Atomoxetine Capsule 10 mg (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 total daily dose in two divided doses, in the morning and late afternoon or early evening. Dosage for adults: Treatment should be initiated 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 are no data indicating increased efficacy at higher doses. 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. Although systemic exposure to this medicine is higher in patients with end-stage renal disease than in healthy subjects (increased by approximately 65%), 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. In placebo-controlled studies, there was no useful evidence to indicate 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 reevaluate the benefits of long-term use 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), treatment with this medicine 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 may be discontinued without reducing the dose.

Child dose

Dosage for children weighing up to 70 kg: Treatment 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 being gradually increased 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). 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: Treatment should be initiated 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 are no data indicating increased efficacy at higher doses. The safety and efficacy of this medicine in children under 6 years of age have not been established. Therefore, this medicine should not be used in children under 6 years of age. For children weighing up to 70 kg who are receiving strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, and quinidine), treatment with this medicine 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. For children weighing 70 kg or more who are receiving strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, and quinidine), treatment with this medicine 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 be associated with suicidal behavior; therefore, children and adolescent patients should be closely monitored. It may provoke aggressive behavior and emotional instability, and if such symptoms arise, prompt action should be taken. The risk of liver damage necessitates immediate discontinuation if symptoms of liver dysfunction (e.g., jaundice, itching, dark urine) appear. It should not be used in individuals with allergies to any of its components, those taking certain medications, and patients with specific conditions (e.g., angle-closure glaucoma, pheochromocytoma, severe cardiovascular disease). Patients exhibiting allergic reactions, cardiac issues, variations in blood pressure and heart rate, liver dysfunction, growth delays, psychotic symptoms, or risk of seizures should be carefully administered the medication. Children under 6 years should not use this medication as its safety and efficacy have not been confirmed for this age group. This medication may affect blood pressure and heart rate, hence regular checks of blood pressure and heart rate should be conducted before and during administration. There is a risk of increased drowsiness or fatigue while driving or operating hazardous machinery. This medication is metabolized differently based on the activity of a specific enzyme (CYP2D6), which may lead to variations in drug concentration and the risk of side effects. In case of overdose, gastrointestinal disturbances, drowsiness, dizziness, tremors, and behavioral abnormalities may occur, necessitating immediate medical attention. It should ideally be avoided during pregnancy due to potential risks to the fetus unless in special circumstances, and it should also be avoided during breastfeeding. This medication may interact with other drugs; thus, patients must inform their doctor or pharmacist about any medications they are currently taking. Long-term use requires periodic evaluation of efficacy and safety, as well as continuous monitoring of growth and developmental status.

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

Store this medication in a tightly sealed container to prevent exposure to air or moisture, and keep it in a cool place between 1°C and 25°C. This way, the efficacy of the medicine can be maintained and deterioration prevented.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle