the hypotensive effect of veratrum alkaloids.

Drug/ Laboratory Test Interactions:

Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.

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.

0

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 ® 10 mg bid

ADDERALL ® 10 mg bid

ADDERALL XR TM 20 mg qd

Amphetamine, in the enantiomer ratio present in ADDERALL ® (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.