Atomoxetine Capsule 40 mg (Atomoxetine Hydrochloride)

Adult dose

This medication may be administered orally once daily in the morning, regardless of meals. Patients who do not achieve a satisfactory clinical response (tolerability or efficacy) with once-daily administration may take the same dose divided twice daily, in the morning and late afternoon or early evening. Dosage for adults and children weighing more than 70 kg: Start this medication at a total daily dose of approximately 40mg. Maintain the initial dose 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 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. 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. Patients with end-stage renal disease have greater systemic exposure to this medication than healthy subjects (approximately 65% higher); however, there is no difference when exposure is adjusted for mg/kg dose. Therefore, patients with ADHD who have end-stage renal disease or mild renal impairment may receive the usual dosage regimen. This medication may worsen hypertension in patients with end-stage renal disease. Elderly patients: Not applicable. This medication 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. For adults and children weighing 70 kg or more who are receiving strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, and quinidine), start this medication at 40mg/day and, 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 be discontinued without dose reduction.

Child dose

Children weighing up to 70 kg: Start this medication at a total daily dose of approximately 0.5 mg/kg. Maintain the initial dose 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 weight and the strength of this medication 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: Start this medication at a total daily dose of approximately 40mg. Maintain the initial dose 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 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 medication have not been established. Therefore, this medication should not be used in children under 6 years of age. Children weighing up to 70kg (with concomitant use of a strong CYP2D6 inhibitor): For children weighing up to 70kg who are receiving a strong CYP2D6 inhibitor (e.g., paroxetine, fluoxetine, and quinidine), start this medication at 0.5mg/kg/day and, 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 70kg or more (with concomitant use of a strong CYP2D6 inhibitor): For adults and children weighing 70kg or more who are receiving a strong CYP2D6 inhibitor (e.g., paroxetine, fluoxetine, and quinidine), start this medication at 40mg/day and, 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 for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and can be administered to children and adults. Because suicidal behavior may rarely occur during use, the patient's mental state should be closely monitored. Aggressive behavior or emotional instability may also occur, so these symptoms should also be regularly checked. There is a risk of liver damage; therefore, if jaundice or signs of liver dysfunction occur, administration should be stopped immediately and should not be resumed. Patients with hypersensitivity to this medication, those taking certain drugs such as MAO inhibitors, patients with narrow-angle glaucoma, pheochromocytoma, and severe cardiovascular disease should not use this drug. Allergic reactions may occur, so watch for symptoms such as rash, hives, and difficulty breathing. Patients with heart disease or who are sensitive to changes in blood pressure and heart rate should consult a cardiologist before use and should regularly monitor heart rate and blood pressure during the treatment. It is not used in children under 6 years, as safety and efficacy have not been established. This medication can increase the risk of seizures, so patients with a history of seizures should use it with caution. Pregnant or breastfeeding women are advised not to use this medication and should consult with a healthcare provider if necessary. This medication may cause drowsiness, dizziness, loss of appetite, indigestion, nausea, constipation, etc., so caution is needed, especially when driving or operating machinery. It may interact with other medications, so inform healthcare providers about any medications being taken. In case of overdose, gastrointestinal symptoms, drowsiness, tremors, abnormal behaviors, etc., may occur, and immediate medical attention is required. Monitor growth and development over long-term use, and consult healthcare providers if abnormalities appear. The capsules should never be opened, and if the contents come into contact with the eyes, rinse immediately with clean water and seek medical attention.

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

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it is advisable to avoid direct sunlight and keep it in a cool place below 25 degrees Celsius.

Appearance

Hard capsule with a blue upper part and a blue lower part containing white powder

Package unit

30 capsules/bottle, 100 capsules/bottle