Risperidon 2 Hasan Treatment Treatment of schizophrenia (6 blisters x 10 tablets)
Dosage form Box of 6 blisters x 10 tablets
Specifications Risperidone
Ingredient
| Composition information | Content |
| Risperidone | 2mg |
Uses
indications
Risperidoni 2 drug is indicated in the following cases:
Risperidon is an aligned anti -psychotic drug, has a selective Monoaminergic antagonistic effect, has a high affinity with a 5HT2 serotonin receptor and Dopamine D2 receptor. Risperidon is also associated with receptor α1 - adrenergic and low affinity with H1 histamine receptors and α2 - adrenergic receptors. Risperidon has no affinity for the Cholinergic receptor.
Although Risperidon is a strong antagonist with D2 receptor, has the effect of improving the positive symptoms of schizophrenia, risperidon is less inhibiting movement activities and is less likely to retain the position of typical sedatives. As a balanced antagonist between Serotonin receptors and central dopamine, Risperidon reduces the risk of unwanted effects on the pagoda and expands the effectiveness of treatment with negative symptoms and emotional symptoms in schizophrenia.
Dynamic pharmacokinetics
absorption
Risperidon is completely absorbed after drinking, not affected by food. Peak concentration in plasma is achieved within 1-2 hours. The absolute bioavailability of Risperidon is 70%. In most patients, Risperidon reaches a stable state within 1 day and 9 - hydroxy - Risperidon reaches a stable state within 4-5 days. During the dose of treatment, the plasma concentration of Risperidon is proportional to the dose.
distribution
Risperidon is quickly distributed. The distribution volume is about 1.2L/kg. Risperidon is attached to albumin and α1 - glycoprotein acid. The ratio of the plasma protein of Risperidon is 90% and of 9 - hydroxy - Risperidon is 77%.
transformation
Risperidon is converted by CYP 2D6 to 9 - hydroxy - risperidon has the same pharmacological effect as Risperidon. Risperidon and 9 - Hydroxy - Risperidon has anti -psychotic activity. Although Risperidon and 9 - Hydroxy - Risperidon is different in patients with strong or weak CYP 2D6 metabolism, the pharmacokinetics of Risperidon and 9 hydroxy - Risperidon are the same.
Elimination
After taking Risperidon for a week, 70% dose is excreted in the urine and 14% in feces. In urine, Risperidon and 9 - Hydroxy - Risperidon accounts for 35 - 40%. The rest are non -active metabolites. In mental patients, the selling time of Risperidon is 3 hours, 9 - Hydroxy - Risperidon and the component of anti -psychotic activity is 24 hours.
pharmacokinetics in some special clinical subjects
Elderly patients
A single dose study showed that the plasma concentration of the component has an anti -psychotic activity increased by 43%, the selling time of waste is more than 38%and the clearance decreases by 30%.
Patients with renal failure
Plasma concentrations of components with higher anti -psychotic activity and 60%average clearance.
Patients with liver failure
Risperidon concentration in normal plasma in patients with hepatic impairment but free risperidon in plasma increased by about 35%.
Children
Pharmacokinetics of Risperidon, 9 -Hydroxy - Risperidon and ingredients with anti -psychotic activity in children are similar to adults.
Sex, race, smoking habits
does not significantly affect the pharmacokinetics of Risperidon, 9 - Hydroxy - Risperidon and the ingredient with anti -psychotic activity.
Before taking Risperidon 2 Hasan Treatment Treatment of schizophrenia (6 blisters x 10 tablets)
How to use
oral medication. Food does not affect the absorption of the drug. The tablet can be broken in half.
Dosage
schizophrenia
Adults
Starting dose of 2mg (1 tablet)/ day; Can increase the dose of 4mg (2 capsules)/day on Monday, divided 1-2 times/day. The dose may then be maintained or increased if necessary depending on the patient. The usual effect is 4 - 6mg (2 - 3 capsules)/day. In some patients, the starting dose and the maintenance dose may be lower and adjust the dose slower. The dose of 10mg (5 capsules)/day does not prove the effectiveness compared to the lower doses but also increases the symptoms of the pagoda. Do not recommend the dose> 16mg (8 tablets)/day.
Elderly
The starting dose of 0.5mg x 2 times/day. Can increase the dose of 1 - 2mg (1/2 - 1 tablet) x 2 times/day.
