Risperidone dispersible tablets

1. Pharmacological action Risperidone is a selective monoamine antagonist with high affinity for 5HT2 receptors, D2 receptors, α1 and α2 receptors and H1 receptors. It also has antagonistic effects on other receptors, but they are weaker. It has low to moderate affinity for 5HT1C, 5HT1D and 5HT1A, weak affinity for D1 and haloperidol-sensitive σ receptors, and no affinity for M receptors or β1 and β2 receptors. Like other drugs for the treatment of schizophrenia, the mechanism of risperidone in the treatment of schizophrenia is still unclear. It is believed that its therapeutic effect is the result of the combined effect of antagonism on D2 receptors and 5HT2 receptors. The antagonism of receptors other than D2 and 5HT2 may be related to other effects of risperidone. See the instructions for details.

Risperidone tablets are white film-coated tablets, which appear white after removing the coating.

1. Used to treat acute and chronic 1. Schizophrenia and other various psychotic states with obvious positive symptoms (such as hallucinations, delusions, disordered thinking, hostility, suspicion) and obvious negative symptoms (such as slow reaction, emotional indifference and social indifference, few words); 2. It can also relieve emotional symptoms related to schizophrenia (such as depression, guilt, anxiety); 3. For patients who are effectively treated in the acute phase, this product can continue to exert its clinical efficacy in the maintenance phase of treatment.

1. Schizophrenia: For patients who switch to this product from other antipsychotics: When starting to use it, the original antipsychotic should be gradually discontinued. If the patient was originally using a long-acting antipsychotic, this product can be used to replace the next course of medication. Whether the anti-Parkinson's syndrome drugs already used need to be continued should be reassessed regularly. 　　Adults: once a day or twice a day. The initial dose is 1 mg, and the dose is gradually increased to 2-4 mg per day within about 1 week. In the second week, the dose can be gradually increased to 4-6 mg per day. Thereafter, this dose can be maintained unchanged, or further adjusted according to personal circumstances. In general, the optimal dose is 2-6 mg per day. The daily dose generally does not exceed 10 mg. 　　2. Treatment of manic episodes of bipolar disorder: Recommended

The safety of this product was evaluated in a clinical trial. 9712 patients with different types of mental illness (including adults, elderly patients with dementia and children) received at least one dose of this product. Among them, 2626 patients received this product when participating in double-blind, placebo-controlled trials. There are great differences in treatment conditions and duration, including double-blind, quantitative and non-quantitative, placebo or active control trials and open-label trials for inpatients and outpatients, short-term (up to 12 weeks) and long-term (up to 3 years) administration (cross-classification). See the instructions for details.

Patients who are allergic to this product are contraindicated.

Precautions for children: For schizophrenia, there is currently a lack of sufficient clinical experience in children under 15 years old. For conduct disorders and other behavioral disorders, there is currently a lack of sufficient clinical experience in children under 5 years old. For manic episodes of bipolar disorder, there is currently a lack of sufficient clinical experience in children under 18 years old and adolescents. Precautions for pregnancy and lactation: It is not clear whether this product is safe for pregnant women to take. Animal experiments have shown that risperidone has no direct toxicity to reproduction, and only some indirect prolactin and central nervous system-mediated effects have been observed. This product has no teratogenic effect. In the last three months of pregnancy, fetuses exposed to antipsychotic drugs (including risperidone) are at risk of developing extrapyramidal symptoms or withdrawal symptoms after birth, which may vary in severity. These symptoms include agitation, hypertonia, hypotonia, tremor, drowsiness, respiratory distress and eating disorders. For pregnant women, the pros and cons should be weighed to decide whether to take this product. Animal experiments have shown that risperidone and 9-hydroxyrisperidone are excreted in animal milk. At the same time, human trials have also proven that this product is excreted through breast milk, so women taking this product should not breastfeed. Elderly precautions: Treatment of schizophrenia: The recommended starting dose is 0.5 mg each time, twice a day, and the dose can be adjusted according to individual needs. The dose increase range is 0.5 mg each time, twice a day, until 1-2 mg each time, twice a day.

1. In view of the effect of this product on the central nervous system, caution should be exercised when it is used in combination with other drugs that act on the central nervous system. 2. This product can antagonize the effects of levodopa and other dopamine agonists. 3. Clinically significant hypotension has been observed when used in combination with antihypertensive drugs after marketing. 4. Caution should be exercised when used in combination with drugs known to prolong the QT interval. 5. Carbamazepine and other CYP3A4 liver enzyme inducers will reduce the plasma concentration of the active ingredient of this product. When starting or stopping carbamazepine or other CYP3A4 liver enzyme inducers, the dosage of this product should be re-determined. 6. Fluoxetine and paroxetine (CYP2D6 inhibitors) can increase the blood concentration of this product, but have little effect on the blood concentration of its antipsychotic active ingredient. When starting or

seal.

1mg

24 months

Jiangsu Nhwa Pharmaceutical Co., Ltd.

• Founded in:

  1999-03-29

• Address:

  No. 18, Yangshan Road, Xuzhou Economic and Technological Development Zone

• Tax NO.:

  913203001363846728

• Registered Funds:

  1016.176792 million yuan

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