Professional Information

Amphetamines (Systemic)

This monograph includes information on the following:

1) Amphetamine ^†
2) Amphetamine and dextroamphetamine ^†
3) Dextroamphetamine
4) Methamphetamine ^†

INN:
Amphetamine ^†—Amfetamine
Dextroamphetamine—Dexamfetamine
Methamphetamine ^†—Metamfetamine

VA CLASSIFICATION
Primary: CN801

Note: Controlled substance classification—

Note: Controlled substances in the U.S. and Canada as follows:

Drug	U.S.	Canada
Amphetamine	II	^†
Dextroamphetamine	II	C
Methamphetamine	II	^†

^† Not commercially available in Canada
Commonly used brand name(s): Adderall²; Desoxyn⁴; Desoxyn Gradumet⁴; Dexedrine³; Dexedrine Spansule³; Dextrostat³.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).

^†Not commercially available in Canada.

Category:

Central nervous system (CNS) stimulant—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Attention-deficit hyperactivity disorder (treatment)^{12}^{13}^{14}^{15}—Amphetamines are indicated as an integral part of a total treatment program that includes other remedial measures (psychological, educational, social) for a stabilizing effect in children [and adults]¹ with attention-deficit hyperactivity disorder, characterized by moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity ^{12} ^{13} ^{15}. Nonlocalizing neurological signs, learning disability, and abnormal electroencephalogram (EEG) may be present also ^{12} ^{13} ^{15}. Amphetamines usually are not indicated when the above symptoms are associated with acute stress reactions ^{15}.

Narcolepsy (treatment)—Amphetamine and dextroamphetamine are indicated in the treatment of well-established and proven narcolepsy ^{13} ^{14}.

Unaccepted
Due to their high potential for abuse ^{12} ^{13} ^{15}, amphetamines are not recommended for use as appetite suppressants.

Amphetamines should not be used to combat fatigue or to replace rest in normal subjects ^{14} ^{15}.

¹ Not included in Canadian product labeling.

Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    Amphetamine sulfate: 368.49
    Dextroamphetamine sulfate: 368.49
    Methamphetamine hydrochloride: 185.70

Mechanism of action/Effect:

Amphetamines are sympathomimetic amines ^{12} ^{13} ^{14} ^{15} that increase motor activity and mental alertness ^{14}, and diminish drowsiness and a sense of fatigue ^{14}.

In attention-deficit hyperactivity disorder, amphetamines decrease motor restlessness and enhance the ability to pay attention.

The exact mechanism of action has not been established. However, in animals, amphetamines facilitate the action of dopamine and norepinephrine by blocking reuptake from the synapse, inhibit the action of monoamine oxidase (MAO), and facilitate the release of catecholamines. Increase in locomotor activity at relatively low doses and increase in stereotypic behavior with a concomitant decrease in activity at higher doses appear to be due to stimulation of mesocorticolimbic and nigrostriatal dopaminergic pathways. Dextroamphetamine may also stimulate inhibitory autoreceptors in the substantia nigra and ventral tegmentum. ^{01}

Some studies support the theory that amphetamine exerts a dual effect on the striatal dopaminergic nerve terminal, thus explaining the paradoxical effects of amphetamines. Amphetamines may selectively facilitate the dopaminergic transmission by promoting the release of recently synthesized dopamine from a reserpine-resistant pool and, in addition, may inhibit the classical dopaminergic neurotransmission involving the calcium-dependent depolarization-evoked release of dopamine from reserpine-sensitive storage sites. ^{02}

Other actions/effects:

Peripheral actions include elevation of both diastolic and systolic blood pressure, and weak bronchodilator and respiratory stimulant actions ^{12} ^{13} ^{15}.

Biotransformation:

Hepatic ^{15}.

Half-life:

Amphetamine:

10 to 30 hours; dependent on urinary pH.

Dextroamphetamine:

10 to 12 hours in adults; 6 to 8 hours in children.

Methamphetamine:

4 to 5 hours; dependent on urinary pH.

Elimination:
    Renal ^{15}; dependent on urinary pH ^{15}. Excretion is accelerated in acidic urine ^{12} ^{13} ^{14} ^{15} and slowed in alkaline urine ^{15}.

Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to other sympathomimetics ^{12} ^{13} ^{14} ^{15} (for example, ephedrine, epinephrine, isoproterenol, metaproterenol, norepinephrine, phenylephrine, phenylpropanolamine, pseudoephedrine, terbutaline) may be sensitive to amphetamines also.

Carcinogenicity/Mutagenicity

Mutagenicity and long-term carcinogenicity studies in animals have not been done ^{10} ^{13} ^{15}.

Pregnancy/Reproduction

Pregnancy—
Although adequate and well-controlled studies in humans have not been done ^{13} ^{15}, use of amphetamines during early pregnancy may be associated with an increased risk of congenital malformations, especially in the cardiovascular system and biliary tract.

Reproduction studies in animals have suggested both an embryotoxic and a teratogenic potential when amphetamines were administered at high multiples of the human dose ^{12} ^{13} ^{14} ^{15}.

FDA Pregnancy Category C ^{12} ^{13} ^{14} ^{15}.

Delivery—

Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight ^{13} ^{15}. These infants may experience symptoms of withdrawal, including agitation and significant drowsiness ^{13} ^{15}.

Breast-feeding

Amphetamines are distributed into breast milk ^{03} ^{04} ^{12} ^{13} ^{14} ^{15}. However, problems in nursing infants have not been documented.

Pediatrics

Data suggest that prolonged administration of amphetamines to children may inhibit growth. Careful monitoring during treatment is recommended. ^{12} ^{14} ^{15}

Psychotic children may experience exacerbation of symptoms of behavior disturbance and thought disorder ^{12} ^{13} ^{15}.

Amphetamines may provoke or exacerbate motor and vocal tics and Tourette's syndrome, necessitating clinical evaluation before administration of amphetamines ^{13} ^{14} ^{15}.

Geriatrics

No information is available on the relationship of age to the effects of the amphetamines in geriatric patients.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Acidifiers, gastrointestinal^{13}^{14} , such as:
Ascorbic acid^{13}
Fruit juices^{13}
Glutamic acid hydrochloride^{13} or
Acidifiers, urinary^{13}^{14} , such as:
Ammonium chloride^{13}
Sodium acid phosphate^{13}    (concurrent use may decrease the effects of amphetamines as a result of decreased absorption and increased elimination ^{13})

Alkalizers, urinary, such as:
Antacids, calcium- and/or magnesium-containing^{21}
Carbonic anhydrase inhibitors^{09}^{13}
Citrates
Sodium bicarbonate^{09}^{13}    (concurrent use may increase the effects of amphetamines as a result of decreased elimination caused by alkalinization of urine ^{13} ^{14})

Anesthetics, inhalation    (halothane and, to a much lesser extent, enflurane, isoflurane, and methoxyflurane, may sensitize the myocardium to the effects of sympathomimetics, including chronic use of amphetamines prior to anesthesia, so that the risk of severe ventricular arrhythmias is increased; sympathomimetics should be used with caution and in substantially reduced dosage in patients receiving these agents)

» Antidepressants, tricyclic    (although tricyclic antidepressants may be used concurrently with amphetamines for therapeutic effect ^{16}, concurrent use may potentiate cardiovascular effects due to the release of norepinephrine, possibly resulting in arrhythmias, tachycardia, or severe hypertension or hyperpyrexia; close monitoring is recommended and dosage adjustments may be necessary ^{04} ^{09} ^{13} ^{14} ^{15})

Antihypertensives^{09} or
Diuretics used as antihypertensives    (hypotensive effects may be reduced when these medications are used concurrently with amphetamines; the patient should be carefully monitored to confirm that the desired effect is obtained ^{12} ^{13} ^{14} ^{15})

