Product Overview
【Drug Name】
Generic Name: Atomoxetine Hydrochloride Capsules
English Name: Atomoxetine Hydrochloride Capsules
Pinyin: YanSuanTuoMoXiTingJiaoNang
【Ingredients】
[Chemical Name](-)-N-methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride
[Molecular Formula]C17H21NO·HCl
[Molecular Weight]291.82
【Indications】
Atomoxetine hydrochloride is used to treat attention deficit hyperactivity disorder (ADHD) in children and adolescents.
【Dosage and Administration】
Dosage for children and adolescents weighing less than 70 kg: Initially, the total daily dose of atomoxetine hydrochloride should be approximately 0.5 mg/kg, and after a minimum dose of 3 days, the dose should be increased until the total target daily dose is approximately 1.2 mg/kg, which can be taken once daily in the morning or divided into two doses, one in the morning and one in the evening. No additional benefit was observed at doses exceeding 1.2 mg/kg/day.
For children and adolescents, the maximum daily dose should not exceed 1.4 mg/kg or 100 mg, whichever is smaller. Dosage for children, adolescents, and adults weighing over 70 kg: The initial total daily dose of atomoxetine hydrochloride should be 40 mg, increasing the dose after 3 days of the lowest possible dose to a total target daily dose of approximately 80 mg, taken as a single dose in the morning or divided into two doses, one in the morning and one in the evening. If optimal efficacy is not achieved after 2 to 4 weeks of continued use, the maximum daily total dose may be increased to 100 mg. There is no data to support that higher doses increase efficacy.
For children and adolescents weighing over 70 kg, and adults, the maximum recommended daily total dose is 100 mg.
General usage notes: Atomoxetine hydrochloride can be taken with or without food; single doses exceeding 120 mg have not been systematically evaluated.
【Adverse Reactions】
In clinical trials, the most common reasons for patient discontinuation included aggression, irritability, drowsiness, and vomiting. The most common adverse reactions included indigestion, nausea, vomiting, fatigue, decreased appetite, dizziness, and mood instability. In addition to the adverse reactions observed in children and adolescents, adults may experience dry mouth, erectile dysfunction, impotence, and abnormal orgasms.
【Contraindications】
This drug is contraindicated in patients with angle-closure glaucoma, as it increases the risk of mydriasis. In addition, this drug should not be used concurrently with monoamine oxidase inhibitors (MAOIs); if an MAOI must be administered, it should only be used two weeks after discontinuing the MAOI. This drug is contraindicated in patients with known hypersensitivity to any of its components or other components of the inhibitor.
【Precautions】
Serum concentrations of this drug may be higher in individuals with poor CYP2D6 metabolism than in normal individuals. Therefore, a reduced dosage is necessary. Clinical trials have found that this drug may slow normal growth in height and weight in children. Rare allergic reactions such as angioedema, urticaria, and rash may occur.
【Pharmacological Action】
This drug selectively inhibits the reuptake of norepinephrine in the brain. Increased norepinephrine in the prefrontal cortex helps improve attention and memory, and over time, it can also cause desensitization of β-adrenergic receptors. This drug has little effect on serotonin or dopamine receptors.
【Storage】
Store at room temperature; temperatures may vary between 15 and 30°C.
【Specifications】
10mg (calculated as C17H21NO)
【Shelf Life】
24 months
【Approval Number】
National Drug Approval Number H20120098
【Manufacturer】
Company Name: Tianfang Pharmaceutical Co., Ltd.
