FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
STRATTERA® (atomoxetine HCl) is a selective
norepinephrine reuptake inhibitor. Atomoxetine HCl is the R(-) isomer as determined by x-ray diffraction. The
chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride. The molecular
formula is C17H21NO•HCl, which
corresponds to a molecular weight of 291.82
Atomoxetine HCl is a white to practically white solid, which has a solubility
of 27.8 mg/mL in water.
STRATTERA capsules are intended for oral administration only.
Each capsule contains atomoxetine HCl equivalent to 10, 18, 25, 40, 60, 80,
or 100 mg of atomoxetine. The capsules also contain pregelatinized starch and
dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and
other inactive ingredients. The capsule shells also contain one or more of the
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action
The precise mechanism by which atomoxetine produces its
therapeutic effects in Attention-Deficit/Hyperactivity Disorder (ADHD) is
unknown, but is thought to be related to selective inhibition of the
pre-synaptic norepinephrine transporter, as determined in ex vivo uptake and
neurotransmitter depletion studies. 12.2 Pharmacodynamics
An exposure-response analysis encompassing doses of atomoxetine
(0.5, 1.2 or 1.8 mg/kg/day) or placebo demonstrated atomoxetine exposure
correlates with efficacy as measured by the Attention-Deficit/Hyperactivity
Disorder Rating Scale-IV-Parent Version: Investigator administered and scored.
The exposure-efficacy relationship was similar to that observed between dose and
efficacy with median exposures at the two highest doses resulting in near
maximal changes from baseline [see Clinical Studies (14.2)].12.3 Pharmacokinetics
Atomoxetine is well-absorbed after oral administration and is
minimally affected by food. It is eliminated primarily by oxidative metabolism
through the cytochrome P450 2D6 (CYP2D6) enzymatic pathway and subsequent
glucuronidation. Atomoxetine has a half-life of about 5 hours. A fraction of the
population (about 7% of Caucasians and 2% of African Americans) are poor
metabolizers (PMs) of CYP2D6 metabolized drugs. These individuals have reduced
activity in this pathway resulting in 10-fold higher AUCs, 5-fold higher peak
plasma concentrations, and slower elimination (plasma half-life of about
24 hours) of atomoxetine compared with people with normal activity [extensive
metabolizers (EMs)]. Drugs that inhibit CYP2D6, such as fluoxetine, paroxetine,
and quinidine, cause similar increases in exposure. The pharmacokinetics of atomoxetine have been evaluated in more than
400 children and adolescents in selected clinical trials, primarily using
population pharmacokinetic studies. Single-dose and steady-state individual
pharmacokinetic data were also obtained in children, adolescents, and adults.
When doses were normalized to a mg/kg basis, similar half-life, Cmax, and AUC values were observed in children, adolescents, and
adults. Clearance and volume of distribution after adjustment for body weight
were also similar.
Absorption and distribution —
Atomoxetine is rapidly absorbed after oral administration, with absolute
bioavailability of about 63% in EMs and 94% in PMs. Maximal plasma
concentrations (Cmax) are reached approximately 1 to
2 hours after dosing.
STRATTERA can be administered with or without food. Administration of
STRATTERA with a standard high-fat meal in adults did not affect the extent of
oral absorption of atomoxetine (AUC), but did decrease the rate of absorption,
resulting in a 37% lower Cmax, and delayed Tmax by 3 hours. In clinical trials with children and
adolescents, administration of STRATTERA with food resulted in a 9% lower Cmax. The steady-state volume of distribution after intravenous administration is
0.85 L/kg indicating that atomoxetine distributes primarily into total body
water. Volume of distribution is similar across the patient weight range after
normalizing for body weight.
At therapeutic concentrations, 98% of atomoxetine in plasma is bound to
protein, primarily albumin.
Metabolism and elimination —
Atomoxetine is metabolized primarily through the CYP2D6 enzymatic pathway.
People with reduced activity in this pathway (PMs) have higher plasma
concentrations of atomoxetine compared with people with normal activity (EMs).
For PMs, AUC of atomoxetine is approximately 10-fold and Css,max is about 5-fold greater than EMs. Laboratory tests are
available to identify CYP2D6 PMs. Coadministration of STRATTERA with potent
inhibitors of CYP2D6, such as fluoxetine, paroxetine, or quinidine, results in a
substantial increase in atomoxetine plasma exposure, and dosing adjustment may
be necessary [see Warnings and Precautions (5.13)]. Atomoxetine did not inhibit or induce the
CYP2D6 pathway. The major oxidative metabolite formed, regardless of CYP2D6 status, is
4-hydroxyatomoxetine, which is glucuronidated. 4-Hydroxyatomoxetine is
equipotent to atomoxetine as an inhibitor of the norepinephrine transporter but
circulates in plasma at much lower concentrations (1% of atomoxetine
concentration in EMs and 0.1% of atomoxetine concentration in PMs).
4-Hydroxyatomoxetine is primarily formed by CYP2D6, but in PMs,
4-hydroxyatomoxetine is formed at a slower rate by several other cytochrome P450
enzymes. N-Desmethylatomoxetine is formed by CYP2C19 and other cytochrome P450
enzymes, but has substantially less pharmacological activity compared with
atomoxetine and circulates in plasma at lower concentrations (5% of atomoxetine
concentration in EMs and 45% of atomoxetine concentration in PMs).
Mean apparent plasma clearance of atomoxetine after oral administration in
adult EMs is 0.35 L/hr/kg and the mean half-life is 5.2 hours. Following oral
administration of atomoxetine to PMs, mean apparent plasma clearance is
0.03 L/hr/kg and mean half-life is 21.6 hours. For PMs, AUC of atomoxetine is
approximately 10-fold and Css,max is about 5-fold greater
than EMs. The elimination half-life of 4-hydroxyatomoxetine is similar to that
of N-desmethylatomoxetine (6 to 8 hours) in EM subjects, while the half-life of
N-desmethylatomoxetine is much longer in PM subjects (34 to 40 hours).
Atomoxetine is excreted primarily as 4-hydroxyatomoxetine-O-glucuronide, mainly in the urine (greater than 80% of the
dose) and to a lesser extent in the feces (less than 17% of the dose). Only a
small fraction of the STRATTERA dose is excreted as unchanged atomoxetine (less
than 3% of the dose), indicating extensive biotransformation.
[See Use In Specific Populations (8.4,
8.5, 8.6, 8.7, 8.8, 8.9)].
Indications & Usage
1 INDICATIONS AND USAGE 1.1 Attention-Deficit/Hyperactivity Disorder (ADHD)
STRATTERA is indicated for the treatment of
Attention-Deficit/Hyperactivity Disorder (ADHD).
The efficacy of STRATTERA Capsules was established in seven clinical trials
in outpatients with ADHD: four 6 to 9-week trials in pediatric patients (ages 6
to 18), two 10-week trial in adults, and one maintenance trial in pediatrics
(ages 6 to 15) [see Clinical Studies (14)].1.2 Diagnostic Considerations
A diagnosis of ADHD (DSM-IV) implies the presence of
hyperactive-impulsive or inattentive symptoms that cause impairment and that
were present before age 7 years. The symptoms must be persistent, must be more
severe than is typically observed in individuals at a comparable level of
development, must cause clinically significant impairment, e.g., in social,
academic, or occupational functioning, and must 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.
The specific etiology of ADHD is unknown, and there is no single diagnostic
test. Adequate diagnosis requires the use not only of medical but also of
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 presence of the required number
of DSM-IV characteristics.
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. For a Combined Type diagnosis, both inattentive and
hyperactive-impulsive criteria must be met. 1.3 Need for Comprehensive Treatment Program
STRATTERA 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. Drug treatment is 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 in children and adolescents with this diagnosis and
psychosocial intervention is often helpful. When remedial measures alone are
insufficient, the decision to prescribe drug treatment medication will depend
upon the physician's assessment of the chronicity and severity of the patient's
4 CONTRAINDICATIONS 4.1 Hypersensitivity
STRATTERA is contraindicated in patients known to be
hypersensitive to atomoxetine or other constituents of the product [see Warnings and Precautions (5.7)].
4.2 Monoamine Oxidase Inhibitors (MAOI)
STRATTERA should not be taken with an MAOI, or within 2 weeks
after discontinuing an MAOI. Treatment with an MAOI should not be initiated
within 2 weeks after discontinuing STRATTERA. With other drugs that affect brain
monoamine concentrations, there have been reports of serious, sometimes fatal
reactions (including hyperthermia, rigidity, myoclonus, autonomic instability
with possible rapid fluctuations of vital signs, and mental status changes that
include extreme agitation progressing to delirium and coma) when taken in
combination with an MAOI. Some cases presented with features resembling
neuroleptic malignant syndrome. Such reactions may occur when these drugs are
given concurrently or in close proximity [see Drug
Interactions (7.1)]. 4.3 Narrow Angle Glaucoma
In clinical trials, STRATTERA use was associated with an
increased risk of mydriasis and therefore its use is not recommended in patients
with narrow angle glaucoma.
6 ADVERSE REACTIONS 6.1 Clinical Trials Experience
STRATTERA was administered to 5382 children or adolescent
patients with ADHD and 1007 adults with ADHD in clinical studies. During the
ADHD clinical trials, 1625 children and adolescent patients were treated for
longer than 1 year and 2529 children and adolescent patients were treated for
over 6 months.
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 practice.
Child and Adolescent Clinical Trials
Reasons for discontinuation of treatment
due to adverse reactions in child and adolescent clinical trials — In
acute child and adolescent placebo-controlled trials, 3.0% (48/1613) of
atomoxetine subjects and 1.4% (13/945) placebo subjects discontinued for adverse
reactions. For all studies, (including open-label and long-term studies), 6.3%
of extensive metabolizer (EM) patients and 11.2% of poor metabolizer (PM)
patients discontinued because of an adverse reaction. Among STRATTERA-treated
patients, irritability (0.3%, N=5); somnolence (0.3%, N=5); aggression (0.2%,
N=4); nausea (0.2%, N=4); vomiting (0.2%, N=4); abdominal pain (0.2%, N=4);
constipation (0.1%, N=2); fatigue (0.1%, N=2); feeling abnormal (0.1%, N=2); and
headache (0.1%, N=2) were the reasons for discontinuation reported by more than
Seizures — STRATTERA has not been
systematically evaluated in pediatric patients with seizure disorder as these
patients were excluded from clinical studies during the product's premarket
testing. In the clinical development program, seizures were reported in 0.2%
(12/5073) of children whose average age was 10 years (range 6 to 16 years). In
these clinical trials, the seizure risk among poor metabolizers was 0.3% (1/293)
compared to 0.2% (11/4741) for extensive metabolizers.
Commonly observed adverse reactions in
acute child and adolescent, placebo-controlled trials — Commonly observed
adverse reactions associated with the use of STRATTERA (incidence of 2% or
greater) and not observed at an equivalent incidence among placebo-treated
patients (STRATTERA incidence greater than placebo) are listed in Table 1. Results were similar in the BID and the QD trial except
as shown in Table 2, which shows both BID and QD results for
selected adverse reactions based on statistically significant Breslow-Day tests.
The most commonly observed adverse reactions in patients treated with STRATTERA
(incidence of 5% or greater and at least twice the incidence in placebo
patients, for either BID or QD dosing) were: nausea, vomiting, fatigue,
decreased appetite, abdominal pain, and somnolence (see Tables 1 and
The following adverse reactions occurred in at least 2% of PM patients and
were either twice as frequent or statistically significantly more frequent in PM
patients compared with EM patients: insomnia (15% of PMs, 10% of EMs); weight
decreased (7% of PMs, 4% of EMs); constipation (7% of PMs, 4% of EMs);
depression1 (7% of PMs, 4% of EMs); tremor (5% of PMs, 1%
of EMs); excoriation (4% of PMs, 2% of EMs); conjunctivitis (3% of PMs, 1% of
EMs); syncope (3% of PMs, 1% of EMs); early morning awakening (2% of PMs, 1% of
EMs); mydriasis (2% of PMs, 1% of EMs).
1Depression includes the following terms: depression,
major depression, depressive symptoms, depressed mood, dysphoria.
Adult Clinical Trials
Reasons for discontinuation of treatment
due to adverse reactions in acute adult placebo-controlled trials — In
the acute adult placebo-controlled trials, 11.3% (61/541) atomoxetine subjects
and 3.0% (12/405) placebo subjects discontinued for adverse reactions. Among
STRATTERA-treated patients, insomnia (0.9%, N=5); nausea (0.9%, N=5); chest
pain (0.6%, N=3); fatigue (0.6%, N=3); anxiety (0.4%, N=2); erectile dysfunction
(0.4%, N=2); mood swings (0.4%, N=2); nervousness (0.4%, N=2); palpitations
(0.4%, N=2); and urinary retention (0.4%, N=2) were the reasons for
discontinuation reported by more than 1 patient.
Seizures — STRATTERA has not been
systematically evaluated in adult patients with a seizure disorder as these
patients were excluded from clinical studies during the product's premarket
testing. In the clinical development program, seizures were reported on 0.1%
(1/748) of adult patients. In these clinical trials, no poor metabolizers (0/43)
reported seizures compared to 0.1% (1/705) for extensive metabolizers.
Commonly observed adverse reactions in
acute adult placebo-controlled trials — Commonly observed adverse
reactions associated with the use of STRATTERA (incidence of 2% or greater) and
not observed at an equivalent incidence among placebo-treated patients
(STRATTERA incidence greater than placebo) are listed in Table 3. The most commonly observed adverse reactions in patients
treated with STRATTERA (incidence of 5% or greater and at least twice the
incidence in placebo patients) were: constipation, dry mouth, nausea, fatigue,
decreased appetite, insomnia, erectile dysfunction, urinary hesitation and/or
urinary retention and/or dysuria, dysmenorrhea, and hot flush (see Table 3).
Male and female sexual dysfunction —
Atomoxetine appears to impair sexual function in some patients. Changes in
sexual desire, sexual performance, and sexual satisfaction are not well assessed
in most clinical trials because they need special attention and because patients
and physicians may be reluctant to discuss them. Accordingly, estimates of the
incidence of untoward sexual experience and performance cited in product
labeling are likely to underestimate the actual incidence. Table
3 above displays the incidence of sexual side effects reported by at least
2% of adult patients taking STRATTERA in placebo-controlled trials.
There are no adequate and well-controlled studies examining sexual
dysfunction with STRATTERA treatment. While it is difficult to know the precise
risk of sexual dysfunction associated with the use of STRATTERA, physicians
should routinely inquire about such possible side effects. 6.2 Postmarketing Spontaneous Reports
The following adverse reactions have been identified during post
approval use of STRATTERA. Unless otherwise specified, these adverse reactions
have occurred in adults and children and adolescents. Because these reactions
are reported voluntarily from a population of uncertain size, it is not always
possible to reliably estimate their frequency or establish a causal relationship
to drug exposure.
Cardiovascular system — QT prolongation,
General disorders and administration site
conditions — Lethargy.
Nervous system disorders — Hypoaesthesia;
paraesthesia in children and adolescents; sensory disturbances; tics.
Psychiatric disorders — Depression and depressed
Seizures — Seizures have been reported in the
postmarketing period. The postmarketing seizure cases include patients with
pre-existing seizure disorders and those with identified risk factors for
seizures, as well as patients with neither a history of nor identified risk
factors for seizures. The exact relationship between STRATTERA and seizures is
difficult to evaluate due to uncertainty about the background risk of seizures
in ADHD patients.
Skin and subcutaneous tissue disorders —
Urogenital system — Male pelvic pain; urinary
hesitation in children and adolescents; urinary retention in children and
10 OVERDOSAGE 10.1 Human Experience
No fatal overdoses occurred in clinical trials. There is limited
clinical trial experience with STRATTERA overdose. During postmarketing, there
have been fatalities reported involving a mixed ingestion overdose of STRATTERA
and at least one other drug. There have been no reports of death involving
overdose of STRATTERA alone, including intentional overdoses at amounts up to
1400 mg. In some cases of overdose involving STRATTERA, seizures have been
reported. The most commonly reported symptoms accompanying acute and chronic
overdoses of STRATTERA were somnolence, agitation, hyperactivity, abnormal
behavior, and gastrointestinal symptoms. Signs and symptoms consistent with mild
to moderate sympathetic nervous system activation (e.g., mydriasis, tachycardia,
dry mouth) have also been observed. Less commonly, there have been reports of QT
prolongation and mental changes, including disorientation and hallucinations.
