Item nanme:Risperidone tablets Item character:This product is a white
Indication: 1. For the treatment of acute and chronic schizophrenia as well as other kinds of psychotic state, the obvious positive symptoms (such as hallucination, delusion, thinking disorder, hostility, suspicion) and obvious negative symptoms (such as slow reaction, emotional apathy and social apathy, less language). It can also reduce the emotional symptoms related to schizophrenia (such as depression, guilt, anxiety). For patients with effective treatment in acute phase, this product can continue to play its clinical efficacy in maintenance phase.
2. It can be used to treat manic episode of bipolar disorder, which is characterized by high emotion, exaggeration or irritability, high self-evaluation, reduced sleep requirements, faster speaking speed, runaway thinking, distraction or low judgment (including disorder or extreme behavior).
Item specifications: 1mg*60tab/box
Usage and dosage:1. Schizophrenia
Those who use other antipsychotics to use this product should stop using the antipsychotics. If the patient originally used long-acting antipsychotics, the drug can be used instead of the next course of treatment. Whether the drugs used to treat Parkinson's syndrome need to be continued or not should be reevaluated regularly.
Adults: once daily or twice daily. The initial dose was 1mg. The dose was gradually increased to 2-4mg per day in about one week, and gradually increased to 4-6mg per day in the second week. After that, the dose can be kept unchanged or further adjusted according to personal conditions. Generally, the optimal dose is 2-6mg per day. The daily dose is usually less than 10mg.
2. Treat manic episode of bipolar disorder
The recommended starting dose is 1-2mg once a day, which can be adjusted according to individual needs. The range of dose increase was 1-2 mg per day. The dose increase was carried out at least every other day or more days. The ideal dosage for most patients is 2-6mg per day. During all symptomatic treatment, the need for continued use of this product should be continuously evaluated.
3. Patients with liver and kidney dysfunction
The ability of eliminating antipsychotic drugs in patients with renal dysfunction was lower than that in healthy adults, and the plasma concentration of free risperidone in patients with liver dysfunction was increased. No matter what indication, the initial and maintenance dose of patients with renal or liver dysfunction should be halved, and the dose adjustment should be slowed down. Such patients should be careful when using this product.
Adverse reactions Clinical trial data
In a clinical trial to evaluate the safety of this product, 9712 patients with different types of mental illness (including adults, Alzheimer's patients and children) received at least one dose of this product. Among them, 2626 patients received the drug in the double-blind, placebo-controlled trial. There are significant differences in treatment status and duration, including double-blind, quantitative and non quantitative, placebo or active controlled trials and open-ended trials in hospitalized and outpatient patients, short-term (to 12 weeks) and long-term (to 3 years) administration (cross classification).
Most of the adverse reactions were mild to moderate.
*Parkinson's syndrome includes extrapyramidal disorders, musculoskeletal ankylosis, Parkinson's syndrome, gear like ankylosis, temporary muscle paralysis, bradycardia, hypokinesia, facial mask, muscular ankylosis and Parkinson's disease. Meditation does not include inability to sit and restlessness. Dystonia includes dystonia and muscle spasm, involuntary muscle contraction, muscle contracture, eye rotation, and tongue paralysis. Tremor includes tremor and resting tremor in Parkinson's disease. Dyskinesia includes dyskinesia, muscle twitch, chorea and chorea.
Other adverse reactions related to risperidone are as follows, excluding those related to dosage form or route of administration.
Infection: lower respiratory tract infection, infection, gastroenteritis, subcutaneous abscess
Blood and lymphatic system: neutropenia
Psychotic disorder: Depression
Nervous system: paresthesia, convulsion
Eye: blepharospasm
Ear and labyrinth: Vertigo
Heart: bradycardia
Blood vessels: hypertension
Gastrointestinal tract: toothache, tongue spasm
Skin and subcutaneous tissue: eczema
Skeletal muscle, connective tissue and bone abnormalities: gluteal pain
Whole body and administration site: pain
Studies: weight loss, elevated gamma glutamic transferase and elevated liver enzyme levels
Poisoning and injury: Falls
Post IPO experience
The adverse events of risperidone first determined after marketing are shown in Table 5. Adverse reactions were classified according to spontaneous reporting rate
Very common ≥ 1 / 10
Common ≥ 1 / 100, and 1 / 10
Rare ≥ 1 / 1000, and < 1 / 100
Rare ≥ 1 / 10000, and 1 / 1000
Very rare < 1 / 10000, including individual cases.
Taboo: It is forbidden for patients with known allergy to this product
Matters needing attention: 1. Senile dementia
1.1 total mortality
A pooled analysis of 17 controlled trials of several atypical antipsychotics including this product showed that the mortality of Alzheimer's patients in the atypical antipsychotics group was higher than that in the placebo group. In the placebo-controlled trial of this product in this kind of population, the mortality rates of this product group and placebo group were 4.0% and 3.1% respectively. The average age of the dead patients was 86 years old (ranging from 67 to 100 years).
1.2 combination with furosemide
In the placebo-controlled study on patients with Alzheimer's disease treated with risperidone and furosemide, the mortality of patients treated with risperidone and furosemide was higher than that of patients treated with risperidone or furosemide alone, which were 7.3% (mean age 89 years, range 75-97 years), 3.1% (mean age 84 years, range 70-96 years) and 4.1% (mean age 80 years, range 67-90 years), respectively. In two of the four clinical trials, increased mortality was observed in patients treated with furosemide and furosemide.
Although no clear pathophysiological mechanism has been found to explain this phenomenon, and the causes of death are different, the risk and benefit of risperidone combined with furosemide should be carefully evaluated in elderly patients. There was no increase in mortality in patients taking risperidone combined with other diuretics. Dehydration is an important cause of death in patients with Alzheimer's disease, so dehydration should be avoided as far as possible.
2. Cerebrovascular accident (CAE)
In a placebo-controlled study of patients with Alzheimer's disease (mean age 85 years, range 73-97 years), a higher incidence of cerebrovascular adverse events (cerebrovascular accident and transient ischemic attack) including death was observed in the risperidone group than in the placebo group.
3. Blocking activity of α - receptor
Because of its blocking effect on α - receptor, hypotension may occur, especially in the early stage of dose adjustment. For patients with known cardiovascular diseases (such as heart failure, myocardial infarction, abnormal conduction, dehydration, hypovolemia or cerebrovascular disease), the dosage should be increased gradually according to the recommended dosage (see usage and dosage). In case of hypotension, the dosage should be reduced.
4. Tardive dyskinesia / extrapyramidal symptoms (TD / EPS)
Similar to all other drugs with dopamine receptor antagonist properties, this product may also cause tardive dyskinesia, characterized by rhythmic involuntary movement, mainly in the tongue and face. It has been reported that extrapyramidal symptoms are a risk factor for the development of tardive dyskinesia. Compared with other traditional antipsychotics, this drug causes less extrapyramidal symptoms. Therefore, compared with traditional antipsychotics, this drug has a lower risk of tardive dyskinesia. If symptoms of tardive dyskinesia appear, discontinuation of all antipsychotics should be considered.
5. Malignant syndrome of antipsychotics (NMS)
It has been reported that taking traditional antipsychotics may lead to malignant syndrome, which is characterized by high fever, muscle stiffness, tremor, disturbance of consciousness, elevated serum creatine phosphokinase level, myoglobinuria (rhabdomyolysis) and acute renal failure. All antipsychotics including this product should be discontinued at this time.
For patients with Lewy's body dementia or Parkinson's disease, the pros and cons of antipsychotics (including this product) should be weighed when prescribing. Such drugs may increase the risk of malignant syndrome. At the same time, the sensitivity of the above population to antipsychotics increased, in addition to extrapyramidal symptoms, there will be confusion, dullness, instability and frequent falls.
6. Hyperglycemia and diabetes
During the use of this product, there have been reports of hyperglycemia, diabetes and aggravation of original diabetes. The high risk of diabetes in schizophrenia and the rising incidence rate of diabetes in the normal population make the assessment of atypical antipsychotics and glucose abnormalities more complicated. Hyperglycemia and schizophrenia should be monitored in patients with diabetes.
7. Increased physical fitness
Significant weight gain has been reported. When using this product, the body weight should be monitored.
8. QT interval
As with other antipsychotics, caution should be exercised when given to patients with a history of arrhythmia, congenital QT prolongation syndrome, or when combined with drugs known to prolong QT interval.
9. Others
Traditional antipsychotics can reduce the seizure threshold of epilepsy, so patients with epilepsy should use this product with caution.
Patients taking this product should avoid eating too much as it may cause weight gain.
For the special dosage recommended for elderly patients, patients with liver function impairment, patients with renal function impairment or patients with Alzheimer's disease, please refer to [medication for the elderly] and [usage and dosage].
This product has an effect on activities requiring vigilance. Therefore, it is suggested that patients should not drive a car or operate a machine during the treatment period until they know the sensitivity of patients to this product.
Please keep it away from children.
Medication for pregnant and lactating women: It is not clear whether it is safe for pregnant women to take this product. The direct and indirect effects of risperidone on the central nervous system were observed. This product has no teratogenic effect.
Fetuses exposed to antipsychotic drugs (including risperidone) in the last three months of pregnancy are at risk of developing extrapyramidal symptoms or withdrawal symptoms after birth, and the severity may vary. These symptoms include agitation, hypertension, hypotonia, tremor, drowsiness, respiratory distress and eating disorders.
For pregnant women, should weigh the pros and cons to decide whether to take this product.
Animal experiments showed that risperidone and 9-hydroxyrisperidone were excreted through animal milk. At the same time, human trials have proved that this product can be excreted through breast milk. Therefore, women taking this product should not breast feed.
FAQ 1.who are we? We are based in Fujian, China, start from 2000,sell to North America(40.00%),Southeast Asia(25.00%),Western Europe(25.00%),Africa(10.00%).There are total about 50 people in our office.
2. how can we guarantee quality? Always a pre-production sample before mass production; Always final Inspection before shipment;
3.what can you buy from us? Pharmaceutical production lines,Intermediates,APIs,Finished Drug Preparations & Vaccines.
4. why should you buy from us not from other suppliers? We have our own manufacture factories and one professional sales team working for the clients all over the world.
5. what services can we provide? Accepted Delivery Terms: FOB,CIF,EXW,DDP,Express Delivery; Accepted Payment Currency:USD,EUR,CAD,AUD,GBP,CNY; Accepted Payment Type: T/T,L/C,PayPal,Western Union; Language Spoken:English,Chinese,Japanese
Our Ddvantage: 1. Quick delivery 2. Online payment 3. Quality assurance 4. Welcome big order 5. After-sales service 24 hours 6. Competitive advantage products 7. Our value information is "Quality is our culture" 8. Work with us to provide you with secure funds, your business is securely protected, our advantages
Our Service a) Free amples can be provided. b) Guide customers through professional technology and teach them how to use our products after sale c) Determine the lowest price of high-quality products 1. Skilled experience: Our company is a leading manufacturer of professional production in Chinapharmaceutical field for manyyears. 2. The highest quality: to ensure high quality, once any problems are found, the package will be re-shipped for you. 3. Safe transportation: by air express (FedEx, UPS, DHL, EMS). It is recommended that you choose the most professional freightforwarder. 4. Fast delivery: We have stock, so once payment is received, we can deliver quickly. 5. Quality service: We will provide you with enthusiastic after-sales service. If you have any questions, we will reply to youwithin 24 hours. 6. Competitive price: discounts will be obtained when making large orders.
Our Manufacture Factory Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd is a comprehensive enterprise which integrates R & D, production and construction of pharmaceutical production equipments, development and transfer of biotechnology, and cooperative production and sales of drugs and vaccines. The self-developed pharmaceutical production equipment branded FUL has been put into operation in many well-known pharmaceutical enterprises such as SINOPHARM, CSPC and also cooperates with many well-known pharmaceutical enterprises in production and sales, including pharmaceutical intermediates, APIs and finished drug preparations.
Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd business radiates to all levels, including direct supply cooperation with government departments and industry representatives, as well as establishing supply cooperation relationship with retail industry. We supply high quality, safe and effective medicines and medical equipment to governments, hospitals, clinics and licensed pharmacies in different countries with timely and effective services at reasonable prices.
At present Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd has the SINOPHARM authorization to sell its intermediates and APIs,and has the authorizations of CSPC & HUABEI PHARM sell its finished drug preparations;then FUL is the only manufacture in China which can supply the complete service from pharmaceutical produciton lines,intermediates and APIs to finished drug preparations and vaccines.Then we are seeking the professional pharmaceutical enterprices to work together for further cooperations.
){kind=link}