In the U.S.—

• Attention deficit hyperactivity disorder therapy agent

Atomoxetine (at-OH-mox-e-teen ) belongs to the group of medicines called selective norepinephrine reuptake inhibitor. It is used to treat children, adolescents, 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, and are emotionally unstable. This medicine is used as part of a total treatment program that also includes social, educational, and psychological treatment.

This medicine is available only with your doctor's prescription, in the following dosage forms:

Oral
• Capsules (U.S.)

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

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to atomoxetine. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies with atomoxetine have not been done in pregnant women. Some unwanted effects have been reported in animal studies, but the risk to human babies is not clear. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether atomoxetine passes into human breast milk. This medicine does pass into the milk of rats. If you want to breast feed be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—Safety and effectiveness has not been established in pediatric patients less than 6 years of age

Older adults—Atomoxetine has not been studied specifically in older people. Therefore, it is not known whether it causes different side effects or problems in the elderly than it does in younger adults.

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 atomoxetine, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Albuterol (e.g., Ventolin)—May increase your heart rate and your blood pressure

• CYP2D6 inhibitors such as
• Fluoxetine (e.g., Prozac) or
• Paroxetine (e.g., Paxil) or
• Quinidine (e.g., Quinadex)—Your doctor may want to reduce the amount of atomoxetine when you take it any of these medicines.

• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])—You should not take any of these medicines while you are taking atomoxetine or for two weeks after you stop taking atomoxetine; serious side effects could occur

• Vasopressor agents (used to treat low blood pressure)—Use with atomoxetine may increase your blood pressure.

• Blood vessel problems or
• Heart disease or
• Hypertension (high blood pressure) or
• Tachycardia (rapid heart rate)—Atomoxetine may make these conditions worse.

• Glaucoma, narrow angle (eye disease)—Atomoxetine may make this condition worse.

• Liver disease—The dose of atomoxetine may need to be adjusted

Dosing—

The dose of atomoxetine 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 atomoxetine. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules 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 taking atomoxetine

• For oral dosage form (capsules):
  • Attention deficit hyperactivity disorder [ADHD]
    • Adults—Oral, 40 milligrams (mg) once a day; your doctor may want to increase or decrease your dose and change the number of times a day you take your medicine.
    • Children (6 years of age and older)—Oral, to start 0.5 milligrams per kilogram (mg per kg) of body weight once daily; your doctor may want to increase or decrease your dose and change the number of times a day you take your medicine.
    • Children (less 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—

To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check you at regular visits.

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.

Tell your doctor about all the medicines you take or plan to take, including prescription and nonprescription medicines, dietary supplements, and herbal remedies.

Tell your doctor if you are nursing, pregnant, or thinking of becoming pregnant.

Call your doctor right away if you get swelling, hives, or if you develop any symptoms that concern you.

Do not give atomoxetine to other people, even if they have the same symptoms as you have.

Atomoxetine may be taken with or without food.

Atomoxetine may cause your mouth to feel dry. You may use sugarless candy or gum, ice or saliva substitute for relief. Tell you doctor or dentist if dry mouth continues for more than 2 weeks.

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 or rare
  • Hives or welts;  irregular heartbeat ;  itching;  large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs;  redness of skin;  skin rash 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

• More Common
  • Acid or sour stomach;  belching;  bleeding between periods;  change in amount of bleeding during periods;  change in pattern of monthly periods;  cough ;  decreased appetite;  decreased interest in sexual intercourse;  decrease in frequency of urination;  decrease in urine volume;  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;  painful urination;  pain or tenderness around eyes and cheekbones;  shortness of breath or troubled breathing;  sleepiness or unusual drowsiness;  sleeplessness;  stomach discomfort, upset, cramps, or pain;  stuffy or runny nose;  tightness of 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 skin;  bloated, 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, scaly skin;  crying;  decreased weight;  diarrhea;  difficulty in moving;  dizziness, faintness, or lightheadedness when getting up from lying or sitting position;  ear drainage;  earache or pain in ear;  excess air or gas in 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 skin;  swollen joints;  swollen, tender prostate  
  
  

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