Sizodon 2 Sunplay Treatment Treatment of schizophrenia (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Risperidone
Ingredient
| Composition information | Content |
| Risperidone | 2mg |
Uses
Indications
Sizodon 2 is indicated in the following cases:
Mechanism of action
Risperidon is a selective antagonist monoaminergic. Risperidon has a high affinity for the HT2 serotonin receptor and Dopamine D. Risperidon receptor is also associated with alpha adrenergic receptors and lower affinity with histamine receptors and alpha2-adrenergic receptors. Risperidon has no affinity for the Cholinergic receptor.
Although Risperidon is a strong D2 antagonist, improving the positive symptoms of schizophrenia, less movement reduction and causing more than the position of anti -psychotic drugs. The balancing of the serotonin and central dopamine can reduce the effects of foreign tower and expand the treatment of negative symptoms and symptoms of the schizophrenia.pharmacokinetics
Sizodon scattered pellets and oral solution are biological equivalent with film tablets.
Risperidon is converted into 9-hydroxy-risperidon with pharmacological activity similar to the risperidon.
absorption
Risperidon is completely absorbed after drinking, the peak plasma concentration is achieved within 1-2 hours. Risperidon's absolute oral bioavailability is 70% (CV = 25%). The relatively oral bioavailability of a Risperidon tablet is 94% (CV = 10%) compared to the solution. The absorption is not affected by food and therefore Risperidon can be taken when hungry or full. The stable state of Risperidon is achieved within 1 day most patients. The stability of 9-hydroxy-risperidon is achieved within 4-5 days of medication.
Distribution
Risperidon is quickly distributed. The distribution volume is 1 - 2L/kg. In plasma, Risperidon is associated with albumin and glycoprotein alphal-acid. The cohesion with the plasma protein of Risperidon is 90%, of 9-Hydroxy-Risperidon is 77%.
Metabolism and elimination
Risperidon is converted by CYP 2D6 to 9-hydroxy-risperidon with pharmacological activity similar to Risperidon. Risperidon and 9-Hydroxy-Risperidon are anti-psychotic active components. CYP 2D6 enzymes are in many forms. The powerful CYP2D6 enzyme is rapidly converting Risperidon into 9-hydroxy-risperidone, while the weak CYP2D6 enzyme converts the Risperidon conversion much slower. Although the enzyme metabolizes strongly for lower Risperidon concentrations and 9-Hydroxy-Risperidon concentration is higher than the weak metabolic enzyme, the pharmacokinetics of Risperidon and 9-Hydroxy-Rperidon when combined (for example, anti-psychotic active parts), after using single and multi-dose is similarly between two enzymes CYP 2D6, powerful and powerful metabolites.
Another metabolic line of Risperidon is N-DEALYLation. In human liver's liver's in vitro microsomes studies show that Risperidon at the concentration of treatment does not significantly inhibit the metabolism of metabolic drugs by iszyme Cytochrom P450, including CYP 1A2, CYP 2A6, CYP 2C8/9/10, CYP 2D6, CYP 2E1, CYP 3A4, and CYP 3A5. A week after drinking, 70% of the dose is excreted in urine and 14% in feces. In urine, Risperidon and 9-Hydroxy-Risperidon accounts for 35-45% of the dose. The rest are inactive metabolites. After giving mental patients, Risperidon is eliminated with a selling time of about 3 hours. The sale time of 9-hydroxy-risperidon and anti-psychotic activity is 24 hours.
Linear/non -linear level
Risperidone concentration in plasma is proportional to the treatment dose range.
Older people, patients with liver failure and kidney failure
A single dose study showed that in the elderly, the concentration of anti -psychotic activity is 43% higher than the average concentration, the sale time is 38% longer and reduces the clearance of the substance with anti -psychotic activity reduced by 30%. Patients with renal failure, concentration of anti -psychotic activity in plasma higher and the clearance of anti -psychotic drugs decreased by 60%. Risperidon concentration in normal plasma in patients with hepatic impairment, but the average concentration of free Risperidon in plasma has increased by about 35%.
Children
Dynamic pharmacokinetics of Risperidon, 9-Hydroxyrisperidon and the substance with anti-psychotic activity similar to adults.
Sex, race and smoking habits
A population analysis indicates that there is no clear effect of gender, race or smoking on the pharmacokinetics of Risperidon or the part of anti -psychotic activity.
Before taking Sizodon 2 Sunplay Treatment Treatment of schizophrenia (3 blisters x 10 tablets)
How to use
Sizodon Using orally. Food does not affect the absorption of sizodon.
Dosage
schizophrenia
Elderly: The starting dose is recommended by 0.5mg twice daily. This dose is adjusted on each patient with 0.5mg twice daily increases to 1-2mg twice daily. Children: Risperidon is not recommended for children under 18 years of age with schizophrenia due to lack of data on efficiency. Agreement in bipolar disorder Elderly: The starting dose is recommended by 0.5mg twice daily. This dose is adjusted on each patient at a dose of 0.5mg twice daily, increasing gradually to 1-2mg twice daily. Clinical experience for elderly people is limited, so it is necessary to be cautious. Prolonged aggression in patients with Alzheimer from medium to severe memory
behavioral disorders
Children and teenagers 5 - 18 years old
Patients with weight> 50kg, the starting dose is recommended by 0.5mg once a day. If necessary, it can be adjusted on each patient by increasing 0.5mg once a day, increasing day by day. For the majority of patients with optimal dose is 1 mg once a day. However, some patients may respond to a dose of 0.5mg once a day, while others may need 1.5mg once a day.
Patients with weight
As well as all symptomatic therapies, the continued use of sizodon must be assessed and adjusted on the current basis. Sizodon is not recommended in children under 5 years old, because there is no record of children under 5 years old with this disorder.
kidney failure and liver failure
Patients with renal impairment The ability to eliminate activity of anti -psychotic drugs positively decreases compared to adults with normal kidney function. Patients with liver function, free risperidon levels in plasma increases. The starting dose and the maintenance dose should be reduced by half and adjust the dose slower for patients with renal or liver impairment. Sizodon should be used carefully in these patients.
When stopped using
Should reduce the dose slowly. Symptoms of acute drug stops include nausea, vomiting, sweating, and insomnia are rarely described after stopping the anti -psychotic drug suddenly in high doses. The recurrence of mental symptoms has recurred, and the appearance of non -autonomous movement disorders (such as restless sitting, muscular disorders and movement disorders).
Use sizodon after other psychotic drugs
When necessary, it is advisable to slowly stop the previous treatment when starting with sizodon. In addition, when changing psychosis, if appropriate should start the Sizodon therapy instead of the schedule of getting the plan. The need for continuing to use anti -Parkinson drug should be re -evaluated periodically.
Note
The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.
What to do when overdose?
Symptoms
Normally, the overdose signs and symptoms are reported from excessive increase in the pharmacological effects of Risperidon. Symptoms include drowsiness, fatigue, tachycardia and hypotension, and pagoda symptoms.
When overdose, record the situation of prolonged QT and convulsions. The torsion is also recorded when combining risperidon and paroxetin overdose. In an overdose, it is necessary to consider the capabilities of combined drugs.
Treatment of airy airway, ensuring enough oxygen and ventilation. Stomach lavage (after intubation, if the patient is unconscious) and the use of active carbon with laxative should only be used when taking the drug less than an hour. Monitor cardiovascular and electrocardiogram continuously to promptly detect arrhythmia.
There is no specific antidote to Sizodon. Therefore, appropriate support measures should be used. Hypotension and circulation should be treated with appropriate measures such as intravenous fluid or sympathetic drugs. In the case of severe foreign symptoms, an acetylcholine anti -drug should be used. Monitor and monitor strict treatment until the patient recovers.
What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.
Side Effects
When using Sizodon 2 , you may experience unwanted effects (ADR).
The most unwanted effects (ADRS) (ratio> 10%) are: Parkinson, headache and insomnia.
The following is all unwanted effects (ADRS) that have been reported in clinical trials and after bringing the drug to the market. The following terms and frequencies are applied: Very common (> 1/10), common (> 1/100 to 1/1000 to 1/10,000 toIn each frequency group, the unwanted effect is shown in the order of severity.
Very popular
Mental disorders: Insomnia.
Common, ADR> 1/100
Respiratory disorders, chest, mediastinum: Difficulty breathing, nosebleeds, cough, stuffy nose, sore throat - larynx. Gastrointestinal disorders: vomiting, diarrhea, constipation, nausea, abdominal pain, digestive disorders, dry mouth, stomach pain. Metabolic and nutrition disorders: Increasing appetite, reducing appetite. Infections and parasitic infections: pneumonia , influenza, bronchitis, upper respiratory tract infections, urinary tract infections. Mental disorders: anxiety, agitation, sleep disorders . Less Blood disorders and lymphatic systems: leukopenia, anemia, thrombocytopenia. Nervous disorders: not responding to stimuli, loss of consciousness, fainting, depression, cerebral vascular events, fleeting anemia, difficult to pronounce, causing stirring, sleeping, dizziness posture, balancing disorders, late movement disorders, speech disorders, abnormal activity, emotional reduction, taste chaos. Respiratory disorders, chest, mediastinum: wheezing, inhaled pneumonia, pulmonary artery obstruction, respiratory disorders, ran, respiratory obstruction, difficult to pronounce. magic and urinary disorders: urinary retention, difficulty urinating, non -autonomous urination, urination. Skin and subcutaneous tissue disorders: Evana, skin damage, skin disorders, itching, skin discoloration, hair loss, seborrheic dermatitis, dry skin, horns, acne. Disorders of metabolism and nutrition: diabetes, anorexia, drinking a lot, hyperglycemia, hyperchemical hypertension, hyperligendo. Vascular disorders: Hypotension, posture hypotension, blushing. Rare Respiratory disorders, chest, mediastinum: Sleep apnea syndrome, increased ventilation. Endocrine disorders: unreasonable anti -hormone secretion. Very rare Not known hyperlactin hypernemia in some cases can lead to female mammary glands, 01 menstrual disorder, amenorrhea, milk secretion. Peripheral disorders can occur: Parkinson (increasing salivation, stiffness of musculoskeletal joints, Parkinson, saliva, seizures, slow movement, reducing movement function, loss of expressions on the face, muscle tensions, motor loss, stiffness, muscle stiffness, Parkinson's body, and reflexes between abnormal eyebrows), lying, restless, restlessness, restlessness, restlessness, restlessness) (movement disorders, muscle convulsions, shock dance, dance, and muscle vibration), tone disorders. Disorders of tongel disorders include tongel disorders, muscle spasms, muscle tone, neck disability, non -self -control muscle spasm, muscle spasms, eyelash spasms, longan, paralysis tongue, face spasms, laryngeal spasms, muscle disorders, bent people, spasms, side spasms, tongue spasms, and jaw stiffness. Run includes tremor and Run Parkinson at rest. It should be noted that an accompanying symptom sequence includes, which is not necessarily due to the source of the pagoda. In placebo control tests, diabetes have been reported at 0.18% of Risperidon treatment groups compared to 0.11% in the placebo group. The general ratio from all clinical trials is 0.43% of all subjects treated with Risperidon. Group impact Like other anti -psychotic drugs, it is very rare for prolonged QT to report after Risperidon drugs are launched. Another effect related to the heart is reported with anti -psychotic drugs that extend the QT interval including ventricular arrhythmia, ventricular vibration, ventricular tachycardia, sudden death, cardiac arrest and torsion. Venous thrombosis Cases of venous thrombosis, including cases of pulmonary embolism and cases of deep vein thrombosis, have been reported to anti -psychotic drugs (unknown frequency). weight gain The percentage of adult patients with schizophrenia when using sizodon compared to placebo, the criteria for weight gainer> 7%of body weight is compared in a 6 to 8 weeks, through placebo control tests, showing a higher weight gain rate with statistical significance in the group using sizodon (18%) compared to placebo (9%). In a 3 -week placebo control study in adult patients with acute sensitive goods, the weight gain rate> 7%at the end of the sizodon (2.5%) and the placebo group (2.4%), and slightly high in the research group (3.5%). In children and adolescents with behavioral disorders and attitudes, in long -term studies, weight increased on average 7.3kg after 12 months of treatment. Achieving the expectations for normal children from 5 - 12 years old is 3 - 5kg per year. From 12 - 16 years old, this amplitude achieved 3-5kg per year maintained for girls, while