1) drug name
1. Generic name: risperidone orally disintegrating tablets.
2. Product name: same.
2) Appropriate diseases
Can be used for treating acute and chronic schizophrenia and other psychotic states with obvious positive symptoms (such as hallucination, delusion, thinking disorder, hostility and suspicion) and obvious negative symptoms (such as unresponsiveness, emotional and social apathy, and reticence).
It can also be used to relieve emotional symptoms related to schizophrenia (such as depression, guilt and anxiety). For patients with effective treatment in acute phase, this product can continue to play its clinical effect in maintenance period.
3) Usage and dosage
When taking risperidone orally disintegrating tablets, put the tablets on your tongue and disintegrate in a few seconds. You can swallow them without water (or water).
Those who switch from other antipsychotics to this product: When starting to use, the original antipsychotics should be gradually stopped. If the patient initially uses long-acting antipsychotic drugs, this product will be used instead of drug treatment every time. Whether the used anti-Parkinson's drugs need to be used continuously should be re-evaluated regularly.
1. Adult: 65438+ 0 times a day or twice a day. The recommended initial dose is 1 mg, twice a day, and the next day it is increased to 2 mg, twice a day; If it can be tolerated, it can be increased to 3 mg each time on the third day, twice a day. After that, this dose can be kept unchanged or further adjusted according to individual circumstances.
The clinical trial of 1-2 years shows that the effective dose of risperidone to delay the recurrence of schizophrenia is 2-8 mg per day, which also proves the effectiveness and safety of taking 1 time per day. The initial dose was 1mg/ day, which was increased to 2mg/ day on the second day and 4mg/ day on the third day. After that, this dose can be maintained or further adjusted according to personal circumstances.
Clinicians should re-evaluate patients regularly to determine the necessity of proper dose maintenance treatment.
No matter what mode of administration is adopted, some patients should be adjusted slowly, and the interval of adjustment is generally not less than 1 week. During the adjustment, the suggested dosage range is 1-2 mg.
The maximum effective dose range of risperidone is 4-8 mg per day, but it needs to be administered twice a day. If the daily dose exceeds 6 mg, it cannot be proved to be more effective than the lower dose, and it is related to more extrapyramidal symptoms and other side effects, so it is generally not recommended. Since the safety of drugs with a daily dose greater than 16 mg has not been evaluated, the daily dose should not exceed 16 mg.
When it is necessary to strengthen sedation, benzodiazepines can be added.
2. Elderly people: It is recommended that the initial dose be 0.5 mg each time, twice a day. According to individual needs, the dosage is gradually increased to 1-2 mg each time, twice a day. Dose adjustment interval should not be less than 1 week, and the dose increase and decrease range should be 0.5 mg each time, twice a day. Before gaining more experience, the elderly should use risperidone with caution.
3. Liver and kidney diseases: It is recommended that the initial dose be 0.5 mg each time, twice a day. According to individual needs, the dosage is gradually increased to 1-2 mg each time, twice a day. Dose adjustment interval should not be less than 1 week, and the dose increase and decrease range should be 0.5 mg each time, twice a day. The clinical experience of these patients is limited, so medication should be cautious.
4) Adverse reactions
1. Common adverse reactions related to taking this product: insomnia, anxiety, agitation, headache and dry mouth.
2. Rare adverse reactions: drowsiness, fatigue, decreased attention, constipation, nausea, vomiting, indigestion, abdominal pain, blurred vision, abnormal erection of penis, erectile dysfunction, ejaculation weakness, frigidity, urinary incontinence, rhinitis, rash and other allergic reactions.
3. It may cause extrapyramidal symptoms, such as muscle tension, tremor, rigidity, salivation, bradykinesia, akathisia and acute dystonia. It can be eliminated by reducing the dose or taking anti-Parkinson's drugs.
4. Occasionally appear (postural) hypotension, (reflex) tachycardia or hypertension symptoms.
5. There will be weight gain, edema, and elevated liver drug enzyme levels.
6. In foreign clinical research, it is reported that the incidence of cerebrovascular adverse events, such as stroke and transient ischemic attack, including death events, in patients with senile dementia-related mental symptoms (average age 85 years old) treated with risperidone tablets is significantly higher than that of placebo.
Therefore, elderly patients with dementia-related mental symptoms may increase the risk of cerebrovascular adverse events when using this product, so it should be used with caution.
7. Occasionally, water poisoning may be caused by the patient's thirst or improper secretion of antidiuretic hormone (SIADH).
8. It will increase the concentration of prolactin in plasma, and its related symptoms are: galactorrhea, male and female breasts, menstrual disorder and amenorrhea.
9. Occasionally cause tardive dyskinesia, malignant syndrome, body temperature disorder and seizures.
10. There is a case report of a slight decrease in neutrophil and/or platelet count. Rare report of hyperglycemia and diabetes aggravation.
5) Precautions
1. Patients with cardiovascular diseases (such as heart failure, myocardial infarction, abnormal conduction, dehydration, blood loss, cerebrovascular diseases, etc.) should use it with caution, starting with a small dose and gradually increasing the dose (see "Usage and Dosage").
2. Because this product has α receptor blocking activity, postural hypotension will appear at the initial stage of administration and when the administration speed is too fast, so the dosage should be reduced.
3. Similar to other drugs with dopamine receptor antagonism, it can cause tardive dyskinesia with rhythmic voluntary movement, mainly in the tongue and face. If tardive dyskinesia occurs, all antipsychotics should be stopped.
4. It is reported that taking classic antipsychotic drugs will lead to malignant syndrome, which is characterized by high fever, trembling, consciousness change and increased creatine phosphatase level. At this time, all antipsychotic drugs including this product should be stopped.
5. Patients with Parkinson's syndrome should use this product with caution, because in theory, this drug will worsen the condition.
6. Classic antipsychotics will lower the threshold of epilepsy, so patients with epilepsy should use this product with caution.
7. Patients taking this product should avoid overeating to avoid getting fat.
8. In view of the influence of this product on the central nervous system, caution should be exercised when taking it together with other drugs acting on the central nervous system.
9. This product has an impact on activities that need vigilance. Therefore, patients are advised not to drive or operate machines until they know their sensitivity to drugs.
10. In the placebo-controlled clinical study of senile dementia patients (average age 85 years old, range 73-97 years old), it was found that the incidence of adverse events of cerebrovascular diseases in risperidone group was higher (3.3%), including cerebrovascular accidents, heart failure and transient ischemic attack, which was three times higher than that in placebo group (1.2%).
The study also found that the mortality rate of patients who used risperidone or furosemide at the same time was higher than that of patients who used risperidone or furosemide alone, which were 7.3% (average age 89 years, ranging from 75 to 97 years old), 3. 1% (average age 84 years, ranging from 70 to 96 years old) and 4. 1% (respectively).
Of the four clinical studies completed, two found the above situation. No pathophysiological evidence has been found to explain the above findings, and there is no fixed model for the cause of patients' disability. Nevertheless, it is necessary to carefully evaluate the risks and benefits of the combination of risperidone and furosemide for the above patients.
In patients taking risperidone combined with other diuretics, the above mortality did not increase. But for Alzheimer's patients, dehydration is a very important fatal factor, so diuretics should be avoided as much as possible.
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1 1) drug overdose
Generally speaking, the reported symptoms and signs of overdose are caused by the extension of its pharmacological action, including drowsiness, sedation, tachycardia and hypotension, as well as extrapyramidal symptoms. Once a patient with hypokalemia took 360 mg of this product, and the Q-T interval was prolonged.
In the case of acute overdose, various measures should be taken to rescue. Establish and keep airway unobstructed, ensure sufficient oxygen and good ventilation, take activated carbon and laxatives after gastric lavage (intubate if the patient loses consciousness), and immediately monitor the cardiovascular system, including continuous ECG monitoring, and find possible arrhythmia.
This product has no specific antagonist.
Therefore, correct supportive therapy should be taken. Hypotension and circulatory failure can be corrected by intravenous infusion or sympathomimetic drugs When severe extrapyramidal symptoms appear, anticholinergic drugs should be given, and close medical monitoring and guardianship should continue until the patient recovers.
12) storage method: Store in a dark, sealed and dry place.
13) packing specification: aluminum-plastic packing; 10 piece/board× 2 board/box; 1 mg/tablet.
14) Validity period: tentatively 24 months.
15) implementation standard: national American food and drug administration standard YBH05672006.
16) Approval number: National Medicine Zhunzi H20060283
Love tip: Please consult the local regular (Chinese medicine) hospital for the above drugs, and choose according to the physiological characteristics and different pathological conditions.
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