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Drugs reference index «atomoxetine»

atomoxetine


atomoxetine (Oral route)

a-toe-MOX-e-teen

Oral routeCapsule
  • Suicidal Ideation in Children and Adolescents:
    • Atomoxetine 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. Co-morbidities 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 .

Increased risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Monitor patients closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior. Close observation and communication with the prescriber by families and caregivers is recommended .

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 atomoxetine

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. atomoxetine is used as part of a treatment program that also includes social, educational, and psychologic treatment.

atomoxetine is available only with your doctor's prescription.

Before Using atomoxetine

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 atomoxetine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to atomoxetine 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 for pediatric patients 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.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal 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

Using atomoxetine 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 atomoxetine 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 atomoxetine 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
  • Doxepin
  • 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 atomoxetine. 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 or
  • Heart rhythm problems or
  • Hypertension (high blood pressure) or
  • Hypotension (low blood pressure) 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.
  • Glaucoma, narrow angle (eye disease)—Should not be used in patients with this condition.
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of atomoxetine

Take atomoxetine 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 atomoxetine is not working properly after you have taken it for several weeks, do not increase the dose. Instead, check with your doctor.

atomoxetine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Swallow the capsule whole. Do not crush, break, chew, or open it.

Atomoxetine may be taken with or without food.

Avoid touching a broken or opened capsule. Wash your hands that touched an opened capsule with water immediately. If atomoxetine 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 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 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 above 6 years of age 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 above 6 years of age 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 up to 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of atomoxetine, 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 atomoxetine

It is very important that your doctor check you or your child's progress at regular visits to make sure atomoxetine is working properly. Blood tests may be needed to check for unwanted effects.

atomoxetine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to atomoxetine 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 atomoxetine 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.

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.

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

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

Tell 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 atomoxetine.

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 atomoxetine, or when the dose is increased.

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.

atomoxetine may cause slow growth. If your child is using atomoxetine, 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.

atomoxetine 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, 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 from a lying or sitting position suddenly
  • 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.

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  • Atomoxetine MedFacts Consumer Leaflet (Wolters Kluwer)
  • Strattera Prescribing Information (FDA)
  • Strattera Detailed Consumer Information (PDR)
  • Strattera Consumer Overview

See Also...

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