Atomoxamine Capsule 60 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

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. Adults and 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. Children under 6 years of age: 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. 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. 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 is used to treat attention deficit hyperactivity disorder (ADHD) and selectively inhibits the reuptake of the neurotransmitter norepinephrine in the brain, relieving symptoms. During treatment with this medication, behaviors related to suicide may appear, so it is essential to closely monitor especially pediatric patients for suicidal thoughts or attempts. Additionally, this medication can cause behavioral changes such as aggression, hostility, and emotional instability; therefore, careful observation is necessary to see if these symptoms emerge or worsen during treatment. It can cause severe liver damage, so if symptoms of jaundice or liver dysfunction appear, it should be discontinued immediately and not restarted. This medication should not be used in combination with certain drugs, especially monoamine oxidase inhibitors (MAOIs), as dangerous side effects may occur if administered within two weeks of such medications. Patients with glaucoma, pheochromocytoma, severe cardiovascular diseases, and lactose intolerance should not use this drug. Allergic reactions may occur rarely, so if symptoms such as rash, hives, or difficulty breathing appear, immediate consultation with a medical professional is necessary. Patients with heart disease or who are sensitive to increases in heart rate and blood pressure should regularly check their heart rate and blood pressure before and during treatment with this medication. It is recommended not to use this medication in children under 6 years of age, as its safety and efficacy have not been established. This medication may cause various side effects including drowsiness, decreased appetite, nausea, abdominal pain, headache, and fatigue; patients should inform healthcare professionals if any unusual symptoms persist or worsen. Caution is required when driving or operating machinery, as drowsiness or fatigue may increase during treatment with this medication. It is advisable for pregnant or nursing women not to use this medication and to consult a physician if necessary. In case of overdose, symptoms such as gastrointestinal disturbances, drowsiness, tremors, and increased heart rate may occur, necessitating immediate emergency treatment. Regular monitoring by healthcare professionals is required during treatment with this medication, and the effectiveness and side effects should be periodically assessed during long-term therapy.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. A storage temperature between 1°C and 25°C in a cool place is appropriate.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle