at usual doses; patients should have a careful history and physical exam to assess for presence of cardiovascular disease; consider not using atomoxetine in adults with clinically significant cardiac abnormalities Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation Particular care should be taken in using stimulants to treat ADHD patients with comorbid bipolar disorder because of concern for possible induction of mixed/manic episode in such patients; it may not be possible to determine whether a manic or mixed episode that appears during treatment is due to an adverse reaction to the drug or a patient’s underlying bipolar disorder; before initiating treatment, patients should be adequately screened for risk factors for bipolar disorder such as a personal or family history of mania and depression Monitor growth of children ages 7 to 10 years during treatment with stimulants; may need to interrupt therapy in patients not growing or gaining weight as expected Urinary hesitancy or sexual dysfunction may occur Rare instances of priapism reported, sometimes necessitating surgical intervention; typically not reported during initiation but often occurring subsequent to dosage increase; immediate medical attention should be sought for abnormally sustained or frequent and painful erections Drug can be discontinued without being tapered Hypesthesia, paresthesia in children and adolescents, sensory disturbances Rare reports of allergic reactions, including anaphylactic reactions, angioneurotic edema, urticaria, and rash Use with caution in patients with bipolar disorder, history of hypertension, hepatic impairment, existing anxiety disorder, history of urinary retention, or tics related to Tourette disorder May cause psychotic or manic symptoms (eg, hallucinations, delusional thinking, or mania), at usual doses, in patients without a prior history of psychotic illness or mania; if such symptoms occur, consider discontinuing therapy Aggressive behavior Aggressive behavior or hostility is often observed in children and adolescents with ADHD; patients beginning treatment should be monitored for appearance or worsening of aggressive behavior or hostility; there is evidence that therapy may cause the emergence or worsening of aggressive behavior or hostility ADHD and other mental illnesses can be associated with irritability, which can make it difficult to determine if the drug or the underlying psychiatric condition is causing the emergence or worsening of aggressive behavior or hostility in specific patients; if such symptoms occur during treatment, consider a possible causal role of therapy Drug interaction overview MAO-I Contraindicated With other drugs that affect brain monoamine concentrations, there have been reports of serious, sometimes fatal reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma) CYP2D6 inhibitors Reduce dose In extensive metabolizers, CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine) increase atomoxetine steady-state plasma concentrations to exposures similar to poor metabolizers Antihypertensive drugs and pressor agents Use with caution Atomoxetine may increase in blood pressure Albuterol Use caution with patients being treated with systemically-administered (oral or IV) albuterol (or other beta2 agonists) Coadministration of albuterol on the cardiovascular system can be potentiated resulting in increases in heart rate and blood pressure Pregnancy Available published studies use in pregnant females are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes Pregnancy exposure registry Monitors pregnancy outcomes in females exposed to ADHD medications during pregnancy Encourage healthcare providers to register by calling g the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/ Animal data Pregnant rabbits treated with up to 100 mg/kg/day during organogenesis resulted in decreased live fetuses and an increase in early resorptions, as well as slight increases in the incidences of atypical origin of carotid artery and absent subclavian artery; observed at AUC 3 times and 0.4 times the human plasma levels in extensive and poor metabolizers receiving the maximum recommended human dose (MRHD), respectively In rats dosed prior to mating and during organogenesis a decrease in fetal weight (female only) and an increase in the incidence of incomplete ossification of the vertebral arch in fetuses were observed at a dose approximately 5 times the MRHD on a mg/m2 basis Lactation There are no data on presence of atomoxetine or its metabolite in human milk, effects on the breastfed children, or its effects on milk production Present in animal milk; when a drug is present in animal milk, it is likely that the drug will be present in human milkPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Selective inhibition of presynaptic norepinephrine reuptake Absorption Bioavailability: 63-94% Onset: 2-4 wk Peak plasma time: 1-2 hr Distribution Vd: 0.85 L/kg (IV) Protein bound: 98% Vd: 0.85 L/kg Metabolism Metabolized in liver by CYP2D6 Metabolites: 4-Hydroxyatomoxetine (equipotent), N-desmethylatomoxetine (less potent) Elimination Half-life: 5.2 hr Total body clearance: 0.35 L/hr/kg Excretion: Urine (80%), feces (17%) Oral Administration Administer either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening Therapy may be discontinued without being tapered Do not open capsules; must be swallowed whole with aid of liquids; must not be chewed, divided, or crushed Storage Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) BRAND FORM. UNIT PRICE PILL IMAGE Strattera oral- 10 mg capsuleStrattera oral- 40 mg capsuleStrattera oral- 60 mg capsuleStrattera oral- 25 mg capsuleStrattera oral- 80 mg capsuleStrattera oral- 100 mg capsuleStrattera oral- 18 mg capsuleatomoxetine oral- 40 mg capsuleatomoxetine oral- 18 mg capsuleatomoxetine oral- 100 mg capsuleatomoxetine oral- 80 mg capsuleatomoxetine oral- 25 mg capsuleatomoxetine oral- 10 mg capsuleatomoxetine oral- 60 mg capsuleatomoxetine oral- 25 mg capsuleatomoxetine oral- 40 mg capsuleatomoxetine oral- 40 mg capsuleatomoxetine oral- 25 mg capsuleatomoxetine oral- 60 mg capsuleatomoxetine oral- 40 mg capsuleatomoxetine oral- 100 mg capsuleatomoxetine oral- 40 mg capsuleatomoxetine oral- 80 mg capsuleatomoxetine oral- 100 mg capsuleatomoxetine oral- 80 mg capsuleatomoxetine oral- 60 mg capsuleatomoxetine oral- 25 mg capsuleatomoxetine oral- 18 mg capsuleatomoxetine oral- 10 mg capsuleatomoxetine oral- 10 mg capsuleatomoxetine oral- 60 mg capsuleatomoxetine oral- 40 mg capsuleatomoxetine oral- 80 mg capsuleatomoxetine oral- 25 mg capsuleatomoxetine oral- 18 mg capsuleatomoxetine oral- 100 mg capsuleatomoxetine oral- 60 mg capsuleatomoxetine oral- 10 mg capsuleatomoxetine oral- 100 mg capsuleatomoxetine oral- 40 mg capsuleatomoxetine oral- 80 mg capsuleatomoxetine oral- 100 mg capsuleatomoxetine oral- 60 mg capsuleatomoxetine oral- 10 mg capsuleatomoxetine oral- 60 mg capsuleatomoxetine oral- 25 mg capsuleatomoxetine oral- 10 mg capsuleatomoxetine oral- 80 mg capsuleatomoxetine oral- 18 mg capsuleatomoxetine oral- 18 mg capsuleatomoxetine oral- 25 mg capsuleatomoxetine oral- 18 mg capsuleCopyright © 2010 First DataBank, Inc.Print Patient Educationatomoxetine oral ATOMOXETINE - ORAL (A-toe-MOX-e-teen) COMMON BRAND NAME(S): Strattera WARNING: A small number of people (especially children/teenagers) who take atomoxetine for attention-deficit hyperactivity disorder (ADHD) may experience worsening of their condition, other mental/mood symptoms, or suicidal thoughts/attempts. It is very important to talk with the doctor about the risks and benefits of this medication (especially for children/teenagers).Tell the doctor right away if you notice worsening of your condition/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, hallucinations, delusions, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when you first start this medication or when the dose is changed. USES: Atomoxetine is used to treat attention-deficit hyperactivity disorder (ADHD) as part of a total treatment plan, including psychological, social, and other treatments. It may help to increase the ability to pay attention, concentrate, stay focused, and stop fidgeting. It is thought to work by restoring the balance of certain natural substances (neurotransmitters) in the brain. HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using atomoxetine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication with or without food as directed by your doctor, usually 1 to 2 times a day. The first dose is usually taken when you wake up in the morning. If a second dose is prescribed, take it as directed by your doctor, usually in the late afternoon/early evening. Taking this medication late in the day may cause trouble sleeping (insomnia).Swallow the capsules whole. Do not crush, chew, or open the capsules. If the capsule is accidentally opened or broken, avoid contact with the powder and wash away any loose powder as soon as possible with water. If the powder gets in your eyes, flush with plenty of water right away and contact your doctor.The dosage is based on your medical condition, response to treatment, and other drugs you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Do not increase your dose or take this drug more often than directed.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.Tell your doctor if your condition does not improve or if it worsens. SIDE EFFECTS: See also Warning section.Stomach upset, nausea, vomiting, constipation, tiredness, loss of appetite/weight loss, dry mouth, dizziness, drowsiness, trouble sleeping, or decrease in sexual ability/desire may occur. In women, menstrual cramps or missed/irregular periods may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.To lessen the chance of dizziness, get up slowly from a sitting or lying position.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.Tell your doctor right away if you have any serious side effects, including: difficulty urinating, unusually fast/irregular heartbeat, fainting, numbness/tingling.Atomoxetine may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: nausea/vomiting that doesn't stop, loss of appetite, dark urine, stomach/abdominal pain, yellowing eyes/skin.This medication may rarely cause serious problems such as a heart attack or stroke. Get medical help right away if you experience any of the following: chest/jaw/left arm pain, shortness of breath, unusual sweating, weakness on one side of the body, confusion, trouble speaking, sudden vision changes.Rarely, males (including young boys and teens) may have a painful or prolonged erection lasting 4 or more hours while using this medication. Caregivers/parents should also be watchful for this serious side effect in boys. If a painful or prolonged erection occurs, stop using this drug and get medical help right away, or permanent problems could occur. Ask your doctor or pharmacist for more details.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. PRECAUTIONS: Before taking atomoxetine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain adrenal problem (pheochromocytoma), bladder or prostate problems, glaucoma, heart problems (such as irregular