Strattera Capsule 40mg (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 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 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. For children weighing up to 70kg: For 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. For children weighing 70kg or more: For children weighing 70kg 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 medicine is used to treat attention deficit hyperactivity disorder (ADHD). Suicidal behaviors may emerge during treatment; hence, especially children and adolescents should be closely monitored for thoughts or behaviors related to suicide. Additionally, aggressive or hostile behaviors, emotional instability may occur, and if these symptoms appear, immediate consultation with a medical professional is necessary. There is a risk of serious liver damage; hence, if symptoms of liver dysfunction occur (e.g., jaundice, dark urine, pain in the upper right abdomen), stop taking the medication immediately and consult a doctor. Patients with hypersensitivity to this drug or those with certain types of glaucoma, pheochromocytoma, or severe cardiovascular diseases should not be administered this medication. Furthermore, concurrent use with certain types of antidepressants or MAO inhibitors can be dangerous; thus, it is essential to inform healthcare providers of any medications currently being taken. This drug may increase heart rate and blood pressure; therefore, patients with hypertension or heart diseases should use it with caution and regularly monitor their blood pressure and heart rate. This drug should not be used in children under 6 years of age due to lack of proven safety and efficacy. During treatment, drowsiness or fatigue may occur, so caution is needed when driving or operating dangerous machinery. Long-term use should involve periodic monitoring of growth or weight changes, and if any unusual symptoms arise, consult a healthcare professional. Overdose may result in gastrointestinal disturbances, drowsiness, tremors, and unstable behavior; therefore, immediate emergency treatment should be sought. It is advisable for pregnant or breastfeeding women to avoid using this medication, and they should consult a doctor before use. Care should be taken not to open the capsule or let the contents come into contact with the eyes; if contact occurs, wash immediately with clean water and seek medical help.

• Suicidal attempts
• suicidal thoughts
• aggression
• defiant behavior
• anger
• emotional instability
• liver damage
• increased liver enzymes
• jaundice
• itching

Store this medication in a sealed container to avoid exposure to air or moisture and keep it at room temperature, below 25 degrees Celsius. Storing it this way will help maintain the medicine's effectiveness for longer.

Appearance

Hard capsule with upper blue and lower blue containing white powder.

Package unit

28 capsules (14 capsules/PTPX2)/carton