Hanin Atomoxetine Capsule 10mg (Atomoxetine Hydrochloride)

Adult dose

This medicine 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 divided into 2 doses daily, in the morning and late afternoon or early evening. Adult dosage Start this medicine at a total dose of approximately 40mg per day. Maintain the initial dose for at least 7 days before gradually increasing it according to clinical response and tolerability. The recommended maintenance dose is 80mg; for patients who do not respond adequately, the dose may be increased to a maximum of 100 mg after 2∼4 weeks. There are no data showing increased efficacy at higher doses. Patients with hepatic impairment For patients with moderate hepatic impairment (Child-Pugh Class B), reduce the initial and target doses to 50% of the usual dose. For patients with severe hepatic impairment (Child-Pugh Class C), reduce the initial and target doses to 25% of the usual dose. Patients with renal impairment Although patients with end-stage renal disease have greater systemic exposure to this medicine than healthy subjects (approximately 65% higher), 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 receive the usual dosage regimen. This medicine may worsen hypertension in patients with end-stage renal disease. Elderly patients: Not applicable. Continuation/extended treatment In placebo-controlled studies, there was no useful evidence indicating how long patients with ADHD should be treated with this medicine. However, it is generally agreed that pharmacologic treatment of ADHD should be continued for an extended period. Nevertheless, physicians who decide to use this medicine for an extended period should periodically reassess the long-term benefits of the medicine for each patient. General dosage information This medicine may be taken on an empty stomach or with food. The safety of single doses greater than 120mg and total daily doses greater than 150mg has not been systematically evaluated. Dose adjustment for concomitant use with strong CYP2D6 inhibitors For adults receiving strong CYP2D6 inhibitors (e.g.; paroxetine, fluoxetine, and quinidine), start this medicine at 40mg/day; if symptoms have not improved after 4 weeks and the initial dose is well tolerated, increase to the target dose of 80mg/day. This medicine may be discontinued without dose reduction.

Child dose

Children weighing up to 70 kg: Start this medicine at a total dose of approximately 0.5 mg/kg per day. Maintain the initial dose for at least 7 days before gradually increasing it according to clinical response and tolerability. The recommended maintenance dose is approximately 1.2mg/kg/day. (depending on the patient's weight and the strength of this medicine used) No additional benefit has been demonstrated at doses greater than 1.2 mg/kg/day. The total daily dose in children should not exceed 1.4mg/kg or 100mg. Children weighing over 70 kg: Start this medicine at a total dose of approximately 40mg per day. Maintain the initial dose for at least 7 days before gradually increasing it according to clinical response and tolerability. The recommended maintenance dose is 80mg; for patients who do not respond adequately, the dose may be increased to a maximum of 100 mg after 2∼4 weeks. There are no data showing increased efficacy at higher doses. Children under 6 years: The safety and efficacy of this medicine have not been established. Therefore, this medicine should not be used in children under 6 years of age. Children weighing up to 70 kg receiving strong CYP2D6 inhibitors: Start this medicine at 0.5mg/kg/day; if symptoms have not improved after 4 weeks and the initial dose is well tolerated, increase to the target dose of 1.2mg/kg/day. Children weighing 70 kg or more receiving strong CYP2D6 inhibitors: Start this medicine at 40mg/day; if symptoms have not improved after 4 weeks and the initial dose is well tolerated, increase to the target dose of 80mg/day.

This medication may manifest behaviors associated with suicidal ideation, and thus, careful monitoring should be conducted for suicidal thoughts or attempts, particularly in pediatric patients. Patients taking this medication may exhibit symptoms of aggression or emotional instability; if such changes occur, immediate consultation with healthcare professionals is necessary. There is a potential for severe liver damage, so if symptoms or test results indicating liver function impairment arise, this medication should be stopped immediately, and a doctor should be consulted. This drug should not be administered to patients who are hypersensitive to it or those currently taking certain medications (especially MAO inhibitors). Patients with glaucoma, pheochromocytoma, or severe cardiovascular diseases should also refrain from using this medication. Allergic reactions may occur infrequently, so if symptoms like rash, urticaria, or difficulty breathing arise, immediate treatment should be sought. Patients with pre-existing heart issues or those at risk of increased blood pressure or heart rate should regularly monitor their heart rate and blood pressure while using this medication. Safety and efficacy have not been established in children under 6 years of age, so this medication should not be used in this population. This medication may cause side effects such as drowsiness, dizziness, loss of appetite, and dyspepsia, necessitating caution when driving or operating machinery. Use during pregnancy or breastfeeding should be avoided. As this medication may interact with other drugs, inform healthcare professionals of any other medications being taken. In case of overdose, gastrointestinal symptoms, drowsiness, tremors, and abnormal behavior may occur, and immediate medical treatment should be sought. Long-term use may require periodic monitoring of growth and development, and if adverse symptoms appear, consulting a doctor is recommended.

• suicidal attempts
• suicidal thoughts
• aggression
• oppositional behavior
• anger
• emotional instability
• liver damage
• increased liver enzymes
• jaundice
• itching

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it is advisable to keep it in a cool place away from direct sunlight at room temperature below 25 degrees Celsius.

Appearance

A hard capsule with white powder inside, with a white upper and white lower part.

Package unit

For domestic use - 30 capsules/bottle, For domestic use - 100 capsules/bottle, For export - 30 capsules/box [10 capsules/PTP X 3]