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Tomoxetine Hydrochloride Oral Solution Instructions
Please read the instructions carefully and use under the guidance of your physician
[Medication Name].
Generic Name:Tomoxetine Hydrochloride Oral Solution
Trade Names:Zestat® , Strattera®
English Name:Atomoxetine Hydrochloride Oral Solution
Hanyu Pinyin: Yansuan Tuomoxiting Koufurongye
[Ingredients].
Chemical Name: (-)-N-methyl-3-phenyl-3-(O-toluene-oxy)propylamine hydrochloride
Chemical structure formula.
Molecular formula: C17H21NO-HCl
Molecular weight: 291.82
[Properties] This product is a colorless to almost colorless clarified liquid.
[Indications]
This product is used for the treatment of 6years andyears and6year-old children and adolescents with attention deficit/hyperactivity disorder(ADHD) .
[Specifications]100ml: 400mg,4 mg/mL (based on C17H21NO)
[Dosage]
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For oral use. This product can be taken alone or with food. Mixing this product in food or water is not recommended as it may prevent the patient from receiving the full dose or have a negative impact on taste.
Dosage
This product is administered as a single dose daily in the morning. Satisfactory clinical effects were not achieved with once daily dosing (tolerability[such as nausea or drowsiness]or efficacy) patients, to morning and afternoon/evening divided into two doses in the evening may achieve satisfactory clinical results.
Dosage for children and adolescents weighing less than 70 kg.
The initial dose of this product is0.5 mg/kg/day. This initial dose should be maintained for at least 7 days and then increased based on treatment response and tolerability. The recommended maintenance dose is 1.2 mg/kg/day (depending on the patient’s body weight and available dosage specifications for tomoxetine). Doses above1.2 mg/kg/day did not show additional benefit. Single doses above1.8 mg/kg or total daily doses above1.8mg/kgfor safety. In some cases, treatment can be continued until the patient reaches adulthood.
For ease of administration, this product is packaged in an oral delivery device consisting of a10 mL oral syringe (in 1 mLin graduated units) and a press-in bottle adapter.
This product should be administered according to the following table: “font-family:Times New Roman”>
Weight rangestarting dosetarget dose(Kg ) (mL/day)(mL/day)16 – 182 5 19 2 6 20 – 21 3 6 22 – 24 3 7 25 – 28 3 8 29 – 31 4 9 32 – 34 4 10 35 4 11 36 – 38 5 11 39 – 41 5 12 42 – 44 5