Hwanin Atomoxetine Tablet 25mg (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 2 divided doses, in the morning and late afternoon or early evening. Dosage for adults: Start this medicine 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 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), reduce the initial and target doses to 50% of the usual dose. For patients with severe hepatic impairment (Child-Pugh Class C), reduce the initial and target doses to 25% of the usual dose. Patients with end-stage renal disease have greater systemic exposure to this medicine than healthy subjects (approximately 65% higher); however, there was no difference when exposure was 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. Placebo-controlled studies have not provided 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 continue 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), start this medicine at 40mg/day. If symptoms have not improved after 4 weeks and the initial dose is well tolerated, increase the dose to the target dose of 80mg/day. This medicine may be discontinued without dose reduction.

Child dose

Children weighing up to 70 kg: Start this medicine 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 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: Start this medicine 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 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. For children weighing up to 70 kg who are receiving strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, and quinidine), start this medicine at 0.5mg/kg/day. If symptoms have not improved after 4 weeks and the initial dose is well tolerated, increase the dose to the target dose of 1.2mg/kg/day. For children weighing 70 kg or more who are receiving strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, and quinidine), start this medicine at 40mg/day. If symptoms have not improved after 4 weeks and the initial dose is well tolerated, increase the dose to the target dose of 80mg/day.

This medication is a treatment for Attention Deficit Hyperactivity Disorder (ADHD). During treatment, suicidal behavior may occur, so it is particularly important to closely monitor children and adolescents for any suicidal thoughts or actions. Additionally, aggressive or emotionally unstable behavior may occur, so if such changes arise, immediate consultation with healthcare professionals is necessary. It can cause severe liver damage, so if jaundice or symptoms of liver dysfunction (e.g., yellowing of skin or eyes, darkened urine, abdominal pain) appear, stop the medication immediately and visit a hospital. This medication should not be used in conjunction with certain drugs, especially MAO inhibitors, as it can cause serious side effects. It is crucial to inform healthcare professionals about any medications being taken. It should not be used in patients with glaucoma, severe cardiovascular diseases, or pheochromocytoma. Allergic reactions may rarely occur; if symptoms such as rash, hives, or difficulty breathing arise, stop use immediately. Patients with heart issues or high blood pressure should regularly monitor their heart rate and blood pressure before and after taking this medication, and consult healthcare professionals if abnormalities occur. This medication is not used in children under 6 years old as its safety and efficacy have not been confirmed. Side effects such as drowsiness, dizziness, decreased appetite, indigestion, headache may occur, so caution is needed when driving or operating machinery. Pregnant or breastfeeding women should consult a doctor before taking this medication, and it is recommended not to use it while breastfeeding. Long-term use may lead to growth delays, so monitor growth and development regularly. Overdose may cause gastrointestinal disturbances, drowsiness, tremors, and abnormal behavior, so the dosage must be strictly adhered to, and in case of overdose, visit a hospital immediately. Before taking this medication, consult with a doctor or pharmacist to inform them about personal health status and other medications being taken, and follow their instructions.

• suicidal attempt
• suicidal ideation
• aggression
• defiant behavior
• anger
• emotional instability
• liver damage
• increased liver enzymes
• jaundice
• itching

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, and it is best kept in a cool place at room temperature below 25 degrees Celsius. Proper storage can help maintain the efficacy of the medication for a longer period.

Appearance

White oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle