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Adderall XR Capsules

  • Generic Name: amphetamine, dextroamphetamine mixed salts
  • Brand Name: Adderall XR
Last reviewed on RxList: 12/24/2016

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Drug Description

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ADDERALL XR®
(mixed salts of a single-entity amphetamine) Capsules

WARNING

POTENTIAL FOR ABUSE

Amphetamines have a high potential for abuse.
Administration of amphetamines for prolonged periods of time may lead to drug
dependence. Pay particular attention to the possibility of subjects obtaining
amphetamines for nontherapeutic use or distribution to others and the drugs
should be prescribed or dispensed sparingly [see Drug Abuse And Dependence ].

Misuse of amphetamine may cause sudden death and
serious cardiovascular adverse reactions.

DESCRIPTION

ADDERALL XR is a once daily extended-release,
single-entity amphetamine product. ADDERALL XR combines the neutral sulfate
salts of dextroamphetamine and amphetamine, with the dextro isomer of
amphetamine saccharate and d,l-amphetamine aspartate monohydrate. The ADDERALL
XR capsule contains two types of drug-containing beads designed to give a
double-pulsed delivery of amphetamines, which prolongs the release of
amphetamine from ADDERALL XR compared to the conventional ADDERALL (immediate-release)
tablet formulation.

Each capsule contains:5 mg10 mg15 mg20 mg25 mg30 mg
Dextroamphetamine Saccharate1.25 mg2.5mg3.75 mg5.0 mg6.25 mg7.5 mg
Amphetamine Aspartate Monohydrate1.25 mg2.5mg3.75 mg5.0 mg6.25 mg7.5 mg
Dextroamphetamine Sulfate USP1.25 mg2.5mg3.75 mg5.0 mg6.25 mg7.5 mg
Amphetamine Sulfate USP1.25 mg2.5mg3.75 mg5.0 mg6.25 mg7.5 mg
Total amphetamine base equivalence3.1 mg6.3mg9.4 mg12.5mg15.6 mg18.8 mg

Inactive Ingredients and Colors

The inactive ingredients in ADDERALL XR capsules include:
gelatin capsules, hydroxypropyl methylcellulose, methacrylic acid copolymer,
opadry beige, sugar spheres, talc, and triethyl citrate. Gelatin capsules
contain edible inks, kosher gelatin, and titanium dioxide. The 5 mg, 10 mg, and
15 mg capsules also contain FD&C Blue #2. The 20 mg, 25 mg, and 30 mg
capsules also contain red iron oxide and yellow iron oxide.

Indications

INDICATIONS

Attention Deficit Hyperactivity Disorder

ADDERALL XR® is indicated for the treatment of attention
deficit hyperactivity disorder ( ADHD ).

The efficacy of ADDERALL XR in the treatment of ADHD was
established on the basis of two controlled trials in children aged 6 to 12, one
controlled trial in adolescents aged 13 to 17, and one controlled trial in
adults who met DSM-IV ® criteria for ADHD [see Clinical Studies ].

A diagnosis of 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 two 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 six 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 six 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 not only of
medical but of special psychological, educational, and social recredits.
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 presence
of the required number of DSM-IV® characteristics.

Need for Comprehensive Treatment Program

ADDERALL XR 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 the patient who exhibits 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 assessment of
the chronicity and severity of the child’s symptoms.

Long-Term Use

The effectiveness of ADDERALL XR for long-term use, i.e.,
for more than 3 weeks in children and 4 weeks in adolescents and adults, has
not been systematically evaluated in controlled trials. Therefore, the
physician who elects to use ADDERALL XR for extended periods should
periodically re-evaluate the long-term usefulness of the drug for the
individual patient.

Dosage

DOSAGE AND ADMINISTRATION

Dosing Considerations For All Patients

Individualize the dosage according to the therapeutic
needs and response of the patient. Administer ADDERALL XR at the lowest
effective dosage.

Based on bioequivalence data, patients taking divided
doses of immediate-release ADDERALL, (for example, twice daily), may be
switched to ADDERALL XR at the same total daily dose taken once daily. Titrate
at weekly intervals to appropriate efficacy and tolerability as indicated.

ADDERALL XR capsules may be taken whole, or the capsule
may be opened and the entire contents sprinkled on applesauce. If the patient
is using the sprinkle administration method, the sprinkled applesauce should be
consumed immediately; it should not be stored. Patients should take the
applesauce with sprinkled beads in its entirety without chewing. The dose of a
single capsule should not be divided. The contents of the entire capsule should
be taken, and patients should not take anything less than one capsule per day.

ADDERALL XR may be taken with or without food.

ADDERALL XR should be given upon awakening. Afternoon
doses should be avoided because of the potential for insomnia.

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

Children

In children with ADHD who are 6-12 years of age and are
either starting treatment for the first time or switching from another
medication, start with 10 mg once daily in the morning; daily dosage may be
adjusted in increments of 5 mg or 10 mg at weekly intervals. When in the
judgment of the clinician a lower initial dose is appropriate, patients may
begin treatment with 5 mg once daily in the morning. The maximum recommended
dose for children is 30 mg/day; doses greater than 30 mg/day of ADDERALL XR
have not been studied in children. ADDERALL XR has not been studied in children
under 6 years of age.

Adolescents

The recommended starting dose for adolescents with ADHD
who are 13-17 years of age and are either starting treatment for the first time
or switching from another medication is 10 mg/day. The dose may be increased to
20 mg/day after one week if ADHD symptoms are not adequately controlled.

Adults

In adults with ADHD who are either starting treatment for
the first time or switching from another medication, the recommended dose is 20
mg/day.

HOW SUPPLIED

Dosage Forms And Strengths

ADDERALL XR 5 mg capsules: Clear/blue (imprinted ADDERALL
XR 5 mg)

ADDERALL XR 10 mg capsules: Blue/blue (imprinted ADDERALL
XR 10 mg)

ADDERALL XR 15 mg capsules: Blue/white (imprinted
ADDERALL XR 15 mg)

ADDERALL XR 20 mg capsules: Orange/orange (imprinted
ADDERALL XR 20 mg)

ADDERALL XR 25 mg capsules: Orange/white (imprinted
ADDERALL XR 25 mg)

ADDERALL XR 30 mg capsules: Natural/orange (imprinted
ADDERALL XR 30 mg)

Storage And Handling

ADDERALL XR 5 mg capsules: Clear/blue (imprinted ADDERALL
XR 5 mg), bottles of 100, NDC 54092-381-01

ADDERALL XR 10 mg capsules: Blue/blue (imprinted ADDERALL
XR 10 mg), bottles of 100, NDC 54092-383-01

ADDERALL XR 15 mg capsules: Blue/white (imprinted
ADDERALL XR 15 mg), bottles of 100, NDC 54092-385-01

ADDERALL XR 20 mg capsules: Orange/orange (imprinted
ADDERALL XR 20 mg), bottles of 100, NDC 54092-387-01

ADDERALL XR 25 mg capsules: Orange/white (imprinted
ADDERALL XR 25 mg), bottles of 100, NDC 54092-389-01

ADDERALL XR 30 mg capsules: Natural/orange (imprinted
ADDERALL XR 30 mg), bottles of 100, NDC 54092-391-01

Dispense in a tight, light-resistant container as defined
in the USP.

Store at 25° C (77° F). Excursions permitted to 15-30° C
(59-86° F) [see USP Controlled Room Temperature]

Manufactured for Shire US Inc., Wayne, PA 19087. Revised: Apr 2015

Side Effects

SIDE EFFECTS

Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a
drug cannot be directly compared to rates in the clinical trials of another
drug and may not reflect the rates observed in clinical practice.

Clinical Studies Experience

The premarketing development program for ADDERALL XR
included exposures in a total of 1315 participants in clinical trials (635
pediatric patients, 350 adolescent patients, 248 adult patients, and 82 healthy
adult subjects). Of these, 635 patients (ages 6 to 12) were evaluated in two
controlled clinical studies, one open-label clinical study, and two single-dose
clinical pharmacology studies (N= 40). Safety data on all patients are included
in the discussion that follows. Adverse reactions were assessed by collecting
adverse reactions, results of physical examinations, vital signs, weights,
laboratory analyses, and ECGs.

Adverse reactions during exposure were obtained primarily
by general inquiry and recorded by clinical investigators using terminology of
their own choosing. Consequently, it is not possible to provide a meaningful
estimate of the proportion of individuals experiencing adverse reactions
without first grouping similar types of reactions into a smaller number of
standardized event categories. In the tables and listings that follow, COSTART
terminology has been used to classify reported adverse reactions.

The stated frequencies of adverse reactions represent the
proportion of individuals who experienced, at least once, a treatment-emergent
adverse event of the type listed.

Adverse Reactions Leading to Discontinuation of Treatment

In two placebo-controlled studies of up to 5 weeks
duration among children with ADHD , 2.4% (10/425) of ADDERALL XR-treated
patients discontinued due to adverse reactions (including 3 patients with loss
of appetite, one of whom also reported insomnia) compared to 2.7% (7/259)
receiving placebo.

The most frequent adverse reactions leading to
discontinuation of ADDERALL XR in controlled and uncontrolled, multiple-dose
clinical trials of children (N=595) were anorexia (loss of appetite) (2.9%),
insomnia (1.5%), weight loss (1.2%), emotional lability (1%), and depression
(0.7%). Over half of these patients were exposed to ADDERALL XR for 12 months
or more.

In a separate placebo-controlled 4-week study in
adolescents with ADHD, five patients (2.1%) discontinued treatment due to
adverse events among ADDERALL XR-treated patients (N=233) compared to none who
received placebo (N=54). The most frequent adverse event leading to
discontinuation and considered to be drug-related (i.e. leading to
discontinuation in at least 1% of ADDERALL XR-treated patients and at a rate at
least twice that of placebo) was insomnia (1.3%, n=3). In one
placebo-controlled 4-week study among adults with ADHD with doses 20 mg to 60
mg, 23 patients (12.0% ) discontinued treatment due to adverse events among
ADDERALL XR-treated patients (N=191) compared to one patient (1.6%) who received
placebo (N=64). The most frequent adverse events leading to discontinuation and
considered to be drug-related (i.e. leading to discontinuation in at least 1%
of ADDERALL XR-treated patients and at a rate at least twice that of placebo)
were insomnia (5.2%, n=10), anxiety (2.1%, n=4), nervousness(1.6%, n=3), dry
mouth (1.6%, n=3), anorexia (1.6%, n=3), tachycardia (1.6%, n=3), headache
(1.6%, n=3), and asthenia (1.0%, n=2).

Adverse Reactions Occurring in Controlled Trials

Adverse reactions reported in a 3-week clinical trial of
children and a 4-week clinical trial in adolescents and adults, respectively,
treated with ADDERALL XR or placebo are presented in the tables below.

Table 1 : Adverse Reactions Reported by 2% or More of
Children (6-12 Years Old) Receiving ADDERALL XR with Higher Incidence Than on
Placebo in a 584-Patient Clinical Study

Body SystemPreferred TermADDERALL XR
(n=374)
Placebo
(n=210)
GeneralAbdominal Pain (stomachache)14%10%
Fever5%2%
Infection4%2%
Accidental Injury3%2%
Asthenia (fatigue)2%0%
Digestive SystemLoss of Appetite22%2%
Vomiting7%4%
Nausea5%3%
Dyspepsia2%1%
Nervous SystemInsomnia17%2%
Emotional Lability9%2%
Nervousness6%2%
Dizziness2%0%
Metabolic/ NutritionalWeight Loss4%0%

Table 2 : Adverse Reactions Reported by 5% or More of
Adolescents (13-17 Years Old) Weighing ≤ 75 kg/165 lbs Receiving ADDERALL
XR with Higher Incidence Than Placebo in a 287 Patient Clinical Forced Weekly-Dose
Titration Study*

Body SystemPreferred TermADDERALL XR
(n=233)
Placebo
(n=54)
GeneralAbdominal Pain (stomachache)11%2%
Digestive SystemLoss of Appetiteb36%2%
Nervous SystemInsomniab12%4%
Nervousness6%6%a
Metabolic/ NutritionalWeight Lossb9%0%
*Included doses up to 40 mg
a Appears the same due to rounding
b Dose-related adverse reactions
Note: The following reactions did notmeet the criterion for inclusion in Table
2 but were reported by 2% to 4% of adolescent patients receiving ADDERALL XR
with a higher incidence than patients receiving placebo in this study:
accidental injury, asthenia (fatigue), dry mouth, dyspepsia, emotional
lability, nausea, somnolence, and vomiting.

Table 3 : Adverse Reactions Reported by 5% or More of
Adults Receiving ADDERALL XR with Higher Incidence Than on Placebo in a 255
Patient Clinical Forced Weekly-Dose Titration Study*

Body SystemPreferred TermADDERALL XR
(n=191)
Placebo
(n=64)
GeneralHeadache26%13%
Asthenia6%5%
Digestive SystemDry Mouth35%5%
Loss of Appetite33%3%
Nausea8%3%
Diarrhea6%0%
Nervous SystemInsomnia27%13%
Agitation8%5%
Anxiety8%5%
Dizziness7%0%
Nervousness13%13%a
Cardiovascular SystemTachycardia6%3%
Metabolic/ NutritionalWeight Loss10%0%
Urogenital SystemUrinary Tract Infection5%0%
*Included doses up to 60 mg.
a Appears the same due to rounding
Note: The following reactions did not meet the criterion for inclusion in Table
3 but were reported by 2% to 4% of adult patients receiving ADDERALL XR with a
higher incidence than patients receiving placebo in this study: infection,
photosensitivity reaction, constipation, tooth disorder (e.g., teeth clenching,
tooth infection), emotional lability, libido decreased, somnolence, speech
disorder (e.g., stuttering, excessive speech), palpitation, twitching, dyspnea,
sweating, dysmenorrhea, and impotence.

Hypertension

[see WARNINGS AND PRECAUTIONS ]

In a controlled 4-week outpatient clinical study of
adolescents with ADHD, isolated systolic blood pressure elevations ≥ 15
mmHg were observed in 7/64 (11%) placebotreated patients and 7/100 (7%)
patients receiving ADDERALL XR 10 or 20 mg. Isolated elevations in diastolic
blood pressure ≥ 8 mmHg were observed in 16/64 (25%) placebo-treated
patients and 22/100 (22%) ADDERALL XR-treated patients. Similar results were
observed at higher doses.

In a single-dose pharmacokinetic study in 23 adolescents
with ADHD, isolated increases in systolic blood pressure (above the upper 95%
CI for age, gender, and stature) were observed in 2/17 (12%) and 8/23 (35%),
subjects administered 10 mg and 20 mg ADDERALL XR, respectively. Higher single
doses were associated with a greater increase in systolic blood pressure. All
increases were transient, appeared maximal at 2 to 4 hours post dose and not
associated with symptoms.

Adverse Reactions Associated With The Use of Amphetamine,
ADDERALL XR, Or ADDERALL

The following adverse reactions have been associated with
the use of amphetamine, ADDERALL XR, or ADDERALL:

Cardiovascular

Palpitations . There have been isolated reports of cardiomyopathy
associated with chronic amphetamine use.

Central Nervous System

Psychotic episodes at recommended doses, overstimulation,
restlessness, irritability, euphoria , dyskinesia , dysphoria , depression,
tremor , tics, aggression, anger, logorrhea, dermatillomania, paresthesia
(including formication ), and bruxism .

Eye Disorders

Vision blurred, mydriasis .

Gastrointestinal

Unpleasant taste, constipation, other gastrointestinal
disturbances.

Allergic

Urticaria , rash, hypersensitivity reactions including
angioedema and anaphylaxis . Serious skin rashes, including Stevens-Johnson
Syndrome and toxic epidermal necrolysis have been reported.

Endocrine

Impotence , changes in libido , frequent or prolonged
erections.

Skin

Alopecia .

Vascular Disorders

Raynaud’s phenomenon .

Musculoskeletal and Connective Tissue Disorders

Rhabdomyolysis

Drug Interactions

DRUG INTERACTIONS

Agents That Increase Blood Levels Of Amphetamines

MAO Inhibitors

MAOI antidepressants 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 toxic
neurological effects and malignant hyperpyrexia can occur, sometimes with fatal
results. Do not administer ADDERALL XR during or within 14 days following the
administration of monoamine oxidase inhibitors [see CONTRAINDICATIONS ].

Alkalinizing Agents

Gastrointestinal alkalinizing agents (e.g., sodium
bicarbonate ) increase absorption of amphetamines. Co-administration of ADDERALL
XR and gastrointestinal alkalinizing agents, such as antacids , should be
avoided. 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.

Agents That Lower Blood Levels Of Amphetamines

Acidifying Agents

Gastrointestinal acidifying agents (e.g., guanethidine,
reserpine, glutamic acid HCl, ascorbic acid ) lower absorption of amphetamines.
Urinary acidifying agents (e.g., ammonium chloride , sodium acid phosphate,
methenamine salts) 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.

Agents Whose Effects May Be Reduced By Amphetamines

Adrenergic Blockers

Amphetamines may reduce the cardiovascular effects of
adrenergic blockers.

Antihistamines

Amphetamines may counteract the sedative effect of
antihistamines .

Antihypertensives

Amphetamines may antagonize the hypotensive effects of
antihypertensives.

Veratrum Alkaloids

Amphetamines inhibit the hypotensive effect of veratrum
alkaloids.

Phenobarbital

Amphetamines may delay intestinal absorption of
phenobarbital .

Phenytoin

Amphetamines may delay intestinal absorption of
phenytoin .

Ethosuximide

Amphetamines may delay intestinal absorption of
ethosuximide.

Agents Whose Effects May Be Potentiated By Amphetamines

Antidepressants, Tricyclic

Amphetamines may enhance the activity of tricyclic
antidepressants 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.

Meperidine

Amphetamines potentiate the analgesic effect of
meperidine .

Norepinephrine

Amphetamines may enhance the adrenergic effect of norepinephrine.

Agents That May Reduce The Effects Of Amphetamines

Chlorpromazine

Chlorpromazine blocks dopamine and norepinephrine
receptors, thus inhibiting the central stimulant effects of amphetamines.

Haloperidol

Haloperidol blocks dopamine receptors, thus inhibiting
the central stimulant effects of amphetamines.

Lithium Carbonate

The anorectic and stimulatory effects of amphetamines may
be inhibited by lithium carbonate .

Agents That May Potentiate The Effects Of Amphetamines

Norepinephrine

Norepinephrine may enhance the adrenergic effect of
amphetamine.