» Beta-adrenergic blocking agents^{13}^{15} , including ophthalmics    (concurrent use with amphetamines may result in unopposed alpha-adrenergic activity with a risk of hypertension and excessive bradycardia and possible heart block; risk may be less with labetalol because of its alpha-blocking activity ^{05})

» CNS stimulation–producing medications, other (see Appendix II )    (additive CNS stimulation to excessive levels may result in nervousness, irritability, insomnia, or possibly seizures; close observation is recommended)

    (also, concurrent use of amphetamines with other sympathomimetics may increase cardiovascular effects of either medication)

    (in addition to possibly increasing CNS stimulation, concurrent use of norepinephrine with large doses of amphetamines may enhance the pressor response to norepinephrine; caution may also be warranted in patients receiving usual doses of amphetamines ^{09} ^{13})

» Digitalis glycosides    (concurrent use with amphetamines may cause additive effects, resulting in cardiac arrhythmias)

Ethosuximide^{13}^{14} or
Phenobarbital or
Phenytoin    (concurrent use with amphetamines may cause a delay in the intestinal absorption of ethosuximide, phenobarbital, or phenytoin ^{13} ^{14})

Haloperidol^{09}^{13}^{14} or
Loxapine or
Molindone or
Phenothiazines^{09}^{13}^{14}^{15} or
Pimozide or
Thioxanthenes    (central stimulant effects of amphetamines may be inhibited because of alpha-adrenergic blockade by these agents; also, concurrent use with amphetamines may reduce the antipsychotic effects of these agents)

Levodopa    (the risk of cardiac arrhythmias may be increased; dosage reduction of amphetamine is recommended)

Lithium    (central stimulant effects of amphetamines may be antagonized by lithium ^{09} ^{13} ^{14})

» Meperidine    (the analgesic effects of meperidine may be potentiated by amphetamines ^{13} ^{14}; however, concurrent use of meperidine is not recommended, as it may potentially result in hypotension, severe respiratory depression, coma, convulsions, hyperpyrexia, vascular collapse, and death in some patients due to the monoamine oxidase inhibition properties of amphetamines ^{16})

Metrizamide    (intrathecal administration of metrizamide may increase the risk of seizures because of lowered seizure threshold; it is recommended that amphetamines be discontinued for at least 48 hours before and 24 hours after myelography)

» Monoamine oxidase (MAO) inhibitors, including furazolidone, procarbazine, and selegiline    (concurrent use may prolong and intensify cardiac stimulant and vasopressor effects [including headache, cardiac arrhythmias, vomiting, sudden and severe hypertensive and hyperpyretic crises] of amphetamines because of the release of catecholamines that accumulate in intraneuronal storage sites during MAO inhibitor therapy; amphetamines should not be administered during or within 14 days following the administration of an MAO inhibitor ^{08} ^{09} ^{12} ^{13} ^{14} ^{15})

Propoxyphene^{13}^{14}    (overdosage of propoxyphene may potentiate central stimulant effects of amphetamines; fatal convulsions can occur ^{13})

» Thyroid hormones    (the effects of either these medications or amphetamines may be increased; thyroid hormones enhance the risk of coronary insufficiency when amphetamines are administered to patients with coronary artery disease)

Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With diagnostic test results
Urinary steroid determinations^{06}^{13}^{20}    (may be altered, interfering with results of such tests as the metyrapone test)

With physiology/laboratory test values
Plasma corticosteroid concentrations^{06}    (may be increased, with greatest increase in evening ^{13} ^{15})

Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).

Risk-benefit should be considered when the following medical problems exist
» Agitated states^{12}^{13}^{14}^{15} or
» Arteriosclerosis, advanced^{12}^{13}^{14}^{15} or
» Cardiovascular disease, symptomatic^{12}^{13}^{14}^{15} or
» Drug abuse or dependence, history of^{12}^{13}^{14}^{15} or
» Glaucoma^{12}^{13}^{14}^{15} or
» Hypertension^{12}^{13}^{14}^{15} or
» Hyperthyroidism^{13}^{14}^{15} or
Psychoses, especially in children^{12}^{13}^{15} or
» Tourette's syndrome or other motor or vocal tics    (increased risk of exacerbation ^{13} ^{14} ^{15})

