Strattera

Generic Name: atomoxetine (Oral route)

a-toe-MOX-e-teen

Oral route(Capsule)

There is an increased risk of suicidal ideation in children or adolescents. No suicides occurred in clinical trials. Monitor patients started on atomoxetine therapy closely .

Commonly used brand name(s)

In the U.S.

• Strattera

Available Dosage Forms:

• Capsule

Therapeutic Class: Central Nervous System Agent

Pharmacologic Class: Norepinephrine Reuptake Inhibitor

Uses For Strattera

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

Atomoxetine increases attention and decreases restlessness in people who are overactive, cannot concentrate for very long, or are easily distracted. This medicine is used as part of a treatment program that also includes social, educational, and psychologic treatment. Carefully follow your doctor's instructions about all treatment procedures.

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

Before Using Strattera

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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of atomoxetine in children. However, safety and efficacy have not been established in children younger than 6 years of age.

Geriatric

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.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

Interactions with 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.

• Brofaromine


• Clorgyline


• Furazolidone


• Iproniazid


• Isocarboxazid


• Lazabemide


• Linezolid


• Moclobemide


• Nialamide


• Pargyline


• Phenelzine


• Procarbazine


• Rasagiline


• Selegiline


• Toloxatone


• 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.

• Albuterol

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

Interactions with Food/Tobacco/Alcohol

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


• Heart disease (e.g., cardiomyopathy) or


• Heart rhythm problems or


• Hypertension (high blood pressure) or


• Hypotension (low blood pressure) or


• Mania or


• Problems with urination or


• Priapism (painful or prolonged erection of the penis) or


• Psychotic disorder (mental illness) or


• Tachycardia (rapid heart rate)—Use with caution. May make these conditions worse.

• Genetic conditions (e.g., CYP2D6 poor metabolizers) or


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

• Glaucoma, narrow angle (eye disease) or


• Pheochromocytoma (an adrenal problem), or history of—Should not be used in patients with these conditions.

Proper Use of Strattera

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. Instead, 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 that touched an opened capsule with water immediately. If this medicine comes in contact with your eyes or your child's eyes, rinse it 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, teenagers, and children 6 years of age and older and weighing over 70 kilograms (kg)—At first, 40 milligrams (mg) once a day, increased after a minimum of 3 days to a total daily dose of 80 mg taken as a single daily dose in the morning or divided in small doses in the morning and late afternoon (or early evening). Your doctor may adjust your dose as needed. However, the dose is usually not more than 100 mg.
    
    
    • Teenagers and children 6 years of age and older and weighing up to 70 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The starting dose is 0.5 milligram (mg) per kilogram (kg) of body weight once a day, and increased after a minimum of 3 days to a total daily dose of 1.2 mg per kg taken as a single daily dose in the morning or divided in small doses in the morning and late afternoon (or early evening). Your doctor may adjust your dose as needed.
    
    
    • 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 Strattera

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. Blood tests may be needed to check for unwanted effects.

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. 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 are not alert.

You should not use this medicine if you have used a drug for depression called a MAO inhibitor (MAOI), such as Eldepryl®, Marplan®, Nardil®, or Parnate®, within the past 14 days. Also after you or your child stop using atomoxetine, do not use an MAO inhibitor for at least 14 days.

Tell your doctor about all the medicines you or your child take or plan to take, including prescription and nonprescription (over-the-counter) medicines, dietary supplements, and herbal remedies.

This medicine may cause serious allergic reactions including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have itching; hives; hoarseness; shortness of breath; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth after you take this medicine.

Stop using this medicine and check with your doctor right away if you or your child get a skin rash, dark urine, persistent loss of appetite, yellow eyes or skin, flu-like symptoms or right upper belly pain or tenderness. These could be symptoms of a serious liver problem.

Do not give atomoxetine to other people, even if they have the same symptoms that you or your child have.

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, shortness of breath, or fainting while taking this medicine.

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

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

This medicine may cause slow growth. If your child is using this medicine, the doctor will need to keep track of your child's height and weight to make sure that your child is growing properly.

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.

Strattera Side Effects

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 or welts


• irregular heartbeat


• itching


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


• redness of the skin


• skin rash

Rare

• Painful, prolonged erection of your penis

Incidence not known

• Convulsions


• dark colored urine


• fainting


• flu-like symptoms


• loss of bladder control


• muscle spasm or jerking of all extremities


• pelvic pain in male


• right upper belly pain or tenderness


• sudden loss of consciousness


• 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


• cough


• decrease in 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


• shortness of breath or troubled breathing


• sleepiness or unusual drowsiness


• sleeplessness


• stomach discomfort, upset, cramps, or pain


• stuffy or runny nose


• tightness of the chest or wheezing


• trouble sleeping


• unable to sleep


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


• unusual stopping of menstrual bleeding


• unusual tiredness or weakness


• 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

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.

See also: Strattera side effects (in more detail)

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More Strattera resources

• Strattera Side Effects (in more detail)
• Strattera Use in Pregnancy & Breastfeeding
• Drug Images
• Strattera Drug Interactions
• Strattera Support Group
• 92 Reviews for Strattera - Add your own review/rating

• Strattera Prescribing Information (FDA)


• Strattera Consumer Overview


• Strattera Monograph (AHFS DI)


• Strattera MedFacts Consumer Leaflet (Wolters Kluwer)


• Atomoxetine Prescribing Information (FDA)

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