Propoxyphene Overdosage

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

Proton Pump Inhibitors (PPI)

PPIs act on proton pumps by blocking acid production,
thereby reducing gastric acidity. When ADDERALL XR (20 mg single-dose) was
administered concomitantly with the proton pump inhibitor, omeprazole (40 mg
once daily for 14 days), the median Tmax of d-amphetamine was decreased by 1.25
hours (from 4 to 2.75 hours), and the median Tmax of l-amphetamine was
decreased by 2.5 hours (from 5.5 to 3 hours), compared to ADDERALL XR
administered alone. The AUC and Cmax of each moiety were unaffected. Therefore,
co-administration of ADDERALL XR and proton pump inhibitors should be monitored
for changes in clinical effect.

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.

Drug Abuse And Dependence

Controlled Substance

ADDERALL XR is a Schedule II controlled substance.

Abuse And Dependence

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 levels many
times higher than 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 may include severe dermatoses, marked insomnia, irritability,
hyperactivity, and personality changes. The most severe manifestation of
chronic intoxication is psychosis, often clinically indistinguishable from
schizophrenia .

Warnings & Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Serious Cardiovascular Events

Sudden Death and 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 [see
CONTRAINDICATIONS
].

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 and ADVERSE REACTIONS ].

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 pre-existing
psychotic disorder.

Bipolar Illness

Particular care should be taken in using stimulants to
treat ADHD patients with comorbid bipolar disorder because of concern for
possible induction of 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 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
3482 exposed to methylphenidate or amphetamine for several weeks at usual
doses) of stimulant-treated patients compared to 0 in placebotreated 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

Monitor growth in children during treatment with
stimulants. Patients who are not growing or gaining weight as expected may need
to have their treatment interrupted. 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
over 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.

In a controlled trial of ADDERALL XR in adolescents, mean
weight change from baseline within the initial 4 weeks of therapy was –1.1 lbs.
and –2.8 lbs., respectively, for patients receiving 10 mg and 20 mg ADDERALL
XR. Higher doses were associated with greater weight loss within the initial 4
weeks of treatment. Chronic use of amphetamines can be expected to cause a
similar suppression of growth.

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 the 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, ADDERALL XR should be discontinued.

Peripheral Vasculopathy, Including Raynaud’s phenomenon

Stimulants, including ADDERALL XR, used to treat ADHD are
associated with peripheral vasculopathy, including Raynaud’s phenomenon . Signs
and symptoms are usually intermittent and mild; however, very rare sequelae
include digital ulceration and/or soft tissue breakdown. Effects of peripheral
vasculopathy, including Raynaud’s phenomenon, were observed in post-marketing
reports at different times and at therapeutic doses in all age groups throughout
the course of treatment. Signs and symptoms generally improve after reduction
in dose or discontinuation of drug. Careful observation for digital changes is
necessary during treatment with ADHD stimulants. Further clinical evaluation
(e.g., rheumatology referral ) may be appropriate for certain patients.

Visual Disturbance

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

Tics

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

Prescribing And Dispensing

The least amount of amphetamine feasible should be
prescribed or dispensed at one time in order to minimize the possibility of
overdosage. ADDERALL XR should be used with caution in patients who use other
sympathomimetic drugs.

Patient Counseling Information

Information On Medication Guide

Inform patients, their families, and their caregivers
about the benefits and risks associated with treatment with ADDERALL XR and
should counsel them in its appropriate use. A patient Medication Guide is
available for ADDERALL XR. Instruct patients, their families, and their
caregivers to read the Medication Guide and assist them in understanding its
contents. Give patients the opportunity to discuss the contents of
theMedication Guide and to obtain answers to any questions theymay have. The
complete text of the Medication Guide is reprinted at the end of this document.

Controlled Substance Status/Potential For Abuse, Misuse, And
Dependence

Advise patients that ADDERALL XR is a federally
controlled substance because it can be abused or lead to dependence.
Additionally, emphasize that ADDERALL XR should be stored in a safe place to
prevent misuse and/or abuse. Evaluate patient history (including family history)
of abuse or dependence on alcohol, prescription medicines, or illicit drugs [see
Drug Abuse And Dependence
].

Serious Cardiovascular Risks

Advise patients of serious cardiovascular risk (including
sudden death, myocardial  infarction, stroke, and hypertension) with ADDERALL
XR. Patients who develop symptoms such as exertional chest pain, unexplained
syncope, or other symptoms suggestive of cardiac disease during treatment
should undergo a prompt cardiac evaluation [see WARNINGS AND PRECAUTIONS].

Psychiatric Risks

Prior to initiating treatment with ADDERALL XR,
adequately screen patients with comorbid depressive symptoms 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/or depression. Additionally, ADDERALL XR therapy at usual doses may cause
treatment-emergent psychotic or manic symptoms in patients without prior
history of psychotic symptoms or mania [see WARNINGS AND PRECAUTIONS].

Circulation Problems In Fingers And Toes [Peripheral
vasculopathy, including Raynaud’s phenomenon]

Instruct patients beginning treatment with ADDERALL XR
about the risk of peripheral vasculopathy, including Raynaud’s Phenomenon, and
in associated signs and symptoms: fingers or toes may feel numb, cool, painful,
and/or may change color from pale, to blue, to red. Instruct patients to report
to their physician any new numbness, pain, skin color change, or sensitivity to
temperature in fingers or toes. Instruct patients to call their physician
immediately with any signs of unexplained wounds appearing on fingers or toes
while taking ADDERALL XR.
Further clinical evaluation (e.g., rheumatology
referral) may be appropriate for certain patients [see WARNINGS AND
PRECAUTIONS
].

Growth

Monitor growth in children during treatment with ADDERALL
XR, and patients who are not growing or gaining weight as expected may need to
have their treatment interrupted [see WARNINGS AND PRECAUTIONS].

Pregnancy

Advise patients to notify their physicians if they become
pregnant or intend to become pregnant during treatment [see Use In Specific
Populations
].

Nursing

Advise patients not to breast feed if they are taking
ADDERALL XR [see Use In Specific Populations].

Impairment In Ability To Operate Machinery Or Vehicles

ADDERALL XR 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.

For more information call 1-800-828-2088

Pharmacist: Medication Guide to be dispensed to patients

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No evidence of carcinogenicity was found in studies in
which d,l-amphetamine (enantiomer ratio of 1:1) was administered to mice and
rats in the diet for 2 years at doses of up to 30 mg/kg/day in male mice, 19
mg/kg/day in female mice, and 5 mg/kg/day in male and female rats. These doses
are approximately 2.4, 1.5, and 0.8 times, respectively, the maximum
recommended human dose for children of 30 mg/day, on a mg/m² body surface area
basis.

Amphetamine, in the enantiomer ratio present in ADDERALL
XR (d- to l- ratio of 3:1), was not clastogenic in the mouse bone marrow
micronucleus test in vivo and was negative when tested in the E. coli component
of the Ames test in vitro. d,l-Amphetamine (1:1 enantiomer ratio) has been
reported to produce a positive response in the mouse bone marrow micronucleus
test, an equivocal response in the Ames test, and negative responses in the in
vitro sister chromatid exchange and chromosomal aberration assays.

Amphetamine, in the enantiomer ratio present in ADDERALL
XR (d- to l- ratio of 3:1), did not adversely affect fertility or early
embryonic development in the rat at doses of up to 20 mg/kg/day (approximately
8 times the maximum recommended human dose for adolescents of 20 mg/day, on a
mg/m² body surface area basis).

Use In Specific Populations

Pregnancy

Teratogenic Effects

Pregnancy Category C

Amphetamine, in the enantiomer ratio present in ADDERALL
XR (d- to l- ratio of 3:1), had no apparent effects on embryofetal
morphological development or survival when orally administered to pregnant rats
and rabbits throughout the period of organogenesis at doses of up to 6 and 16
mg/kg/day, respectively. These doses are approximately 2 and 12 times,
respectively, the maximum recommended human dose (MRHD) for adolescents of 20
mg/day, on a mg/m² body surface area basis. Fetal malformations and death have
been reported in mice following parenteral administration of d-amphetamine
doses of 50 mg/kg/day (approximately 10 times the MRHD for adolescents on a
mg/m² basis) or greater to pregnant animals. Administration of these doses was
also associated with severe maternal toxicity.

A study was conducted in which pregnant rats received
daily oral doses of amphetamine (d- to l- enantiomer ratio of 3:1, the same as
in ADDERALL XR) of 2, 6, and 10 mg/kg from gestation day 6 to lactation day 20.
These doses are approximately 0.8, 2, and 4 times the MRHD for adolescents of
20 mg/day, on a mg/m² basis. All doses caused hyperactivity and decreased
weight gain in the dams. A decrease in pup survival was seen at all doses. A
decrease in pup bodyweight was seen at 6 and 10 mg/kg which correlated with
delays in developmental landmarks. Increased pup locomotor activity was seen at
10 mg/kg on day 22 postpartum but not at 5 weeks postweaning. When pups were
tested for reproductive performance at maturation, gestational weight gain, number
of implantations, and number of delivered pups were decreased in the group whose
mothers had been given 10 mg/kg.

A number of studies in rodents indicate that prenatal or
early postnatal exposure to amphetamine (d- or d, l-), at doses similar to
those used clinically, can result in long-term neurochemical and behavioral
alterations. Reported behavioral effects include learning and memory deficits,
altered locomotor activity, and changes in sexual function.

There are no adequate and well-controlled studies in
pregnant women. There has been one report of severe congenital bony deformity,
tracheo- esophageal 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. Amphetamines 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 .

Labor And Delivery

The effects of ADDERALL XR on labor and delivery in
humans is unknown.

Nursing Mothers

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

Pediatric Use

ADDERALL XR is indicated for use in children 6 years of
age and older.

The safety and efficacy of ADDERALL XR in children under
6 years of age have not been studied. Long-termeffects of amphetamines in
children have not been well established.

In a juvenile developmental study, rats received daily
oral doses of amphetamine (d to l enantiomer ratio of 3:1, the same as in
ADDERALL XR) of 2, 6, or 20 mg/kg on days 7-13 of age; from day 14 to
approximately day 60 of age these doses were given b.i.d. for total daily doses
of 4, 12, or 40 mg/kg. The latter doses are approximately 0.6, 2, and 6 times
the maximum recommended human dose for children of 30 mg/day, on a mg/m² basis.
Post dosing hyperactivity was seen at all doses; motor activity measured prior
to the daily dose was decreased during the dosing period but the decreased
motor activity was largely absent after an 18 day drug-free recovery period.
Performance in the Morris water maze test for learning and memory was impaired
at the 40 mg/kg dose, and sporadically at the lower doses, when measured prior
to the daily dose during the treatment period; no recovery was seen after a 19
day drug-free period. A delay in the developmental milestones of vaginal
opening and preputial separation was seen at 40 mg/kg but there was no effect
on fertility.

Geriatric Use

ADDERALL XR has not been studied in the geriatric
population.

Overdosage

OVERDOSE

Individual patient response to amphetamines varies
widely. Toxic symptoms may occur idiosyncratically at low doses.

Symptoms

Manifestations of acute overdosage with amphetamines
include restlessness, tremor, hyperreflexia, rapid respiration , confusion,
assaultiveness, hallucinations, panic states, hyperpyrexia and rhabdomyolysis .
Fatigue and depression usually follow the central nervous system stimulation.
Cardiovascular effects include arrhythmias, hypertension or hypotension and
circulatory collapse. Gastrointestinal symptoms include nausea, vomiting,
diarrhea, and abdominal cramps. Fatal poisoning is usually preceded by convulsions
and coma.

Treatment

Consult with a Certified Poison Control Center for up to
date guidance and advice. The prolonged release of mixed amphetamine salts from
ADDERALL XR should be considered when treating patients with overdose.

Contraindications

CONTRAINDICATIONS

ADDERALL XR administration is contraindicated in patients
with the following conditions:

  • Advanced arteriosclerosis
  • Symptomatic cardiovascular disease
  • Moderate to severe hypertension
  • Hyperthyroidism
  • Known hypersensitivity or idiosyncrasy to the
    sympathomimetic amines (e.g., anaphylaxis , angioedema, serious skin rashes) [see
    ADVERSE REACTIONS
    ]
  • Glaucoma
  • Agitated states
  • History of drug abuse

During or within 14 days following the administration of
monoamine oxidase inhibitors ( hypertensive crises may result) [see DRUG
INTERACTIONS
]

Clinical Pharmacology

CLINICAL PHARMACOLOGY

Mechanism Of Action

Amphetamines are non- catecholamine sympathomimetic amines
with CNS stimulant activity. The mode of therapeutic action in ADHD is not
known. Amphetamines are thought to block the reuptake of norepinephrine and
dopamine into the presynaptic neuron and increase the release of these
monoamines into theextraneuronal space.

