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Dexedrine User Reviews >>

Dexedrine
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Drug Descriptionfont sizeAAA

DEXEDRINE®
(dextroamphetamine sulfate)
SPANSULE® Sustained-Release Capsules

WARNING

AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF
AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE
AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE
POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE
OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR
DISPENSED SPARINGLY.

MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS
CARDIOVASCULAR ADVERSE EVENTS.

DRUG DESCRIPTION

DEXEDRINE (dextroamphetamine sulfate) is the dextro isomer of the
compound d,l -amphetamine sulfate, a sympathomimetic amine of the
amphetamine group. Chemically, dextroamphetamine is d-alpha-methylphenethylamine,
and is present in all forms of DEXEDRINE as the neutral sulfate.
Structural formula:

DEXEDRINE® (dextroamphetamine sulfate) Structural Formula Illustration

SPANSULE capsules: Each SPANSULE sustained-release capsule is so
prepared that an initial dose is released promptly and the remaining
medication is released gradually over a prolonged period. Each
capsule, with brown cap and clear body, contains dextroamphetamine
sulfate. The 5-mg capsule is imprinted 5 mg and 3512 on the brown cap
and is imprinted 5 mg and SB on the clear body. The 10-mg capsule is
imprinted 10 mg-3513-on the brown cap and is imprinted 10 mg-SB-on the
clear body. The 15-mg capsule is imprinted 15 mg and 3514 on the brown
cap and is imprinted 15 mg and SB on the clear body. A narrow bar
appears above and below 15 mg and 3514. Product reformulation in 1996
has caused a minor change in the color of the time-released pellets
within each capsule. Inactive ingredients now consist of cetyl
alcohol, D&C Yellow No. 10, dibutyl sebacate, ethylcellulose, FD&C
Blue No. 1, FD&C Blue No. 1 aluminum lake, FD&C Red No. 40, FD&C
Yellow No. 6, gelatin, hypromellose, propylene glycol, povidone,
silicon dioxide, sodium lauryl sulfate, sugar spheres, and trace
amounts of other inactive ingredients.

Last updated on RxList: 7/14/2008

INDICATIONS

DEXEDRINE is indicated in:

Narcolepsy

Attention Deficit Disorder with Hyperactivity: As an integral part of
a total treatment program that typically includes other measures
(psychological, educational, social) for patients (ages 6 years to 16
years) with this syndrome. A diagnosis of Attention Deficit
Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of
hyperactive-impulsive or inattentive symptoms that caused impairment
and were present before age 7 years. The symptoms must cause
clinically significant impairment, e.g., in social, academic, or
occupational functioning, and be present in 2 or more settings, e.g.,
school (or work) and at home. The symptoms must not be better
accounted for by another mental disorder. For the Inattentive Type, at
least 6 of the following symptoms must have persisted for at least 6
months: lack of attention to details/careless mistakes; lack of
sustained attention; poor listener; failure to follow through on
tasks; poor organization; avoids tasks requiring sustained mental
effort; loses things; easily distracted; forgetful. For the
Hyperactive-Impulsive Type, at least 6 of the following symptoms must
have persisted for at least 6 months: fidgeting/squirming; leaving
seat; inappropriate running/climbing; difficulty with quiet
activities; "on the go"; excessive talking; blurting answers; can't
wait turn; intrusive. The Combined Type requires both inattentive and
hyperactive-impulsive criteria to be met.

Special Diagnostic Considerations: Specific etiology of this syndrome
is unknown, and there is no single diagnostic test. Adequate diagnosis
requires the use of medical and special psychological, educational,
and social resources. Learning may or may not be impaired. The
diagnosis must be based upon a complete history and evaluation of the
patient and not solely on the presences of the required number of
DSM-IV characteristics.

Need for Comprehensive Treatment Program: DEXEDRINE is indicated as an
integral part of a total treatment program for ADHD that may include
other measures (psychological, educational, social) for patients with
this syndrome. Drug treatment may not be indicated for all patients
with this syndrome. Stimulants are not intended for use in patients
who exhibit symptoms secondary to environmental factors and/or other
primary psychiatric disorders, including psychosis. Appropriate
educational placement is essential and psychosocial intervention is
often helpful. When remedial measures alone are insufficient, the
decision to prescribe stimulant medication will depend upon the
physician's the chronicity and severity of the patient's symptoms.

DOSAGE AND ADMINISTRATION

Amphetamines should be administered at the lowest effective dosage and
dosage should be individually adjusted. Late evening doses should be
avoided because of the resulting insomnia.

Narcolepsy: Usual dose is 5 to 60 mg per day in divided doses,
depending on the individual patient response.

Narcolepsy seldom occurs in children under 12 years of age; however,
when it does, DEXEDRINE may be used. The suggested initial dose for
patients aged 6 to 12 is 5 mg daily; daily dose may be raised in
increments of 5 mg at weekly intervals until an optimal response is
obtained. In patients 12 years of age and older, start with 10 mg
daily; daily dosage may be raised in increments of 10 mg at weekly
intervals until an optimal response is obtained. If bothersome adverse
reactions appear (e.g., insomnia or anorexia), dosage should be
reduced. SPANSULE capsules may be used for once-a-day dosage wherever
appropriate.

Attention Deficit Disorder with Hyperactivity: The SPANSULE capsule
formulation is not recommended for pediatric patients younger than 6
years of age.

In pediatric patients 6 years of age and older, start with 5 mg once
or twice daily; daily dosage may be raised in increments of 5 mg at
weekly intervals until optimal response is obtained. Only in rare
cases will it be necessary to exceed a total of 40 mg per day.

SPANSULE capsules may be used for once-a-day dosage wherever
appropriate.

Where possible, drug administration should be interrupted occasionally
to determine if there is a recurrence of behavioral symptoms
sufficient to require continued therapy.

HOW SUPPLIED

DEXEDRINE SPANSULE capsules: Each capsule, with brown cap and clear
body, contains dextroamphetamine sulfate. The 5-mg capsule is
imprinted 5 mg and 3512 on the brown cap and is imprinted 5 mg and SB
on the clear body. The 10-mg capsule is imprinted 10 mg - 3513 - on
the brown cap and is imprinted 10 mg - SB - on the clear body. The
15-mg capsule is imprinted 15 mg and 3514 on the brown cap and is
imprinted 15 mg and SB on the clear body. A narrow bar appears above
and below 15 mg and 3514.

Available: 5 mg, 10 mg, and 15 mg in bottles of 100. DEXEDRINE
SPANSULE capsules are manufactured by Cardinal Health, Winchester, KY
40391.

Store at controlled room temperature between 20° and 25°C (68° and
77°F) see USP.

Dispense in a tight, light-resistant container.

1. mg 100s: NDC 0007-3512-20
2. mg 90s: NDC 0007-3512-59
3. 0 mg 100s: NDC 0007-3513-20
4. 0 mg 90s: NDC 0007-3513-59
5. 5 mg 100s: NDC 0007-3514-20
6. 5 mg 90s NDC 0007-3514-59

GlaxoSmithKline Research Triangle Park, NC 27709. FDA Rev date:
5/23/2008

Last updated on RxList: 7/14/2008

SIDE EFFECTS

Cardiovascular: Palpitations, tachycardia, elevation of blood pressure.
There have been isolated reports of cardiomyopathy associated with
chronic amphetamine use.

Central Nervous System: Psychotic episodes at recommended doses
(rare), overstimulation, restlessness, dizziness, insomnia, euphoria,
dyskinesia, dysphoria, tremor, headache, exacerbation of motor and
phonic tics, and Tourette's syndrome.

Gastrointestinal: Dryness of the mouth, unpleasant taste, diarrhea,
constipation, other gastrointestinal disturbances. Anorexia and weight
loss may occur as undesirable effects.

Allergic: Urticaria.

Endocrine: Impotence, changes in libido.

Drug Abuse And Dependence

Dextroamphetamine sulfate is a Schedule II controlled substance.

Amphetamines have been extensively abused. Tolerance, extreme
psychological dependence and severe social disability have occurred.
There are reports of patients who have increased the dosage to many
times that recommended. Abrupt cessation following prolonged high
dosage administration results in extreme fatigue and mental depression;
changes are also noted on the sleep EEG.

Manifestations of chronic intoxication with amphetamines include
severe dermatoses, marked insomnia, irritability, hyperactivity, and
personality changes. The most severe manifestation of chronic
intoxication is psychosis, often clinically indistinguishable from
schizophrenia. This is rare with oral amphetamines.

DRUG INTERACTIONS

Acidifying Agents: Gastrointestinal acidifying agents (guanethidine,
reserpine, glutamic acid HCl, ascorbic acid, fruit juices, etc.) lower
absorption of amphetamines. Urinary acidifying agents (ammonium
chloride, sodium acid phosphate, etc.) increase the concentration of
the ionized species of the amphetamine molecule, thereby increasing
urinary excretion. Both groups of agents lower blood levels and
efficacy of amphetamines.

Adrenergic Blockers: Adrenergic blockers are inhibited by
amphetamines.

Alkalinizing Agents: Gastrointestinal alkalinizing agents (sodium
bicarbonate, etc.) increase absorption of amphetamines. Urinary
alkalinizing agents (acetazolamide, some thiazides) increase the
concentration of the non-ionized species of the amphetamine molecule,
thereby decreasing urinary excretion. Both groups of agents increase
blood levels and therefore potentiate the actions of amphetamines.

Antidepressants, Tricyclic: Amphetamines may enhance the activity of
tricyclic or sympathomimetic agents; d-amphetamine with desipramine or
protriptyline and possibly other tricyclics cause striking and
sustained increases in the concentration of d-amphetamine in the brain;
cardiovascular effects can be potentiated.

MAO Inhibitors: MAOI antidepressants, as well as a metabolite of
furazolidone, slow amphetamine metabolism. This slowing potentiates
amphetamines, increasing their effect on the release of norepinephrine
and other monoamines from adrenergic nerve endings; this can cause
headaches and other signs of hypertensive crisis. A variety of
neurological toxic effects and malignant hyperpyrexia can occur,
sometimes with fatal results.

Antihistamines: Amphetamines may counteract the sedative effect of
antihistamines.

Antihypertensives: Amphetamines may antagonize the hypotensive effects
of antihypertensives.

Chlorpromazine: Chlorpromazine blocks dopamine and norepinephrine
reuptake, thus inhibiting the central stimulant effects of
amphetamines, and can be used to treat amphetamine poisoning.

Ethosuximide: Amphetamines may delay intestinal absorption of
ethosuximide.

Haloperidol: Haloperidol blocks dopamine and norepinephrine reuptake,
thus inhibiting the central stimulant effects of amphetamines.

Lithium Carbonate: The stimulatory effects of amphetamines may be
inhibited by lithium carbonate.

Meperidine: Amphetamines potentiate the analgesic effect of
meperidine.

Methenamine Therapy: Urinary excretion of amphetamines is increased,
and efficacy is reduced, by acidifying agents used in methenamine
therapy.

Norepinephrine: Amphetamines enhance the adrenergic effect of
norepinephrine.

Phenobarbital: Amphetamines may delay intestinal absorption of
phenobarbital; co-administration of phenobarbital may produce a
synergistic anticonvulsant action.

Phenytoin: Amphetamines may delay intestinal absorption of phenytoin;
co-administration of phenytoin may produce a synergistic
anticonvulsant action.

Propoxyphene: In cases of propoxyphene overdosage, amphetamine CNS
stimulation is potentiated and fatal convulsions can occur.

Veratrum Alkaloids: Amphetamines inhibit the hypotensive effect of
veratrum alkaloids.

Drug/Laboratory Test Interactions: Amphetamines can cause a
significant elevation in plasma corticosteroid levels. This increase
is greatest in the evening. Amphetamines may interfere with urinary
steroid determinations.

Last updated on RxList: 7/14/2008

WARNINGS

Serious Cardiovascular Events

Sudden Death in Patients With Pre-existing Structural Cardiac
Abnormalities or Other Serious Heart Problems: Children and
Adolescents: Sudden death has been reported in association with CNS
stimulant treatment at usual doses in children and adolescents with
structural cardiac abnormalities or other serious heart problems.
Although some serious heart problems alone carry an increased risk of
sudden death, stimulant products generally should not be used in
children or adolescents with known serious structural cardiac
abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or
other serious cardiac problems that may place them at increased
vulnerability to the sympathomimetic effects of a stimulant drug.

Adults: Sudden deaths, stroke, and myocardial infarction have been
reported in adults taking stimulant drugs at usual doses for ADHD.
Although the role of stimulants in these adult cases is also unknown,
adults have a greater likelihood than children of having serious
structural cardiac abnormalities, cardiomyopathy, serious heart rhythm
abnormalities, coronary artery disease, or other serious cardiac
problems. Adults with such abnormalities should also generally not be
treated with stimulant drugs (see CONTRAINDICATIONS).

Hypertension and Other Cardiovascular Conditions: Stimulant
medications cause a modest increase in average blood pressure (about
2-4 mmHg) and average heart rate (about 3-6 bpm), and individuals may
have larger increases. While the mean changes alone would not be
expected to have short-term consequences, all patients should be
monitored for larger changes in heart rate and blood pressure. Caution
is indicated in treating patients whose underlying medical conditions
might be compromised by increases in blood pressure or heart rate,
e.g., those with pre-existing hypertension, heart failure, recent
myocardial infarction, or ventricular arrhythmia (see
CONTRAINDICATIONS).

Assessing Cardiovascular Status in Patients Being Treated With
Stimulant Medications: Children, adolescents, or adults who are being
considered for treatment with stimulant medications should have a
careful history (including assessment for a family history of sudden
death or ventricular arrhythmia) and physical exam to assess for the
presence of cardiac disease, and should receive further cardiac
evaluation if findings suggest such disease (e.g., electrocardiogram
and echocardiogram). Patients who develop symptoms such as exertional
chest pain, unexplained syncope, or other symptoms suggestive of
cardiac disease during stimulant treatment should undergo a prompt
cardiac evaluation.

Psychiatric Adverse Events

Pre-Existing Psychosis: Administration of stimulants may exacerbate
symptoms of behavior disturbance and thought disorder in patients with
a pre-existing psychotic disorder.

Bipolar Illness: Particular care should be taken in using stimulants
to treat ADHD in patients with comorbid bipolar disorder because of
concern for possible induction of a mixed/manic episode in such
patients. Prior to initiating treatment with a stimulant, patients
with comorbid depressive symptoms should be adequately screened to
determine if they are at risk for bipolar disorder; such screening
should include a detailed psychiatric history, including a family
history of suicide, bipolar disorder, and depression.

Emergence of New Psychotic or Manic Symptoms: Treatment emergent
psychotic or manic symptoms, e.g., hallucinations, delusional
thinking, or mania in children and adolescents without a prior history
of psychotic illness or mania can be caused by stimulants at usual
doses. If such symptoms occur, consideration should be given to a
possible causal role of the stimulant, and discontinuation of
treatment may be appropriate. In a pooled analysis of multiple
short-term, placebo-controlled studies, such symptoms occurred in
about 0.1% (4 patients with events out of 3,482 exposed to
methylphenidate or amphetamine for several weeks at usual doses) of
stimulant-treated patients compared to 0 in placebo-treated patients.

Aggression: Aggressive behavior or hostility is often observed in
children and adolescents with ADHD, and has been reported in clinical
trials and the postmarketing experience of some medications indicated
for the treatment of ADHD. Although there is no systematic evidence
that stimulants cause aggressive behavior or hostility, patients
beginning treatment for ADHD should be monitored for the appearance
of, or worsening of, aggressive behavior or hostility.

Long-Term Suppression of Growth: Careful follow-up of weight and
height in children ages 7 to 10 years who were randomized to either
methylphenidate or non-medication treatment groups over 14 months, as
well as in naturalistic subgroups of newly methylphenidate-treated and
non-medication treated children older than 36 months (to the ages of
10 to 13 years), suggests that consistently medicated children (i.e.,
treatment for 7 days per week throughout the year) have a temporary
slowing in growth rate (on average, a total of about 2 cm less growth
in height and 2.7 kg less growth in weight over 3 years), without
evidence of growth rebound during this period of development.
Published data are inadequate to determine whether chronic use of
amphetamines may cause a similar suppression of growth, however, it is
anticipated that they likely have this effect as well. Therefore,
growth should be monitored during treatment with stimulants, and
patients who are not growing or gaining height or weight as expected
may need to have their treatment interrupted.

Seizures: There is some clinical evidence that stimulants may lower
the convulsive threshold in patients with prior history of seizures,
in patients with prior EEG abnormalities in absence of seizures, and,
very rarely, in patients without a history of seizures and no prior
EEG evidence of seizures. In the presence of seizures, the drug should
be discontinued.

Visual Disturbance: Difficulties with accommodation and blurring of
vision have been reported with stimulant treatment.

PRECAUTIONS

General: The least amount feasible should be prescribed or dispensed
at 1 time in order to minimize the possibility of overdosage.

Information for Patients: Amphetamines may impair the ability of the
patient to engage in potentially hazardous activities such as
operating machinery or vehicles; the patient should therefore be
cautioned accordingly.

Prescribers or other health professionals should inform patients,
their families, and their caregivers about the benefits and risks
associated with treatment with dextroamphetamine and should counsel
them in its appropriate use. A patient Medication Guide is available
for DEXEDRINE. The prescriber or health professional should instruct
patients, their families, and their caregivers to read the Medication
Guide and should assist them in understanding its contents. Patients
should be given the opportunity to discuss the contents of the
Medication Guide and to obtain answers to any questions they may have.
The complete text of the Medication Guide is reprinted at the end of
this document.

Carcinogenesis/Mutagenesis: Mutagenicity studies and long-term studies
in animals to determine the carcinogenic potential of DEXEDRINE have
not been performed.

Pregnancy:Teratogenic Effects: Pregnancy Category C. DEXEDRINE has
been shown to have embryotoxic and teratogenic effects when
administered to A/Jax mice and C57BL mice in doses approximately 41
times the maximum human dose. Embryotoxic effects were not seen in New
Zealand white rabbits given the drug in doses 7 times the human dose
nor in rats given 12.5 times the maximum human dose. While there are
no adequate and well-controlled studies in pregnant women, there has
been 1 report of severe congenital bony deformity, tracheoesophageal
fistula, and anal atresia (VATER association) in a baby born to a
woman who took dextroamphetamine sulfate with lovastatin during the
first trimester of pregnancy. DEXEDRINE should be used during
pregnancy only if the potential benefit justifies the potential risk
to the fetus.

Nonteratogenic Effects: Infants born to mothers dependent on
amphetamines have an increased risk of premature delivery and low
birth weight. Also, these infants may experience symptoms of
withdrawal as demonstrated by dysphoria, including agitation, and
significant lassitude.

Nursing Mothers: Amphetamines are excreted in human milk. Mothers
taking amphetamines should be advised to refrain from nursing.

Pediatric Use: Long-term effects of amphetamines in pediatric patients
have not been well established.

DEXEDRINE is not recommended for use in pediatric patients younger
than 6 years of age with Attention Deficit Disorder with Hyperactivity
described under INDICATIONS AND USAGE.

Clinical experience suggests that in psychotic children,
administration of amphetamines may exacerbate symptoms of behavior
disturbance and thought disorder.

Amphetamines have been reported to exacerbate motor and phonic tics
and Tourette's syndrome. Therefore, clinical evaluation for tics and
Tourette's syndrome r families should precede use of stimulant
medications.

Data are inadequate to determine whether chronic administration of
amphetamines may be associated with growth inhibition; therefore,
growth should be monitored during treatment.

Drug treatment is not indicated in all cases of Attention Deficit
Disorder with Hyperactivity and should be considered only in light of
the complete history and evaluation of the child. The decision to
prescribe amphetamines should depend on the physician's of the
chronicity and severity of the child's symptoms and their
appropriateness for his or her age. Prescription should not depend
solely on the presence of one or more of the behavioral
characteristics.

When these symptoms are associated with acute stress reactions,
treatment with amphetamines is usually not indicated.

Last updated on RxList: 7/14/2008

OVERDOSE

Individual patient response to amphetamines varies widely. While toxic
symptoms occasionally occur as an idiosyncrasy at doses as low as 2
mg, they are rare with doses of less than 15 mg; 30 mg can produce
severe reactions, yet doses of 400 to 500 mg are not necessarily
fatal.

In rats, the oral LD50 of dextroamphetamine sulfate is 96.8 mg/kg.
Manifestations of acute overdosage with amphetamines include
restlessness, tremor, hyperreflexia, rhabdomyolysis, rapid respiration,
hyperpyrexia, confusion, assaultiveness, hallucinations, panic states.

Fatigue and depression usually follow the central stimulation.

