Atomoxetine Capsule 18 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 and 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. 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 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. 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. 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. For adults and children weighing more than 70 kg who are 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. Children under 6 years of age: The safety and efficacy of this drug 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 drug is used to treat Attention Deficit Hyperactivity Disorder (ADHD). Since suicidal behaviors may occur during the use of this medication, especially in pediatric patients, careful observation for any suicidal thoughts or attempts is required. Patients may become aggressive, hostile, or emotionally unstable, so if such symptoms appear, immediate consultation with healthcare professionals is necessary. As it may cause severe liver damage, if symptoms of liver dysfunction (e.g., jaundice, itching, dark urine, pain in the upper right abdomen) appear, discontinue the medication and inform a physician. Patients with hypersensitivity to this drug or those taking certain medications (MAO inhibitors), as well as those with closed-angle glaucoma, pheochromocytoma, or severe cardiovascular disease, should not use this medication. Allergic reactions may occur rarely, so if rashes, hives, or difficulty in breathing occur, immediate notification to healthcare professionals is required. Patients with heart problems or a tendency for increased blood pressure and heart rate should monitor their blood pressure and heart rate regularly and take it with caution. This medication is not recommended for children under 6 years old, as safety and efficacy have not been established. Long-term use requires regular monitoring of growth and developmental status, and if growth delay or weight loss occurs, consultation with a physician is needed. Psychotic symptoms or manic symptoms may occur, so immediate consultation with healthcare professionals is necessary if these symptoms appear. Patients with a history of seizures may have an increased risk of seizures when taking this medication, so special caution is required. This medication may interact with other drugs, so if other medications are being taken, it is essential to inform the healthcare professionals. It is advisable not to use this medication during pregnancy or breastfeeding, and consultation with a physician is recommended if needed. This drug can cause side effects such as drowsiness, dizziness, and fatigue, hence caution is necessary while driving or operating hazardous machinery. In cases of overdose, symptoms such as gastrointestinal disturbances, drowsiness, tremors, anxiety, increased heart rate may occur; therefore, strict adherence to the dosage is required. The capsules of this drug must not be opened, and if the contents get into the eyes, they should be washed immediately with clean water and a doctor's care should be sought.

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

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

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle