Hwanin Atomoxetine Capsule 18 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 dose divided into 2 doses daily, in the morning and late afternoon or early evening. - Adult dosage Start this medicine at a total dose of approximately 40mg per day. Maintain the initial dose for at least 7 days before gradually increasing it according to clinical response and tolerability. The recommended maintenance dose is 80mg; for patients who do not respond adequately, 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. - Patients with hepatic impairment 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 renal impairment Although patients with end-stage renal disease have greater systemic exposure to this medicine than healthy subjects (approximately 65% higher), 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 was no useful evidence indicating how long patients with ADHD should be treated with this medicine. However, it is generally agreed that pharmacologic treatment of ADHD should be continued for an extended period. Nevertheless, physicians who decide to use this medicine for an extended period should periodically reassess the long-term benefits 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 greater than 120mg and total daily doses greater than 150mg has not been systematically evaluated. -Dose adjustment for concomitant use with strong CYP2D6 inhibitors 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 to the target dose of 80mg/day. This medicine may be discontinued without dose reduction.

Child dose

- Dosage for children weighing up to 70 kg Start this medicine at a total dose of approximately 0.5 mg/kg per day. Maintain the initial dose for at least 7 days before gradually increasing it 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 greater than 1.2 mg/kg/day. The total daily dose in children should not exceed 1.4mg/kg or 100mg. - Dosage for adults and children weighing over 70 kg (children) Start this medicine at a total dose of approximately 40mg per day. Maintain the initial dose for at least 7 days before gradually increasing it according to clinical response and tolerability. The recommended maintenance dose is 80mg; for patients who do not respond adequately, 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 The safety and efficacy of this medicine in children under 6 years have not been established. Therefore, this medicine should not be used in children under 6 years of age. -Dose adjustment for concomitant use with strong CYP2D6 inhibitors 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 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 to the target dose of 80mg/day.

This drug may induce behavior related to suicide, so careful observation is required, especially for pediatric patients, for symptoms such as suicidal thoughts or attempts. Also, aggressive behavior or emotional instability may appear, so care should be taken to avoid exacerbation of these symptoms. Due to the risk of liver damage, if there are signs of liver dysfunction or jaundice, administration must be stopped immediately, and liver function tests, including liver enzyme tests, should be conducted as necessary. This drug should not be used in patients with hypersensitivity to this medication or those with certain heart diseases, glaucoma, pheochromocytoma, or severe cardiovascular diseases. Moreover, this medication should not be administered in conjunction with MAO inhibitors or within 2 weeks of their discontinuation, nor should MAO inhibitors be taken within 2 weeks after the administration of this medication. Allergic reactions can occur rarely, so if symptoms like rash, urticaria, or anaphylaxis appear, consult a healthcare provider immediately. Patients with heart diseases or unstable heart rate and blood pressure should regularly monitor their heart rate and blood pressure both before and during medication administration. If signs of liver damage arise, medication should be stopped immediately, and growth and development should be continuously monitored. Psychotic or manic symptoms may occur, so careful observation of changes in the patient's mental state is necessary. Patients with a history of seizures may have an increased risk of seizures when taking this drug, so it should be administered cautiously and should not be used in children under 6 years of age. Various adverse reactions may occur during treatment, so if any uncomfortable symptoms arise, the patient should inform and consult with a healthcare provider. Drowsiness or fatigue may occur while driving or operating dangerous machinery, so caution is advised. Pregnant or breastfeeding women are advised not to use this medication, especially during the breastfeeding period. This medication may interact with other drugs, so if other medications are being taken, the healthcare provider must be informed. In case of overdose, immediate visit to a medical institution for appropriate treatment is necessary, and the capsules must not be opened, taking care to avoid contact with the contents to the eyes.

• suicidal attempt
• suicidal ideation
• aggression
• oppositional behavior
• anger
• emotional instability
• liver damage
• increased liver enzymes
• jaundice
• weight loss

This medication may be sensitive to air and moisture, so it must be stored in a sealed container. It is recommended to maintain a storage temperature below 25 degrees Celsius. This will help maintain the efficacy of the medication for a longer period.

Appearance

A hard capsule with a yellow upper part and a white lower part filled with 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]