Strattera (Atomoxetine HCl) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 3, 2012

Strattera

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What is attention deficit hyperactivity disorder (ADHD)?

ADHD refers to a chronic biobehavioral disorder that initially manifests in childhood and is characterized by hyperactivity, impulsivity, and/or inattention. Not all of those affected by ADHD manifest all three behavioral categories. These symptoms can lead to difficulty in academic, emotional, and social functioning. The diagnosis is established by satisfying specific criteria and may be associated with other neurological, significant behavioral, and/or developmental/learning disabilities. Therapy may consider the use of medication, behavioral therapy, and adjustments in day-to-day lifestyle activities.

Studies in the United States indicates approximately 8%-10% of children satisfy diagnostic criteria for ADHD. ADHD is, therefore, one of the most common disorders of childhood. ADHD occurs two to four times more commonly in boys than girls (male to female ratio 4:1 for the predominant...

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STRATTERA®
(atomoxetine hydrochloride) Capsules for Oral Use

WARNING

SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS

STRATTERA (atomoxetine hcl) (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 (atomoxetine hcl) 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 (atomoxetine hcl) is approved for ADHD in pediatric and adult patients. STRATTERA (atomoxetine hcl) is not approved for major depressive disorder. Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of STRATTERA (atomoxetine hcl) 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 (atomoxetine hcl) compared to placebo. The average risk of suicidal ideation in patients receiving STRATTERA (atomoxetine hcl) was 0.4% (5/1357 patients), compared to none in placebotreated patients (851 patients). No suicides occurred in these trials [see STRATTERA WARNINGS AND STRATTERA PRECAUTIONS].

DRUG DESCRIPTION

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. The chemical structure is:

STRATTERA® (atomoxetine hydrochloride) Structural Formula Illustration

Atomoxetine HCl is a white to practically white solid, which has a solubility of 27.8 mg/mL in water.

STRATTERA (atomoxetine hcl) 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 following:

FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink.

What are the possible side effects of atomoxetine (Strattera)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking atomoxetine and call your doctor at once if you have a serious side effect such as:

chest pain, shortness of breath, fast or uneven heartbeats;
feeling light-headed or fainting;
unusual thoughts or behavior, aggression, hallucinations (seeing things that are not there);
nausea, stomach pain, low fever, loss of appetite,...

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What are the precautions when taking atomoxetine hcl (Strattera)?

Before taking atomoxetine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: glaucoma (narrow angle).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, heart disease (e.g., high blood pressure, fast/irregular heartbeat, coronary artery disease, cardiomyopathy, structural heart abnormalities, past heart attacks), family history of irregular heartbeat (cardiac sudden death), low...

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Last reviewed on RxList: 4/29/2011
This monograph has been modified to include the generic and brand name in many instances.