Sensitivity to amphetamines and other sympathomimetics

Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

Assessment of potential tolerance, dependence, or drug-seeking behavior and
Blood pressure determinations and
Cardiac rhythm determinations    (recommended at periodic intervals during therapy)

Monitoring of growth in children    (recommended during therapy since data suggest that chronic administration of amphetamines may be associated with growth inhibition ^{12} ^{14} ^{15})

Monitoring for motor and vocal tics    (recommended during therapy)

Reassessment of need for therapy for attention-deficit hyperactivity disorder in children    (interruption of therapy at periodic intervals is recommended to determine if a recurrence of behavioral symptoms is sufficient to continue therapy)

Side/Adverse Effects

Note: Psychological dependence and tolerance may occur with amphetamines following prolonged use or high doses.

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence more frequent

Irregular heartbeat^{04}^{12}^{13}^{14}^{15}

Incidence rare

Allergic reaction (skin rash or hives)^{12}^{13}^{14}^{15}

chest pain

CNS stimulation, severe, or Tourette's syndrome^{13}^{14}^{15} (uncontrolled movements of the head, neck, arms, and legs)

hyperthermia^{16}^{17}^{18} (extremely high body temperature)

With prolonged use or high doses

Cardiomyopathy^{12}^{13}^{14} (chest discomfort or pain; difficulty in breathing; dizziness or feeling faint; irregular or pounding heartbeat; unusual tiredness or weakness)

increase in blood pressure^{12}^{13}^{14}

psychotic reactions^{12}^{13}^{14}^{15} or toxic psychoses^{12}^{13}^{14}^{15} (mood or mental changes)

Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent

CNS stimulation (false sense of well-being; irritability; nervousness; restlessness; trouble in sleeping)—drowsiness, fatigue, trembling, or mental depression may follow the stimulant effects^{12}^{13}^{14}^{15}

Incidence less frequent

Blurred vision

changes in sexual desire or decreased sexual ability^{12}^{13}^{14}^{15}

constipation
diarrhea
loss of appetite
nausea
stomach cramps or pain
weight loss
vomiting ^{12}^{13}^{14}^{15}

dizziness
lightheadedness
headache

dryness of mouth or unpleasant taste^{12}^{13}^{14}^{15}

fast or pounding heartbeat^{12}^{13}^{14}^{15}

increased sweating

Those indicating possible withdrawal and the need for medical attention if they occur after medication is discontinued

Mental depression^{12}

nausea
stomach cramps or pain
vomiting

trembling

unusual tiredness or weakness^{12}

Overdose
For specific information on the agents used in the management of amphetamine overdose, see:
   • Barbiturates (Systemic) monograph;
   • Chlorpromazine in Phenothiazines (Systemic) monograph; and/or
   • Phentolamine (Systemic) monograph.
For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center Listing ).

Treatment of overdose
Since there is no specific antidote for overdosage with amphetamines, treatment is symptomatic ^{12} ^{13} ^{14} ^{15} and supportive ^{14}.

To decrease absorption:
Induction of emesis ^{14} and/or use of gastric lavage ^{12} ^{13} ^{14} ^{15} is primary.

Use of saline cathartics to hasten evacuation of sustained-release dosage forms ^{13} ^{14} ^{15}.

To enhance elimination:
Acidification of urine to increase amphetamine excretion ^{12} ^{13} ^{14} ^{15}. Acidification is contraindicated in presence of rhabdomyolysis, myoglobinuria, or hemoglobinemia, as renal failure may result ^{16} ^{19}.

Forced diuresis if condition permits.

Specific treatment:
Barbiturate sedatives or chlorpromazine sometimes used to control excessive CNS stimulation ^{12} ^{13} ^{14} ^{15}.

Intravenous phentolamine to control hypertension ^{12} ^{13} ^{14} ^{15}.

Monitoring:
Cardiovascular and respiratory monitoring.

Supportive care:
Protection of patient from self-injury by use of restraints if necessary.

