Strattera Capsule 18 mg (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 it twice daily in equal doses, in the morning and late afternoon or early evening. Dosage for adults: This medication should be initiated at a total daily dose of approximately 40mg. The initial dose should be maintained for at least 7 days before being titrated upward 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 is no evidence that efficacy increases 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 dose. For patients with severe hepatic impairment (Child-Pugh Class C), the initial and target doses should be reduced to 25% of the usual dose. Although patients with end-stage renal disease have greater systemic exposure to this medication than healthy subjects (approximately 65% higher), there was no difference when exposure was adjusted for the mg/kg dose. Therefore, this medication may be administered at the usual dosage to patients with ADHD who have end-stage renal disease or mild renal impairment. 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 to indicate how long patients with ADHD should be treated with this medication. However, it is generally agreed that pharmacological treatment of ADHD should be provided for an extended period. Nevertheless, physicians who decide to use this medication for an extended period should periodically reevaluate 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. For adults receiving a strong CYP2D6 inhibitor (e.g., paroxetine, fluoxetine, and quinidine), this medication should be initiated at 40mg/day and increased to the target dose of 80mg/day if symptoms have not improved after 4 weeks and the initial dose is well tolerated. This medication may be discontinued without dose reduction.

Child dose

Children under 6 years of age: The safety and efficacy of this medication have not been established. Therefore, this medication should not be used in children under 6 years of age. Children weighing up to 70 kg: This medication should be initiated at a total daily dose of approximately 0.5 mg/kg. The initial dose should be maintained for at least 7 days before being titrated upward 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 medication used) Additional benefit has not been demonstrated at doses above 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: This medication should be initiated at a total daily dose of approximately 40mg. The initial dose should be maintained for at least 7 days before being titrated upward 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 is no evidence that efficacy increases at higher doses. Children weighing up to 70kg who are receiving a strong CYP2D6 inhibitor (e.g., paroxetine, fluoxetine, and quinidine): This medication should be initiated at 0.5mg/kg/day and increased to the target dose of 1.2mg/kg/day if symptoms have not improved after 4 weeks and the initial dose is well tolerated. Children weighing 70 kg or more who are receiving a strong CYP2D6 inhibitor (e.g., paroxetine, fluoxetine, and quinidine): This medication should be initiated at 40mg/day and increased to the target dose of 80mg/day if symptoms have not improved after 4 weeks and the initial dose is well tolerated.

This medication may result in suicidal behavior, so careful monitoring for thoughts or behaviors related to suicide is required during treatment. Patients taking this medication may exhibit aggressive behavior or emotional instability; consult a healthcare provider immediately if these symptoms occur. Serious liver damage may result, so if jaundice or symptoms of liver dysfunction appear, discontinue use immediately and consult a doctor. This medication should not be administered to those with hypersensitivity to it or with specific heart diseases, glaucoma, or pheochromocytoma. Taking it with MAO inhibitors may cause serious side effects; therefore, MAO inhibitors should not be used within 2 weeks before or after taking this medication. Patients with heart conditions or those sensitive to increases in blood pressure and heart rate should regularly monitor their heart rate and blood pressure while taking this medication. Allergic reactions may occur rarely, so contact a healthcare provider immediately if symptoms such as rash or difficulty breathing arise. The safety and efficacy of this medication have not been established in children under 6 years of age; thus, it should not be used in this age group. This medication may cause drowsiness or fatigue, so caution is needed when driving or operating hazardous machinery. This medication may interact with other medications; inform your doctor or pharmacist about any other medications being taken. It is advisable to avoid using this medication during pregnancy or breastfeeding and to consult with a healthcare provider before use. Long-term use should involve regular monitoring of growth and developmental status, and any unusual signs should be discussed with a doctor.

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

This medication should be stored in a tightly closed container to protect it from air and moisture, preferably at a temperature below 25 degrees Celsius. This will help maintain the medication's efficacy for a long time.

Appearance

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

Package unit

28 capsules (14 capsules/PTPX2)/carton