Hwanin Atomoxetine Tablet 10mg (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. - 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 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. - Continued/long-term treatment 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. - 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 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

- Dosage for 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. - Dosage for 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. - The safety and efficacy of this medicine in children under 6 years of age have not been established. Therefore, this medicine should not be used in children under 6 years of age. - Dosage 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 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 used to treat Attention Deficit Hyperactivity Disorder (ADHD) and may rarely cause behaviors associated with suicide, so patients should be observed carefully. In particular, pediatric patients may exhibit increased aggressive or emotionally unstable behavior, so caution is necessary. There is a risk of serious liver damage; if symptoms of liver dysfunction occur, administration should be discontinued immediately. Patients with allergic reactions to this medication or specific heart diseases, glaucoma, or pheochromocytoma should not use it. Patients with heart disease or those whose blood pressure and heart rate may be affected should take this medication cautiously after consultation with a physician. The safety and efficacy in children under the age of 6 have not been established, so this medication should not be used in that age group. Drowsiness or fatigue may occur during treatment, so caution should be exercised when driving or operating machinery. There may be interactions with other medications, so patients taking other medications should inform their healthcare provider. It is advisable to avoid using this medication during pregnancy or breastfeeding, and to regularly monitor growth and development status. In case of overdose, symptoms such as gastrointestinal disturbances, drowsiness, and tremors may occur, so medical attention should be sought immediately. Long-term use should involve regular evaluation of therapeutic effects and side effects, and patients should consult a professional if any unusual reactions occur.

• suicidal attempt
• suicidal ideation
• aggression
• defiance
• 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 from entering and should be kept in a cool place at room temperature below 25 degrees Celsius.

Appearance

White oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle