Strattera

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,...

Read All Potential Side Effects and See Pictures of Strattera »

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...

Read All Potential Precautions of Strattera »


Strattera Consumer (continued)

SIDE EFFECTS: See also Warning section.

Stomach upset, nausea, vomiting, constipation, fatigue, loss of appetite, dry mouth, dizziness, trouble sleeping, menstrual cycle changes, or mood changes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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

Tell your doctor immediately if any of these unlikely but serious side effects occur: weight loss, decrease in sexual ability/desire (e.g., impotence, ejaculation problems), difficulty urinating, unusually fast/irregular heartbeat, fainting, numbness/tingling.

This medication may rarely cause serious problems such as heart attacks or stroke. Seek immediate medical attention if you experience any of the following: chest/jaw/left arm pain, sudden severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (e.g., double vision, loss of vision).

Atomoxetine has very rarely caused very serious liver problems. If you notice any of the following highly unlikely but very serious side effects, seek immediate medical attention: yellowing of skin or eyes, dark urine, severe stomach pain, "flu-like" symptoms (e.g., fever, chills, unexplained fatigue). If you experience any of these symptoms ask your doctor about whether or not you should ever take atomoxetine again.

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, seek immediate medical attention, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

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

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 blood pressure, strokes, bladder or prostate problems, certain adrenal problem (pheochromocytoma), mental/mood disorders (such as bipolar disorder, depression, suicide attempts, family history of suicide).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To minimize dizziness or fainting, get up slowly from a lying or seated position (especially when you first start using this drug or if your doctor changes your dose).

Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially dizziness.

Caution is advised when using this drug in children because it may have a minor effect on weight, growth rate, and final height. Monitor your child's weight and height and consult your doctor or pharmacist for more details.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Strattera Patient Information Including Side Effects

Brand Names: Strattera

Generic Name: atomoxetine (Pronunciation: AT oh mox e teen)

  • What is atomoxetine (Strattera)?
  • What are the possible side effects of atomoxetine (Strattera)?
  • What is the most important information I should know about atomoxetine (Strattera)?
  • What should I discuss with my healthcare provider before taking atomoxetine (Strattera)?
  • How should I take atomoxetine (Strattera)?
  • What happens if I miss a dose (Strattera)?
  • What happens if I overdose (Strattera)?
  • What should I avoid while taking atomoxetine (Strattera)?
  • What other drugs will affect atomoxetine (Strattera)?
  • Where can I get more information?

What is atomoxetine (Strattera)?

Atomoxetine affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Atomoxetine is used to treat attention deficit hyperactivity disorder (ADHD).

Atomoxetine may also be used for other purposes not listed in this medication guide.

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, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure); or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • feeling irritable;
  • feeling dizzy or drowsy;
  • constipation;
  • cough, dry mouth;
  • skin rash or itching;
  • sleep problems (insomnia);
  • increased menstrual cramps; or
  • impotence, loss of interest in sex, or trouble having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about atomoxetine (Strattera)?

Do not use atomoxetine if you have used an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam) within the past 14 days. Serious, life-threatening side effects can occur if you use atomoxetine before the MAO inhibitor has cleared from your body.

Do not use this medication if you are allergic to atomoxetine, or if you have glaucoma.

Some ADHD medicines have caused sudden death in children and adolescents with serious heart problems or congenital heart defects. Tell your doctor if you have any heart problems.

You may have suicidal thoughts or behavior while taking atomoxetine. Watch for symptoms of depression, unusual behavior, or thoughts of hurting yourself. Your doctor may need to check you at regular visits while you are taking this medication.

In addition to you watching for changes in your mood or behavior, your family or caregivers should be alert to changes in your mood or symptoms.

Do not use an open or broken capsule. If the medicine from inside the capsule gets into your eyes, rinse thoroughly with water and call your doctor.

Atomoxetine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

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