Hanin Atomoxetine Tablet 80mg (Atomoxetine hydrochloride)

Adult dose

This drug 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 2 divided doses, in the morning and late afternoon or early evening. - Dosage for adults Start this drug 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 Patients with end-stage renal disease have greater systemic exposure to this drug 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 receive the usual dosage regimen. This drug may worsen hypertension in patients with end-stage renal disease. - Elderly patients: Not applicable. - Continued/extended treatment In placebo-controlled studies, there is no useful evidence indicating how long patients with ADHD should be treated with this drug. However, it is generally agreed that pharmacological treatment of ADHD should be continued for an extended period. Nevertheless, physicians who decide to use this drug for an extended period should periodically reassess the benefit of long-term use for each patient. - General dosage information This drug 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), start this drug at 40mg/day and, if symptoms have not improved after 4 weeks and the initial dose is well tolerated, increase it to the target dose of 80mg/day. This drug may be discontinued without dose reduction.

Child dose

- Dosage for children weighing up to 70 kg Start this drug 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 drug used.) Additional benefit has not been demonstrated at doses above 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 Start this drug 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 of age The safety and efficacy of this drug in children under 6 years of age have not been established. Therefore, this drug should not be used in children under 6 years of age. -Dosage adjustment for concomitant use with strong CYP2D6 inhibitors For children weighing up to 70 kg who are receiving strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, and quinidine), start this drug at 0.5mg/kg/day and, if symptoms have not improved after 4 weeks and the initial dose is well tolerated, increase it to the target dose of 1.2mg/kg/day. For children weighing 70 kg or more who are receiving strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, and quinidine), start this drug at 40mg/day and, if symptoms have not improved after 4 weeks and the initial dose is well tolerated, increase it to the target dose of 80mg/day.

This drug is used for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD), and it may be associated with behaviors related to suicide during administration, so patients should be closely monitored. Additionally, there may be a risk of increased aggressive behavior or emotional instability, so caution is necessary. Due to the risk of liver damage, if symptoms of liver dysfunction occur, the medication should be discontinued immediately, and liver enzyme tests may be needed. This drug should not be administered to patients with allergies to its components or those who are taking certain medications (MAO inhibitors), patients with narrow-angle glaucoma or pheochromocytoma, or patients with severe cardiovascular disorders. It should be administered cautiously to patients with a history of allergic reactions, heart disease, fluctuations in blood pressure and heart rate, liver dysfunction, growth delays, psychotic symptoms, or seizure history. It is not used in children under the age of 6 years because safety and efficacy have not been established. This drug can interact with other medications, especially MAO inhibitors, CYP2D6 inhibitors, cardiovascular medications, and serotonergic medications, so caution should be exercised when combined. Pregnant or nursing women are advised not to use this drug. Caution is needed when driving or operating dangerous machinery as drowsiness or fatigue may increase. In case of overdose, gastrointestinal symptoms, drowsiness, tremors, abnormal behavior, etc., may occur, and immediate consultation with a medical professional is necessary. For long-term administration, growth and development should be monitored periodically, and treatment effects and side effects should be assessed for appropriate adjustments.

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

This drug should be stored in a tightly closed container to protect it from air and moisture and should be kept in a cool place below room temperature (25 degrees Celsius). This way of storage will help maintain the drug's effectiveness for a long time.

Appearance

White oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle