Hwanin Atomoxetine Capsule 40 mg (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 total dose in 2 divided doses, in the morning and late afternoon or early evening. Dosage for adults and children weighing more than 70 kg: This medicine should be started at a total daily dose of approximately 40mg. The initial dose should be maintained 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 are no data indicating increased efficacy at higher doses. In patients with moderate hepatic impairment (Child-Pugh Class B), the initial and target doses should be reduced to 50% of the usual dose. In 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 medicine than healthy subjects (approximately 65% higher); however, there is no difference when exposure is adjusted for the mg/kg dose. Therefore, patients with ADHD who have end-stage renal disease or mild renal impairment may receive the usual dosage regimen. This medicine may worsen hypertension in patients with end-stage renal disease. Elderly patients: Not applicable. In placebo-controlled studies, there was 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 re-evaluate 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. In adults and children weighing 70 kg or more receiving strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, and quinidine), this medicine should be started at 40mg/day and, if symptoms have not improved after 4 weeks and the initial dose is well tolerated, increased to the target dose of 80mg/day. This medicine may be discontinued without reducing the dose.

Child dose

Children weighing up to 70 kg: This medicine should be started at a total daily dose of approximately 0.5 mg/kg. The initial dose should be maintained 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) 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 medicine should be started at a total daily dose of approximately 40mg. The initial dose should be maintained 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 are no data indicating increased efficacy at higher doses. Children under 6 years of age: The safety and efficacy of this medicine in children under 6 years of age have not been established. Therefore, this medicine 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): This medicine should be started at 0.5mg/kg/day and, if symptoms have not improved after 4 weeks and the initial dose is well tolerated, increased to the target dose of 1.2mg/kg/day.

This medication is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and may result in suicidal behaviors; patients should be monitored carefully. Aggressive or emotionally unstable behaviors may occur during treatment with this medication; attention should be paid to whether such symptoms worsen. Due to the risk of liver damage, if symptoms of liver dysfunction such as jaundice, itching, dark urine, or pain in the upper right abdomen occur, discontinue use immediately and consult a physician. This drug should not be administered in cases of hypersensitivity to it or when taking certain medications (MAO inhibitors), nor to patients with narrow-angle glaucoma, pheochromocytoma, or severe cardiovascular disease. There is a possibility of allergic reactions; if symptoms such as rash or difficulty breathing occur, notify medical personnel immediately. Patients with heart disease or sensitivity to changes in blood pressure and heart rate should monitor their heart rate and blood pressure regularly before and after taking this medication. It should not be used in children under 6 years of age as safety and effectiveness have not been established. This medication may increase the risk of seizures, so it should be used with caution in patients with a history of seizures. Increased drowsiness or fatigue may occur when driving or operating machinery, requiring caution. Pregnant or nursing women are advised not to use this medication and should consult a physician if necessary. This medication may interact with other drugs; therefore, particularly when used concurrently with MAO inhibitors, CYP2D6 inhibitors, and cardiovascular medications, the direction of a physician should be followed. With long-term use, monitoring of growth and development is necessary, and dosage adjustment or temporary discontinuation should be considered if adverse reactions occur. Overdose may cause gastrointestinal disturbances, drowsiness, dizziness, tremors, and behavioral abnormalities; immediate medical attention is required. Capsules of this medication must not be opened; if the contents come into contact with the eyes, rinse immediately with clean water and seek medical attention.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. Additionally, it is best to store the medication at room temperature, below 25 degrees Celsius.

Appearance

A hard capsule with a blue upper part and a blue lower part containing a white powder

Package unit

30 capsules/bottle, 100 capsules/bottle