WHAT IS STRATTERA?

Strattera (atomoxetine) affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Strattera is used to treat attention deficit hyperactivity disorder (ADHD).Strattera may also be used for purposes not listed in this medication guide.

Important information

You should not use Strattera if you have narrow-angle glaucoma, an adrenal gland tumor, heart disease or coronary artery disease, or moderate to severe high blood pressure.

Do not use Strattera if you have taken a MAO inhibitor in the past 14 days, including isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Strattera may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder.

Strattera 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.

Before taking this medicine

Do not use Strattera 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 atomoxetine, or if you have:

• severe heart or blood vessel problems;
• narrow-angle glaucoma; or
• pheochromocytoma (tumor of the adrenal gland).

Strattera 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 Strattera, or whenever the dose is changed. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant before taking Strattera.

It is not known whether atomoxetine passes into breast milk or if it could affect a nursing baby. Tell your doctor if you are breast-feeding a baby while taking Strattera.

Strattera is not FDA-approved for use by anyone younger than 6 years old.

How should I take Strattera?

Take Strattera 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.

Strattera 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 Strattera capsule. Swallow the capsule whole. Tell your doctor if you have trouble swallowing the capsules.

Use Strattera 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.

While taking Strattera, 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.

Store at room temperature away from moisture and heat.

Strattera dosing information

Usual Adult 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 dose once a day in the morning OR as evenly divided doses in the morning and late afternoon/early evening.

Use: Treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Usual Pediatric 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.

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

Use: Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients age 6 and older.

What happens if I miss a dose?

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 the missed dose.

What happens if I overdose?

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

Overdose symptoms may include drowsiness, dizziness, stomach problems, tremors, or unusual behavior.

What should I avoid while taking Strattera?

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

Strattera may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Strattera side effects

Get emergency medical help if you have signs of an allergic reaction to Strattera: hives; difficult breathing; 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.

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

Stop using this medicine and 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).

Common Strattera side effects may include:

• nausea, vomiting, upset stomach, constipation;
• dry mouth, loss of appetite;
• mood changes, insomnia, feeling tired;
• dizziness;
• increased sweating;
• urination problems; or
• impotence, trouble having an erection.