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Tomoxetine hydrochloride capsule (zesta)

For the treatment of attention deficit / hyperactivity disorder (ADHD) in children and adolescents. More role
App download minus 10 yuan
Common name:
Atomoxetine Hydrochloride Capsules
Product No.:
C14200011906
Approval No.:
H20160115 (inquired by the State Drug Administration)
Jianke price:
¥195.65
Product specification:
40mg * 7 capsules (100ml:400mg,4mg/mL)*100ml 10mg*7s 25mg*7s
Manufacturer:
Lilly del Caribe Inc. (USA)
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Product name Tomoxetine hydrochloride capsule (zesta)
Main raw materials The main component of this product is tomoxetine hydrochloride.
Main role For the treatment of attention deficit / hyperactivity disorder (ADHD) in children and adolescents.
Product specification 25mg*7s
Usage and dosage For children and adolescent patients whose weight is less than 70kg, the initial total daily dose can be 0.5mg/kg, which will increase to 1.2mg/kg after 3 days. The total daily dose can not exceed 1.4mg/kg or 100mg for single or divided medication. In addition, for children and adolescent patients weighing more than 70kg, the total daily initial dose of the product can be 40mg / D, which can be increased to the target dose of 80mg / d after 3 days. The total daily dose can not exceed 100mg for single or multiple doses. The product does not need to be gradually reduced when it is stopped.
manufacturing enterprise Lilly del Caribe Inc. (USA)
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[drug name] Tomoxetine hydrochloride capsule (zesta)

[common name] Atomoxetine Hydrochloride Capsules

[specification and model] 25mg*7s

[manufacturer] Lilly del Caribe Inc. (USA)

[drug type] Western medicine

[approval No.] H20160115

[validity period] 36 months

[functional indications] For the treatment of attention deficit / hyperactivity disorder (ADHD) in children and adolescents.

[usage and dosage] For children and adolescent patients whose weight is less than 70kg, the initial total daily dose can be 0.5mg/kg, which will increase to 1.2mg/kg after 3 days. The total daily dose can not exceed 1.4mg/kg or 100mg for single or divided medication. In addition, for children and adolescent patients weighing more than 70kg, the total daily initial dose of the product can be 40mg / D, which can be increased to the target dose of 80mg / d after 3 days. The total daily dose can not exceed 100mg for single or multiple doses. The product does not need to be gradually reduced when it is stopped.

[adverse reactions] Tomoxetine hydrochloride has been clinically studied in 2067 children or adolescents with ADHD and 270 adults with ADHD. In the ADHD clinical trial, 169 patients were treated for more than 1 year and 526 patients were treated for more than 6 months. The data and contents in the following table are not suitable for predicting the incidence of adverse reactions in general medical practice, because the characteristics of patients and other factors are different from those in clinical trials. Similarly, the incidence of adverse reactions cited cannot be compared with the data of clinical studies using other treatments, means or eyelids. The data cited provide some basis for prescription doctors to estimate the relative impact of drug and non drug factors on the incidence of adverse events in the study population. Clinical trials in children and adolescents: in the children and adolescents study, the reasons for discontinuation of treatment due to adverse time - in the short-term children and adolescents placebo-controlled study, 3.5% (15 / 427) in the tomoxetine treatment group and 1.4% (4 / 294) in the placebo group discontinued treatment due to adverse events. In all studies (including open and long-term studies), 5% of patients with strong metabolism (EM) and 7% of patients with weak metabolism (PM) discontinued the study due to adverse events. Among the patients treated with atomoxetine hydrochloride, the reasons for more than one patient to stop treatment were aggressive behavior (0.5%, n = 2), irritability (0.5%, n = 2), drowsiness (0.5%, n = 2) and vomiting (0.5%, n = 2).

[precautions] If combined with CYP2D6 inhibitors such as paroxetine, fluoxetine and quinidine, this product can increase the blood concentration of tomoxetine hydrochloride; Combined with salbutamol, it can accelerate heart rate and increase blood pressure. Moderate and severe liver dysfunction and CYP2D6 metabolic enzyme deficiency should be reduced as appropriate. Please read the instructions carefully and follow the doctor's advice.

[taboo] Allergy: toloxetine hydrochloride is prohibited for patients known to be allergic to toloxetine or other components of the product (see warning). Monoamine oxidase inhibitor (MAOI): atomoxetine hydrochloride should not be combined with MAOI or used within two weeks after stopping MAOI. Similarly, MAOI treatment should not begin within 2 weeks of discontinuation of tomoxetine hydrochloride. It has been reported that the combination of other drugs affecting the concentration of monoamine in the brain with MAOI can cause serious and sometimes fatal reactions (including high fever, ankylosis, myoclonus, instability of autonomic nervous system function, possible rapid fluctuations of vital signs, and changes in mental state, including extreme agitation that can develop into delirium and coma). Some cases show characteristics similar to malignant syndrome caused by nerve blockers. Such reactions may occur when these drugs are used at the same time or the cleaning period is too short. Narrow angle glaucoma: in clinical studies, the use of tomoxetine hydrochloride is related to the increased risk of pupil dilation. Therefore, this product is not recommended for patients with narrow angle glaucoma.

[listing Permit Holder] Lillydel Caribe Inc. (USA)

[packaging unit] box

[main ingredients] The main component of this product is tomoxetine hydrochloride.

[character] This product is a capsule, and the capsule shell is opaque blue and milky white.

[applicable population] unlimited

[medication for pregnant and lactating women] No adequate and standardized controlled studies were conducted in pregnant women. Tomoxetine hydrochloride should not be used during pregnancy unless the potential benefits to the fetus outweigh the potential risks.

[medication for children] Anyone considering the use of tomoxetine hydrochloride capsule in children or adolescents must weigh the risk of its use against the clinical needs (see warnings on suicidal concept and various warnings). The safety and efficacy of tomoxetine hydrochloride in pediatric patients younger than 6 years old have not been determined. The efficacy and safety of tomoxetine hydrochloride for more than 9 weeks and more than 1 year have not been systematically evaluated.

[medication for elderly patients] The safety and efficacy in elderly patients have not been determined.

[storage] Store at room temperature.

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    Tomoxetine hydrochloride capsule (zesta)

    ¥195.65

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