Dextroamphetamine Mixed Salts

Pronunciation: DEX-troe-am-FET-a-meen
Class: Amphetamine

Trade Names

Adderall
- Tablets 5 mg (1.25 mg of each: dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate)
- Tablets 7.5 mg (1.875 mg of each: dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate)
- Tablets 10 mg (2.5 mg of each: dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate)
- Tablets 12.5 mg (3.125 mg of each: dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate)
- Tablets 15 mg (3.75 mg of each: dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate)
- Tablets 20 mg (5 mg of each: dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate)
- Tablets 30 mg (7.5 mg of each: dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate)

Adderall XR
- Capsules, extended-release 5 mg (1.25 mg of each: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate)
- Capsules, extended-release 10 mg (2.5 mg of each: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate)
- Capsules, extended-release 15 mg (3.75 mg of each: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate)
- Capsules, extended-release 20 mg (5 mg of each: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate)
- Capsules, extended-release 25 mg (6.25 mg of each: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate)
- Capsules, extended-release 30 mg (7.5 mg of each: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate)

Pharmacology

Activates noradrenergic neurons, causing CNS and respiratory stimulation.

Pharmacokinetics

Absorption

T max is approximately 3 h (immediate release [IR]) and approximately 7 h (extended release [ER]). Food prolongs T max by 2.5 h for the ER formulation.

Distribution

Excreted in breast milk.

Elimination

The t ½ is 10 h (d-amphetamine) and 13 h (l-amphetamine) for adults.

Special Populations

Children

The t ½ for adolescents 13 to 17 yr of age is 11 h for d-amphetamine and 13 to 14 h for l-amphetamine. The t ½ for children 6 to 12 yr of age is 9 h and 11 h for d-amphetamine and l-amphetamine, respectively.

Indications and Usage

Attention deficit hyperactivity disorder (ADHD); narcolepsy (IR only).

Contraindications

Advanced arteriosclerosis; symptomatic CV disease; moderate to severe hypertension; hyperthyroidism; hypersensitivity to sympathomimetic amines; glaucoma; agitated states; history of drug abuse. Do not use concomitantly with an MAOI or within 14 days of MAOI use.

Dosage and Administration

ADHD
Adults ER

PO Recommended dose is 20 mg/day.

Adolescents 13 to 17 years of age ER

PO Start with 10 mg once daily in the morning. Dose may be increased to 20 mg/day after 7 days if symptoms are not adequately controlled.

Children 6 yr of age or older IR

PO 5 mg once or twice daily; may be increased weekly by 5 mg to max of 40 mg/day in divided doses. Usual range: 0.1 to 0.5 mg/kg/dose in the morning.

ER

PO Start with 10 mg once daily in the morning. Dosage may be adjusted in increments of 5 or 10 mg at weekly intervals. Max dose is 30 mg/day.

Children 3 to 5 yr of age IR

PO 2.5 mg/day; may be increased weekly by 2.5 mg. Usual range: 0.1 to 0.5 mg/kg/dose in the morning.

Narcolepsy
Adults and children older than 12 yr of age

PO 10 mg/day; may be increased weekly by 10 mg to max of 60 mg/day in divided doses.

Children 6 to 12 yr of age

PO 5 mg/day; may be increased weekly by 5 mg to max of 60 mg/day in divided doses.

General Advice

  • ER capsules may be taken whole or capsules may be opened and the entire contents sprinkled on applesauce and ingested immediately without chewing.

Storage/Stability

Store at 59° to 86°F. Dispense in light-resistant container.

Drug Interactions

Adrenergic blockers (eg, doxazosin, propranolol)

May be inhibited by amphetamines.

Alkalinizing agents (acetazolamide, sodium bicarbonate)

May increase amphetamine effect.

Antihistamines, antihypertensives

Activity may be decreased.

Ethosuximide

Intestinal absorption may be delayed by amphetamines.

Furazolidone, MAOIs

May cause hypertensive crisis and intracranial hemorrhage.

GI acidifying agents (eg, ascorbic acid, glutamic acid hydrochloride, reserpine)

Lower absorption of amphetamines.

Guanethidine

Effectiveness may be decreased.

Haloperidol, phenothiazines (eg, chlorpromazine)

May block central stimulant effect of amphetamines.