Intravenous fluids to control hypotension.

Patients in whom intentional overdose is confirmed or suspected should be referred for psychiatric consultation.

Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Amphetamines (Systemic) .

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to amphetamines and other sympathomimetics

Pregnancy—Increased risk of congenital malformations, especially in cardiovascular system and biliary tract; potential embryotoxic and teratogenic effects in animals given large doses; risk of premature delivery and low birth weight may be increased; newborn may experience withdrawal symptoms

Breast-feeding—Not recommended since amphetamines are distributed into breast milk

Use in children—May inhibit growth; may provoke motor and vocal tics and Tourette's syndrome; may exacerbate behavior problems and thought disorder in psychotic children

Other medications, especially tricyclic antidepressants, beta-adrenergic blocking agents, digitalis glycosides, meperidine, monoamine oxidase inhibitors, other CNS stimulation–producing medications, or thyroid hormones
Other medical problems, especially agitated states, advanced arteriosclerosis or symptomatic cardiovascular disease, history of drug dependence, glaucoma, hypertension, hyperthyroidism, or Tourette's syndrome or other tics

Proper use of this medication
Taking the last dose of the day of the regular dosage form at least 6 hours before bedtime and the daily dose of the extended-release dosage form about 10 to 14 hours before bedtime to minimize the possibility of insomnia

Proper administration of extended-release dosage forms:

Swallowing whole;

not breaking, crushing, or chewing

» Importance of not taking more medication than the amount prescribed because of habit-forming potential ^{15}

» Not increasing dose if medication becomes less effective after a few weeks; checking with physician ^{12} ^{13} ^{15}

» Proper dosing
Missed dose: If dosing schedule is—

Once a day: Taking as soon as possible but not later than stated above; if remembered later, not taking until next day; not doubling doses

Two or three times a day: Taking as soon as possible if remembered within an hour or so; not taking if remembered later; not doubling doses

» Proper storage

Precautions while using this medication
Regular visits to physician to check progress during therapy

» Checking with physician before discontinuing medication after prolonged high-dose therapy; gradual dosage reduction may be necessary to avoid possibility of withdrawal symptoms ^{12}

» Caution if dizziness or euphoria occurs; not driving, using machinery, or doing other activities that are potentially hazardous ^{12} ^{13} ^{14} ^{15}

Caution if any laboratory tests required; possible interference with results of metyrapone test

» Suspected psychological or physical dependence ^{12} ^{13} ^{14} ^{15}; checking with physician

Side/adverse effects
Signs of potential side effects, especially irregular heartbeat; allergic reaction; chest pain; tics or other signs of severe CNS stimulation; hyperthermia; cardiomyopathy; increased blood pressure; psychotic reactions

Potential unwanted effects during long-term use in children

Possibility of withdrawal effects, especially mental depression, nausea, stomach cramps or pain, vomiting, trembling, or unusual tiredness or weakness

General Dosing Information
When the regular tablet dosage form of amphetamines is administered, the first dose should be taken on awakening, followed by 1 or 2 additional doses at intervals of 4 to 6 hours ^{07} ^{13} ^{14}.

To reduce the possibility of insomnia, the last dose of the day of the regular dosage form should be administered at least 6 hours before bedtime, and the daily dose of the extended-release dosage form should be administered approximately 10 to 14 hours before bedtime ^{12} ^{13} ^{14} ^{15}.

The extended-release dosage form may be used for once-a-day dosing whenever it is feasible ^{10} ^{12} ^{13} ^{15}.

When symptoms of attention-deficit hyperactivity disorder are controlled in children, dosage reduction or interruption in therapy may be possible ^{12} ^{13} ^{15} during the summer months and at other times when the child is under less stress ^{14}; medication may be given on each of the 5 school days during the week, with medication-free weekends and school holidays.

Prolonged use of amphetamines may result in tolerance, extreme psychological dependence, or severe social disability ^{12} ^{13} ^{15}.

When the medication is to be discontinued following prolonged high-dose administration, the dosage should be reduced gradually since abrupt withdrawal may result in extreme fatigue and mental depression ^{12} ^{13} ^{14} ^{15}.

AMPHETAMINE

Oral Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.

AMPHETAMINE SULFATE TABLETS USP

Usual adult dose
[Attention-deficit hyperactivity disorder] or
Narcolepsy
Oral, 5 to 20 mg one to three times a day ^{22}.

Usual pediatric dose
Attention-deficit hyperactivity disorder
Children younger than 3 years of age: Use is not recommended.

Children 3 to 6 years of age: Oral, 2.5 mg once a day, the dosage being increased by 2.5 mg per day at one-week intervals until the desired response is obtained ^{12}.

Children 6 years of age and older: Oral, 5 mg one or two times a day, the dosage being increased by 5 mg per day at one-week intervals until the desired response is obtained ^{12}.

Narcolepsy
Children younger than 6 years of age: Dosage has not been established.

Children 6 to 12 years of age: Oral, 2.5 mg two times a day, the dosage being increased by 5 mg per day at one-week intervals until the desired response is obtained or until the adult dose is reached.

Children 12 years of age and older: Oral, 5 mg two times a day, the dosage being increased by 10 mg per day at one-week intervals until the desired response is obtained or until the adult dose is reached.

Strength(s) usually available
U.S.—

5 mg (Rx)[Generic]

10 mg (Rx)[Generic]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a well-closed container.

Note: Controlled substance in the U.S.

AMPHETAMINE AND DEXTROAMPHETAMINE

Oral Dosage Forms

AMPHETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AND DEXTROAMPHETAMINE SULFATE TABLETS

Usual adult dose
Narcolepsy
Oral, 5 to 60 mg a day in divided doses ^{07}.

Usual pediatric dose
Attention-deficit hyperactivity disorder
Children younger than 3 years of age: Use is not recommended ^{07}.

Children 3 to 6 years of age: Oral, initially 2.5 mg a day, the dosage being increased by 2.5 mg per day at one-week intervals until the desired response is obtained ^{07}.

Children 6 years of age and older: Oral, initially 5 mg one or two times a day, the dosage being increased by 5 mg per day at one-week intervals until the desired response is obtained ^{07}.

Narcolepsy
Children younger than 6 years of age: Dosage has not been established.

Children 6 to 12 years of age: Oral, initially 5 mg a day, the dosage being increased by 5 mg per day at one-week intervals until the desired response is obtained.

Children 12 years of age and older: Oral, initially 10 mg a day, the dosage being increased by 10 mg per day at one-week intervals until the desired response is obtained ^{07}.

Note: The usual pediatric dose rarely exceeds 40 mg a day ^{07}.

Strength(s) usually available
U.S.—

5 mg (1.25 mg each: amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, dextroamphetamine sulfate) (Rx) [Adderall (double scored) (acacia) (corn starch) (FD&C Blue #1) (lactose) (magnesium stearate) (sucrose)^{07}]

10 mg (2.5 mg each: amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, dextroamphetamine sulfate) (Rx) [Adderall (double scored) (acacia) (corn starch) (FD&C Blue #1) (lactose) (magnesium stearate) (sucrose)^{07}]

20 mg (5 mg each: amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, dextroamphetamine sulfate) (Rx) [Adderall (double scored) (acacia) (corn starch) (FD&C Yellow #6) (lactose) (magnesium stearate) (sucrose)^{07}]

30 mg (7.5 mg each: amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, dextroamphetamine sulfate) (Rx) [Adderall (double scored) (acacia) (corn starch) (FD&C Yellow #6) (lactose) (magnesium stearate) (sucrose)^{07}]

Canada—
Not commercially available.

Packaging and storage:
Store between 15 and 30 °C (59 and 86 °F) ^{07}, unless otherwise specified by manufacturer. Store in a tight, light-resistant container ^{07}.

Note: Controlled substance in the U.S.

