Hwanin Atomoxetine Tablet 40mg (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 in two divided doses, in the morning and late afternoon or early evening. Dosage for adults Start this medicine at a total daily dose of approximately 40mg. 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 show an adequate response, the dose may be increased to a maximum of 100 mg after 2∼4 weeks. There is no evidence that higher doses provide greater efficacy. For patients with moderate hepatic impairment (Child-Pugh Class B), reduce both the initial and target doses to 50% of the usual dose. For patients with severe hepatic impairment (Child-Pugh Class C), reduce both the initial and target doses to 25% of the usual dose. 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 mg/kg dose. Therefore, this medicine may be administered at the usual dosage to patients with ADHD who have end-stage renal disease or mild renal impairment. This medicine may worsen hypertension in patients with end-stage renal disease. Elderly patients: Not applicable. In placebo-controlled studies, there is no useful evidence indicating how long patients with ADHD should be treated with this medicine. However, it is generally agreed that pharmacological 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 usefulness of the medicine for each patient. This medicine 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. 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 daily dose of approximately 0.5 mg/kg. 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 above 1.2 mg/kg/day. The total daily dose in children should not exceed 1.4mg/kg or 100mg. Children weighing more than 70 kg: Start this medicine at a total daily dose of approximately 40mg. 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 show an adequate response, the dose may be increased to a maximum of 100 mg after 2∼4 weeks. There is no evidence that higher doses provide greater efficacy. Children under 6 years of age: 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 who are receiving strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, and quinidine): 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 who are 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 medication is used to treat Attention Deficit Hyperactivity Disorder (ADHD). While taking this medication, behaviors associated with suicidality may occur, so especially pediatric patients should be closely monitored for behavioral changes such as suicidal thoughts or attempts. Aggressive behavior or increased hostility, as well as emotional instability, may also occur, so if these symptoms develop, it is important to consult healthcare professionals immediately. There is a risk of serious liver damage, so this medication should not be used in patients with poor liver function or jaundice, and should be discontinued immediately if abnormal symptoms appear. This medication may pose risks when combined with certain drugs, so especially patients with MAO inhibitors or cardiovascular diseases should consult a doctor before using it. Patients with allergies, sudden heart abnormalities, or a history of seizures should also use this medication with caution. The safety and efficacy of this medication have not been established in children under 6 years of age, so it is best not to use it. During treatment, weight loss, loss of appetite, drowsiness, headache, nausea, constipation, and other side effects may occur, and if these symptoms are severe or persistent, patients should inform their healthcare provider. There may be drowsiness or dizziness when driving or operating machinery, so caution is advised. During pregnancy or breastfeeding, the use of this medication is not recommended, and it is important to consult with a physician before administration. This medication may affect growth and development when taken for a long period, so especially in children, regular monitoring of growth status is necessary. Lastly, it is important to routinely measure heart rate and blood pressure during treatment to ensure that there are no abnormalities.

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

This medication should be stored in a tightly closed container to prevent air or moisture from entering. Additionally, it should be kept in a cool place at room temperature, ideally below 25 degrees Celsius, to maintain its effectiveness.

Appearance

White oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle