Pharmacy Author: Emmanuel Saltiel, Pharm.D.
Medical Editor: Jay Marks, M.D.
GENERIC NAME: atomoxetine
BRAND NAME: Strattera
DRUG CLASS AND MECHANISM: Atomoxetine is an oral drug that is used for treating attention deficit hyperactivity disorder (ADHD). An estimated 15 million Americans have ADHD, and approximately half will require drug therapy to control symptoms. While some children outgrow ADHD, about 60% continue to have symptoms into adulthood. Until recently, drug therapy has consisted almost exclusively of stimulants such as amphetamines and methylphenidate (Ritalin and others). These stimulants are restricted in availability under the Controlled Substances Act because of their potential for abuse. Atomoxetine is the first drug for ADHD that is not a stimulant under the Controlled Substances Act.
Although it is not known precisely how atomoxetine reduces the symptoms of ADHD, scientists believe it works by affecting neurotransmitters in the brain, chemicals that the nerves use for communicating with one another. One neurotransmitter, norepinephrine, is considered important in regulating attention, impulsivity and activity levels, all of which are abnormal in ADHD. Norepinephrine is manufactured by nerves in the brain and then is released from the nerves. The norepinephrine travels to other nerves and attaches to the nerves, causing changes in the way the nerves function. Some of the norepinephrine that is released is reabsorbed by the nerves that produce it thereby reducing the amount of epinephrine that is available to travel to other nerves. Atomoxetine is believed to reduce the reabsorption of epinephrine by nerves. This makes more norepinephrine available to attach to other nerves in the brain. Atomoxetine was approved by the FDA November, 2002.
PRESCRIPTION: Yes
GENERIC AVAILABLE: No
PREPARATIONS: Capsules of 10, 18, 25, 40, and 60 mg strengths.
STORAGE: Atomoxetine capsules should be stored at room temperature, 59-86°F (15-30 °C).
PRESCRIBED FOR: Atomoxetine is used for the treatment of ADHD in children, adolescents and adults.
DOSING: Atomoxetine is taken once or twice daily. It may be taken with or without food. The capsules should never be broken and sprinkled on food. They must be taken whole.
DRUG INTERACTIONS: Atomoxetine should not be taken with a monoamine oxidase inhibitor (MAOI) or within 14 days of stopping an MAOI, e.g., Nardil (phenelzine sulfate) and Parnate (tranylcypromine sulfate).
Fluoxetine (Prozac), paroxetine (Paxil), quinidine, and other medications can block the enzyme in the liver that eliminates atomoxetine from the body. This can increase the amount of atomoxetine in the blood and possibly increase the risk of side effects.
PREGNANCY: In some animal studies (rabbits and rats), very high doses of atomoxetine (6- to 23-fold higher than those that would be used in humans) were associated with lower birth weight and lower fetal survival. No adequate studies have been done in pregnant humans. Therefore, before prescribing atomoxetine to pregnant women, physicians must weight the potential benefits against the potential and unknown risks.
NURSING MOTHERS: Atomoxetine is excreted in the breast milk of animals. Although not similarly studied in humans, it is likely that atomoxetine is excreted in human breast milk as well. The benefits and potential risks of atomoxetine therefore must be weighed before it is prescribed to nursing mothers.
SIDE EFFECTS: The most common side effects of atomoxetine in children and adolescents are upset stomach, decreased appetite, nausea and vomiting, dizziness, tiredness, and mood swings. Some children may experience a loss of weight. The most common side effects in adults are problems sleeping, dry mouth, decreased appetite, upset stomach, nausea or vomiting, dizziness, problems urinating and sexual side effects. In rare cases, atomoxetine causes allergic reactions, such as fluid accumulation (edema) or hives, which can be serious.
Additional drug information:
Strattera (atomoxetine hydrochloride) FDA approved labeling at RxList.
http://www.rxlist.com/strattera-drug/article.htm
Last Editorial Review: 1/22/2003 5:47:31 PM
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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