Product Overview
【Drug Name】
Generic Name: Atomoxetine Hydrochloride Capsules
Brand Name: Zhengding
English Name: Atomoxetine Hydrochloride Capsules
Pinyin: YanSuanTuoMoXiTingJiaoNang
【Ingredients】
The main ingredient of this product is atomoxetine hydrochloride.
【Indications】
Atomoxetine is used to treat attention deficit hyperactivity disorder (ADHD) in children and adolescents.
【Dosage and Administration】
Initial treatment dosage for children and adolescents weighing less than 70 kg: The initial total daily dose of atomoxetine hydrochloride should be approximately 0.5 mg/kg, and after 3 days of the lowest dose, the dose should be increased to the total target daily dose of approximately 1.2 mg/kg, which can be taken once daily in the morning or divided into two equal doses in the morning and evening. No additional benefit has been shown for 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 less. Dosage for children and adolescents weighing over 70 kg: The initial total daily dose of atomoxetine hydrochloride should be 40 mg, and the dose should be increased after 3 days of the lowest dose to a total target daily dose of approximately 80 mg.
【Adverse Reactions】
See package insert for details.
【Contraindications】
Hypersensitivity: Atomoxetine hydrochloride is contraindicated in patients with known hypersensitivity to atomoxetine or any other component of this product (see Warnings). Monoamine oxidase inhibitors (MAOIs): Atomoxetine hydrochloride should not be used in combination with MAOIs, or within two weeks of discontinuing MAOIs. Similarly, MAOI treatment should not be initiated within two weeks of discontinuing atomoxetine hydrochloride. There have been reports of other drugs affecting monoamine concentrations in the brain causing serious, sometimes fatal, reactions when used in combination with MAOIs (including high fever, rigidity, myoclonus, autonomic instability, potentially rapid fluctuations in vital signs, and altered mental status, including extreme agitation that can develop into delirium and coma). Some cases have presented with characteristics similar to malignant syndromes induced by neuroleptic blockers. These reactions may occur with these medications.
【Precautions】
See package insert for details.
【Special Populations】
Precautions for children: Anyone considering the use of atomoxetine hydrochloride capsules in children or adolescents must weigh the risks against the clinical need (see the warnings regarding suicidal ideation and various other warnings). The safety and efficacy of atomoxetine hydrochloride in pediatric patients under 6 years of age have not been established. The efficacy and safety of atomoxetine hydrochloride treatment for more than 9 weeks and 1 year have not been systematically evaluated. Studies evaluating the effects of atomoxetine on growth, neurobehavioral development, and sexual development have been conducted in young rats. By tube feeding, from early postnatal (10 days old) through adulthood, rats were given atomoxetine at doses of 1, 10, and 50 mg/kg/day (approximately 0.2, 2, and 8 times the highest human dose, respectively). Vaginal non-closure was observed (at all doses).
Pregnancy and lactation precautions:
Pregnancy: There are no adequate and well-established controlled studies in pregnant women. Atomoxetine hydrochloride should not be used during pregnancy unless the potential benefits to the fetus outweigh the potential risks. Parturition in rats was not affected by atomoxetine. The effects of atomoxetine hydrochloride on human parturition are currently unknown. Atomoxetine and/or its metabolites are excreted in the milk of rats. It is currently unknown whether atomoxetine is excreted in human milk. Atomoxetine hydrochloride should be used with caution in breastfeeding mothers.
【Specifications】
10mg*10 tablets
【Packaging Specifications】
Box
【Shelf Life】
24 months
【Approval Number】
National Drug Approval Number H20133346
【Manufacturer】
Company Name: Jiangsu Zhengda Fenghai Pharmaceutical Co., Ltd.
