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Atomoxetine is a prescription medication used to treat attention deficit hyperactivity disorder (ADHD) in children and adults. Atomoxetine belongs to a group of drugs called selective norepinepherine reuptake inhibitors, which are thought to work by increasing levels of norepinepherine, a natural chemical in the brain.
CYP2D6 is a protein in your body that is involved in the elimination of atomoxetine and other drugs from your body. Some patients have less of this protein in their bodies, affecting how much of the drug gets eliminated. Levels of CYP2D6 can vary greatly between individuals, and those having less of this protein are known as “poor metabolizers.”
CYP2D6 testing is done to determine whether you are a poor metabolizer. If you are a poor metabolizer, the levels of atomoxetine in your blood can become too high. As a result you may be at an increased risk of having more side effects from atomoxetine.
Your doctor may adjust your dose of atomoxetine if you are a poor metabolizer.
Atomoxetine is a prescription medication used to treat attention deficit hyperactivity disorder (ADHD) in children and adults. Atomoxetine may increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
Atomoxetine may be found in some form under the following brand names:
Atomoxetine is part of the drug class:
Serious side effects have been reported. See “Drug Precautions” section.
Common side effects in children and teenagers include:
Common side effects in adults include:
Other serious side effects include:
Other information for children, teenagers, and adults:
Tell your doctor about all the medicines that you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Atomoxetine and some medicines may interact with each other and cause serious side effects. Your doctor will decide whether atomoxetine can be taken with other medicines.
Especially tell your doctor if you take:
Know the medicines that you take. Keep a list of your medicines with you to show your doctor and pharmacist. Do not start any new medicine while taking atomoxetine without talking to your doctor first.
The following serious side effects have been reported with use of atomoxetine :
1. Suicidal thoughts and actions in children and teenagers (see Black Box Warning). Children and teenagers sometimes think about suicide, and many report trying to kill themselves. Results from atomoxetine 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 has (or there is a family history of):
The chance for suicidal thoughts and actions may be higher:
Prevent suicidal thoughts and action in your child or teenager by:
Watch for the following signs in your child or teenager during atomoxetine treatment:
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. Atomoxetine can cause liver injury in some patients. Call your doctor right away if you have the following signs of liver problems:
Tell your doctor if you have any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you carefully for heart problems before starting atomoxetine.
Your doctor should check your blood pressure and heart rate regularly during treatment with atomoxetine.
Call your doctor right away if you have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking atomoxetine.
4. New mental (psychiatric) problems in children and teenagers.
Call your child or teenager’s doctor right away about any new mental symptoms because adjusting or stopping atomoxetine treatment may need to be considered.
Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of atomoxetine there are no specific foods that you must exclude from your diet when receiving atomoxetine.
Before starting atomoxetine tell your doctor about all health conditions (or a family history of) including if you:
Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding.
Tell your doctor about all the medicines that you take including prescription and nonprescription medicines, vitamins, and herbal supplements.
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if atomoxetine will harm your unborn baby. Atomoxetine has not been studied in pregnant women. Atomoxetine should be used during pregnancy only if clearly needed.
Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if atomoxetine is excreted in human breast milk or if it will harm your nursing baby.
Take atomoxetine exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you.
Acute Treatment: Dosing of children and adolescents up to 70 kg body weight — atomoxetine 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.
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 — atomoxetine 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.
The maximum recommended total daily dose in children and adolescents over 70 kg and adults is 100 mg.
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 atomoxetine 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 atomoxetine 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 atomoxetine for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
If you take too much atomoxetine, call your local Poison Control Center or seek emergency medical attention right away.
WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS
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 atomoxetine 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. Atomoxetine is approved for ADHD in pediatric and adult patients. Atomoxetine is not approved for major depressive disorder.
Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of atomoxetine 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 atomoxetine compared to placebo. The average risk of suicidal ideation in patients receiving atomoxetine was 0.4% (5/1357 patients), compared to none in placebo-treated patients (851 patients). No suicides occurred in these trials.
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