Hanin Atomoxetine Capsule 60 Milligrams (Atomoxetine Hydrochloride)

Adult dose

This medication 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 medication is administered once daily may take the same total daily dose in 2 divided doses, in the morning and late afternoon or early evening. Dosage in adults This medication 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 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 doses. For patients with severe hepatic impairment (Child-Pugh Class C), the initial and target doses should be reduced to 25% of the usual doses. Although patients with end-stage renal disease have greater systemic exposure to this medication than healthy subjects (increased by approximately 65%), 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 medication may worsen hypertension in patients with end-stage renal disease. Elderly patients: Not applicable. There is no useful evidence from placebo-controlled studies indicating how long patients with ADHD should be treated with this medication. However, it is generally agreed that pharmacological treatment of ADHD should be continued for an extended period. Nevertheless, physicians who decide to use this medication for an extended period should periodically reassess the benefits of long-term use for each patient. This medication 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. In adults receiving a potent CYP2D6 inhibitor (e.g., paroxetine, fluoxetine, and quinidine), this medication should be started 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 medication may be discontinued without reducing the dose.

Child dose

Pediatric patients weighing up to 70 kg: This medication 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 medication used) No additional benefit has been demonstrated at doses higher than 1.2 mg/kg/day. The total daily dose in pediatric patients should not exceed 1.4mg/kg or 100mg. Pediatric patients weighing more than 70 kg: This medication 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, and 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. Pediatric patients under 6 years of age: The safety and efficacy of this medication in pediatric patients under 6 years of age have not been established. Therefore, this medication should not be used in pediatric patients under 6 years of age. Pediatric patients weighing up to 70kg receiving a strong CYP2D6 inhibitor (e.g.; paroxetine, fluoxetine, and quinidine): This medication 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. Pediatric patients weighing 70kg or more receiving a strong CYP2D6 inhibitor (e.g.; paroxetine, fluoxetine, and quinidine): This medication 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 may lead to suicidal behavior, so special attention should be paid to monitor children patients for any suicidal thoughts or attempts. During the use of this drug, there may be an increase in aggressive behaviors or emotional instability, and if such symptoms appear, it is crucial to consult with a healthcare professional without delay. There is a risk of liver damage, so if symptoms of liver dysfunction such as jaundice, itching, changes in urine color, or pain in the upper right abdomen occur after taking this medication, it should be stopped immediately and the doctor should be notified. This drug should not be administered to patients with allergies to the active ingredient or other ingredients, as well as those with certain heart diseases, glaucoma, or pheochromocytoma. It is dangerous to use this medication in combination with MAO inhibitors or to take it within 2 weeks after taking an MAO inhibitor, and this must be avoided. Patients with heart or blood pressure issues should consult with a healthcare professional before taking this medication, and during its use, heart rate and blood pressure should be regularly monitored. The safety and efficacy of this medication have not been established in children under 6 years of age, so it should not be used in this population. Women who are pregnant or breastfeeding are advised to avoid taking this medication and consult with a healthcare professional when necessary. Caution is needed as drowsiness or fatigue may occur when driving or operating hazardous machinery. Overdosing on this medication can lead to gastrointestinal disturbances, drowsiness, tremors, abnormal behavior, etc., so it is essential to adhere to the prescribed dosage, and in case of overdose, seek immediate medical attention. This medication may interact with other drugs, so it is essential to inform the healthcare professional of any other medications being taken. Prolonged use may lead to growth delays or weight changes, so regular checks of growth and developmental status are necessary. There is a risk of seizures during the use of this medication, and patients with a history of seizures should be closely monitored. If any abnormal symptoms or side effects occur during use, it is imperative to consult a healthcare professional for appropriate action.

• suicidal attempts
• suicidal thoughts
• aggression
• oppositional behavior
• anger
• emotional instability
• liver damage
• increased liver enzymes
• jaundice
• rash

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The recommended storage temperature is preferably at room temperature below 25 degrees Celsius. This helps maintain the medication's efficacy and ensures safe use.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle