Strattera Capsule 60 mg (Atomoxetine Hydrochloride)

Adult dose

This medication may be administered orally once daily in the morning, with or without food. Patients who do not achieve a satisfactory clinical response (tolerability or efficacy) with once-daily administration may take the same dose in two divided doses, in the morning and late afternoon or early evening. - Dosage for adults This medication should be started at a total daily dose of approximately 40mg. The initial dose should be maintained for at least 7 days before being gradually increased according to clinical response and tolerability. The recommended maintenance dose is 80mg. For patients who do not show an adequate response, the dose may be increased to a maximum of 100 mg after 2∼4 weeks. There is no evidence that efficacy increases at higher doses. - Patients with hepatic impairment For patients with moderate hepatic impairment (Child-Pugh Class B), the initial and target doses should be reduced to 50% of the usual doses. For patients with severe hepatic impairment (Child-Pugh Class C), the initial and target doses should be reduced to 25% of the usual doses. - Patients with renal impairment Patients with end-stage renal disease have higher systemic exposure to this medication than healthy subjects (approximately 65% higher); however, there is no difference when exposure is adjusted for the mg/kg dose. Therefore, patients with ADHD who have end-stage renal disease or mild renal impairment may be treated with the usual regimen. This medication may worsen hypertension in patients with end-stage renal disease. - Elderly patients: Not applicable. - Maintenance/extended treatment In placebo-controlled studies, there is no useful evidence indicating how long patients with ADHD should be treated with this medication. However, it is generally agreed that pharmacological treatment of ADHD should be carried out over an extended period. Nevertheless, physicians who decide to use this medication for an extended period should periodically reassess the long-term usefulness of the medication for each patient. - General dosage information This medication may be taken on an empty stomach or with food. The safety of single doses exceeding 120mg and total daily doses exceeding 150mg has not been systematically evaluated. -Dosage adjustment for concomitant use with strong CYP2D6 inhibitors For adults receiving strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, and quinidine), this medication should be started at 40mg/day and increased to the target dose of 80mg/day if symptoms have not improved after 4 weeks and the initial dose is well tolerated. This medication may be discontinued without dose reduction.

Child dose

- Dosage for children weighing up to 70 kg This medication should be initiated at a total daily dose of approximately 0.5 mg/kg. The initial dose should be maintained for at least 7 days before the dose is gradually increased according to clinical response and tolerability. The recommended maintenance dose is approximately 1.2mg/kg/day. (Depending on the patient's body weight and the strength of this medication used) No additional benefit has been demonstrated at doses higher than 1.2 mg/kg/day. The total daily dose in children should not exceed 1.4mg/kg or 100mg. - Dosage for children weighing more than 70 kg This medication should be initiated at a total daily dose of approximately 40mg. The initial dose should be maintained for at least 7 days before the dose is gradually increased according to clinical response and tolerability. The recommended maintenance dose is 80mg, and the dose may be increased to a maximum of 100 mg after 2∼4 weeks in patients who do not show an adequate response. There are no data indicating increased efficacy at higher doses. - Children under 6 years of age The safety and efficacy of this medication in children under 6 years of age have not been established. Therefore, this medication should not be used in children under 6 years of age. - Dosage adjustment for concomitant use with strong CYP2D6 inhibitors In children weighing up to 70kg who are receiving strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, and quinidine), this medication should be initiated at 0.5mg/kg/day and increased to the target dose of 1.2mg/kg/day if symptoms have not improved after 4 weeks and the initial dose is well tolerated. In children weighing 70kg or more who are receiving strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, and quinidine), this medication should be initiated at 40mg/day and increased to the target dose of 80mg/day if symptoms have not improved after 4 weeks and the initial dose is well tolerated.

This medicine has been reported to be associated with suicidal behavior; therefore, patients should be closely monitored for any suicidal thoughts or attempts during treatment. In particular, there may be an increase in aggressive or hostile behavior and emotional instability among children and adolescents, so changes in symptoms should be carefully observed. It can cause severe liver damage, and if there are any signs of liver dysfunction, the medicine should be stopped immediately and a physician consulted. It should not be used by patients who are allergic to this medicine or have certain heart diseases, glaucoma, or pheochromocytoma. Additionally, interactions may occur when used with certain antidepressants or antihypertensive medications, so patients must inform their doctor or pharmacist. This medicine is not to be used in children under 6 years of age, as safety and efficacy have not been established. During treatment, blood pressure and heart rate should be monitored regularly, and if any abnormalities are detected, healthcare professionals should be informed immediately. Caution is advised when driving or operating dangerous machinery, as drowsiness or dizziness may occur. Long-term use may lead to growth delays or weight changes, so the growth status should be periodically checked. It is not recommended to take this during pregnancy or breastfeeding, and a consultation with a physician is advised. In case of overdose, symptoms such as gastrointestinal disturbances, drowsiness, tremors, and behavioral changes may occur, so the prescribed dosage and regimen should be strictly adhered to. Care should be taken not to open the capsule to avoid contact with the eyes, and if contact occurs, it should be washed immediately with clean water, and a doctor's evaluation should be sought.

• suicidal ideation
• suicide attempt
• aggression
• oppositional behavior
• anger
• emotional instability
• liver damage
• increased liver enzymes
• jaundice
• itching

This medicine should be stored in a tightly closed container to protect it from air and moisture, and it is best kept at room temperature below 25 degrees Celsius. Storing it this way will help maintain the efficacy of the medicine safely.

Appearance

A hard capsule with a blue upper half and a yellow lower half filled with white powder.

Package unit

28 capsules (14 capsules/PTPX2)/carton