10.2 Management of Overdose
An airway should be established. Monitoring of cardiac and vital
signs is recommended, along with appropriate symptomatic and supportive
measures. Gastric lavage may be indicated if performed soon after ingestion.
Activated charcoal may be useful in limiting absorption. Because atomoxetine is
highly protein-bound, dialysis is not likely to be useful in the treatment of
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 2.1 Acute Treatment
Dosing of children and adolescents up to
70 kg body weight — STRATTERA should be initiated at a total daily dose
of approximately 0.5 mg/kg and increased after a minimum of 3 days to a target
total daily dose of approximately 1.2 mg/kg administered either as a single
daily dose in the morning or as evenly divided doses in the morning and late
afternoon/early evening. No additional benefit has been demonstrated for doses
higher than 1.2 mg/kg/day [see Clinical Studies (14)].
The total daily dose in children and adolescents should not exceed 1.4 mg/kg
or 100 mg, whichever is less.
Dosing of children and adolescents over
70 kg body weight and adults — STRATTERA should be initiated at a total
daily dose of 40 mg and increased after a minimum of 3 days to a target total
daily dose of approximately 80 mg administered either as a single daily dose in
the morning or as evenly divided doses in the morning and late afternoon/early
evening. After 2 to 4 additional weeks, the dose may be increased to a maximum
of 100 mg in patients who have not achieved an optimal response. There are no
data that support increased effectiveness at higher doses [see Clinical Studies (14)].
The maximum recommended total daily dose in children and adolescents over
70 kg and adults is 100 mg. 2.2 Maintenance/Extended Treatment
It is generally agreed that pharmacological treatment of ADHD may
be needed for extended periods. The benefit of maintaining pediatric patients
(ages 6-15 years) with ADHD on STRATTERA after achieving a response in a dose
range of 1.2 to 1.8 mg/kg/day was demonstrated in a controlled trial. Patients
assigned to STRATTERA in the maintenance phase were generally continued on the
same dose used to achieve a response in the open label phase. The physician who
elects to use STRATTERA for extended periods should periodically reevaluate the
long-term usefulness of the drug for the individual patient [see Clinical Studies (14.1)].2.3 General Dosing Information
STRATTERA may be taken with or without food.
STRATTERA can be discontinued without being tapered.
STRATTERA capsules are not intended to be opened, they should be taken whole
[see Patient Counseling Information (17.6)].
The safety of single doses over 120 mg and total daily doses above 150 mg
have not been systematically evaluated. 2.4 Dosing in Specific Populations
Dosing adjustment for hepatically impaired
patients — For those ADHD patients who have hepatic insufficiency (HI),
dosage adjustment is recommended as follows: For patients with moderate
HI (Child-Pugh Class B), initial and target doses should be reduced to 50% of
the normal dose (for patients without HI). For patients with severe
HI (Child-Pugh Class C), initial dose and target doses should be reduced to 25%
of normal [see Use In Specific Populations (8.6)].
Dosing adjustment for use with a strong
CYP2D6 inhibitor or in patients who are known to be CYP2D6 PMs — In
children and adolescents up to 70 kg body weight administered strong CYP2D6
inhibitors, e.g., paroxetine, fluoxetine, and quinidine, or in patients who are
known to be CYP2D6 PMs, STRATTERA should be initiated at 0.5 mg/kg/day and only
increased to the usual target dose of 1.2 mg/kg/day if symptoms fail to improve
after 4 weeks and the initial dose is well tolerated.
In children and adolescents over 70 kg body weight and adults administered
strong CYP2D6 inhibitors, e.g., paroxetine, fluoxetine, and quinidine, STRATTERA
should be initiated at 40 mg/day and only increased to the usual target dose of
80 mg/day if symptoms fail to improve after 4 weeks and the initial dose is well
Opaque Blue,LILLY 3228
16.2 Storage and Handling
Store at 25°C (77°F); excursions permitted to 15° to 30°C
(59° to 86°F) [see USP Controlled Room Temperature].
Information For Patients
17 PATIENT COUNSELING INFORMATION
See FDA-approved Medication Guide.17.1 General Information
Physicians should instruct their patients to read the Medication
Guide before starting therapy with STRATTERA and to reread it each time the
prescription is renewed.
Prescribers or other health professionals should inform patients, their
families, and their caregivers about the benefits and risks associated with
treatment with STRATTERA and should counsel them in its appropriate use. 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
Patients should be advised of the following issues and asked to alert their
prescriber if these occur while taking STRATTERA. 17.2 Suicide Risk
Patients, their families, and their caregivers should be
encouraged to be alert to the emergence of anxiety, agitation, panic attacks,
insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia
(psychomotor restlessness), hypomania, mania, other unusual changes in behavior,
depression, and suicidal ideation, especially early during STRATTERA treatment
and when the dose is adjusted. Families and caregivers of patients should be
advised to observe for the emergence of such symptoms on a day-to-day basis,
since changes may be abrupt. Such symptoms should be reported to the patient's
prescriber or health professional, especially if they are severe, abrupt in
onset, or were not part of the patient's presenting symptoms. Symptoms such as
these may be associated with an increased risk for suicidal thinking and
behavior and indicate a need for very close monitoring and possibly changes in
the medication. 17.3 Severe Liver Injury
Patients initiating STRATTERA should be cautioned that severe
liver injury may develop. Patients should be instructed to contact their
physician immediately should they develop pruritus, dark urine, jaundice, right
upper quadrant tenderness, or unexplained “flu-like” symptoms [see Warnings and Precautions (5.2)].
17.4 Aggression or Hostility
Patients should be instructed to call their doctor as soon as
possible should they notice an increase in aggression or hostility. 17.5 Priapism
Rare postmarketing cases of priapism, defined as painful and
nonpainful penile erection lasting more than 4 hours, have been reported for
pediatric and adult patients treated with STRATTERA. The parents or guardians of
pediatric patients taking STRATTERA and adult patients taking STRATTERA should
be instructed that priapism requires prompt medical attention. 17.6 Ocular Irritant
STRATTERA is an ocular irritant. STRATTERA capsules are not
intended to be opened. In the event of capsule content coming in contact with
the eye, the affected eye should be flushed immediately with water, and medical
advice obtained. Hands and any potentially contaminated surfaces should be
washed as soon as possible. 17.7 Drug-Drug Interaction
Patients should be instructed to consult a physician if they are
taking or plan to take any prescription or over-the-counter medicines, dietary
supplements, or herbal remedies. 17.8 Pregnancy
Patients should be instructed to consult a physician if they are
nursing, pregnant, or thinking of becoming pregnant while taking STRATTERA.
Patients may take STRATTERA with or without food. 17.10 Missed Dose
If patients miss a dose, they should be instructed to take it as
soon as possible, but should not take more than the prescribed total daily
amount of STRATTERA in any 24-hour period. 17.11 Interference with Psychomotor Performance
Patients should be instructed to use caution when driving a car
or operating hazardous machinery until they are reasonably certain that their
performance is not affected by atomoxetine.
Literature revised July 29, 2010
Eli Lilly and Company
Indianapolis, IN 46285, USA
Copyright © 2002, 2010, Eli Lilly and Company. All rights reserved.
WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS
STRATTERA (atomoxetine) increased the risk of
suicidal ideation in short-term studies in children or adolescents with
Attention-Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of
STRATTERA in a child or adolescent must balance this risk with the clinical
need. Co-morbidities occurring with ADHD may be associated with an increase in
the risk of suicidal ideation and/or behavior. Patients who are started on
therapy should be monitored closely for suicidality (suicidal thinking and
behavior), clinical worsening, or unusual changes in behavior. Families and
caregivers should be advised of the need for close observation and communication
with the prescriber. STRATTERA is approved for ADHD in pediatric and adult
patients. STRATTERA is not approved for major depressive disorder.