Additional information:
The 5 mg, 10 mg, 20 mg, and 30 mg tablets are equivalent to 3.13 mg, 6.3 mg, 12.5 mg, and 18.8 mg of amphetamine base, respectively ^{07}.

DEXTROAMPHETAMINE

Oral Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.

DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES

Note: The extended-release dosage form should not be used for initiation of dosage, nor should it be used until the conventional titrated daily dosage is equal to or greater than the dosage provided in the extended-release dosage form.

Usual adult dose
[Attention-deficit hyperactivity disorder]¹ ^{22} or
Narcolepsy
Oral, 5 to 60 mg ^{11} ^{13} once a day, or in divided doses ^{11} ^{22}.

Usual pediatric dose
Attention-deficit hyperactivity disorder
Children younger than 3 years of age: Use is not recommended ^{11}.

Children 3 to 6 years of age: Oral, initially 2.5 mg once a day, the dosage being increased by 2.5 mg per day at one-week intervals until the desired response is obtained ^{11}.

Children 6 years of age and older: Oral, 5 mg once or twice a day, the dosage being increased by 5 mg a day at one-week intervals until the desired response is obtained ^{11}.

Narcolepsy
Children younger than 3 years of age: Use is not recommended.

Children 3 to 6 years of age: Dosage has not been established.

Children 6 to 12 years of age: Oral, initially 5 mg once a day, the dosage being increased by 5 mg a day at one-week intervals until the desired response is obtained ^{11}.

Children 12 years of age and older: Oral, initially 10 mg once a day, the dosage being increased by 10 mg a day at one-week intervals until the desired response is obtained ^{11}.

Note: The usual pediatric dose rarely exceeds 40 mg a day ^{11} ^{13} ^{14}.

Strength(s) usually available
U.S.—

5 mg (Rx) [Dexedrine Spansule (tartrazine)]

10 mg (Rx) [Dexedrine Spansule (tartrazine)]

15 mg (Rx) [Dexedrine Spansule (tartrazine)]

Canada—

10 mg (Rx) [Dexedrine Spansule (tartrazine)]

15 mg (Rx) [Dexedrine Spansule (tartrazine)]

Packaging and storage:
Store between 15 and 30 °C (59 and 86 °F), in a tight, light-resistant container, unless otherwise specified by manufacturer.

Auxiliary labeling:
• Swallow capsules whole.

Note: Controlled substance in both the U.S. and Canada.

DEXTROAMPHETAMINE SULFATE TABLETS USP

Usual adult dose
[Attention-deficit hyperactivity disorder]¹ or
Narcolepsy
Oral, 5 to 60 mg a day in divided doses as needed and tolerated ^{13} ^{22}.

Usual pediatric dose
Attention-deficit hyperactivity disorder
Children younger than 3 years of age: Use is not recommended.

Children 3 to 6 years of age: Oral, 2.5 mg once a day, the dosage being increased by 2.5 mg a day at one-week intervals until the desired response is obtained ^{13} ^{14}.

Children 6 years of age and older: Oral, 5 mg one or two times a day, the dosage being increased by 5 mg a day at one-week intervals until the desired response is obtained ^{13}.

Narcolepsy
Children younger than 6 years of age: Dosage has not been established.

Children 6 to 12 years of age: Oral, 5 mg a day, the dosage being increased by 5 mg a day at one-week intervals until the desired response is obtained ^{13} ^{14} or until the adult dose is reached.

Children 12 years of age and older: Oral, 10 mg a day, the dosage being increased by 10 mg a day at one-week intervals until the desired response is obtained ^{13} ^{14} or until the adult dose is reached.

Note: The usual pediatric dose rarely exceeds 40 mg a day ^{13} ^{14}.

Strength(s) usually available
U.S.—

5 mg (Rx) [Dexedrine (tartrazine)] [Dextrostat][Generic]

10 mg (Rx)[Generic]

Canada—

5 mg (Rx) [Dexedrine (tartrazine)]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Note: Controlled substance in both the U.S. and Canada.

