Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate ER (Page 6 of 9)

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release is a Schedule II controlled substance.

9.2 Abuse and Dependence

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release is a CNS stimulant that contains amphetamine, which has a high potential for abuse. Abuse is characterized by impaired control of drug use, compulsive use despite harm, and craving.

Signs and symptoms of amphetamine abuse may include increased heart rate, respiratory rate, blood pressure, and/or sweating, dilated pupils, hyperactivity, restlessness, insomnia, decreased appetite, loss of coordination, tremors, flushed skin, vomiting, and/or abdominal pain. Anxiety, psychosis, hostility, aggression, suicidal or homicidal ideation have also been observed. Abusers of amphetamines may use other unapproved routes of administration which can result in overdose and death [see Overdosage (10)].

To reduce the abuse of CNS stimulants, including Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release, assess the risk of abuse prior to prescribing. After prescribing, keep careful prescription records, educate patients and their families about abuse and proper storage and disposal of CNS stimulants. Monitor for signs of abuse while on therapy and re-evaluate the need for Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release use.

9.3 Dependence

Tolerance (a state of adaptation in which exposure to a specific dose of a drug results in a reduction of the drug’s desired and/or undesired effects over time, in such a way that a higher dose of the drug is required to produce the same effect that was once obtained at a lower dose) may occur during chronic therapy of CNS stimulants including Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release.

Physical Dependence (which is manifested by a withdrawal syndrome produced by abrupt cessation, rapid dose reduction, or administration of an antagonist) may occur in patients treated with CNS stimulants including Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release. Withdrawal symptoms after abrupt cessation of CNS stimulants include dysphoric mood; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.

10 OVERDOSAGE

Manifestations of acute overdosage with amphetamines include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, hyperpyrexia and rhabdomyolysis. Fatigue and depression usually follow the central nervous system stimulation. Serotonin syndrome has been reported with amphetamine use, including Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release. Cardiovascular effects include arrhythmias, hypertension or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma.

Treatment

Consult with a Certified Poison Control Center for up to date guidance and advice.

The prolonged release of mixed amphetamine salts from Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release should be considered when treating patients with overdose.

d-Amphetamine is not dialyzable.

11 DESCRIPTION

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent.

The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release contains two types of drug-containing beads (immediate-release and delayed release) which prolong the release of amphetamine compared to the Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate (immediate-release) tablet formulation.

Each capsule contains:

Capsule Strength

5 mg

10 mg

15 mg

20 mg

25 mg

30 mg

Dextroamphetamine Saccharate

1.25 mg

2.5 mg

3.75 mg

5.0 mg

6.25 mg

7.5 mg

Amphetamine (D,L)-Aspartate Monohydrate 1.25 mg

2.5 mg

3.75 mg

5.0 mg

6.25 mg

7.5 mg

Dextroamphetamine Sulfate

1.25 mg

2.5 mg

3.75 mg

5.0 mg

6.25 mg

7.5 mg

Amphetamine Sulfate

1.25 mg

2.5 mg

3.75 mg

5.0 mg

6.25 mg

7.5 mg

Total amphetamine base equivalence

3.1 mg

6.3 mg

9.4 mg

12.5 mg

15.6 mg

18.8 mg

d-amphetamine base equivalence

2.4 mg

4.7 mg

7.1 mg

9.5 mg

11.9 mg

14.2 mg

l-amphetamine base equivalence

0.75 mg

1.5 mg

2.3 mg

3.0 mg

3.8 mg

4.5 mg

Inactive Ingredients and Colors

The inactive ingredients in Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release capsules include: methacrylic acid copolymer, methocel E5 premium, sugar spheres, talc, and triethyl citrate. The gelatin capsules contain edible inks: ammonium hydroxide, ammonia solution, dehydrated alcohol, iron oxide black, isopropyl alcohol, n-butyl alcohol, potassium hydroxide, propylene glycol, shellac glaze and titanium dioxide. The 5 mg, 10 mg, and 15 mg capsules also contain FD&C Blue #1, FD&C red #40, and iron oxide red. The 20 mg, 25 mg and 30 mg contain FD&C yellow #6.

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