Domotin Capsule 40mg (Atomoxetine Hydrochloride)

Adult dose

This drug 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 total dose divided into two doses, in the morning and late afternoon or early evening. Dosage for adults: Treatment with this drug should be initiated at a total daily dose of approximately 40mg. The initial dose should be maintained for at least 7 days before the dose is gradually increased according to clinical response and tolerability. The recommended maintenance dose is 80mg; in patients who do not respond adequately, the dose may be increased to a maximum of 100 mg after 2∼4 weeks. There are no data indicating increased efficacy 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. Patients with end-stage renal disease have greater systemic exposure to this drug than healthy subjects (approximately 65% higher), but there is no difference when exposure is adjusted for mg/kg dose. Therefore, this drug may be administered at the usual dosage to patients with ADHD who have end-stage renal disease or mild renal impairment. This drug may worsen hypertension in patients with end-stage renal disease. Older patients: Not applicable. In placebo-controlled studies, there was no useful evidence indicating how long patients with ADHD should be treated with this drug. However, it is generally agreed that pharmacological treatment of ADHD should be continued for an extended period. Nevertheless, physicians who decide to use this drug for an extended period should periodically reassess the benefit of long-term use for each patient. This drug 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 strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, and quinidine), this drug 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 drug may be discontinued without dose reduction.

Child dose

Children weighing up to 70 kg: Treatment with this drug 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 the dose is gradually increased 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 drug used) No additional benefit has been demonstrated at doses higher than 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: Treatment with this drug should be initiated at a total daily dose of approximately 40mg. The initial dose should be maintained for at least 7 days before the dose is gradually increased according to clinical response and tolerability. The recommended maintenance dose is 80mg; in patients who do not respond adequately, the dose may be increased to a maximum of 100 mg after 2∼4 weeks. There are no data indicating increased efficacy at higher doses. Children under 6 years of age: The safety and efficacy of this drug have not been established. Therefore, this drug should not be used in children under 6 years of age. Children weighing up to 70 kg receiving strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, and quinidine): Treatment with this drug 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 receiving strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, and quinidine): Treatment with this drug 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 drug is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and can be administered to children and adults. During treatment, suicidal thoughts or behaviors may occur, so especially children and adolescents should be monitored closely for these changes. Aggressive behaviors or emotional instability may increase, so behavioral changes in the patient should be monitored closely. Since this medication may affect liver function, if signs of liver damage appear, discontinue use immediately and consult a healthcare provider. This drug cannot be used in combination with certain medications, especially monoamine oxidase inhibitors (MAOIs). It should not be administered to patients with glaucoma, pheochromocytoma, or severe cardiovascular diseases. Allergic reactions may occur rarely, so if symptoms such as rash or difficulty breathing appear, inform a healthcare provider immediately. Patients with heart disease should be administered carefully, monitoring heart rate and blood pressure changes. Children under 6 years of age should not use this drug due to safety and efficacy not being established. Side effects such as drowsiness, reduced appetite, nausea, abdominal pain, and headache may occur, so symptoms should be observed carefully. Care should be taken when driving or operating machinery; avoid activities if drowsy or dizzy. Pregnant or nursing women are advised not to use this medication. With long-term use, regular checks on growth and development are necessary, as well as ongoing assessment of mental health. In case of overdose, gastrointestinal disturbances, drowsiness, tremors, and mental changes may occur, and immediate emergency treatment should be sought. This drug may interact with other medications; therefore, inform your healthcare provider of any other medications you are taking. Capsules should not be opened, and if the contents come into contact with the eyes, wash immediately with clean water and seek medical attention.

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

This medication should be stored in a tightly closed container to prevent air and moisture from entering. The appropriate storage temperature is in a cool place between 1 degree and 25 degrees.

Appearance

Hard capsule with blue upper and lower part filled with white powder.

Package unit

30 capsules (10 capsules/PTP x 3)