Pronunciation:

a-toe-MOX-e-teen

Brand Names:

• Strattera

Dosage Forms:

• Capsule

Warnings:

Suicidal Ideation in Children and AdolescentsAtomoxetine 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. Comorbidities 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 .

Classifications:

Therapeutic—

Central Nervous System Agent

Pharmacologic—

Norepinephrine Reuptake Inhibitor

Uses of This Medicine:

Atomoxetine is used to treat attention-deficit hyperactivity disorder (ADHD) in children, teenagers, and adults. It belongs to the group of medicines called selective norepinephrine reuptake inhibitors (SNRIs).

Atomoxetine works in the brain to increase attention and decrease restlessness in people who are hyperactive, have problems with concentration, or are easily distracted. This medicine may be used as part of a treatment program that includes social, educational, and psychologic treatment.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of atomoxetine in children younger than 6 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies on the relationship of age to the effects of atomoxetine have not been performed in the geriatric population. Safety and efficacy have not been established.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Isocarboxazid
• Linezolid
• Methylene Blue
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abiraterone Acetate
• Adagrasib
• Albuterol
• Bupropion
• Desvenlafaxine
• Donepezil
• Duloxetine
• Escitalopram
• Fedratinib
• Fluoxetine
• Givosiran
• Levoketoconazole
• Methotrexate
• Panobinostat
• Paroxetine
• Tocilizumab
• Venlafaxine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amitriptyline
• Amoxapine
• Clomipramine
• Desipramine
• Dibenzepin
• Dothiepin
• Imipramine
• Lofepramine
• Nortriptyline
• Opipramol
• Protriptyline
• Trimipramine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bipolar disorder (mood disorder), or family history of or
• Blood vessel problems or
• Depression, or family history of or
• Heart disease (eg, cardiomyopathy) or
• Heart rhythm problems (eg, tachycardia) or
• Hypertension (high blood pressure) or
• Hypotension (low blood pressure) or
• Mental illness, or family history of or
• Problems with urination or
• Priapism (painful or prolonged erection of the penis)—Use with caution. May make these conditions worse.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Glaucoma, narrow angle or
• Heart disease, severe or
• Pheochromocytoma (an adrenal problem), or history of—Should not be used in patients with these conditions.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more or less of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

If you or your child think this medicine is not working properly after you have taken it for several weeks, do not increase the dose. Check with your doctor.

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Swallow the capsule whole. Do not crush, break, chew, or open it. You may take this medicine with or without food.

Avoid touching a broken or opened capsule. Wash your hands with water right away if you do touch an opened capsule. If this medicine comes in contact with your eyes, rinse them with water and call your doctor right away.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For attention-deficit hyperactivity disorder (ADHD):
    • Adults and children 6 years of age and older weighing over 70 kilograms (kg)—At first, 40 milligrams (mg) once a day. The dose is increased after a minimum of 3 days to a total daily dose of 80 mg as a single dose in the morning or divided in 2 doses (morning and late afternoon). Your doctor may adjust your dose as needed. However, the dose is usually not more than 100 mg per day.
    • Children 6 years of age and older weighing less than 70 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. At first, 0.5 milligram (mg) per kilogram (kg) of body weight once a day. The dose is increased after a minimum of 3 days to a total daily dose of 1.2 mg/kg as a single dose in the morning or divided in 2 doses (morning and late afternoon). Your doctor may adjust your dose as needed. However, the dose is usually not more than 1.4 mg/kg per day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check you or your child's progress at regular visits to make sure this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

This medicine may make you more drowsy, dizzy, less alert, or lightheaded than normal. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert. Dizziness, lightheadedness, or fainting may also occur when you get up suddenly from a lying or sitting position. Getting up slowly or lying down for awhile may help.

Do not take atomoxetine with or within 14 days of taking a drug with monoamine oxidase (MAO) inhibitor activity (eg, isocarboxazid [Marplan®], phenelzine [Nardil®], procarbazine [Matulane®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]). If you do, you may develop serious side effects.

This medicine may cause serious allergic reactions, including anaphylaxis, angioneurotic edema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, puffiness or swelling of the eyelids or around the eyes, face, lips or tongue, trouble breathing, or unusual tiredness or weakness after you take this medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Atomoxetine may cause serious heart or blood vessel problems. This may be more likely in patients who have a family history of heart disease. Check with your doctor right away if you or your child have chest pain, trouble breathing, or fainting while taking this medicine.

You will also need to have your blood pressure and heart rate measured before starting this medicine and while you are using it. If you notice any change in your blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. These symptoms are more likely to occur when you begin taking this medicine or when the dose is increased. Getting up slowly or lying down for awhile may help.

Tell your doctor right away if you, your child, or a caregiver notices any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behavior. Also tell your doctor if you have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly.

This medicine may cause slow growth in children. Your child's doctor will keep track of height and weight.

If you or your child experience a prolonged or painful erection of the penis for more than 4 hours, check with your doctor right away.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Hives, itching, skin rash

irregular heartbeat

itching

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

redness of the skin

Rare

Painful, prolonged erection of your penis

Incidence not known

Dark colored urine

fainting

flu-like symptoms

irregular heartbeat recurrent

loss of bladder control

muscle spasm or jerking of all extremities

paleness or cold feeling in the fingertips and toes

pelvic pain in male

right upper stomach pain or tenderness

seizures

sudden loss of consciousness

tingling or pain in the fingers or toes when exposed to cold

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

belching

bleeding between periods

change in amount of bleeding during periods

change in pattern of monthly periods

chest tightness

cough

decrease in the frequency of urination

decrease in urine amount

decreased appetite

decreased interest in sexual intercourse

difficulty having a bowel movement (stool)

difficulty in passing urine (dribbling)

dizziness

dry mouth

fever

headache

heartburn

heavy bleeding

inability to have or keep an erection

indigestion

irritability

loss in sexual ability, desire, drive, or performance

nausea

pain or tenderness around the eyes and cheekbones

painful urination

sleepiness or unusual drowsiness

stomach discomfort, upset, cramps, or pain

stuffy or runny nose

trouble breathing

trouble sleeping

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

unusual stopping of menstrual bleeding

vomiting

Less common

Abnormal dreams

abnormal orgasm

back pain

blistering, crusting, irritation, itching, or reddening of the skin

bloated or full feeling

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

change in hearing

change or problem with discharge of semen

chills

cold sweats

confusion

cough

cracked, dry, or scaly skin

crying

decreased weight

diarrhea

difficulty with moving

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

ear drainage

earache or pain in the ear

excess air or gas in the stomach or intestines

feeling of warmth, redness of the face, neck, arms, and occasionally, upper chest

feeling unusually cold

frequent urination

general feeling of discomfort or illness

groin pain

increased or sudden sweating

joint pain

loss of appetite

mood swings

muscle aches, cramping, pains, or stiffness

pain or burning with urination

passing gas

shivering

sinus headache

sleep disorder

swelling of the skin

swollen joints

swollen, tender prostate

Incidence not known

Loss or thinning of the hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.