Hwanin Atomoxetine Capsule 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) when this medicine is administered once daily may take the same dose in two divided doses, in the morning and late afternoon or early evening. Dosage for adults: This medicine should be initiated at a total daily dose of approximately 40mg. The initial dose should be maintained for at least 7 days before the dose is gradually increased based on clinical response and tolerability. The recommended maintenance dose is 80mg, and the dose may be increased to a maximum of 100 mg after 2∼4 weeks in patients who do not show an adequate response. There are no data indicating increased efficacy at higher doses. Patients with hepatic impairment: In patients with moderate hepatic impairment (Child-Pugh Class B), the initial and target doses should be reduced to 50% of the usual dose. In 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 renal impairment: Patients with end-stage renal disease have higher systemic exposure to this medicine than healthy subjects (approximately 65% higher); 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 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. Continuation/extended treatment: 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 provided for an extended period. Nevertheless, physicians who decide to use this medicine for an extended period should periodically reassess the benefits of long-term use of the medicine for each patient. General dosage information: 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. Dosage adjustment for concomitant use with strong CYP2D6 inhibitors: In adults receiving strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, and quinidine), this medicine should be initiated at 40mg/day and increased to the target dose of 80mg/day after 4 weeks if symptoms have not improved and the initial dose is well tolerated. This medicine may be discontinued without dose reduction.

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 being gradually increased according to clinical response and tolerability. The recommended maintenance dose is approximately 1.2 mg/kg/day. (Depending on the patient’s body 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 1.4 mg/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 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 have not been established. Therefore, this medicine should not be used in children under 6 years of age. Children weighing up to 70kg receiving strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, and quinidine): This medicine should be started at 0.5mg/kg/day and, if symptoms have not improved after 4 weeks and the initial dose is well tolerated, increased to the target dose of 1.2mg/kg/day. Children weighing 70kg or more receiving strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, and quinidine): This medicine should be started at 40mg/day and, if symptoms have not improved after 4 weeks and the initial dose is well tolerated, increased to the target dose of 80mg/day.

This medication is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and has been reported to be associated with suicidal behavior, so patients taking it should be closely monitored for suicidal thoughts or actions. Aggressive or emotionally unstable behavior may also occur, and if these symptoms appear, medical consultation should be sought immediately. Serious liver problems may occur, so if there is a liver disease or symptoms of liver damage, this medication should be discontinued, and it is important to regularly check liver enzyme levels and bilirubin levels. This medication should not be used in patients with hypersensitivity to this drug, certain heart diseases, glaucoma, specific tumors, severe cardiovascular diseases, etc., and it should not be taken with MAO inhibitors. Allergic reactions can occur infrequently, so if symptoms like rash, hives, or difficulty breathing occur, visit a medical facility immediately. This medication can affect heart disease, blood pressure, and heart rate, so patients with heart disease or unstable blood pressure should monitor their heart rate and blood pressure regularly and take it carefully. The safety and effectiveness of this medication in children under 6 years old have not been established, so it should not be used in these children, and even in children over 6, growth and developmental status should be continuously monitored while taking. Patients with a history of psychotic symptoms, mania, or seizures should exercise caution when using this medication and consult a healthcare professional if symptoms worsen. It is advisable for pregnant or breastfeeding women to avoid using this medication, especially during breastfeeding. Drowsiness or fatigue may occur during driving or operating hazardous machinery, so caution is needed. This medication can interact with various drugs, so if you are taking other medications, you must inform your healthcare provider, especially if using MAO inhibitors, certain antidepressants, or cardiovascular drugs. In case of overdose, symptoms such as gastrointestinal symptoms, drowsiness, tremors, and increased heart rate may occur, and immediate emergency treatment should be sought, and treatment should be followed as directed by a healthcare professional. The efficacy and safety of this medication should be periodically re-evaluated with long-term use, and if adverse reactions or side effects occur, immediate consultation with healthcare professionals should be obtained for appropriate measures.

suicidal attempt

This medication should be stored in a tightly sealed container to prevent air or moisture ingress, and it should be kept in a cool place at room temperature below 25 degrees to maintain effectiveness.

Appearance

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

Package unit

For domestic use - 30 capsules/bottle, For domestic use - 100 capsules/bottle, For export - 30 capsules/box [10 capsules/PTP X 3]