Domotin Capsule 10 mg (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 and 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. Patients with hepatic impairment 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 renal impairment 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. Continuation/long-term treatment 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. General dosage information 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. Dosage adjustment for concomitant use with strong CYP2D6 inhibitors For adults and children weighing 70 kg or more 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

Dosage for 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. The safety and efficacy of this drug in children under 6 years of age have not been established. Therefore, this drug should not be used in children under 6 years of age. For children weighing up to 70 kg receiving strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, and quinidine), 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.

This medication may cause suicidal behavior; hence, particularly in pediatric patients, signs of suicidal thoughts or behaviors should be monitored carefully. During treatment with this medication, aggressive or emotionally unstable behavior may occur; if such symptoms arise, consult a healthcare professional immediately. Due to the risk of serious liver damage, if symptoms of liver dysfunction (e.g., jaundice, itching, dark urine) occur, discontinue the medication and seek medical attention immediately. This medication should not be used in patients with allergic reactions to it or with certain heart diseases, glaucoma, pheochromocytoma, or cardiovascular diseases. It may interact with other medications, so inform your doctor or pharmacist if you are taking any other drugs. Safety and efficacy in children under 6 years have not been established, so its use is not recommended in this age group. Pregnant or breastfeeding women should consult a healthcare professional before using this medication. This medication may cause drowsiness or fatigue; caution is advised when driving or operating hazardous machinery. Long-term use may result in growth delays or weight changes, so regular monitoring of growth is advised. If seizure symptoms appear or pre-existing seizures worsen while taking this medication, consult a healthcare professional immediately. In case of overdose, gastrointestinal disturbances, drowsiness, tremors, and abnormal behavior may occur, so do not exceed the recommended dose without medical advice. Regular measurement of blood pressure and heart rate is necessary while taking this medication, and if symptoms related to the heart occur, seek medical attention immediately. It is advisable to taper the dosage gradually when discontinuing this medication to avoid sudden withdrawal.

• suicidal attempts
• suicidal thoughts
• aggression
• defiant behavior
• anger
• liver damage
• increased liver enzymes
• jaundice
• itching
• angioedema

Store this medication in a tightly closed container to prevent air and moisture from entering. Additionally, avoid storing it in extremely hot or cold places, maintaining a cool temperature between 1°C and 25°C.

Appearance

A hard capsule with white powder filled in the upper and lower white parts.

Package unit

30 capsules (10 capsules/PTP x 3)