| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
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| product name | Atomoxetine HCl |
| CAS NO. | 82248-59-7 |
| Specification | 99% |
| Appearance | white powder |
| Package | 1KG/Bag,25Kg/drum |
| MOQ | 100g |
Atomoxetine hydrochloride capsules are used to treat attention-deficit/hyperactivity disorder (ADHD) in children and adolescents (6 to 18 years old).
Atomoxetine hydrochloride capsules are mainly used to treat ADHD in some children and adolescents. The positive effect of this drug on children is that it can control the disease, and the negative effect is that it brings some side effects, such as irritability, drowsiness, gastrointestinal discomfort and other symptoms.
1. Irritability: Some children may show some aggressive behaviors after taking it;
2. Drowsiness: Children sleep more after taking the drug, and are often prone to drowsiness and fatigue;
3. Gastrointestinal discomfort: Side effects appear in the gastrointestinal tract, which can be manifested as nausea, vomiting, abdominal pain, etc.;
4. Decreased appetite: Some children may experience decreased appetite and anorexia after taking atomoxetine hydrochloride capsules;
4. Others: The use of this drug may also cause symptoms such as urticaria, abnormal heartbeat, redness of the skin, or muscle spasms, convulsions and other discomforts, but they are all rare symptoms.
Considering the impact of atomoxetine hydrochloride capsules on children, it is usually not recommended for children under 6 years old. When parents take children who need medication to see a doctor, they should also provide details of their allergy history, medical history and other basic information. They should follow the doctor's instructions and be supervised by their parents. They should not stop or increase the dosage at will to prevent the discomfort from worsening.
| Items | Standards | Results |
| Physical Analysis | ||
| Appearance | white powder | Complies |
| Specification | 99% | Complies |
| Mesh Size | 100 % pass 80 mesh | Complies |
| Ash | ≤ 5.0% | 2.85% |
| Loss on Drying | ≤ 5.0% | 2.85% |
| Chemical Analysis | ||
| Heavy Metal | ≤ 10.0 mg/kg | Complies |
| Pb | ≤ 2.0 mg/kg | Complies |
| As | ≤ 1.0 mg/kg | Complies |
| Hg | ≤ 0.1 mg/kg | Complies |
| Microbiological Analysis | ||
| Total Plate Count | ≤ 1000cfu/g | Complies |
| Yeast&Mold | ≤ 100cfu/g | Complies |
| E.coil | Negative | Negative |
| Salmonella | Negative | Negative |
| Conclusion: in conformity with the enterprise standard | ||
Dosage and Administration:
Initial Treatment:
Dosage for Children and Adolescents with a Weight of Less than 70 kg - Initially, the total daily dose of atomoxetine hydrochloride should be approximately 0.5 mg/kg, and after 3 days of the lowest dose, the dose is increased to a total daily target dose of approximately 1.2 mg/kg, which can be taken as a single dose in the morning or divided into 2 doses evenly in the morning and evening. Doses exceeding 1.2 mg/kg/day have not shown additional benefits. 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 with a Weight of More than 70 kg - Initially, the total daily dose of atomoxetine hydrochloride should be 40 mg, and after 3 days of the lowest dose, the dose is increased to a total daily target dose of approximately 80 mg, which can be taken as a single dose in the morning or divided into 2 doses evenly in the morning and evening. After 2-4 weeks of continued use, if optimal efficacy is not achieved, the total daily dose can be increased to a maximum of 100 mg. There is no data to support increased efficacy at higher doses. The maximum recommended total daily dose is 100 mg for children and adolescents weighing more than 70 kg and adults.
Maintenance/Long-term Treatment: There are no controlled trial data to indicate how long atomoxetine hydrochloride should be used in patients with ADHD. However, it is generally believed that ADHD may require long-term drug treatment. If the physician chooses to use atomoxetine hydrochloride long-term, the effectiveness of long-term treatment for the patient should be re-evaluated regularly. Atomoxetine hydrochloride can be taken with or without food. The safety of single doses exceeding 120 mg or total daily doses exceeding 150 mg has not been systematically evaluated.
Dosage Adjustment in Patients with Hepatic Impairment - The following recommendations for dose adjustment are made for ADHD patients with hepatic impairment (HI): For patients with moderate HI (Child-Pugh Class B), the initial and target doses should be reduced to 50% of the usual dose (for patients without HI). For patients with severe HI (Child-Pugh Class C), the initial and target dose should be reduced to 25% of the usual dose (see Special Populations under Pharmacokinetics).
Dose Adjustment for Concomitant Use with Strong CYP 2D6 Inhibitors -Children and adolescents weighing less than 70 kg taking strong CYP 2D6 inhibitors such as paroxetine, fluoxetine, and quinidine should start with 0.5 mg/kg/day of atomoxetine hydrochloride; only increase to the usual target dose of 1.2 mg/kg/day if symptoms do not improve after 4 weeks and the initial dose is well tolerated. Children, adolescents, and adults weighing more than 70 kg taking strong CYP 2D6 inhibitors such as paroxetine, fluoxetine, and quinidine should start with 40 mg/day of atomoxetine hydrochloride; only increase to the usual target dose of 80 mg/day if symptoms do not improve after 4 weeks and the initial dose is well tolerated. When stopping treatment, no gradual reduction is required.
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