Pharmacokinetics

Pharmacokinetic studies of ADDERALL XR have been
conducted in healthy adult and pediatric (children aged 6-12 yrs) subjects, and
adolescent (13-17 yrs) and children with ADHD. Both ADDERALL
(immediate-release) tablets and ADDERALL XR capsules contain d-amphetamine and
l-amphetamine salts in the ratio of 3:1. Following administration of ADDERALL
(immediate-release), the peak plasma concentrations occurred in about 3 hours
for both d-amphetamine and l-amphetamine.

The time to reach maximum plasma concentration (Tmax) for
ADDERALL XR is about 7 hours, which is about 4 hours longer compared to
ADDERALL (immediaterelease).This is consistent with the extended-release nature
of the product.

Figure 1 : Mean d-amphetamine and l-amphetamine Plasma
Concentrations Following Administration of ADDERALL XR 20 mg (8 am) and
ADDERALL (immediate-release) 10 mg Twice Daily (8 am and 12 noon) in the Fed
State.

Mean d-amphetamine and l-amphetamine Plasma Concentrations - Illustration

A single dose of ADDERALL XR 20 mg capsules provided
comparable plasma concentration profiles of both d-amphetamine and
l-amphetamine to ADDERALL (immediate-release) 10 mg twice daily administered 4
hours apart.

The mean elimination half-life for d-amphetamine is 10 hours
in adults; 11 hours in adolescents aged 13-17 years and weighing less than or
equal to 75 kg/165 lbs; and 9 hours in children aged 6 to 12 years. For the
l-amphetamine, the mean elimination half-life in adults is 13 hours; 13 to 14
hours in adolescents; and 11 hours in children aged 6 to 12 years. On a mg/kg
body weight basis, children have a higher clearance than adolescents or adults
(see Special Populations below).

ADDERALL XR demonstrates linear pharmacokinetics over the
dose range of 20 to 60 mg in adults and adolescents weighing greater than 75
kg/165 lbs, over the dose range of 10 to 40 mg in adolescents weighing less
than or equal to 75 kg/165 lbs, and 5 to 30 mg in children aged 6 to 12 years.
There is no unexpected accumulation at steady state in children.

Food does not affect the extent of absorption of
d-amphetamine and l-amphetamine, but prolongs Tmax by 2.5 hours (from 5.2 hrs
at fasted state to 7.7 hrs after a high-fat meal) for d-amphetamine and 2.7
hours (from 5.6 hrs at fasted state to 8.3 hrs after a high fat meal) for
l-amphetamine after administration of ADDERALL XR 30 mg. Opening the capsule
and sprinkling the contents on applesauce results in comparable absorption to
the intact capsule taken in the fasted state. Equal doses of ADDERALL XR
strengths are bioequivalent.

Metabolism and Excretion

Amphetamine is reported to be oxidized at the 4 position
of the benzene ring to form 4-hydroxyamphetamine, or on the side chain α
or β carbons to form alpha-hydroxyamphetamine or norephedrine, respectively.
Norephedrine and 4-hydroxyamphetamine are both active and each is subsequently
oxidized to form 4-hydroxy-norephedrine. Alpha-hydroxy-amphetamine undergoes
deamination to form phenylacetone, which ultimately forms benzoic acid and its
glucuronide and the glycine conjugate hippuric acid. Although the enzymes
involved in amphetamine metabolism have not been clearly defined, CYP2D6 is
known to be involved with formation of 4-hydroxy-amphetamine. Since CYP2D6 is
genetically polymorphic , population variations in amphetamine metabolism are a
possibility.

Amphetamine is known to inhibit monoamine oxidase,
whereas the ability of amphetamine and its metabolites to inhibit various P450
isozymes and other enzymes has not been adequately elucidated. In vitro experiments
with human microsomes indicate minor inhibition of CYP2D6 by amphetamine and
minor inhibition of CYP1A2, 2D6, and 3A4 by one or more metabolites. However,
due to the probability of auto-inhibition and the lack of information on the
concentration of these metabolites relative to in vivo concentrations, no
predications regarding the potential for amphetamine or its metabolites to
inhibit the metabolism of other drugs by CYP isozymes in vivo can be made.

With normal urine pHs, approximately half of an
administered dose of amphetamine is recoverable in urine as derivatives of
alpha-hydroxy-amphetamine and approximately another 30-40% of the dose is
recoverable in urine as amphetamine itself. Since amphetamine has a pKa of 9.9,
urinary recovery of amphetamine is highly dependent on pH and urine flow rates.
Alkaline urine pHs result in less ionization and reduced renal elimination, and
acidic pHs and high flow rates result in increased renal elimination with
clearances greater than glomerular filtration rates, indicating the involvement
of active secretion. Urinary recovery of amphetamine has been reported to range
from 1%to 75%, depending on urinary pH, with the remaining fraction of the dose
hepatically metabolized. Consequently, both hepatic and renal dysfunction have the
potential to inhibit the elimination of amphetamine and result in prolonged exposures.
In addition, drugs that effect urinary pH are known to alter the elimination of
amphetamine, and any decrease in amphetamine’smetabolismthatmight occur due to
drug interactions or genetic polymorphisms is more likely to be clinically
significant when renal elimination is decreased [see DRUG INTERACTIONS ].

Special Populations

Comparison of the pharmacokinetics of d- and
l-amphetamine after oral administration of ADDERALL XR in children (6-12 years)
and adolescent (13-17 years) ADHD patients and healthy adult volunteers
indicates that body weight is the primary determinant of apparent differences
in the pharmacokinetics of d- and l-amphetamine across the age range. Systemic
exposure measured by area under the curve to infinity (AUC∞) and maximumplasma
concentration (Cmax) decreased with increases in body weight, while oral volume
of distribution (VZ/F), oral clearance (CL/F), and elimination half-life (t½)
increased with increases in body weight.

