Atomoxetine Capsule 80 mg (Atomoxetine Hydrochloride)

Adult dose

This medicine may be taken orally once daily in the morning, with or without food. Patients who do not achieve a satisfactory clinical response (tolerability or efficacy) when this medicine is given once daily may take the same total daily dose in two divided doses, in the morning and late afternoon or early evening. Dosage for adults: This medicine should be started at a total daily dose of approximately 40mg. The initial dose should be maintained for at least 7 days before increasing the dose incrementally based on 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 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 higher systemic exposure to this medicine than healthy subjects (an increase of approximately 65%); however, there is no difference when exposure is adjusted for the mg/kg dose. Therefore, patients with ADHD who have end-stage renal disease or a lower level of 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 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 reevaluate the long-term benefits 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), this medicine should be started at 40mg/day and increased to the target dose of 80mg/day if symptoms do not improve 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: This medicine should be started at a total daily dose of approximately 0.5 mg/kg. The initial dose should be maintained for at least 7 days before increasing the dose incrementally based on 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 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: This medicine should be started at a total daily dose of approximately 40mg. The initial dose should be maintained for at least 7 days before increasing the dose incrementally based on 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 showing increased efficacy at higher doses. 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): This medicine should be started at 0.5mg/kg/day and increased to the target dose of 1.2mg/kg/day if symptoms do not improve 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): This medicine should be started at 40mg/day and increased to the target dose of 80mg/day if symptoms do not improve after 4 weeks and the initial dose is well tolerated.

This drug is used to treat Attention Deficit Hyperactivity Disorder (ADHD). During treatment, suicidal behavior may occur, so particularly pediatric patients should be carefully observed for suicidal thoughts or attempts. Also, symptoms of aggression or intensifying hostility and emotional instability may arise, necessitating caution to prevent their exacerbation. Since there is a risk of serious liver damage, patients should immediately stop taking the medication if symptoms indicating liver dysfunction (e.g., jaundice, itching, dark urine, pain in the upper right abdomen) appear. This drug should not be used by patients allergic to the active ingredient or any other components, patients with certain heart diseases, glaucoma, or pheochromocytoma. Additionally, it should not be taken with MAO inhibitors, and there should be no overlap in usage for 2 weeks before and after taking this medication. There may be an increase in blood pressure and heart rate; thus, patients with existing cardiovascular disease should use this medication cautiously, and it is crucial to regularly check blood pressure and heart rate before and during treatment. Safety and efficacy have not been established in children under 6 years old, and use is not recommended. There may be an increased risk of seizures during treatment, so patients with a seizure history should exercise caution. Common side effects include drowsiness, fatigue, decreased appetite, nausea, vomiting, abdominal pain, headache, insomnia, among others. If symptoms become severe, consultation with a physician is advised. It is preferable for women who are pregnant or breastfeeding to avoid using this medication, particularly during the breastfeeding period. Caution is needed when driving or operating hazardous machinery while taking this medication, as drowsiness or fatigue may increase. In case of overdose, symptoms may include gastrointestinal disturbances, drowsiness, trembling, and increased heart rate; therefore, immediate medical attention is required in such cases. This medication may interact with other drugs, so it is essential to inform the healthcare provider of any other medications being taken and to consult about them. During long-term use, it is important to regularly monitor growth and development, and if any abnormal symptoms appear, consulting a physician is necessary.

• 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 air or moisture ingress. It is best to keep it in a cool place between 1 and 25 degrees Celsius. Storing it this way ensures that the drug retains its effectiveness and can be used safely.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle