Atomoxetine enhances the function of the prefrontal cortex by blocking norepinephrine transporters, increasing the concentration of norepinephrine in synaptic cleft, and improving patients' attention, impulse control, and activity levels.

1、 Drug name

1. Common name: Atomoxetine

2. Product Name: STRATTERA ®

2、 Indications

Used for treating Attention Deficit/Hyperactivity Disorder (ADHD). Its efficacy has been established in seven clinical trials for outpatient ADHD patients, including four trials for pediatric patients (6-18 years old), two trials for adults, and one trial for pediatric maintenance therapy.

3、 Specifications

Specification: This product is a tablet, 40mg * 70 tablets/box.

4、 Main components

Active ingredient: Atomoxetine hydrochloride.

5、 Usage and dosage

1. Usage: Oral administration, can be taken on an empty stomach or after meals. Capsules should be swallowed whole and should not be chewed, crushed, or opened.

2. Dosage:

Children and adolescents (weight ≤ 70 kg): The initial total daily dose is approximately 0.5 mg/kg. At least 3 days later, it can be increased to the target total daily dose of approximately 1.2 milligrams per kilogram, taken in the morning or twice in the morning and evening. The total daily dose should not exceed 1.4 milligrams per kilogram or 100 milligrams, whichever is lower.

Children and adolescents (weight>70 kg) and adults: The initial total daily dose is 40 milligrams. At least 3 days later, it can be increased to the target total daily dose of about 80 milligrams, taken in the morning or twice in the morning and evening. After 2-4 weeks, if the optimal therapeutic effect is not achieved, the maximum daily dose can be increased to 100 milligrams. The maximum recommended daily dose is 100 milligrams.

Maintenance therapy: Long term medication may be necessary. The necessity of long-term medication for individuals should be regularly evaluated.

6、 Dose adjustment

1. Patients with liver dysfunction:

Moderate liver dysfunction (Child Pugh B grade): The initial and target doses should be reduced to 50% of the normal dose.

Severe liver dysfunction (Child Pugh C grade): The initial and target doses should be reduced to 25% of the normal dose.

2. Co administration with potent CYP2D6 inhibitors or known CYP2D6 weak metabolizers:

Children and adolescents weighing ≤ 70 kg: The initial dose is 0.5 mg/kg/day. If symptoms do not improve after 4 weeks and the initial dose is well tolerated, the target dose can be increased to 1.2 mg/kg/day.

Children, adolescents, and adults with a weight greater than 70 kilograms: The starting dose is 40 milligrams per day. If symptoms do not improve after 4 weeks and the starting dose is well tolerated, it can be increased to the regular target dose of 80 milligrams per day.

7、 Medication precautions

1. Medication time: It can be taken with food or alone to alleviate possible gastrointestinal discomfort.

2. Omission: If missed, it should be taken as soon as possible, but should not exceed the prescribed total daily dose within 24 hours.

3. Vomiting: If vomiting occurs shortly after taking medication, it is not recommended to take it immediately and wait until the next scheduled medication time.

4. Discontinue medication: The medication can be abruptly stopped without the need for gradual reduction.

8、 Medication for special populations

1. Children and adolescents: It is necessary to balance their suicide risk with clinical needs. The safety and effectiveness of children under 6 years old have not been evaluated.

2. Elderly: Safety and efficacy have not been evaluated yet.

3. Pregnant women: The existing data is insufficient to determine drug-related risks. Pregnant women are advised to use it under the guidance of medical professionals.

4. Breastfeeding women: It is not yet clear whether atomoxetine is secreted with human milk, and the pros and cons should be weighed.

9、 Adverse reactions

1. Common symptoms in children and adolescents (with an incidence rate of ≥ 5% and at least twice that of the placebo group) include nausea, vomiting, fatigue, decreased appetite, abdominal pain, and drowsiness.

2. Common in adults (incidence ≥ 5%, and at least twice that of the placebo group): constipation, dry mouth, nausea, loss of appetite, dizziness, erectile dysfunction, and urinary retention.

3. Serious adverse reactions: including suicidal ideation, severe liver injury, serious cardiovascular events, new psychotic or manic symptoms, aggressive behavior or hostility, allergic reactions, urinary retention, abnormal erection of penis, growth inhibition, etc., which need to be closely monitored.

10、 Contraindications

1. Individuals known to be allergic to atomoxetine or any of its ingredients.

2. Currently taking monoamine oxidase inhibitors (MAOIs) or within 14 days after discontinuing MAOIs.

3. Suffering from narrow angle glaucoma.

4. Suffering from pheochromocytoma or having a history of pheochromocytoma.

5. Suffering from severe cardiovascular disease, the condition may worsen due to clinically significant increases in heart rate or blood pressure.

11、 Drug interactions

1. Monoamine oxidase inhibitors (MAOIs): Do not use in combination.

2. Strong CYP2D6 inhibitors (such as paroxetine, fluoxetine, quinidine): can significantly increase the blood concentration of atomoxetine.

3. Antihypertensive drugs and vasopressors: may affect blood pressure and should be used with caution.

4. Salbutamol (or other β 2 receptor agonists): may enhance the effects of Salbutamol on the cardiovascular system, leading to increased heart rate and blood pressure, and should be used with caution.

5. Alcohol: Combination does not alter the intoxicating effect of alcohol.

12、 Storage method

1. Stored at 25 ° C (77 ° F), allows for short distance transportation between 15 ° C and 30 ° C (59 ° F and 86 ° F).

2. Please keep out of reach of children.

Atomoxetineinformation