Hanin Atomoxetine Capsule 80 Milligrams (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) with once-daily administration may take the same dose in 2 divided 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 gradually increased based on 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 showing 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 higher systemic exposure to this medication than healthy subjects (approximately 65% higher); however, there is no difference when exposure is 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 potent CYP2D6 inhibitor (e.g., paroxetine, fluoxetine, and quinidine), this medication 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 medication may be discontinued without dose reduction.

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 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 medicine 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: 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 the dose is gradually increased according to clinical response and tolerability. The recommended maintenance dose is 80mg, and 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 showing increased efficacy at higher doses. 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 70kg: For children weighing up to 70kg who are taking a strong CYP2D6 inhibitor (e.g., paroxetine, fluoxetine, and quinidine), this medicine should be started 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 70kg or more: For children weighing 70kg or more who are taking a strong CYP2D6 inhibitor (e.g., paroxetine, fluoxetine, and quinidine), this medicine should be started 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 cause suicidal behavior, so careful observation for thoughts or attempts of suicide and other risky behaviors should be conducted during treatment. Aggressive or hostile behaviors, as well as an increase in emotional instability, may occur, and any such changes should be reported immediately. It may affect liver function; if symptoms of liver damage, such as jaundice, itching, dark urine, or right upper abdominal pain occur, discontinue use and consult a doctor immediately. This medication may cause serious side effects when combined with certain drugs, so inform your doctor or pharmacist if you are taking other medications. Patients with glaucoma, pheochromocytoma, severe cardiovascular disease should not use this drug, and those with lactose intolerance should also refrain from taking it. Allergic reactions may occur; treatment should be sought immediately for rashes, hives, or difficulty in breathing. Patients with heart disease or problems with blood pressure or heart rate should regularly check their heart rate and blood pressure while taking this medication. Children under the age of 6 should not use this drug as its safety and efficacy have not been established. Long-term use should regularly monitor growth and development, and consult a doctor if there are concerns about insufficient weight gain or height. Psychotic or manic symptoms may appear, so pay close attention to changes in the patient's mental state. Patients with a history of seizures should be cautious as the risk of seizures may increase when using this medication. Drowsiness or fatigue may occur while driving or operating machinery, so caution is needed. In case of overdose, symptoms such as vomiting, drowsiness, tremors, and heart irregularities may appear, necessitating immediate medical attention. Pregnant or breastfeeding women should avoid taking this medication, and consultation with a physician is recommended for those planning to become pregnant. This medication should be taken only according to a doctor's prescription and instructions, and it is important to consult a specialist immediately if unusual symptoms occur.

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

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. It should also be kept in a cool place, maintaining a temperature below 25 degrees.

Appearance

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

Package unit

30 capsules/bottle, 100 capsules/bottle