Strattera Capsule 10mg (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. 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. 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. 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 more than 70kg 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 suicidal behavior may occur during treatment, so patients and guardians should closely observe for such symptoms. Moreover, aggressive or emotionally unstable behavior may occur, so if such changes occur, it is essential to consult healthcare professionals immediately. Due to the risk of liver damage, if symptoms such as jaundice, itching, dark urine, or pain in the right upper abdomen appear, discontinue the medication and inform the doctor. This medication should not be combined with certain drugs, especially monoamine oxidase inhibitors (MAOIs), as serious side effects can occur, so be sure to consult with healthcare professionals. It should not be administered to patients with glaucoma, pheochromocytoma, or severe cardiovascular disease, and if any of these conditions exist, it is essential to inform the doctor. Allergic reactions may occur, so immediate treatment is required if symptoms like rash, hives, or difficulty breathing occur. There is a risk of cardiac problems, blood pressure, and increased heart rate, so regular monitoring of blood pressure and heart rate is necessary, and any abnormalities should be discussed with healthcare providers. Safety and efficacy have not been established in children under 6 years old, and growth and development status should be closely monitored. Psychotic symptoms, mania, or seizures may occur, so consult a doctor if such symptoms appear. Caution is needed while driving or operating hazardous machinery, as drowsiness or fatigue may increase. Pregnant or nursing women should avoid using this medication, and consult healthcare providers if planning for pregnancy or already pregnant. In case of drug overdose, seek medical care immediately for appropriate treatment; gastric lavage or supportive care may be necessary depending on the symptoms. The long-term use of this medication should be regularly evaluated for efficacy and safety, and dosage adjustments or discontinuation should be considered if adverse reactions occur. Finally, regular monitoring and consultation with healthcare professionals are necessary while taking this medication, and any unusual symptoms should be reported immediately.

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

This medication can be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it should be kept in a cool place below room temperature (25 degrees Celsius) to maintain its effectiveness.

Appearance

A hard capsule with a white body and a white cap filled with white powder

Package unit

28 capsules (14 capsules/PTPX2) / carton