Children
Do not recommend use for children
Patriarchal attack in patients with bipolar disorder
Adults
The starting dose of 2mg (1 tablet)/time/day. The dose can be adjusted if needed for at least 24 hours and an increase of 1mg (1/2 tablets)/ day. The appropriate dose is from 1 - 6mg (1/2 - 3 capsules)/day depending on the effectiveness and level of tolerance of the patient. The dose is over 6mg (3 tablets)/day has not been studied in Hung Cam patient. Need to regularly evaluate the effectiveness of Risperidon treatment.
Elderly
The starting dose of 0.5mg x 2 times/day. The dose of 1 - 2mg can be increased (1/2 - 1 capsule) x 2 times/day. Due to the limited clinical experience in the elderly, it is necessary to be cautious.
Children
It is not recommended for children
persistent impure in patients with dementia Aizheimer has just been severe
Adults
The starting dose of 0.25mg x 2 times/day. The dose may be increased if necessary. The optimal dosage in most patients is 0.5mg 2 times/day. Some patients take a dose of 1mg (1/2 tablet) x 2 times/day to bring better effect. Need to re -evaluate the effectiveness of treatment, do not use Risperidon for more than 6 weeks.
behavioral disorders in children 5 - 18 years old
Children ≥ 50 kg
The starting dose of 0.5mg/time/ivory. The dose can be adjusted if necessary by increasing 0.5mg/day. The optimal dose in most patients is 1mg (1/2 tablets)/time/day. However, in some patients, dose 0.5mg/time/day or 1.5mg/time/day effectively.
Children
The starting dose of 0.25mg/time/day. The dose can be adjusted if necessary by increasing 0.25mg/day. The optimal dose in most patients is 0.5mg/time/day. However, in some patients, dose 0.25mg/time/day or 0.75mg/time/day effectively. Risperidon 2 is not suitable for this object.
Need to re -evaluate the effectiveness of treatment.
Children
Do not recommend use because there is no experience.
Dosage in some special clinical subjects
Patients with liver failure, kidney failure
The ability to eliminate ingredients with anti -psychotic activity in patients with less renal failure in adults with normal kidney function. Free risperidon concentration in plasma increases in patients with hepatic impairment. Lower the dose half and adjust the dose slower in this patient group.
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
Common symptoms when risperidon overdose: drowsiness and sedation, tachycardia and hypotension, and symptoms of foreign tower. The case of extending the QT and convulsions may be encountered. Overdose when coordinating Risperidon with paroxetin can cause torsion.
How to handle
Airways, sufficient oxygen and ventilation.
Only consider gastric lavage (after the intubation if the patient is unconscious) and use activated carbon in combination with laxatives within 1 hour after an overdose.
Cardiovascular monitoring immediately and continuously to detect possible arrhythmia.
There is no specific antidote for Risperidon, so it is necessary to take appropriate support measures. When hypotension occurs or reducing circulation, intravenous fluid can be transmitted or using sympathetic drugs to support. In the event of a serious surgeon syndrome, the use of anti -cholinergic drugs. Closely and continuously until the patient recovers.
What to do when you forget 1 dose? If the time of remembering is close to the next dose time, skip the forgotten dose and continue taking the next dose as usual. Do not take double the dose to compensate for the forgotten dose.
If the patient forgets more than 2 doses, it is necessary to notify the doctor for instructions.
Side Effects
When using Risperidoni 2, you may experience unwanted effects (ADR).
Unwanted unwanted effects: Parkinson, sedation, sleep, headache and insomnia. Unwanted effects related to the dose are: Parkinson and restless sitting.
Unwanted effects are grouped by frequency: Very common (ADR ≥ 1/10), common (1/100 ≤ ADR inflammation and infection
pneumonia, bronchitis, upper respiratory tract infections, sinusitis, urinary tract infections, ear infections, influenza (common). Respiratory infections, cystitis, eye infections, tonsillitis, nail fungus, local cellular tissue, virus infection, dermatitis (rare), infection (rare).
Blood and lymphatic system
Neutral leukopenia, reduced leukemia, thrombocytopenia, anemia, hematocrit reduction, eosinophilia (rarely), granular leukopenia (rare).
immune system
Increased sensitivity (rarely). Anaphylactic reaction (rare).
Endocrine:
Hypertosis hyperkemin (common). Excretion of anti -urinary hormones inappropriate, appearing glucose in urine (rare).