boys nearly 5kg per year. More information on special subjects The unwanted effects of the drug are reported at a higher rate in elderly patients with dementia or pediatric patients compared to adults described below: Elderly patients with dementia Against anemia and cerebral vascular events are reported to ADRS in clinical trials with a corresponding frequency of 1.4% and 1.5% in elderly patients with dementia. In addition, the following ADRS has been reported at a frequency of> 5% in elderly patients with dementia and at least twice the frequency of seeing in adults: urinary tract infections, peripheral edema, indifference, and cough. Children In general, adverse reactions in children are expected to be similar to adults. ADRS has been reported at a frequency of> 5% in pediatric patients (5-17 years old) and at least twice the frequency of observed in clinical trials in adults: Sleeping/Drowsiness, fatigue, headache, increased appetite, vomiting, upper respiratory tract infection, stuffy nose, abdominal pain, dizziness, cough, fever, tremor, diarrhea, bedwetting. The effect of long -term Risperidon treatment on sexual maturity and height has not been fully studied. Instructions on how to handle ADR When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Sizodon 2 contraindicated in the following cases:
Precautions when using
Elderly patients with dementia
Increase mortality rate in elderly people with dementia.
In a gross analysis of 17 studies that control non -typical anti -psychotic drugs, including sizodon, elderly patients with dementia are treated with an anti -psychotic drug that is not typical with a place of death compared to placebo. In placebo control tests with oral sizodon in this population, the mortality rate is 4.0% for patients treated with sizodon compared to 3.1% for placebo patients. The difference ratio (95%confidence interval) is 1.21 (0.7; 2.1). The average age of the patient died was 86 years old (from 67 - 100). Data from two major observation studies shows that elderly people who have dementia are treated with anti -psychotic drugs are also small at risk of increasing death compared to those who are not treated. Not enough data to accurately estimate risks and do not know the cause of increased risk. It is unclear the mechanism of increasing the level of death when using anti -stem drugs in studies.
Use simultaneously with Furosemid
In the test with Sizodon control in elderly patients with dementia, higher mortality rate in patients treated with Furosemid in combination with Risperidon (7.3%; Average age 89, from 75 - 97) when compared to patients only treated with Risperidon (3.1%, average age 84, from 70 - 96) or Furosemid (average age; 80, from 67 - 90). Increasing mortality in patients treated with Furosemid combined with Risperidon is recorded in two of the four clinical trials. Simultaneous use of risperidon with other diuretics (mainly low -dose thiazid diuretics) does not give similar results.
It is unclear the pathophysiological mechanism and the cause to explain this result. However, it is necessary to carefully consider the risks and benefits of this combination or treatment in combination with other strong diuretics before deciding to use. Do not increase the mortality rate in patients who are taking other diuretics when treated simultaneously with Risperidon. Regardless of any treatment, dehydration is a risk factor for death, so it should be avoided in elderly patients with dementia.
Unwanted effect on the blood vessels (CVAE)
The risk of unwanted effects on the blood vessels increases about 3 times in random clinical trials using placebo in patients with dementia treated with some typical anti -psychotic drugs. Synthetic data from six placebo control studies with sizodon in patients who are mainly elderly (> 65 years) have dementia shows that CVES (serious, not serious and both) at a rate of 3.3% (33/1009) patients treated with Risperidon and 1.2% (8/712) patients treated with placebo. The difference ratio (95%confidence interval) is 2.96 (1.34; 7.50). It is unclear that the mechanism of increasing this risk is not excluded by the risk due to other anti -psychotic drugs or other patients. Sizodon should be used carefully in patients at risk of stroke.
The risk of unwanted effect on cerebral vessels is significantly higher in patients with many diseases or dementia due to blood vessels compared to Alzheimer's disease. Therefore, patients with dementia are different from Alzheimer's disease should not be treated with Risperidon.
