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Atomoxetine is a non-stimulant medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children 6 years of age and over, adolescents, and adults. It works by increasing the amount of noradrenaline, a natural chemical in the brain, which may help improve attention and decrease impulsiveness and hyperactivity. Unlike many other ADHD medications, atomoxetine is not a stimulant and is not addictive.
The usual starting dose for adults and children weighing over 70 kg is 40 mg once daily. After a minimum of 7 days, the dose is increased to a target of approximately 80 mg daily, taken as a single dose or divided into two doses. The maximum recommended daily dose is 100 mg. For children weighing up to 70 kg, dosing is based on body weight.
The administration form is capsules containing 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine hydrochloride. The capsules should not be opened, as the content can irritate the eyes.
Atomoxetine does not work overnight. It may take several weeks of steady dosing before you notice the full benefit for ADHD symptoms. Do not stop taking it just because you do not feel an effect in the first few days.
Alcohol should be avoided during treatment. It can increase the risk of drowsiness and dizziness, and it may worsen some of the side effects of the medication.
The most common side effects in children and adolescents are headache, abdominal pain, and decreased appetite. In adults, common side effects include constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction, and urinary hesitancy.
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Common Use Atomoxetine

Atomoxetine is a selective norepinephrine reuptake inhibitor. It works by blocking the reuptake of norepinephrine in the brain, which increases its availability in the spaces between nerve cells. This is thought to improve attention and reduce impulsivity in people with ADHD. Health Canada has approved atomoxetine for the treatment of ADHD in children 6 years of age and older, adolescents, and adults. It is not a stimulant and is not a controlled substance. Atomoxetine is often considered when stimulant medications are not effective, not tolerated, or when there is a concern about substance abuse. The Canadian ADHD Resource Alliance (CADDRA) recommends atomoxetine as a second-line treatment because clinical experience and studies suggest a lower efficacy rate in ADHD compared to psychostimulants. It is also used in some cases for treatment-resistant depression, although this is an off-label use. Atomoxetine is not approved for use in children under 6 years of age.

Basic Atomoxetine Information

• INN (International Nonproprietary Name): Atomoxetine hydrochloride
• Brand names available in Canada: Strattera® (original brand, marketed by Eli Lilly Canada Inc.); generics include Apo-Atomoxetine (Apotex Inc.), Auro-Atomoxetine (Auro Pharma Inc.), Jamp Atomoxetine (Jamp Pharma Corporation), Novo-Atomoxetine (Teva Canada Limited), pms-Atomoxetine (Pharmascience Inc.), Sanis Atomoxetine (Sanis Health Inc.), Sivem Atomoxetine (Sivem Pharmaceuticals ULC), and Teva-Atomoxetine (Teva Canada Limited)
• ATC Code: N06BA09
• Forms and dosages: Capsules – 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, and 100 mg
• Manufacturers in Canada: Eli Lilly Canada Inc. (Strattera), Apotex Inc. (Apo-Atomoxetine), Auro Pharma Inc. (Auro-Atomoxetine), Jamp Pharma Corporation (Jamp Atomoxetine), Teva Canada Limited (Novo-Atomoxetine, Teva-Atomoxetine), Pharmascience Inc. (pms-Atomoxetine), Sanis Health Inc. (Sanis Atomoxetine), Sivem Pharmaceuticals ULC (Sivem Atomoxetine), and Angita Pharma Inc. (AG-Atomoxetine)
• Registration status in Canada: Approved by Health Canada. Strattera 10 mg is listed under DIN 02262800, 18 mg under DIN 02262819, 25 mg under DIN 02262827, and 40 mg under DIN 02262835. Generic atomoxetine is available under multiple DINs, including Apo-Atomoxetine 10 mg (DIN 02318024), Auro-Atomoxetine 25 mg (DIN 02471507), Jamp Atomoxetine 10 mg (DIN 02506807), and AG-Atomoxetine 18 mg (DIN 02508826)
• OTC / Rx classification: Prescription only (Rx) – not legally sold over-the-counter in Canadian pharmacies

Dosage & Direction

Take Atomoxetine exactly as your doctor prescribes. The dose depends on your body weight and how you respond to treatment. For adults and children weighing more than 70 kg, the recommended starting dose is 40 mg once daily. After a minimum of 7 days, your doctor will increase the dose to a target of approximately 80 mg daily. This can be taken as a single dose in the morning or as evenly divided doses in the morning and late afternoon or early evening. The maximum recommended daily dose is 100 mg. For children weighing up to 70 kg, the starting dose is approximately 0.5 mg/kg per day, and the target dose is about 1.2 mg/kg per day. Your child's doctor will calculate the exact dose. Atomoxetine can be taken with or without food. If it upsets your stomach, taking it with a meal may help. Do not open, crush, or chew the capsules. Swallow them whole with water. If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed one and continue with your regular schedule. Do not take two doses at once to make up for a missed one. Do not stop taking Atomoxetine suddenly without talking to your doctor. Your ADHD symptoms may return if you stop the medication.

Precautions

Atomoxetine can cause serious liver injury. This is rare, but it can happen. If you develop jaundice (yellowing of the skin or eyes), dark urine, or laboratory evidence of liver injury, the medication should be discontinued and not restarted. Contact your doctor right away if you notice any of these symptoms. Atomoxetine can increase heart rate and blood pressure. Health Canada has issued safety information about this risk. A Dear Healthcare Professional Letter from Eli Lilly Canada Inc. noted that in clinical trials, approximately 25% of pediatric patients experienced an increase in blood pressure of 10 mmHg, and 33% had a heart rate increase of 10 bpm. Your doctor should check your blood pressure and pulse before you start treatment and periodically during treatment, especially after any dose adjustment. This is particularly important if you have a history of high blood pressure, heart disease, or other cardiovascular conditions. Atomoxetine is contraindicated in patients with symptomatic cardiovascular diseases, moderate to severe hypertension, or severe cardiovascular disorders. The medication can cause drowsiness, dizziness, and fatigue. Do not drive or operate hazardous machinery until you know how Atomoxetine affects you. Atomoxetine can cause urinary hesitation or retention. This is more likely in men with an enlarged prostate. Tell your doctor if you have difficulty urinating. The medication can cause priapism, a prolonged and painful erection that requires emergency medical attention. If you experience an erection lasting more than 4 hours, seek immediate medical help. Atomoxetine can cause allergic reactions, including rash, swelling of the face, lips, tongue, or throat, and difficulty breathing. If you experience any of these, stop the medication and seek emergency care. Atomoxetine can cause a condition called serotonin syndrome when taken with other serotonergic drugs. Symptoms include agitation, confusion, rapid heartbeat, muscle rigidity, and sweating. This is a medical emergency. The medication can cause orthostatic hypotension, a drop in blood pressure when standing up, leading to dizziness and fainting. Move slowly when getting up from a sitting or lying position. Atomoxetine should be used with caution in patients with a history of seizures or with conditions that increase the risk of seizures. Tell your doctor if you have a seizure disorder. Atomoxetine is not recommended during pregnancy unless the benefit clearly outweighs the risk to the fetus. It is not known whether atomoxetine passes into human breast milk. Because data are lacking, the use of atomoxetine during breastfeeding should be avoided. Women who could become pregnant should use effective contraception. Atomoxetine has not been studied in children under 6 years of age and should not be used in that age group. Older adults may be more sensitive to the side effects of Atomoxetine and may need lower doses. Tell your doctor if you have kidney or liver problems, as dose adjustments may be needed.

Contraindications

Do not take Atomoxetine if you have had an allergic reaction to atomoxetine or any of the inactive ingredients in the capsule. Atomoxetine is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs), including phenelzine, tranylcypromine, and moclobemide. Do not start an MAOI within 14 days of stopping Atomoxetine, and do not start Atomoxetine within 14 days of stopping an MAOI. This combination can cause a life-threatening condition called serotonin syndrome. Atomoxetine is contraindicated in patients with narrow-angle glaucoma, because its anticholinergic effects can raise intraocular pressure. Do not take Atomoxetine if you have pheochromocytoma, a tumour of the adrenal gland, because it can trigger a hypertensive crisis. The medication is contraindicated in patients with severe cardiovascular disorders, including severe hypertension, because it can increase blood pressure and heart rate. Atomoxetine should not be used during pregnancy or breastfeeding unless specifically directed by a doctor. Do not take Atomoxetine if you have a history of severe liver disease. If you are unsure whether any of these apply to you, check with your doctor or pharmacist.

