Strattera Capsule 25 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 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 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 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 is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), and it is not a psychostimulant; it works by selectively inhibiting norepinephrine transporters. During the course of treatment, behaviors associated with suicide may occur rarely, so especially pediatric patients should be closely monitored for symptoms such as suicidal thoughts or attempts. Additionally, aggressive or emotionally unstable behaviors may emerge, so if such symptoms appear, immediate consultation with medical staff is required. Due to the risk of severe liver damage, if symptoms of jaundice or liver function impairment appear, the medication should be discontinued immediately and a hospital visit should be made. This medication can be risky when taken with certain drugs, so it must not be combined with MAO inhibitors. Patients with severe glaucoma or cardiovascular diseases, patients with pheochromocytoma, and others should not take this medication. Allergic reactions may occur, so if symptoms such as rash, hives, or difficulty breathing appear, immediate medical attention should be sought. Patients with pre-existing heart conditions or fluctuations in blood pressure and heart rate should regularly check their heart rate and blood pressure before and after taking this medication. This medication has not been established as safe and effective for children under 6 years of age, hence it should not be used in this population. Women who are pregnant or nursing should avoid taking this medication due to potential risks to the fetus and the baby. Symptoms such as drowsiness, fatigue, and dizziness may occur during treatment, necessitating caution when driving or operating machinery. In cases of overdose, gastrointestinal disturbances, drowsiness, tremors, and abnormal behavior may manifest; therefore, the dosage must be strictly adhered to. Prolonged use may result in growth delay, and regular checks of the growth status should be made, and caution should be exercised in patients with a history of psychotic symptoms or seizures. Finally, this medication should be taken strictly according to the prescription and instructions of a healthcare provider, and any unusual symptoms should be reported immediately.

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

This medication should be stored in a sealed container to protect it from air and moisture. Moreover, the medication should be kept at room temperature below 25 degrees Celsius to maintain its efficacy for a longer time.

Appearance

Blue opaque hard capsule with a white powder filling

Package unit

28 capsules (14 capsules/PTPX2)/carton