Doctors should assess the risk and benefits of using sizodon in elderly patients with dementia, paying attention to the risk of stroke in this patient. Patients/family members should be warned of potential signs and symptoms of unwanted effects on brain vessels such as sudden weakness or numbness on the face, arms or legs, linguistic and visual disorders. All treatment options need to be carefully considered, including risperidon stopping.
Sizodon should only be used short -term for persistent aggressive treatment in Alzheimer patients with average to severe dementia to support unlimited or ineffective measures and when there is a risk of harm to themselves or others. Patients need to be evaluated regularly, and the treatment continues also need to be re -evaluated.
posture hypotension
Due to Risperidon's alpha blocking, posture hypotension may occur, especially during the initial dose adjustment. Clinically significant hypotension has been observed with simultaneous use of risperidon and treating hypotension. Sizodon should be used carefully in patients with cardiovascular disease (for example, heart failure, myocardial infarction, conduction disorders, dehydration, reduction of circulatory volume, or cerebrovascular disease), and must adjust the dose slowly as recommended. The dose should be considered for hypotension.
leukopenia, neutropenia and grain leukocytes
leukopenia, neutropenia and grain leukocytes have been recorded when using anti -psychotic agents including risperidon. The grain leukemia is recorded very rarely (
Patients with neutropenia should be monitored with fever and other infections or signs of infection and should be treated immediately if these conditions or signs occur. Patients with serious neutropenia (total neutropenia number
Late movement disorders/foreign symptoms (TD/EPS)
The dopamine receptor is associated with the release of late movement disorders characterized by unconscious movement, mainly of the tongue and face. The beginning of extracurricular symptoms is a risk factor for late movement disorders. If the signs and symptoms of late movement disorders appear, consider all anti -psychotic drugs.
Malignant syndrome caused by sedatives (NMS)
Malignant syndrome caused by sedative drugs characterized by hyperthermia, muscle stiffness, plant instability, changing consciousness and increased creatin phosphokinase has been reported to occur with anti -psychotic drugs. Other signs may include myoglobinuria (pattern) and acute renal failure. In this case, all psychotic drugs should be stopped, including sizodon.
Parkinson's disease and Lewy intellectual decline
Doctors should consider risks compared to the benefits of prescribing anti -psychotic drugs, including sizodon, for patients with Parkinson's disease or Lewy (DLB). Parkinson's disease can deteriorate when using Risperidon. Both groups are at risk of increased malignant syndrome due to sedative drugs as well as increased sensitivity to anti -psychotic drugs, which have been excluded from clinical trials. The manifestation of this sensitivity may include confusion, loss of sensory, unstable posture often falling, symptoms of foreign tower.
Hyperglycemia and diabetes
Record cases of hyperglycemia, diabetes and worsen diabetes during treatment with sizodon. In some cases, it may be the previous weight gain. Rarely cases of keton acidosis and diabetes coma. The patient's condition should be monitored when treated with anti -psychotic drugs. The patient is treated with any typical anti -psychotic drugs, including sizodon, which should be monitored with symptoms of hyperglycemia (such as drinking, multi -urinary, eating a lot and fatigue), patients with diabetes need to be monitored regularly to control blood sugar worsening.
weight gain
Record the case of significant weight gain when using sizodon. Body weight should be monitored regularly.
Hyperlactin in the blood
Tissue culture research shows that cell growth in the breast tumor in humans may be stimulated by prolactin. Although there is no clear relationship in the use of anti -psychotic drugs that have been proven in clinical and epidemiological studies, still need to be cautious in patients with a history of relevant disease. Sizodon should be used cautiously in patients with a history of hypertension blood prolactin and in patients with tumors dependent on prolactin.
extended qt
Very rare cases of prolonged QT are recorded. Like other anti -psychotic drugs, need to be cautious when prescribing Risperidon patients who have a history of cardiovascular disease, family history with prolonged QT, slow heart rate, or electrolyte disorders (hypotension, hyperchemical blood), as it can increase the risk of heart rate disorders, and use simultaneously with known drugs to extend QT.
epilepsy
Sizodon should be used cautiously in patients with a history of epilepsy or other conditions with seizures.
Penis erection
Penis erection may occur during treatment with sizodon due to the effect of blocking Alpha-adrenergic.
Adjust body temperature
Anti -psychotic drugs have the ability to disrupt the body's body temperature reduction. Reasonable care for patients treated with sizodon is likely to encounter body temperature, for example: heavy exercise, extremely high temperature exposure, simultaneously treated with drugs with acetylcholin -resistant drugs, or dehydrated.
anti -vomiting
An anti -vomiting effect has been reported in preclinical studies with Risperidon. If this effect occurs with a person who can cover the signs and overdose symptoms of the drugs being used or obstruction of the digestive system, Reye syndrome and brain tumor.
Hepatic failure and kidney failure
Patients with renal impairment are capable of eliminating the drug that has a lower anti -psychotic activity than people with normal kidney function. In patients with liver failure, free risperidon concentration in plasma increases.
venous thrombosis (VTE)
Cases of venous thromboembolism (VTE) have been reported with anti -psychotic drugs. Patients treated with anti -psychotic drugs often occur with venous thrombosis, all risk factors that can cause venous thrombosis should be determined before and during treatment with sizodon and need to take preventive measures.
Soft syndrome in surgery (ifis)
Surgery syndrome in surgery has been recorded when cataract surgery in patients treated with drugs with alpha 1 -adrenergic activity including Risperidon, this syndrome may increase the risk of complications on the eye and after surgery. The surgeon needs to know the Alpha 1 -Drenergic medications used simultaneously or used earlier before surgery. The hidden benefits of stopping Alpha-1 inhibitors before unclear cataract surgery and should be assessed with the risk of stopping anti-psychotic drugs.
Children
Before prescribing a child or young adolescence with behavioral disorders, it is necessary to fully assess the physical and social causes of aggressive behavior such as pain or inappropriate environmental needs.
The sedative effect of Risperidon should be closely monitored in children because it can affect learning ability. The change during the time of using Risperidon can improve the sedative effects on the concentration of children and teenagers.Risperidon is associated with an increase in body weight and body weight index (BMI). Encourage initial weight measurement before treatment and monitoring regular weight. The changes in height in expanding studies lasting steadily in the standard suitable for the expected age. The effect of long -term Risperidon treatment on genital maturity and height development has not been fully studied.
Because prolonged prolactin proliferation has the potential to affect the growth and growth of genital growth in children and young people, it is necessary to consider clinical assessment of regular endocrine status, including height, weight, genital maturity, menstrual monitoring, and other effects related to Prolactin.
During the treatment period with Risperidon, it is necessary to regularly check the symptoms of foreign tapes and other movement disorders.
excipients
Lactose -containing film tablets. Patients with rare genetic problems are galactose intolerance, lapp lactase deficiency or glucose-galactose absorption should not be taken.
The ability to drive and operate machinery
Sizodon may have a slight or medium impact on the ability to drive and use machinery due to the effect on the nervous system and visual disorders. Therefore, the patient is advised not to drive or operate machinery until the effect of the drug on the body.
Pregnancy
There is no enough data for the use of Risperidon in pregnant women. Risperidon does not cause teratogenicity in animal research but records toxicity on the genital system. It is unclear the potential risks to humans.
Infants are exposed to anti -psychotic drugs (including sizodon) in the third quarter of pregnancy and after birth, there is a risk of unwanted reactions including foreign tower or cessation syndrome that may get worse. Record cases of excitement, increase muscle tone, reduce tone, tremor, drowsiness, respiratory failure, or anorexia. Therefore, it is necessary to monitor babies carefully.
Do not use sizodon during pregnancy unless really necessary. If you need to stop the drug during pregnancy, do not stop suddenly.
Breastfeeding period
In animal studies, Risperidon and 9-Hydroxy-Risperidon are excreted in milk. It has also proved that Risperidon and 9-Hydroxy-Risperidon are excreted in human milk in small amounts. There is no data on unwanted effects in breastfeeding. Therefore, it is necessary to consider the benefits of breastfeeding with potential risks for children.
Drug interaction
Interaction
Interactions related to pharmaceutical force.