Pediatric Patients

On a mg/kg weight basis, children eliminated amphetamine
faster than adults. The elimination half-life (t½) is approximately 1 hour
shorter for d-amphetamine and 2 hours shorter for l-amphetamine in children
than in adults. However, children had higher systemic exposure to amphetamine
(Cmax and AUC) than adults for a given dose of ADDERALL XR, which was
attributed to the higher dose administered to children on a mg/kg body weight
basis compared to adults. Upon dose normalization on a mg/kg basis, children
showed 30% less systemic exposure compared to adults.

Gender

Systemic exposure to amphetamine was 20-30% higher in
women (N=20) than in men (N=20) due to the higher dose administered to women on
a mg/kg body weight basis. When the exposure parameters (Cmax and AUC) were
normalized by dose (mg/kg), these differences diminished. Age and gender had no
direct effect on the pharmacokinetics of d- and l-amphetamine.

Race

Formal pharmacokinetic studies for race have not been
conducted. However, amphetamine pharmacokinetics appeared to be comparable
among Caucasians (N=33), Blacks (N=8) and Hispanics (N=10).

Animal Toxicology And/Or Pharmacology

Acute administration of high doses of amphetamine (d- or
d,l-) has been shown to produce long-lasting neurotoxic effects, including
irreversible nerve fiber damage, in rodents. The significance of these findings
to humans is unknown.

Clinical Studies

Pediatric Patients

A double-blind, randomized, placebo-controlled, parallel-group
study was conducted in children aged 6-12 (N=584) who met DSM-IV® criteria for
ADHD (either the combined type or the hyperactive-impulsive type). Patients
were randomized to fixed-dose treatment groups receiving final doses of 10, 20,
or 30 mg of ADDERALL XR or placebo once daily in the morning for three weeks.
Significant improvements in patient behavior, based upon teacher ratings of
attention and hyperactivity, were observed for all ADDERALL XR doses compared
to patients who received placebo, for all three weeks, including the first week
of treatment, when all ADDERALL XR subjects were receiving a dose of 10 mg/day.
Patients who received ADDERALL XR showed behavioral improvements in both
morning and afternoon assessments compared to patients on placebo.

In a classroom analogue study, patients (N=51) receiving
fixed doses of 10 mg, 20 mg or 30 mg ADDERALL XR demonstrated statistically
significant improvements in teacher-rated behavior and performance measures,
compared to patients treated with placebo.

A double-blind, randomized,multi-center, parallel-group,
placebo-controlled study was conducted in adolescents aged 13-17 (N=327) who
met DSM-IV® criteria for ADHD. The primary cohort of patients (n=287, weighing ≤
75kg/165lbs) was randomized to fixed-dose treatment groups and received four
weeks of treatment. Patients were randomized to receive final doses of 10 mg,
20 mg, 30 mg, and 40 mg ADDERALL XR or placebo once daily in the morning.
Patients randomized to doses greater than 10 mg were titrated to their final
doses by 10 mg each week. The secondary cohort consisted of 40 subjects
weighing > 75kg/165lbs who were randomized to fixed-dose treatment groups
receiving final doses of 50 mg and 60 mg ADDERALL XR or placebo once daily in
the morning for 4 weeks. The primary efficacy variable was the Attention Deficit
Hyperactivity Disorder-Rating Scale IV (ADHD-RS-IV) total score for the primary
cohort. The ADHD-RS-IV is an 18-item scale that measures the core symptoms of
ADHD. Improvements in the primary cohort were statistically significantly
greater in all four primary cohort active treatment groups (ADDERALL XR 10 mg,
20 mg, 30 mg, and 40 mg) compared with the placebo group. There was not adequate
evidence that doses greater than 20 mg/day conferred additional benefit.

Adult Patients

A double-blind, randomized, placebo-controlled,
parallel-group study was conducted in adults (N=255) who met DSM-IV® criteria
for ADHD. Patients were randomized to fixed-dose treatment groups receiving
final doses of 20, 40, or 60 mg of ADDERALL XR or placebo once daily in the
morning for four weeks. Significant improvements, measured with the Attention
Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS), an 18-item scale that
measures the core symptoms of ADHD, were observed at endpoint for all ADDERALL
XR doses compared to patients who received placebo for all four weeks. There
was not adequate evidence that doses greater than 20 mg/day conferred
additional benefit.

Medication Guide

PATIENT INFORMATION

ADDERALL XR®
(ADD-ur-all X-R) Capsules

Read the Medication Guide that comes with ADDERALL XR
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 you or your child’s treatment with ADDERALL XR.

What is the most important information I should know
about ADDERALL XR?

ADDERALL XR is a stimulant medicine. The following
have been reported with use of 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 ADDERALL XR.

Your doctor should check you or your child’s blood
pressure and heart rate regularly during treatment with ADDERALL XR.

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 ADDERALL XR.

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 ADDERALL XR,
especially seeing or hearing things that are not real, believing things that
are not real, or are suspicious.

3. Circulation problems in fingers and toes
[Peripheral vasculopathy, including Raynaud’s phenomenon]:

  • Fingers or toes may feel numb, cool, painful
  • Fingers or toes may change from pale, to blue, to red

Tell your doctor if you have or your child has numbness,
pain, skin color change, or sensitivity to temperature in your fingers or toes.

Call your doctor right away if you have or your child
has any unexplained wounds appearing on fingers or toes while taking ADDERALL
XR.

What Is ADDERALL XR?

ADDERALL XR is a once daily central nervous system
stimulant prescription medicine. It is used for the treatment of Attention Deficit
Hyperactivity Disorder (ADHD).
ADDERALL XR may help increase attention and
decrease impulsiveness and hyperactivity in patients with ADHD .

ADDERALL XR should be used as a part of a total treatment
program for ADHD that may include counseling or other therapies.

ADDERALL XR is a federally controlled substance (CII)
because it can be abused or lead to dependence. Keep ADDERALL XR in a safe
place to prevent misuse and abuse. Selling or giving away ADDERALL XR 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 ADDERALL XR?

ADDERALL XR 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
    anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
  • is sensitive to, allergic to, or had a reaction to other
    stimulant medicines

ADDERALL XR has not been studied in children less than 6
years old.

ADDERALL XR may not be right for you or your child.
Before starting ADDERALL XR tell you or your child’s doctor about all health
conditions (or a family history of) including:

  • heart problems, heart defects, or high blood pressure
  • mental problems including psychosis, mania, bipolar
    illness, or depression
  • tics or Tourette’s syndrome
  • liver or kidney problems
  • thyroid problems
  • seizures or have had an abnormal brain wave test (EEG)
  • circulation problems in fingers and toes

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

Can ADDERALL XR be taken with other medicines?

