Strattera Capsule 80mg (Atomoxetine Hydrochloride)

Adult dose

This medicine 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) with once-daily administration may take the same dose in divided doses twice daily, in the morning and late afternoon or early evening. Dose in adults: Start this medicine at a total daily dose of approximately 40mg. Maintain the initial dose for at least 7 days before gradually increasing the dose 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), reduce the initial and target doses to 50% of the usual doses. For patients with severe hepatic impairment (Child-Pugh Class C), reduce the initial and target doses to 25% of the usual doses. Patients with end-stage renal disease have greater systemic exposure to this medicine than healthy subjects (approximately 65% higher), but there is no difference when exposure is adjusted for mg/kg dose. Therefore, this medicine may be administered at the usual dosage to patients with ADHD who have end-stage renal disease or mild renal impairment. This medicine may worsen hypertension in patients with end-stage renal disease. Elderly patients: Not applicable. In placebo-controlled studies, there is no useful evidence indicating how long patients with ADHD should be treated with this medicine. However, it is generally agreed that pharmacological treatment of ADHD should continue for an extended period. Nevertheless, physicians who decide to use this medicine for an extended period should periodically reassess the benefits of long-term use for each patient. This medicine 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 potent CYP2D6 inhibitor (e.g., paroxetine, fluoxetine, and quinidine), start this medicine at 40mg/day. If symptoms have not improved after 4 weeks and the initial dose is well tolerated, increase to the target dose of 80mg/day. This medicine may be discontinued without dose reduction.

Child dose

Children weighing up to 70 kg: Start this medicine at a total daily dose of approximately 0.5 mg/kg. Maintain the initial dose for at least 7 days before gradually increasing the dose according to clinical response and tolerability. The recommended maintenance dose is approximately 1.2mg/kg/day (depending on the patient's body weight and the strength of this medicine used). No additional benefit has been demonstrated at doses higher than 1.2 mg/kg/day. Do not exceed a total daily dose of 1.4mg/kg or 100mg in children. Adults and children weighing more than 70 kg: Start this medicine at a total daily dose of approximately 40mg. Maintain the initial dose for at least 7 days before gradually increasing the dose 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 medicine have not been established in children under 6 years of age. Therefore, this medicine should not be used in children under 6 years of age. Children weighing up to 70 kg who are receiving a potent CYP2D6 inhibitor (e.g., paroxetine, fluoxetine, and quinidine): Start this medicine at 0.5mg/kg/day. If symptoms have not improved after 4 weeks and the initial dose is well tolerated, increase to the target dose of 1.2mg/kg/day. Children weighing 70 kg or more who are receiving a potent CYP2D6 inhibitor (e.g., paroxetine, fluoxetine, and quinidine): Start this medicine at 40mg/day. If symptoms have not improved after 4 weeks and the initial dose is well tolerated, increase to the target dose of 80mg/day.

This medication may cause suicidal behavior, so careful monitoring for thoughts or attempts of suicide is necessary, especially in pediatric patients. Aggressive or hostile behaviors and emotional instability may occur during treatment, and should these symptoms arise, immediate consultation with a healthcare professional is necessary. Due to the risk of liver damage, if symptoms of liver dysfunction (e.g., jaundice of the skin or eyes, changes in urine color, pain in the upper right abdomen) occur, discontinue use immediately and consult a doctor. This medication should not be used in patients with a known allergy to its ingredients, those with certain heart diseases, glaucoma, or pheochromocytoma, and should not be used in conjunction with MAO inhibitors. Patients with heart disease or hypertension must consult their doctor before taking this medication and should regularly monitor blood pressure and heart rate during treatment. This medication can affect growth and development, so the growth of children should be periodically monitored during long-term use. Patients with a history of psychotic symptoms, mania, or seizures require careful observation while taking this medication. It is not safe to use in children under 6 years of age. Drowsiness or fatigue may increase during treatment, so caution is advised when driving or operating hazardous machinery. There may be interactions with other medications, so inform your doctor or pharmacist of any other medications being taken. Pregnant or nursing women should avoid using this medication, especially during nursing as the drug may be excreted in breast milk. In case of overdose, gastrointestinal disturbances, drowsiness, tremors, and abnormal behavior may occur, and immediate medical attention should be sought.

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

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is advisable to store the medication at room temperature, specifically below 25 degrees Celsius, for safe storage.

Appearance

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

Package unit

28 capsules (14 capsules/PTPX2)/carton