Strattera Drug Description

STRATTERA® (atomoxetine HCl) is a selective norepinephrine reuptakeinhibitor. 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 Tadagra molecular formula is C₁₇H₂₁NO•HCl, which corresponds to a molecular weight of 291.82. The chemical structure is:

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.

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.