Atomoxetine

Atomoxetine (Strattera) is a non-stimulant prescription medication used to treat attention deficit hyperactivity disorder (ADHD) in adults and children 6 years and older. Atomoxetine is a selective noradrenaline reuptake inhibitor (NRI) that may help improve attention and impulse control by increasing norepinephrine and dopamine levels. Atomoxetine is usually used together with psychological, educational, and social measures.

Atomoxetine is not a controlled substance.

Strattera, the original brand of atomoxetine, received FDA approval on November 26, 2002, for the treatment of Attention-Deficit/Hyperactivity Disorder. The brand Strattera has been discontinued, but generic atomoxetine is available.

Atoncy oral solution is FDA-approved for the treatment of ADHD in adults and pediatric patients 6 years and older.

Atomoxetine has not been studied in children less than 6 years old.

Take atomoxetine exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Take the medicine at the same time each day, with a full glass of water.

Atomoxetine is usually taken once daily in the morning or two times per day in the morning and late afternoon. Follow your doctor's instructions.

You may take this medicine with or without food.

Do not crush, chew, break, or open a capsule. Swallow the capsule whole. Tell your doctor if you have trouble swallowing the capsules.

Atomoxetine solution (Atoncy) should be taken by mouth. Solution should be measured using the oral dosing syringe and bottle adapter that comes with this medicine.

Use atomoxetine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not use a capsule that has been opened or accidentally broken. The medicine from inside the capsule can be dangerous if it gets in your eyes. If this occurs, rinse your eyes with water. Ask your doctor or pharmacist how to safely handle and dispose of a broken capsule.

When stopping atomoxetine, no gradual dose reduction (taper) is needed.

While taking atomoxetine, your doctor will need to check your progress at regular visits. Your heart rate, blood pressure, height, and weight may also need to be checked often.

Atomoxetine has a boxed warning for an increased risk of suicidal thoughts and behavior in children and adolescents 6 years of age and older. A boxed warning is the strongest safety-related warning issued by the FDA. In short-term studies, this increased risk was seen in pediatric patients but was not seen in adults treated for ADHD.

All pediatric patients should be monitored and observed closely for suicidal thoughts and behavior, clinical worsening, or unusual changes in behavior, especially during the first few months of treatment and when the dose is changed. Consider stopping atomoxetine in patients who develop these symptoms. See the full prescribing information for more details.

You should not use this medicine if you have narrow-angle glaucoma, an adrenal gland tumor (pheochromocytoma) or a history of one, or severe heart or blood vessel problems that could get worse if your blood pressure or heart rate increases.

Do not use atomoxetine if you have taken an MAO inhibitor in the past 14 days, including such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Before starting atomoxetine, your doctor should check you or your child for a personal or family history of bipolar disorder, mania, or hypomania. Atomoxetine may cause new or worsening psychosis (unusual thoughts or behavior) or trigger manic symptoms, especially if you have a history of depression, mental illness, or bipolar disorder.

Atomoxetine has caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.

Some young people have thoughts about suicide when they first start taking this medicine, or whenever the dose is changed. Stay alert to changes in your mood or symptoms, especially if you have ever had suicidal thoughts.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

You should not use this medicine if you

• are allergic to the active ingredient atomoxetine, any of the inactive ingredients
• severe heart or blood vessel problems
• narrow-angle glaucoma
• are taking or have stopped taking within the past 14 days a medicine called a monoamine oxidase inhibitor (MAOI)
• have pheochromocytoma or a history of pheochromocytoma (a tumor of the adrenal gland).

This medicine has caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

• heart problems or a congenital heart defect;
• high blood pressure; or
• a family history of heart disease or sudden death.

To make sure this medicine is safe for you, tell your doctor if you or anyone in your family has ever had:

• depression, mental illness, bipolar disorder, psychosis;
• suicidal thoughts or actions;
• low blood pressure; or
• liver disease.