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. Management of acute amphetamine intoxication is largely
symptomatic and includes gastric lavage, administration of activated
charcoal, administration of a cathartic, and sedation. Experience with
hemodialysis or peritoneal dialysis is inadequate to permit
recommendation in this regard. Acidification of the urine increases
amphetamine excretion, but is believed to increase risk of acute renal
failure if myoglobinuria is present. If acute, severe hypertension
complicates amphetamine overdosage, administration of intravenous
phentolamine (Bedford Laboratories) has been suggested. However, a
gradual drop in blood pressure will usually result when sufficient
sedation has been achieved.

Chlorpromazine antagonizes the central stimulant effects of
amphetamines and can be used to treat amphetamine intoxication.

Since much of the SPANSULE capsule medication is coated for gradual
release, therapy directed at reversing the effects of the ingested
drug and at supporting the patient should be continued for as long as
overdosage symptoms remain. Saline cathartics are useful for hastening
the evacuation of pellets that have not already released medication.

CONTRAINDICATIONS

Advanced arteriosclerosis, symptomatic cardiovascular disease,
moderate to severe hypertension, hyperthyroidism, known
hypersensitivity or idiosyncrasy to the sympathomimetic amines,
glaucoma.

Agitated states. Patients with a history of drug abuse.

During or within 14 days following the administration of monoamine
oxidase inhibitors (hypertensive crises may result).

Last updated on RxList: 7/14/2008

CLINICAL PHARMACOLOGY

Amphetamines are noncatecholamine, sympathomimetic amines with CNS
stimulant activity. Peripheral actions include elevations of systolic
and diastolic blood pressures and weak bronchodilator and respiratory
stimulant action.

There is neither specific evidence that clearly establishes the
mechanism whereby amphetamines produce mental and behavioral effects
in children, nor conclusive evidence regarding how these effects
relate to the condition of the central nervous system.

DEXEDRINE SPANSULE capsules are formulated to release the active drug
substance in vivo in a more gradual fashion than the standard
formulation, as demonstrated by blood levels. The formulation has not
been shown superior in effectiveness over the same dosage of the
standard, noncontrolled-release formulations given in divided doses.

Pharmacokinetics: The pharmacokinetics of the tablet and
sustained-release capsule were compared in 12 healthy subjects. The
extent of bioavailability of the sustained-release capsule was similar
compared to the immediate-release tablet. Following administration of
three 5-mg tablets, average maximal dextroamphetamine plasma
concentrations (Cmax) of 36.6 ng/mL were achieved at approximately 3
hours. Following administration of one 15-mg sustained-release
capsule, maximal dextroamphetamine plasma concentrations were obtained
approximately 8 hours after dosing. The average Cmax was 23.5 ng/mL.
The average plasma T½ was similar for both the tablet and
sustained-release capsule and was approximately 12 hours.

In 12 healthy subjects, the rate and extent of dextroamphetamine
absorption were similar following administration of the
sustained-release capsule formulation in the fed (58 to 75 gm fat) and
fasted state.

Last updated on RxList: 7/14/2008

PATIENT INFORMATION

Medication Guide

DEXEDRINE®
(dextroamphetamine sulfate)
SPANSULE® sustained-release capsules

Read the Medication Guide that comes with DEXEDRINE before you or your
child starts taking it and each time you get a refill. There may be
new information. This Medication Guide does not take the place of
talking to your doctor about your or your s treatment with DEXEDRINE.

What is the most important information I should know about DEXEDRINE?

The following have been reported with use of DEXEDRINE and other
stimulant medicines.

1. Heart-related problems:

Sudden death in patients who have heart problems or heart defects

Stroke and heart attack in adults

Increased blood pressure and heart rate

Tell your doctor if you or your child have any heart problems, heart
defects, high blood pressure, or a family history of these problems.

Your doctor should check you or your child carefully for heart
problems before starting DEXEDRINE.

Your doctor should check your or your child's blood pressure and heart
rate regularly during treatment with DEXEDRINE.

Call your doctor right away if you or your child has any signs of
heart problems such as chest pain, shortness of breath, or fainting
while taking DEXEDRINE.

2. Mental (Psychiatric) problems: All Patients

new or worse behavior and thought problems

new or worse bipolar illness

new or worse aggressive behavior or hostility

Children and Teenagers

new psychotic symptoms (such as hearing voices, believing things
 that are not true, are suspicious) or new manic symptoms

Tell your doctor about any mental problems you or your child have, or
about a family history of suicide, bipolar illness, or depression.

Call your doctor right away if you or your child have any new or
worsening mental symptoms or problems while taking DEXEDRINE,
especially seeing or hearing things that are not real, believing
things that are not real, or are suspicious.

What Is DEXEDRINE?

DEXEDRINE is a central nervous system stimulant prescription medicine.
It is used for the treatment of Attention-Deficit Hyperactivity
Disorder (ADHD).

DEXEDRINE may help increase attention and decrease impulsiveness and
hyperactivity in patients with ADHD. DEXEDRINE should be used as a
part of a total treatment program for ADHD that may include counseling
or other therapies. DEXEDRINE is also used in the treatment of a sleep
disorder called narcolepsy.

DEXEDRINE is a federally controlled substance (CII) because it can be
abused or lead to dependence. Keep DEXEDRINE in a safe place to
prevent misuse and abuse. Selling or giving away DEXEDRINE may harm
others, and is against the law.

Tell your doctor if you or your child have (or have a family history
of) ever abused or been dependent on alcohol, prescription medicines
or street drugs.

Who should not take DEXEDRINE?

DEXEDRINE should not be taken if you or your child:

Have heart disease or hardening of the arteries

Have moderate to severe high blood pressure

Have hyperthyroidism

Have an eye problem called glaucoma

Are very anxious, tense, or agitated

Have a history of drug abuse

Are taking or have taken within the past 14 days an antidepression
 medicine called a monoamine oxidase inhibitor or MAOI

Is sensitive to, allergic to, or had a reaction to other stimulant
 medicines DEXEDRINE is not recommended for use in children less
 than 6 years old.

DEXEDRINE may not be right for you or your child.

Before starting DEXEDRINE tell your or your child's doctor about all
health conditions (or a family history of) including:

Heart problems, heart defects, high blood pressure

Mental problems including psychosis, mania, bipolar illness, or
 depression

Tics or Tourette's syndrome

Thyroid problems

Seizures or have had an abnormal brain wave test (EEG)

Tell your doctor if you or your child is pregnant, planning to become
pregnant, or breastfeeding.

Can DEXEDRINE be taken with other medicines?

Tell your doctor about all of the medicines that you or your child
take including prescription and nonprescription medicines, vitamins,
and herbal supplements. DEXEDRINE and some medicines may interact with
each other and cause serious side effects. Sometimes the doses of
other medicines will need to be adjusted while taking DEXEDRINE.

Your doctor will decide whether DEXEDRINE can be taken with other
medicines.

Especially tell your doctor if you or your child takes:

Anti-depression medicines including MAOIs

Blood pressure medicines

Antacids

Seizure medicines

Know the medicines that you or your child takes. Keep a list of your
medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking DEXEDRINE without talking
to your doctor first.

How should DEXEDRINE be taken?

Take DEXEDRINE exactly as prescribed. Your doctor may adjust the
 dose until it is right for you or your child.

DEXEDRINE comes as a capsule.

DEXEDRINE SPANSULE capsules are usually taken once a day in
the morning. DEXEDRINE SPANSULE is an extended release
capsule. It releases medicine into your body throughout the
day.

From time to time, your doctor may stop treatment with DEXEDRINE
for a while to check ADHD symptoms.

Your doctor may do regular checks of the blood, heart, and blood
 pressure while taking DEXEDRINE. Children should have their height
 and weight checked often while taking

DEXEDRINE. Treatment with DEXEDRINE may be stopped if a problem is
 found during these check-ups.

If you or your child takes too much DEXEDRINE or overdoses, call
 your doctor or poison control center right away, or get emergency
 treatment.

What are possible side effects of DEXEDRINE?

See "What is the most important information I should know about
DEXEDRINE?" for information on reported heart and mental problems.

Other serious side effects include:

Slowing of growth (height and weight) in children

Seizures, mainly in patients with a history of seizures

Eyesight changes or blurred vision

Common side effects include:

Fast heartbeat

Tremors

Trouble sleeping

Stomach upset

Dry mouth

Decreased appetite

Headache

Dizziness

Weight loss

DEXEDRINE may affect your or your child's ability to drive or do other
dangerous activities.

Talk to your doctor if you or your child has side effects that are
bothersome or do not go away.

This is not a complete list of possible side effects. Ask your doctor
or pharmacist for more information.

How should I store DEXEDRINE?

Store DEXEDRINE SPANSULE capsules in a safe place at room
 temperature, 68° to 77°F (20° to 25°C). Protect from light.

Keep DEXEDRINE and all medicines out of the reach of children.

General information about DEXEDRINE

Medicines are sometimes prescribed for purposes other than those
listed in a Medication Guide. Do not use DEXEDRINE for a condition for
which it was not prescribed. Do not give DEXEDRINE to other people,
even if they have the same condition. It may harm them and it is
against the law.

This Medication Guide summarizes the most important information about
DEXEDRINE. If you would like more information, talk with your doctor.
You can ask your doctor or pharmacist for information about DEXEDRINE
that was written for healthcare professionals. For more information
about DEXEDRINE, please contact GlaxoSmithKline (makers of DEXEDRINE)
at 1-888-825-5249 or visit www.gsk.com.

What are the ingredients in DEXEDRINE?

Active Ingredient: Dextroamphetamine sulfate

Inactive Ingredients:

SPANSULE Capsules: Cetyl alcohol, D&C Yellow No. 10, dibutyl sebacate,
ethylcellulose, FD&C Blue No. 1, FD&C Blue No. 1 aluminum lake, FD&C
Red No. 40, FD&C Yellow No. 6, gelatin, hypromellose, propylene
glycol, povidone, silicon dioxide, sodium laurate sulfate, and sugar
spheres

This Medication Guide has been approved by the U.S. Food and Drug
Administration.

Last updated on RxList: 7/14/2008

Disclaimer

Consumer

IMPORTANT NOTE: This is a summary and does not contain all possible
information about this product. For complete information about this
product or your specific health needs, ask your health care
professional. Always seek the advice of your health care professional
if you have any questions about this product or your medical
condition. This information is not intended as individual medical
advice and does not substitute for the knowledge and judgment of your
health care professional. This information does not contain any
assurances that this product is safe, effective, or appropriate for
you.