Pooled analyses of short-term (6 to 18 weeks)
placebo-controlled trials of STRATTERA in children and adolescents (a total of
12 trials involving over 2200 patients, including 11 trials in ADHD and 1 trial
in enuresis) have revealed a greater risk of suicidal ideation early during
treatment in those receiving STRATTERA compared to placebo. The average risk of
suicidal ideation in patients receiving STRATTERA was 0.4% (5/1357 patients),
compared to none in placebo-treated patients (851 patients). No suicides
occurred in these trials [see Warnings and
STRATTERA - atomoxetine
STRATTERA - atomoxetine
Eli Lilly and Company
Read the Medication Guide that comes with STRATTERA®
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 treatment or your child's treatment with STRATTERA.
What is the most important
information I should know about STRATTERA?
The following have been reported with use of
1. Suicidal thoughts and actions in children and
Children and teenagers sometimes think about suicide, and
many report trying to kill themselves. Results from STRATTERA clinical studies
with over 2200 child or teenage ADHD patients suggest that some children and
teenagers may have a higher chance of having suicidal thoughts or
actions. Although no suicides occurred in these studies, 4 out of every
1000 patients developed suicidal thoughts. Tell your child or teenager's doctor
if your child or teenager (or there is a family history of):
- has bipolar illness (manic-depressive illness)
- had suicide thoughts or actions before starting STRATTERA
The chance for suicidal thoughts and actions may be
- early during STRATTERA treatment
- during dose adjustments
Prevent suicidal thoughts and action in your child or
- paying close attention to your child or teenager's moods, behaviors,
thoughts, and feelings during STRATTERA treatment
- keeping all follow-up visits with your child or teenager's doctor as
Watch for the following signs in your child or teenager
during STRATTERA treatment:
- panic attacks
- trouble sleeping
- suicide thoughts
Call your child or teenager's doctor right away if they have
any of the above signs, especially if they are new, sudden, or severe.
Your child or teenager may need to be closely watched for suicidal thoughts and
actions or need a change in medicine.
2. Severe liver damage:
STRATTERA can cause liver injury in some patients. Call your
doctor right away if you or your child has the following signs of liver
- right upper belly pain
- dark urine
- yellow skin or eyes
- unexplained flu-like symptoms
3. Heart-related problems:
- sudden death in patients who have heart problems or heart
- stroke and heart attack in adults
- increased blood pressure and heart rate
Tell your doctor if you or your child has 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 STRATTERA.
Your doctor should check your blood pressure or your child's blood pressure
and heart rate regularly during treatment with STRATTERA.
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 STRATTERA.
4. New mental (psychiatric) problems in children
- new psychotic symptoms (such as hearing voices, believing things that are
not true, being suspicious) or new manic symptoms
Call your child or teenager's doctor right away about any
new mental symptoms because adjusting or stopping STRATTERA treatment may
need to be considered.
What Is STRATTERA?
STRATTERA is a selective norepinephrine reuptake inhibitor medicine. It is
used for the treatment of attention deficit and hyperactivity disorder (ADHD).
STRATTERA may help increase attention and decrease impulsiveness and
hyperactivity in patients with ADHD.
STRATTERA should be used as a part of a total treatment program for ADHD that
may include counseling or other therapies.
STRATTERA has not been studied in children less than 6 years old.
Who should not take STRATTERA?
STRATTERA should not be taken if you or your
- are taking or have taken within the past 14 days an anti-depression medicine
called a monoamine oxidase inhibitor or MAOI. Some names of MAOI medicines are
Nardil® (phenelzine sulfate), Parnate® (tranylcypromine sulfate) and Emsam®
(selegiline transdermal system).
- have an eye problem called narrow angle glaucoma
- are allergic to anything in STRATTERA. See the end of this Medication Guide
for a complete list of ingredients.
STRATTERA may not be right for you or your child. Before
starting STRATTERA tell your doctor or your child's doctor about all health
conditions (or a family history of) including:
- have or had suicide thoughts or actions
- heart problems, heart defects, irregular heart beat, high blood pressure, or
low blood pressure
- mental problems, psychosis, mania, bipolar illness, or depression
- liver problems
Tell your doctor if you or your child is pregnant, planning to become
pregnant, or breastfeeding.
Can STRATTERA be taken with other medicines?