Lithium

May block anorectic and stimulatory effect of amphetamines.

Meperidine

Analgesic effect may be potentiated by amphetamines.

Norepinephrine

Adrenergic effect may be enhanced by amphetamines.

Phenobarbital, phenytoin

Intestinal absorption of phenobarbital or phenytoin may be delayed; coadministration may produce synergistic anticonvulsant effects.

Propoxyphene

Amphetamine CNS stimulation is potentiated and fatal convulsions can occur in propoxyphene overdosage.

SSRIs (eg, fluoxetine)

Risk of serotonin syndrome may be increased.

Tricyclic antidepressants (eg, desipramine)

Activity may be increased.

Urinary acidifiers (ammonium chloride, methenamine, sodium acid phosphate)

May decrease amphetamine effect.

Veratrum alkaloids

Hypotensive effect may be inhibited by amphetamines.

Laboratory Test Interactions

Plasma and urine steroid levels may be altered.

Adverse Reactions

Cardiovascular

Tachycardia (6%); cardiomyopathy, increased BP, MI, palpitations, sudden death.

CNS

Insomnia (27%); headache (26%); emotional lability (9%); agitation, anxiety (8%); dizziness (7%); asthenia, nervousness (6%); change in libido, depression, dyskinesia, euphoria, exacerbation of motor and phonic tics and Tourette syndrome, overstimulation, psychotic episodes, restlessness, seizures, stroke, tremor.

Dermatologic

Rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria.

GI

Anorexia (36%); dry mouth (35%); abdominal pain (14%); nausea (8%); vomiting (7%); diarrhea (6%); dyspepsia (2%); constipation, GI disturbance, unpleasant taste.

Genitourinary

UTI (5%); impotence.

Hypersensitivity

Anaphylaxis, angioedema.

Metabolic-Nutritional

Weight loss (11%).

Miscellaneous

Fever (5%); infection (4%); accidental injury (3%); viral infection (2%).

Precautions

Warnings

Drug dependence may develop with chronic use. Avoid prolonged periods of use. Prescribe/dispense sparingly because of high diversion potential.

Misuse of amphetamines may cause sudden death or serious CV adverse reactions.


Monitor

Monitor for large changes in heart rate and BP.


Pregnancy

Category C .

Lactation

Excreted in breast milk.

Children

Not recommended in children younger than 3 yr of age (IR). Safety and efficacy not established in children younger than 6 yr of age (ER).

Abuse and dependence

Amphetamines have been extensively abused. Tolerance, extreme psychological dependence, and severe social disability have occurred.

Continuation of therapy

Where possible, interrupt drug administration occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continuation of therapy.

Hypertension

Amphetamines can cause increases in average heart rate and BP.

Psychosis

May exacerbate symptoms of behavior disturbance and thought disorder in patients with preexisting psychotic disorder. Use with caution in ADHD patients with comorbid bipolar disorder because of possible induction of mixed/manic episodes. Can cause treatment-emergent psychotic or manic symptoms in children and adolescents who do not have a prior history of psychotic illness or mania. Aggressive behavior or hostility has been associated with treatment in children and adolescents.

Seizures

Stimulants may lower the convulsive threshold in patient with prior history of seizures.

Tics

Motor and phonic tics and Tourette syndrome may be exacerbated.

Tolerance

May occur; do not exceed recommended dose.

Overdosage

Symptoms

Abdominal cramps, arrhythmias, circulatory collapse, coma, confusion, convulsions, depression, diarrhea, fatigue, hallucinations, hyperreflexia, hypertension, hypotension, nausea, panic, restlessness, tremor, vomiting.

Patient Information

  • Caution patient to take medication exactly as prescribed and not to increase dosage unless advised by health care provider.
  • Advise patient to avoid caffeine, which increases drug effect.
  • Instruct patient to report the following symptoms to health care provider: GI disturbances, insomnia, skin discolorations.
  • Instruct patient to take sips of water frequently, suck on ice chips or sugarless hard candy, or chew sugarless gum if dry mouth occurs.
  • Advise patient that drug may cause drowsiness, and to use caution while driving or performing other tasks requiring mental alertness.

Copyright © 2009 Wolters Kluwer Health.

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