As well as other anti -psychotic drugs, it is necessary to be cautious when prescribing Risperidon with drug products extending QT, for example, anti -arrhythmia group (for example: quinidin, dysopiramid, process), anti -arrhythmic group III (e. Maprotilin), some antihistamines, other anti -psychotic drugs, some anti -malaria drugs (for example, Quinin and Mefloquin), and with drugs that cause electrolyte imbalance (hypotension, hypercholidemia), slow heartbeat), or inhibitors inhibit the metabolism of Risperidon's liver.
Sizodon ability affects other drugs.
Risperidon should be used cautiously when combined with other central effects, notably alcohol, opium, antihistamine and benzodiazepine drugs due to an increase in the risk of sleep.
levodopa and dopamine owner
Sizodon can impact against levodopa and other dopamine owners. If this combination is necessary, especially at the end of Parkinson's disease, the lowest -dose prescription should only be effective.
Drugs have hypotension effect
The drug circulation report shows a significant hypotension when used simultaneously Risperidon and drugs for hypertension.
Paliperidon
It is not recommended to simultaneously use oral Risperidon with paliperidon because paliperidon is a metabolic substance that has the activity of risperidon and the combination of these two drugs can lead to increased riseridon anti -psychotic concentration concentration.
Pharmaceutical interactions
Food does not affect the absorption of drugs, Risperidon is metabolized mainly by CYP2D6 and leads to a decrease in concentration by CYP3A4. Both Risperidon and its active metabolites 9-Hydroxyrisperidon are the substrate of p-glycoprotein (PGP).
The substances that have the ability to change the activity of CYP2D6 or substances that have the ability to inhibit or touch CYP3A4 or PGP activity, can affect the pharmacokinetics of the anti -psychotic activity of Risperidon.
Strong inhibitors CYP2D6
Simultaneous use of Risperidon with a powerful CYP2D6 inhibitor may increase risperidon levels in plasma but the anti -psychotic activity increases less. The higher dosage of CYP2D6 inhibitors may increase the concentration of anti -psychotic activity Risperidon (such as paroxetin). Other CYP2D6 inhibitors such as Quinidine may affect the same way as Risperidon. When used simultaneously with paroxetin, quinidine or other powerful CYP2D6 inhibitors, especially when taking high doses, when starting or when stopping treatment, the doctor needs to re -evaluate the dose of risperidon.
CYP3A4 or PGP inhibitors
Concomitant use of Risperidon with a powerful CYP3A4 or PEP inhibitor can significantly increase the concentration of Risperidon psychotic activity in plasma. When starting to use or when stopping in combination with iTraconazole or strong inhibitors CYP3A4 or PGP, the doctor needs to re -evaluate the dose of Risperidon.
CYP3A4 or PGP induction
Simultaneous use of Risperidon with a strong CYP3A4 or PGP induction can reduce the plasma concentration of stools with anti -dysplasia. When starting to use or when stopping in combination with carbamazepine or strong CYP3A4 or other PGP touch substances, the doctor needs to reassess the risperidon dose. CYP3A4 induction has a time -dependent effect, which can take at least 2 weeks after taking the drug to achieve the highest effect. Conversely, when stopping treatment, the CYP3A4 touch substance can take at least 2 weeks to lose its effect.
Strongly linked drugs with protein
When Risperidon is used simultaneously with strongly connected drugs with protein, there is no significant replacement between the two drugs for plasma proteins. When combined with treatment, it is necessary to consider the corresponding information about the transformation and appropriate dose adjustments.
Children
Interactive studies are conducted only for adults. Related results from these studies to children are not known. Combining nerve stimulants (such as methylphenidat) with risperidon in children and minors does not change the dynamics and effectiveness of Risperidon.
The effect of other drugs on Risperidon's pharmacokinetics
Antibiotics
erythromycin, an average CYP3A4 inhibitor and PGP inhibitors, does not change the pharmacokinetics of Risperidon and the anti -psychotic activity.
Rifampicin, a strong CYP3A4 touch and PGP induction, reduces the concentration of anti -psychotic activity.