DEXTROAMPHETAMINE SUSTAINED-ACTION CAPSULE - ORAL

(DEX-troe-am-FET-a-meen)

COMMON BRAND NAME(S): Dexedrine

WARNING: Misuse or abuse of amphetamine may result in serious
(possibly fatal) heart and blood pressure problems. Amphetamine-type
medications can be habit-forming and should be used cautiously by
people who have mental/mood disorders or a history of alcohol/drug
abuse. Such people may be more likely to increase their dose of this
drug unnecessarily or take this medication too often. With prolonged
use or abuse of this medication, drug dependence and abnormal behavior
may occur. Withdrawal symptoms may occur after stopping the drug.
Consult your doctor or pharmacist for more details. (See also How to
Use section).

USES: Dextroamphetamine is used to treat attention deficit
hyperactivity disorder (ADHD) as part of a total treatment plan,
including psychological, social, and other treatments. It may help to
increase the ability to pay attention, concentrate, stay focused, and
stop fidgeting.

This drug may also be used to treat certain sleeping disorders
(narcolepsy) to help you stay awake during the day. It should not be
used to treat tiredness or to hold off sleep in people who do not have
a sleep disorder.

Dextroamphetamine is a stimulant. It is thought to work by restoring
the balance of certain natural chemicals (neurotransmitters) in the
brain.

This medication is not recommended for use in children younger than 6
years.

HOW TO USE: Read the Medication Guide provided by your pharmacist
before you start using dextroamphetamine and each time you get a
refill. If you have any questions, consult your doctor or pharmacist.

Take this medication with or without food, usually when you first wake
up in the morning or as directed by your doctor. If additional doses
are prescribed, take them 4-6 hours apart. Taking this medication late
in the day may cause trouble sleeping (insomnia).

Swallow the capsules whole. Do not crush or chew them. Doing so may
destroy the long action of the drug and may increase the risk of side
effects. If you have difficulty swallowing this medication whole, you
may sprinkle the entire contents of a capsule on a small amount of
applesauce just before taking. Swallow the mixture immediately. Do not
chew the mixture, and do not save it for future use. Drink a glass of
liquid after each dose.

Use this medicine regularly exactly as your doctor prescribes in order
to get the most benefit. To help you remember, take it at the same
time(s) each day on the days that you take it.

Dosage is based on your medical condition and response to therapy.
Your doctor may adjust your dose to find the dose that is best for
you. Follow your doctor's instructions carefully. If your symptoms
persist or worsen, notify your doctor immediately.

This medication may cause dependence, especially if it has been used
in high doses. In such cases, if you suddenly stop this drug,
withdrawal reactions may occur. Such reactions can include severe
tiredness, mood changes (e.g., depression), and sleep problems. Report
any such reactions to your doctor immediately. When stopping
long-term, regular treatment with this drug, gradually reducing the
dosage as directed will help prevent withdrawal reactions. Consult
your doctor or pharmacist for more details.

Though it is unlikely to occur, this medication can also result in
abnormal drug-seeking behavior (addiction/habit forming). Do not
increase your dose, take it more frequently or use it for a longer
period of time than prescribed. Properly stop the medication when so
directed. This will lessen the chances of becoming addicted.

If you are taking this for ADHD, your doctor may recommend "drug
holidays" when the medication is stopped for a short time to observe
any changes in behavior.

Disclaimer

Consumer (continued)

SIDE EFFECTS: Nausea, stomach upset, cramps, loss of appetite,
diarrhea, dry mouth, headache, nervousness, dizziness, trouble
sleeping, sweating, weight loss, irritability or restlessness may
occur. If any of these effects persist or worsen, notify your doctor
promptly.

Remember that your doctor has prescribed this medicine because he or
she has judged that the benefit to you is greater than the risk of
side effects. Many people using this medication do not have serious
side effects.

Tell your doctor immediately if any of these unlikely but serious side
effects occur: mental/mood/behavior changes (e.g., agitation,
aggression, mood swings, depression, hallucinations, abnormal
thoughts/behavior), uncontrolled movements, muscle twitching/shaking,
outbursts of words/sounds, change in sexual ability/interest, swelling
of the ankles/feet, extreme tiredness, significant unexplained weight
loss.

Seek immediate medical attention if any of these rare but very serious
side effects occur: shortness of breath, chest pain, severe headache,
fast/pounding/irregular heartbeat, jaw/left arm pain, seizures,
weakness on one side of the body, slurred speech, confusion, fainting,
blurred vision.

A very serious allergic reaction to this drug is unlikely, but seek
immediate medical attention if it occurs. Symptoms of a serious
allergic reaction may include: rash, itching, swelling, severe
dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice
other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The
following numbers do not provide medical advice, but in the US you may
report side effects to the Food and Drug Administration (FDA) at
1-800-FDA-1088. In Canada, you may call Health Canada at
1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or
pharmacist if you are allergic to it; or to other sympathomimetic
amines (e.g., epinephrine, ephedrine); or if you have any other
allergies.

This medication should not be used if you have certain medical
conditions. Before using this medicine, consult your doctor or
pharmacist if you have: certain mental/mood conditions (e.g., severe
agitation, psychosis), heart/blood vessel disease (irregular
heartbeat, coronary artery disease, angina, heart failure,
cardiomyopathy), problems with heart structure (e.g., valve problems),
moderate or severe high blood pressure (hypertension), overactive
thyroid (hyperthyroidism), history of heart attack or stroke, a
certain eye problem (glaucoma), personal or family history of regular
use/abuse of drugs/alcohol.