Tell your doctor about all the medicines that you or your
child takes including prescription and nonprescription medicines, vitamins, and
herbal supplements. STRATTERA and some medicines may interact with each
other and cause serious side effects. Your doctor will decide whether STRATTERA
can be taken with other medicines.
Especially tell your doctor if you or your child
- asthma medicines
- anti-depression medicines including MAOIs
- blood pressure 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 STRATTERA without
talking to your doctor first.
How should STRATTERA be taken?
- Take STRATTERA exactly as prescribed. STRATTERA comes in
different dose strength capsules. Your doctor may adjust the dose until
it is right for you or your child.
- Do not chew, crush, or open the capsules. Swallow
STRATTERA capsules whole with water or other liquids. Tell your doctor if you or
your child cannot swallow STRATTERA whole. A different medicine may need to be
- Avoid touching a broken STRATTERA capsule. Wash hands and surfaces that
touched an open STRATTERA capsule. If any of the powder gets in your eyes or
your child's eyes, rinse them with water right away and call your doctor.
- STRATTERA can be taken with or without food.
- STRATTERA is usually taken once or twice a day. Take STRATTERA at the same
time each day to help you remember. If you miss a dose of STRATTERA, take it as
soon as you remember that day. If you miss a day of STRATTERA, do not double
your dose the next day. Just skip the day you missed.
- From time to time, your doctor may stop STRATTERA treatment for a while to
check ADHD symptoms.
- Your doctor may do regular checks of the blood, heart, and blood pressure
while taking STRATTERA. Children should have their height and weight checked
often while taking STRATTERA. STRATTERA treatment may be stopped if a problem is
found during these check-ups.
- If you or your child takes too much STRATTERA or overdoses,
call your doctor or poison control center right away, or get emergency
What are possible side effects of STRATTERA?
See “What is the most important information I
should know about STRATTERA?” for information on reported suicidal
thoughts and actions, other mental problems, severe liver damage, and heart
Other serious side effects include:
- serious allergic reactions (call your doctor if you have trouble breathing,
see swelling or hives, or experience other allergic reactions)
- slowing of growth (height and weight) in children
- problems passing urine including
- trouble starting or keeping a urine stream
- cannot fully empty the bladder
Common side effects in children and teenagers
- upset stomach
- decreased appetite
- nausea or vomiting
- mood swings
Common side effects in adults include:
- dry mouth
- decreased appetite
- trouble sleeping
- sexual side effects
- menstrual cramps
- problems passing urine
Other information for children, teenagers, and
- Erections that won't go away (priapism) have occurred rarely during
treatment with STRATTERA. If you have an erection that lasts more than 4 hours,
seek medical help right away. Because of the potential for lasting damage,
including the potential inability to have erections, priapism should be
evaluated by a doctor immediately.
- STRATTERA may affect your ability or your child's ability to drive or
operate heavy machinery. Be careful until you know how STRATTERA affects you or
- 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. Call your doctor for
medical advice about side effects. You may report side effects to FDA at
How should I store STRATTERA?
- Store STRATTERA in a safe place at room temperature, 59 to 86°F (15 to
- Keep STRATTERA and all medicines out of the reach of
General information about STRATTERA
Medicines are sometimes prescribed for purposes other than those listed in a
Medication Guide. Do not use STRATTERA for a condition for which it was not
prescribed. Do not give STRATTERA to other people, even if they have the same
condition. It may harm them.
This Medication Guide summarizes the most important information about
STRATTERA. If you would like more information, talk with your doctor. You can
ask your doctor or pharmacist for information about STRATTERA that was written
for healthcare professionals. For more information about STRATTERA call
1-800-Lilly-Rx (1-800-545-5979) or visit www.strattera.com.
What are the ingredients in STRATTERA?
Active ingredient: atomoxetine hydrochloride.
Nardil® is a registered trademark of Pfizer Inc.
Parnate® is a registered trademark of GlaxoSmithKline.
Emsam® is a registered trademark of Somerset
This Medication Guide has been approved by the US Food
and Drug Administration.
Patient Information revised July 29, 2010
Eli Lilly and Company
Indianapolis, IN 46285,
Copyright © 2003, 2010, Eli Lilly and Company. All rights reserved.
PV 5855 AMP Revised: 08/2010Eli Lilly and Company
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