Tell your doctor about all of the medicines that you
or your child takes including prescription and non-prescription medicines, vitamins,
and herbal supplements.
ADDERALL XR 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 ADDERALL XR.

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

Especially tell your doctor if you or your child
takes:

  • anti-depression medicines including MAOIs
  • anti-psychotic medicines
  • lithium
  • narcotic pain medicines
  • seizure medicines
  • blood thinner medicines
  • blood pressure medicines
  • stomach acid medicines
  • cold or allergy medicines that contain decongestants

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 ADDERALL XR
without talking to your doctor first.

How should ADDERALL XR be taken?

  • Take ADDERALL XR exactly as prescribed. Your
    doctor may adjust the dose until it is right for you or your child.
  • Take ADDERALL XR once a day in the morning when you first
    wake up. ADDERALL XR is an extended release capsule. It releases medicine into
    your body throughout the day.
  • Swallow ADDERALL XR capsules whole with water or other liquids.
    If you or your child cannot swallow the capsule, open it and sprinkle the medicine
    over a spoonful of applesauce. Swallow all of the applesauce and medicine
    mixture without chewing immediately. Follow with a drink of water or other
    liquid. Never chew or crush the capsule or the medicine inside the capsule.
  • ADDERALL XR can be taken with or without food.
  • From time to time, your doctor may stop ADDERALL XR treatment
    for a while to check ADHD symptoms.
  • Your doctor may do regular checks of the blood, heart,
    and blood pressure while taking ADDERALL XR. Children should have their height
    and weight checked often while taking ADDERALL XR. ADDERALL XR treatment may be
    stopped if a problem is found during these check-ups.
  • If you or your child takes too much ADDERALL XR or overdoses,
    call your doctor or poison control center right away, or get emergency
    treatment.

What are possible side effects of ADDERALL XR?

See “What is the most important information I should
know about ADDERALL XR?”
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:

  • headache
  • decreased appetite
  • stomach ache
  • nervousness
  • trouble sleeping
  • mood swings
  • weight loss
  • dizziness
  • dry mouth
  • fast heart beat

ADDERALL XR may affect you 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

Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.

How should I store ADDERALL XR?

  • Store ADDERALL XR in a safe place at room temperature, 59
    to 86° F (15 to 30° C).
  • Keep ADDERALL XR and all medicines out of the reach of
    children.

General information about ADDERALL XR

Medicines are sometimes prescribed for purposes other
than those listed in a Medication Guide. Do not use ADDERALL XR for a condition
for which it was not prescribed. Do not give ADDERALL XR 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 ADDERALL XR. If you would like more information, talk with your
doctor. You can ask your doctor or pharmacist for information about ADDERALL XR
that was written for healthcare professionals. For more information, you may
also contact Shire Pharmaceuticals (the maker of ADDERALL XR) at 1-800-828-2088
or visit the website at http://www.adderallxr.com.

What are the ingredients in ADDERALL XR?

Active Ingredients: dextroamphetamine saccharate, amphetamine
aspartate monohydrate, dextroamphetamine sulfate, USP, amphetamine sulfate USP

Inactive Ingredients: gelatin capsules,
hydroxypropylmethylcellulose, methacrylic acid copolymer, opadry beige, sugar
spheres, talc, and triethyl citrate. Gelatin capsules contain edible inks,
kosher gelatin, and titanium dioxide. The 5 mg, 10 mg, and 15 mg capsules also
contain FD&C Blue #2. The 20 mg, 25 mg, and 30 mg capsules also contain red
iron oxide and yellow iron oxide

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Adderall Drug Imprint

001151328_PB

capsule, blue, imprinted with M Amphet Salts, 5 mg

001151329_PB

capsule, blue, imprinted with M Amphet Salts, 10 mg

001151330_PB

capsule, blue/white, imprinted with M Amphet Salts, 15 mg

001151331_PB

capsule, orange, imprinted with M Amphet Salts, 20 mg

001151332_PB

capsule, orange/white, imprinted with M Amphet Salts, 25 mg

001151333_PB

capsule, brown/orange, imprinted with M Amphet Salts, 30 mg

005550775_PB

round, blue, imprinted with b 775, 7 1/2

005550776_PB

oval, orange, imprinted with b 776, 12 1/2

005550777_PB

round, orange, imprinted with b 777, 1 5

005550788_PB

capsule, orange, imprinted with M Amphet Salts, 20 mg

005550790_PB

capsule, blue, imprinted with M Amphet Salts, 5 mg

005550971_PB

oval, blue, imprinted with b 971, 5

005550972_PB

oval, blue, imprinted with b 972, 1 0

005550973_PB

oval, peach, imprinted with b 973, 2 0

005550974_PB

oval, peach, imprinted with b 974, 3 0

540920381_PB

capsule, blue/clear, imprinted with ADDERALL XR, 5 mg

540920383_PB

capsule, blue/light blue, imprinted with Adderall XR, 10 mg

540920385_PB

capsule, blue/white, imprinted with ADDERALL XR, 15 mg

540920387_PB

capsule, orange, imprinted with ADDERALL XR, 20 mg

540920389_PB

capsule, orange/white, imprinted with ADDERALL XR, 25 mg

540920391_PB

capsule, brown/orange, imprinted with ADDERALL XR, 30 mg

Adderall 10 mg

round, blue, imprinted with AD, 1 0

Adderall 20 mg

round, orange, imprinted with 20, AD

Adderall 5 mg

round, blue, imprinted with AD, 5

Adderall XR 10 mg

capsule, blue, imprinted with Shire 381, 10 mg

Adderall XR 15 mg

capsule, blue/white, imprinted with ADDERALL XR, 15 mg

Adderall XR 20 mg

capsule, orange, imprinted with ADDERALL XR, 20 mg

Adderall XR 25 mg

capsule, orange/white, imprinted with ADDERALL XR, 25 mg

Adderall XR 30 mg

capsule, brown/orange, imprinted with ADDERALL XR, 30 mg

Adderall XR 5 mg

capsule, blue, imprinted with ADDERALL XR, 5 mg

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    Zenzedi
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  • Health Resources

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