Atomoxetine Capsule 25 mg (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) when this drug is administered once daily may take the same daily dose in 2 divided doses, in the morning and late afternoon or early evening. Dosage for adults Treatment with this drug should be initiated at a total daily dose of approximately 40mg. The initial dose should be maintained for at least 7 days before gradually increasing the dose according to clinical response and tolerability. The recommended maintenance dose is 80mg. For patients who do not have an adequate response, 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), the initial and target doses should be reduced to 50% of the usual dose. For patients with severe hepatic impairment (Child-Pugh Class C), the initial and target doses should be reduced to 25% of the usual dose. Patients with renal impairment Patients with end-stage renal disease have higher systemic exposure to this drug than healthy subjects (an increase of approximately 65%), but there was no difference when exposure was adjusted for the mg/kg dose. Therefore, this drug may be administered using the usual regimen to patients with ADHD who have end-stage renal disease or mild renal impairment. This drug may worsen hypertension in patients with end-stage renal disease. Elderly patients: Not applicable. Continuation/long-term treatment There is no useful evidence from placebo-controlled studies to indicate 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 reevaluate 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 with concomitant use of strong CYP2D6 inhibitors For adults receiving strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, and quinidine), this drug 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 drug may be discontinued without dose reduction.

Child dose

Children weighing up to 70 kg: Treatment with this drug 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 gradually increasing the dose 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 drug 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. Children weighing more than 70 kg: Treatment with this drug should be initiated at a total daily dose of approximately 40mg. The initial dose should be maintained for at least 7 days before gradually increasing the dose according to clinical response and tolerability. The recommended maintenance dose is 80mg. For patients who do not have an adequate response, 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. 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. Children weighing up to 70 kg who are receiving strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, and quinidine): Treatment with this drug 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. Children weighing more than 70 kg who are receiving strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, and quinidine): Treatment with this drug 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 medication may lead to suicidal behaviors, so pediatric patients must be carefully monitored for thoughts or actions related to suicide. Aggressive or emotionally unstable behaviors may appear during treatment, so these symptoms must be reported immediately. It may cause liver damage; thus, if any signs of liver dysfunction appear, discontinue use immediately and consult a doctor. This medication should not be used in patients with allergies to its active ingredient or other components, or those taking specific drugs (such as MAO inhibitors). Patients with glaucoma, pheochromocytoma, or severe cardiovascular diseases should also avoid using this drug. There are risks of allergic reactions, heart problems, changes in blood pressure and heart rate, liver dysfunction, growth delays, etc., thus careful monitoring during administration is required. Use cautiously in patients with a history of psychotic symptoms or seizures, and this medication is not for use in children under 6 years old. It can interact with various medications, so patients must inform their healthcare provider of any other drugs being taken, particularly heart-related medications or antidepressants. It is advisable not to use this drug during pregnancy or while breastfeeding. Caution is necessary as drowsiness or fatigue may occur while driving or operating dangerous machinery. In case of overdose, symptoms such as gastrointestinal disturbances, drowsiness, tremors, and abnormal heart rhythms might occur, so the dosage must be adhered to precisely. Regular monitoring of growth and development is necessary during prolonged use, and consultation with a doctor is required if symptoms do not improve or abnormal reactions occur.

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

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, and it is important to maintain the storage temperature between 1°C to 25°C. Therefore, avoid direct sunlight and store safely in a cool place.

Appearance

A hard capsule with a blue upper part and a white lower part filled with white powder

Package unit

30 capsules/bottle, 100 capsules/bottle