Cholineseterase resistant
Donepezil and Galantamin, the substrate of both CYP2D6 and CYP3A4, has no significant effects on Risperidon's pharmacokinetics and molecules with anti -psychotic activity.
epilepsy pills
Carbamazepin, a strong CYP3A4 touch and PGP induction, reduces the concentration in plasma parts with anti -psychotic activity of Risperidon. The same effects are recorded with phenytoin and phenobarbital- CYP3A4 induction substances in the liver as well as P-Glycoprotein.
Topiramat reduces moderate bioavailability of Risperidon but does not reduce the bioavailability of the anti -psychotic activity. Therefore, this interaction is not clinical characteristics.
antifungal drugs
iTraconazole, a strong CYP3A4 inhibitor and PGP inhibitor, at a dose of 200mg/day, increases the concentration of anti -psychotic activity to about 70% when using Risperidon 2 - 8mg/day.
Ketoconazole, a strong CYP3A4 inhibitor and PGP inhibitor, at a dose of 200mg/day, increases the level of risperidon in plasma and reduces the concentration of 9-hydroxiderisidides in plasma.
Anti -psychotic drugs
Phenothiazine may increase risperidon levels but do not increase the concentration of anti -psychotic activity.
Virus resistance
Protease inhibitors: No data. However, because Ritonavir is a powerful CYP3A4 inhibitor and weak inhibitor CYP2D6, Ritonavir and protease inhibitors enhance Ritonavir (Ritonavir-Boosted Protease Inhabitors) increase the concentration of Risperidon anti-dysplasia activity.
Beta blockers
Some beta blockers may increase the plasma concentration of risperidon but do not increase the concentration of anti -psychotic activity.
Calcium channel blockers
Verapamil, an average CYP3A4 inhibitor and PGP inhibitors, increases Risperidon concentration and the anti -psychotic activity.
Medications on the digestive system
H2 receptor antagonists: cimetidine and ranitidine, weak inhibitors CYP2D6 and CYP3A4, increasing the bioavailability of Risperidon but only increases a small amount of anti -psychotic activity.
SSRI antidepressants and 3 rounds
fluoxetin, a strong CYP2D6 inhibitor, increases the plasma concentration of risperidon, the concentration of anti -psychotic activity increases less.
Paroxetin, a powerful CYP2D6 inhibitor, increases risperidone levels in plasma but when the dose is up to 20mg/day, the concentration of anti -psychotic activity increases less. However, using higher doses of paroxetin may increase the concentration of anti -psychotic activity Risperidon.
3 -round antidepressant can increase the level of risperidon in plasma but does not increase the concentration of the anti -psychotic activity. Amitriptylin does not affect the pharmacokinetics of risperidon or the anti -psychotic activity.
Sertralin, which is a weak inhibitor CYP2D6, Fluvoxamin, is a weak inhibitor CYP3A4, when using the dose up to 100mg/day is not related to significant changes in the anti -psychotic activity of the clinically risperidon. However, the dose is higher than 100mg/day sertralin or fluvoxamine may increase the concentration of anti -psychotic activity of Risperidon.
The effect of Risperidon on the pharmacokinetics of other drugs
epilepsy pills
Risperidon has no clinical related effects on pharmacokinetics of Valproat or Topiramat.
Anti -psychotic drugs
Aripiprazol, a substrate of CYP2D6 and CYP3A4: Risperidon uses oral or injections that do not affect the total dynamic of Aripiprazol and its active metabolites, dehydraripipipolazol.
Digitalis glycosides
Risperidon does not cause the effects on clinical Digoxin dynamics.
lithium
Risperidon does not cause the effects on clinical lithium dynamics.
Concomitance use Risperidon with Furosemid
See the warning and caution when taking the drug due to an increase in the likelihood of death in the elderly when treating dementia to use simultaneously with Furosemid.
Cavalry
Due to the absence of studies on the correlation of the drug, not mixing this drug with other drugs.
Storage
Storage below 30 ° C. In the original packaging, avoid light.
Expiry date: 24 months from the date of manufacture. Do not use overdue drugs stated on the packaging.
Manufacturer: Sun Pharmaceutical Industries Ltd.
Other drugs
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