Possible Side Effects

In clinical trials with children, the most common side effects were headache (about 19%), abdominal pain (about 18%), and decreased appetite (about 16%). In adults, the most common side effects are constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction, and urinary hesitancy. Other common side effects include sleepiness, fatigue, and dizziness, which may impair your ability to drive or operate machinery. Some people experience vomiting, especially during the first month of treatment. These effects are usually mild to moderate and often go away on their own. Serious side effects require immediate medical attention. Severe liver injury can cause jaundice, dark urine, and abdominal pain. Heart problems can cause chest pain, shortness of breath, and fainting. Priapism, a prolonged erection, is a medical emergency. Serotonin syndrome can cause agitation, confusion, rapid heartbeat, and muscle rigidity. Severe allergic reactions can cause rash, swelling, and difficulty breathing. Orthostatic hypotension can cause dizziness and fainting. If you develop any of these serious effects, stop the medication and seek medical help right away. Weight loss and decreased appetite are common, especially in children. Growth should be monitored in children and adolescents during treatment with Atomoxetine.

Drug Interaction

Atomoxetine interacts with several medications. MAO inhibitors are strictly contraindicated and must not be used with Atomoxetine. CYP2D6 inhibitors, such as fluoxetine, paroxetine, quinidine, and terbinafine, can increase atomoxetine exposure by 6 to 8 times and Cmax by 3 to 4 times because atomoxetine is metabolized by CYP2D6. If you take one of these medications, your doctor should start you on a lower dose of Atomoxetine and titrate more slowly. Drugs that prolong the QT interval, such as neuroleptics, moxifloxacin, erythromycin, methadone, phenothiazines, butyrophenones, bupropion, and tramadol, may increase the risk of QT prolongation when taken with atomoxetine. Beta-2 agonists such as salbutamol (albuterol) given by inhalation or systemically can have their cardiovascular effects enhanced by atomoxetine. Caution is advised when using these together. Atomoxetine can interact with other serotonergic drugs, including SSRIs, SNRIs, tricyclic antidepressants, tramadol, and triptans, increasing the risk of serotonin syndrome. Decongestants such as pseudoephedrine or phenylephrine can increase blood pressure and heart rate when taken with Atomoxetine. Tell your doctor and pharmacist about every medication you take, including over-the-counter products, vitamins, and herbal supplements.

Missed Dose

If you miss a dose of Atomoxetine, take it as soon as you remember. If it is almost time for your next dose, skip the missed one and continue with your regular schedule. Do not take two doses at once to make up for a missed one. If you miss several doses in a row, contact your doctor before restarting. Your ADHD symptoms may return if you miss doses, so try to take the medication at the same time each day.

Overdose

Overdose with Atomoxetine can cause severe drowsiness, dizziness, nausea, vomiting, and tremors. In severe cases, it can cause seizures, fast heart rate, high blood pressure, and coma. There is no specific antidote. Treatment is supportive and may include activated charcoal if the overdose was recent, intravenous fluids, and monitoring of vital signs. Contact a poison control centre or go to an emergency department immediately if you or someone else has taken too much. Do not try to manage an overdose at home.

Storage

Store Atomoxetine capsules at room temperature between 20 and 25 degrees Celsius (68 and 77 degrees Fahrenheit). Keep the container tightly closed and protect it from light and moisture. Do not store in the bathroom or near a sink. Keep out of reach of children and pets. Do not use after the expiry date on the label. Dispose of unused medication according to local guidelines. Do not flush Atomoxetine down the toilet or pour it down the sink.

Disclaimer

We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information at the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

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