METHAMPHETAMINE

Oral Dosage Forms

METHAMPHETAMINE HYDROCHLORIDE TABLETS USP

Usual pediatric dose
Attention-deficit hyperactivity disorder
Children younger than 6 years of age: Use is not recommended.

Children 6 years of age and older: Oral, 5 mg one or two times a day, the dosage being increased by 5 mg per day at one-week intervals until the desired response is obtained (usually 20 to 25 mg per day) ^{15}.

Strength(s) usually available
U.S.—

5 mg (Rx) [Desoxyn (lactose)^{15}]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer.

Note: Controlled substance in the U.S.

METHAMPHETAMINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS

Note: The extended-release dosage form should not be used for initiation of dosage or until the conventional titrated daily dosage is equal to or greater than the dosage provided in the extended-release dosage form.

Usual pediatric dose
Attention-deficit hyperactivity disorder
Children younger than 6 years of age: Use is not recommended.

Children 6 years of age and older: Oral, 20 to 25 mg once a day ^{15}.

Strength(s) usually available
U.S.—

5 mg (Rx) [Desoxyn Gradumet]

10 mg (Rx) [Desoxyn Gradumet]

15 mg (Rx) [Desoxyn Gradumet (tartrazine)]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer.

Auxiliary labeling:
• Swallow tablets whole.
• Keep container tightly closed.

Note: Controlled substance in the U.S.

Revised: 08/13/1998

References

Solanto MV. Neuropharmacological basis of stimulant drug action in attention deficit disorder with hyperactivity: a review and synthesis. Psychol Bull 1984 May; (95)3: 387-409.

TIPS 1984 Sep: 387-9.

Ped Pharm and Therap 1965; (66)6: 1068-82.

Panelist comment.

Beta-adrenergic blocking agents (Systemic). In: USP DI Vol I. Drug information for the health care professional. Rockville, MD: The United States Pharmacopeial Convention, Inc; 1986.

Physicians' Desk Reference. 40th ed. Oradell NJ: Medical Economics Company; 1986. p. 1712.

Adderall package insert (Shire/Richwood—US), Rev 6/97, Rec 4/98.

Antidepressants, Monoamine Oxidase Inhibitor (Systemic). In: USP DI Vol I. Drug information for the health care professional. Rockville, MD: The United States Pharmacopeial Convention, Inc; 1988.

Hansten PD, Horn JR. Drug Interactions. 5th ed. Philadelphia: Lea & Febiger, 1985.

Dexedrine (dextroamphetamine) monograph. In: Physicians' Desk Reference. 43rd ed. Oradell NJ: Medical Economics Company; 1989.

Dextroamphetamine package insert (Dexedrine, SmithKline Beecham—US), Rev 7/92. Rec 7/93.

Amphetamine and dextroamphetamine resin complex package insert (Biphetamine, Fisons Pharmaceuticals—US), Rev 2/89, Rec 6/89.

Dextroamphetamine package insert (Dexedrine, SmithKline French—US), Rev 3/88, Rec 5/89.

Dextroamphetamine product monograph (Dexedrine, SmithKline French—Canada), Rev 10/88, Rec 6/89.

Desoxyn (methamphetamine) monograph. In: Physicians' Desk Reference. 43rd ed. Oradell NJ: Medical Economics Company; 1989. p. 514-6.

Panel comments, 2/90.

Barone JA, Peppers MP. Use of dantrolene in the management of amphetamine-induced hyperthermia. Clin Pharm 1989 May; 8: 324-7.

Derlet RW, Rice P, Horowitz BZ, et al. Amphetamine toxicity: experience with 127 cases. J Emerg Med l989 Mar-Apr; 7(2): 157-61.

Poison Management Manual; 1984. p. 42-3.

Metyrapone (Systemic). In: USP DI Vol I. Drug information for the health care professional. Rockville, MD: The United States Pharmacopeial Convention, Inc; 1991.

Hurwitz A. Antacid therapy and drug kinetics. Clin Pharmacokinet 1977; 2: 269-80.

Reviewers' responses to Psychiatric Disease Advisory Panel Memo of 4/20/94.

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