Adderall

ADDERALL- dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablet
Teva Pharmaceuticals USA, Inc.

WARNING: ABUSE, MISUSE, AND ADDICTION

Adderall® has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including Adderall® , can result in overdose and death (see OVERDOSAGE), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Before prescribing Adderall® , assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout Adderall® treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction (see WARNINGS and DRUG ABUSE AND DEPENDENCE).

DESCRIPTION

A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate.

EACH TABLET CONTAINS

5 mg

7.5 mg

10 mg

12.5 mg

15 mg

20 mg

30 mg

Dextroamphetamine

Saccharate

1.25 mg

1.875 mg

2.5 mg

3.125 mg

3.75 mg

5 mg

7.5 mg

Amphetamine Aspartate Monohydrate Equivalent

1.25 mg 1

1.875 mg 2

2.5 mg 3

3.125 mg 4

3.75 mg 5

5 mg 6

7.5 mg 7

Dextroamphetamine

Sulfate, USP

1.25 mg

1.875 mg

2.5 mg

3.125 mg

3.75 mg

5 mg

7.5 mg

Amphetamine

Sulfate, USP

1.25 mg

1.875 mg

2.5 mg

3.125 mg

3.75 mg

5 mg

7.5 mg

Total Amphetamine Base Equivalence

3.13 mg

4.7 mg

6.3 mg

7.8 mg

9.4 mg

12.6 mg

18.8 mg

1 1.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as supplied

2 1.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as supplied

3 2.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as supplied

4 3.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg Amphetamine Aspartate (Anhydrous) as supplied

5 3.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as supplied

6 5 mg of Amphetamine Aspartate Monohydrate equivalent to 4.6 mg Amphetamine Aspartate (Anhydrous) as supplied

7 7.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied

Inactive Ingredients: colloidal silicon dioxide, compressible sugar, corn starch, magnesium stearate, microcrystalline cellulose and saccharin sodium.

Colors: Adderall® 5 mg is a white to off-white tablet, which contains no color additives.

Adderall ® 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake as a color additive.

Adderall ® 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive.

CLINICAL PHARMACOLOGY

Pharmacodynamics

Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

Pharmacokinetics

Adderall® tablets contain d-amphetamine and l-amphetamine salts in the ratio of 3:1. Following administration of a single dose 10 or 30 mg of Adderall® to healthy volunteers under fasted conditions, peak plasma concentrations occurred approximately 3 hours post-dose for both d-amphetamine and l-amphetamine. The mean elimination half-life (t1/2 ) for d-amphetamine was shorter than the t1/2 of the l-isomer (9.77 to 11 hours vs. 11.5 to 13.8 hours). The PK parameters (Cmax , AUC0-inf ) of d-and l-amphetamine increased approximately three-fold from 10 mg to 30 mg indicating dose-proportional pharmacokinetics.

The effect of food on the bioavailability of Adderall® has not been studied.

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