Before using this medication, tell your doctor or pharmacist your
medical history, especially of: family history of sudden
death/irregular heartbeat, family/personal history of mental/mood
disorders (e.g., bipolar disorder, depression, psychotic disorder,
suicidal thoughts), seizures, personal or family history of
uncontrolled movements or outbursts of words/sounds (e.g., due to
Tourette's syndrome), mild high blood pressure (hypertension).

This drug may make you dizzy or cause blurred vision; use caution
engaging in activities requiring alertness or clear vision such as
driving or using machinery. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are taking
this medication.

Caution is advised when using this drug in children because it may
affect weight, growth rate, and final height. The doctor may recommend
temporarily stopping the medication from time to time to reduce this
risk. Monitor your child's weight and height and consult your doctor
or pharmacist for more details.

This medication should be used only if clearly needed during
pregnancy. Discuss the risks and benefits with your doctor. Infants
born to mothers who are dependent on this medication may be born too
soon (premature) and have low birth weight. They may also have
withdrawal symptoms. Tell your doctor immediately if you notice
possible mood changes, agitation, or unusual tiredness in your
newborn.

This medication passes into breast milk and may have undesirable
effects on a nursing infant. Breast-feeding is not recommended while
using this drug. Consult your doctor before breast-feeding.

Disclaimer

Consumer (continued)

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or
pharmacist) may already be aware of any possible drug interactions and
may be monitoring you for them. Do not start, stop or change the
dosage of any medicine before checking with them first.

Avoid taking MAO inhibitors (e.g., furazolidone, isocarboxazid,
linezolid, moclobemide, phenelzine, procarbazine, selegiline,
tranylcypromine) within 2 weeks before, during, and after treatment
with this medication. In some cases a serious (possibly fatal) drug
interaction may occur.

If you are currently using any of these medications listed above, tell
your doctor or pharmacist before starting this medication.

Before using this medication, tell your doctor or pharmacist of all
prescription and nonprescription/herbal products you may use,
especially: alpha blockers (e.g., prazosin), certain antidepressants
(e.g., tricyclics such as nortriptyline/imipramine, SSRIs such as
fluoxetine/paroxetine, duloxetine, venlafaxine), medication for high
blood pressure (e.g., beta blockers such as atenolol/metoprolol,
clonidine, guanabenz, methyldopa), antipsychotics (e.g.,
chlorpromazine, haloperidol), lithium, certain pain medications (e.g.,
meperidine, propoxyphene), sedatives (e.g., lorazepam, certain
antihistamines such as diphenhydramine), certain anti-seizure drugs
(e.g., ethosuximide, phenytoin, phenobarbital), medications that can
raise blood pressure (e.g., norepinephrine, phenylephrine,
pseudoephedrine), other stimulants (e.g., methylphenidate), certain
street drugs (e.g., LSD, MDMA/ "ecstasy"), veratrum alkaloids (e.g.,
cevadine, veratridine).

Certain foods and drugs can affect the amount of acid in your
stomach/intestines or urine. This can affect how well your body
absorbs and uses this medication. Tell your doctor if you take any of
these products: ammonium chloride, antacids, anti-ulcer medicine
(e.g., H2 blockers such as famotidine/ranitidine, proton pump
inhibitors such as omeprazole/lansoprazole), ascorbic acid (vitamin
C), carbonic anhydrase inhibitors (e.g., acetazolamide), fruit juices,
glutamic acid, guanethidine, methenamine, reserpine, sodium acid
phosphate, sodium bicarbonate, certain "water pills" (diuretics,
including some thiazides).

Consult your doctor or pharmacist for more details.

Check the labels on all your medicines (e.g., cough-and-cold products,
diet aids) because they may contain ingredients that could increase
your heart rate or blood pressure. Ask your pharmacist about the safe
use of those products.

Avoid drinking large amounts of beverages containing caffeine (e.g.,
coffee, tea, colas) or eating large amounts of chocolate. Caffeine can
increase the side effects of this medication.

This medication may affect the results of certain lab tests (blood and
urine steroid levels). Tell laboratory personnel and all your doctors
that you are taking this medication.

Also report the use of drugs which might increase seizure risk when
combined with this medication such as isoniazid (INH), phenothiazines
(e.g., thioridazine), theophylline, or tricyclic antidepressants
(e.g., amitriptyline), among others. Consult your doctor or pharmacist
for details.

This document does not contain all possible interactions. Therefore,
before using this product, tell your doctor or pharmacist of all the
products you use. Keep a list of all your medications with you, and
share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control
center or emergency room immediately. US residents can call the US
national poison hotline at 1-800-222-1222. Canadian residents should
call their local poison control center directly. Symptoms of overdose
may include: severe mental/mood changes, seizures, severe or
persistent headache, severe restlessness, fast breathing.

NOTES: Do not share this medication with others. It is against the
law.

This medication may raise your blood pressure. Laboratory and/or
medical tests (e.g., blood pressure, heart rate, growth monitoring in
children) may be performed to check for side effects. Consult your
doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember in
the morning hours. If it is late in the afternoon or near the time of
the next dose, skip the missed dose and resume your usual dosing
schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68-77 degrees F (20-25
degrees C) away from light and moisture. Do not store in the bathroom.
Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain
unless instructed to do so. Properly discard this product when it is
expired or no longer needed. Consult your pharmacist or local waste
disposal company for more details about how to safely discard your
product.

Information last revised August 2008 Copyright(c) 2008 First DataBank,
Inc.

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