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|Dextroamphetamine Saccharate/Amphetamine Aspartate Monohydrate/Dextroamphetamine Sulfate/Amphetamine Sulfate

Dextroamphetamine Saccharate/Amphetamine Aspartate Monohydrate/Dextroamphetamine Sulfate/Amphetamine Sulfate

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

Trade Names:
Adderall XR
- Capsules 10 mg (2.5 mg dextroamphetamine sulfate, 2.5 mg dextroamphetamine saccharate, 2.5 mg amphetamine aspartate monohydrate, 2.5 mg amphetamine sulfate)
- Capsules 20 mg (5 mg dextroamphetamine sulfate, 5 mg dextroamphetamine saccharate, 5 mg amphetamine aspartate monohydrate, 5 mg amphetamine sulfate)
- Capsules 30 mg (7.5 mg dextroamphetamine sulfate, 7.5 mg dextroamphetamine saccharate, 7.5 mg amphetamine aspartate monohydrate, 7.5 mg amphetamine sulfate)

Mechanism of Action

Pharmacology

Activates nonadrenergic neurons, causing CNS and respiratory stimulation. Stimulates satiety center in brain, causing appetite suppression.

Indications and Usage

Narcolepsy ( Adderall ), treatment of attention deficit hyperactivity disorder.

Contraindications

Advanced arteriosclerosis, symptomatic cardiovascular disease; moderate to severe hypertension; hyperthyroidism; glaucoma; known hypersensitivity or idiosyncrasy to sympathomimetics amines; agitated states; history of drug abuse; during or within 14 days following the administration of MAO inhibitors.

Dosage and Administration

PO Start with 2.5 mg/day, increasing the daily dose in increments of 2.5 mg at weekly intervals until optimal response is obtained.

PO Start with 5 mg qd or bid, increasing the daily dose in increments of 5 mg at weekly intervals until optimal response is obtained. Rarely will it be necessary to exceed 40 mg/day. Administer first dose on awakening; 1 or 2 additional doses at intervals of 4 to 6 hr.

Narcolepsy seldom occurs in children younger than 12 yr; however, when it does, dextroamphetamine may be administered.

PO Start with 10 mg, increasing the daily dose in increments of 10 mg at weekly intervals until optimal response is obtained.

PO Start with 5 mg daily, increasing the daily dose in increments of 5 mg at weekly intervals until optimal response is obtained.

PO Start with 10 mg qd in the morning; daily dose may be increased in 10 mg increments at weekly intervals (max, 30 mg/day).

General Advice

• Swallow capsules whole. Do not crush or chew.
• Capsules also can be opened and the entire contents sprinkled on applesauce. The applesauce mixture must be consumed immediately and not stored for future use. The applesauce must be swallowed in its entirety without chewing.

Storage/Stability

Store at controlled room temperature (59° to 86°F).

Drug Interactions

Effect may be inhibited by amphetamines.

Effects may be antagonized by amphetamines.

May inhibit the CNS stimulant effects of amphetamines.

Amphetamines may delay absorption.

May cause hypertensive crisis and intracranial hemorrhage.

Decreased amphetamine absorption, reducing plasma levels and therapeutic effects.

Increased amphetamine absorption, increasing plasma levels, and pharmacologic and adverse effects.

Amphetamines potentiate their effects.

May slow amphetamine metabolism, increasing plasma levels and potentiating the effects. May cause hypertensive crisis and intracranial hemorrhage.

Absorption may be delayed by amphetamines; coadministration with amphetamines may produce a synergistic anticonvulsant action.

Propoxyphene overdose may potentiate amphetamine CNS stimulation, leading to fatal convulsions.

Activity of both agents may be increased; cardiovascular effects may be potentiated.

Increased amphetamine urinary excretion, decreasing plasma levels and therapeutic effects.

Decreased amphetamine urinary excretion, increasing plasma levels as well as pharmacologic and adverse effects.

Laboratory Test Interactions

Plasma and urinary steroid levels may be altered.

Adverse Reactions

Cardiovascular

Palpitations; tachycardia; hypertension; cardiomyopathy.

CNS

Psychotic episodes; overstimulation; restlessness; dizziness; nervousness; insomnia; emotional lability; depression; euphoria; dyskinesia; dysphoria; tremor; headache; exacerbation of motor and phonic tics and Tourette syndrome; changes in libido.

Dermatologic

Urticaria.

GI

Dry mouth; unpleasant taste; diarrhea; dyspepsia; nausea; vomiting; constipation; anorexia; weight loss; loss of appetite; GI disturbances.

Genitourinary

Impotence; changes in libido.

Metabolic

Weight loss.

Miscellaneous

Abdominal pain; accidental injury; asthenia; fever; infection; viral infection; allergy.

Precautions

Pregnancy

Category C .

Lactation

Excreted in breast milk.

Children

Safety and efficacy not established in children younger than 3 yr ( Adderall ). Safety and efficacy not established in children less than 6 yr ( Adderall XR ).

Elderly

Safety and efficacy in geriatric population not established ( Adderall XR ).

Drug dependence

Has high potential for dependence and abuse.

Hypertension

Use with caution.

Psychosis

Symptoms of behavior disturbance and thought disorder may be exacerbated.

Tics

Motor and phonic tics and Tourette syndrome may be exacerbated.

Tolerance

May occur; do not exceed recommended dose.

Overdosage

Symptoms

Restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucination, panic states, hyperpyrexia, rhabdomyolysis, CNS stimulation, arrhythmias, hypertension, hypotension, circulatory collapse, fatigue, depression, nausea, vomiting, diarrhea, abdominal cramps, convulsions, coma, death.

Patient Information

• Explain name, dose, action, and potential side effects of drug.
• Caution patient or caregiver to swallow capsules whole and not to crush or chew the capsules.
• Advise patient or caregiver that capsules may be opened and the entire contents sprinkled on applesauce. The applesauce mixture must be consumed immediately and not stored for future use. The applesauce must be swallowed in its entirety without chewing.
• Advise patient, family, or caregiver that medication is started at a low dose and gradually increased as needed and tolerated.
• Advise patient, family, or caregiver to take medication as prescribed and not to stop taking or change dosage unless advised by health care provider.
• Advise patient, family, or caregiver that the drug is part of a total treatment program that should also include psychological, educational, and social interventions.
• Advise parents to inform school or daycare personnel about drug use and administration.
• Caution patient that drug may impair the ability to drive or perform other tasks requiring mental alertness.
• Advise women to notify health care provider if pregnant, planning to become pregnant, or breastfeeding.
• Warn patient, family, or caregiver not to take any prescription or OTC drugs or dietary supplements without consulting health care provider.
• Advise patient, family, or caregiver that follow-up visits may be necessary to monitor therapy and to keep appointments.