Some young people have thoughts about suicide when first taking this medicine, or whenever the dose is changed. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Pregnancy

It is not known whether atomoxetine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant before taking this medicine. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medicines, including atomoxetine, during pregnancy. You can register by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388.

Breastfeeding

It may not be safe to breastfeed while using atomoxetine. Ask your doctor about any risks.

Common atomoxetine side effects

Common atomoxetine side effects may include nausea, vomiting, upset stomach, constipation, dry mouth, loss of appetite, mood changes, feeling tired, dizziness, urination problems, or impotence, which is trouble having an erection.

Serious atomoxetine side effects

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

Report any new or worsening symptoms to your doctor, such as anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

This medicine can affect children's growth. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Other serious atomoxetine side effects. Call your doctor at once if you have:

• signs of heart problems - chest pain, trouble breathing, feeling like you might pass out;
• signs of psychosis - hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;
• liver problems - stomach pain (upper right side), itching, flu-like symptoms, dark urine, jaundice (yellowing of the skin or eyes);
• painful or difficult urination; or
• erection is painful or lasts longer than 4 hours (this is a rare side effect).

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 the FDA at 1-800-FDA-1088.

Usual Adult Atomoxetine Dose for Attention Deficit Disorder

Initial Dose: 40 mg/day orally.Maintenance Dose: Increase dose to 80 mg/day orally after a minimum of 3 days at the initial dose.Maximum Dose: After 2 to 4 additional weeks, the dose may be increased up to 100 mg/day in patients who have not achieved an optimal response.Comments: Take a dose once a day in the morning OR as evenly divided doses in the morning and late afternoon/early evening.

Usual Pediatric Atomoxetine Dose for Attention Deficit Disorder

70 kg or Less:Initial Dose: 0.5 mg/kg/day orally.Maintenance dose: Increase dose to 1.2 mg/kg/day after a minimum of 3 days at the initial dose.Maximum dose: 1.4 mg/kg/day or 100 mg/day, whichever is less.Over 70 kg:Initial Dose: 40 mg/day orally.Maintenance dose: Increase dose to 80 mg/day after a minimum of 3 days at the initial dose.Maximum dose: After 2 to 4 additional weeks, the dose may be increased up to 100 mg/day in patients who have not achieved an optimal response.

Atoncy solution dose:

Comments: Take a dose once a day in the morning OR as evenly divided doses in the morning and late afternoon/early evening.

Note: Dosing adjustment may be required in patients with hepatic impairment, strong CYP2D6 Inhibitors, and patients who are known to be CYP2D6-poor metabolizers.For more detailed Strattera dosing information, click on the link below.

Dose adjustments

In patients with moderate hepatic impairment (Child-Pugh class B), the initial and target dose should be reduced to 50% of the usual dose. In patients with severe hepatic impairment (Child-Pugh class C), the initial and target dose should be reduced to 25% of the usual dose. No adjustment is needed for mild hepatic impairment (Child-Pugh class A).

For patients who are CYP2D6 poor metabolizers, or who take a strong CYP2D6 inhibitor, a longer titration interval of 4 weeks is recommended before increasing the dose if ADHD symptoms have not improved and the starting dose is well tolerated. Genetic testing to determine CYP2D6 metabolizer status may be considered.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up for the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include drowsiness, dizziness, stomach problems, tremors, fast heartbeat, dry mouth, or unusual behavior. Seizures have been reported in some cases. Because atomoxetine is highly protein-bound, dialysis is not likely to help treat an overdose.

Avoid using or handling an open or broken capsule. If the powder from inside the capsule gets in your eyes, rinse them with water right away and call your doctor.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• an antidepressant;
• asthma medication;
• blood pressure medicine; or
• a cold or allergy medicine that contains a decongestant such as pseudoephedrine or phenylephrine.

This list is not complete. Other drugs, including prescription and over-the-counter medicines, vitamins, and herbal products, may interact with atomoxetine. Not all possible interactions are listed in this medication guide.

Store in a safe place at room temperature, 59 to 86°F (15 to 30°C). Throw away any unused atomoxetine oral solution 45 days after first opening the bottle.

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