Nutrition and metabolism
gain weight, appetite, anorexia (common). Diabetes, hyperglycemia, thirst, weight loss, anorexia, hypercholesterol (rare). Poisoning, hypoglycemia, increased blood insulin, hyper triglycerides (rare). Ceton metabolism of diabetes (very rare).
Mental
Insomnia (very common). Sleep disorders, agitation, depression, anxiety (common). Crazy, confusion, decreased libido, anxiety, nightmares (rarely). Exampling emotions, inferiority (rare).
Neurology
sedation/sleep, Parkinson, headache (very common). Sitting restless, muscular disorders, dizziness, movement disorders, tremor (common). Late movement disorders, cerebral ischemia, no reaction to irritation, loss of consciousness, consciousness of decline, convulsions, fainting, increased mental activity, balanced disorders, coordination disorders, dizziness, loss of attention, stuttering, taste disorders, tactile reduction, abnormalities (less common). Malignant neurological syndrome, cerebrovascular disorders, diabetes coma, staggering (rare).
Eyes
Fuzzy vision, conjunctivitis (common). Fear of light, dry eyes, increased tears, eye congestion (rarely). Object hypertension, eye movement disorders, eye shells, eyelid skin shells, soft iris syndrome (during surgery) (rare).
ears and mesmerizing
Dizziness, tinnitus, ear pain (rarely).
heart
Heart fast (common). Atrial fibrillation, atrial atrial block, conduction disorders, extending the QT range, slow heart, abnormal electrocardiograms, chest drums (rarely). Sinus arrhythmia (rare).
blood vessels
Hypertension (common). Hypotension, hypotension standing, flushed (rarely). Pulmonary embolism, venous thrombosis (rare).
Respiratory
Difficulty breathing, angina - larynx, cough, angina, nasal congestion (common). Pneumonia due to inhalation, obstruction of the lungs, respiratory tract obstruction, wheezing, scarcity, respiratory disorders (rarely). Sleeping syndrome, sleeping (rare).
digestive
Abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhea, indigestion, dry mouth, toothache (common). The defecation is not self -control, stool tumor, gastritis, difficulty swallowing, flatulence (rare). Pancreatitis, tongue swelling, lipitis (rare). Intestinal obstruction (very rare).
Skin and subcutaneous tissue
rash, erythema (common). Urticaria, itching, hair loss, weight gain, eczema, dry skin, skin discoloration, acne, seborrheic dermatitis, skin disorders, skin damage (rarely). The rash caused by drugs, dandruff (rare). Evaluation (very rare).
musculoskeletal and connective tissue
muscle spasm, musculoskeletal pain, back pain, joint pain (common). Increasing creatinine phosphokinase, posture abnormalities, stiffness, swelling of joints, muscle weakness, neck pain (rarely). Tieu Co Van (rare).
Kidney and urinary tract
Unreces of urination (common). Urine, urine stasis, difficult urine (rarely).
Pregnancy, childbirth period and neonatal status
Newborn suspension syndrome (rare).
Reproductive and lactation system
erectile dysfunction, ejaculation disorders, menstrual loss, menstrual disorders, large breasts in men, increased milk secretion, sexual dysfunction, breast pain, uncomfortable breasts, damaged gases (rarely). The erection lasts long, delayed menstruation, breast tightness, big breasts, nipple secretion (rare).
honey
Increase transaminase, increase gamma - glutamyltransferase, increase liver enzyme (rare). Jaundice (rare).
injury, poisoning and complications in tips
Falling (rarely). Pain (rare)
General disorder
edema, high fever, chest pain, weakness, fatigue, pain (common). Facial edema, chills, body temperature increased, abnormal gait, thirst, uncomfortable chest, restlessness, abnormal feeling, discomfort (less common). Lower body heat, peripheral cold, drug suspension syndrome, hard (rare).
Paliperidon
is the metabolic substance that has the activity of risperidon, so they have the same unwanted effect. In addition to the above effects, Paliperidon also causes "posture tachycardia syndrome" - the effect is expected to occur with Risperidon.
Elderly people are in intellectual decline
Transient infarction and stroke are two unwanted effects reported with a frequency of 1.4% and 1.5% respectively. In addition, unwanted effects are reported with a frequency of 5% and at least 2 times in clinical studies include: urinary tract infection, peripheral edema, sleep, cough.
Instructions for handling unwanted effects:
Notice immediately to the doctor if the patient has the following unwanted effects:
rarely
Rare
Serious allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, skin rash or hypotension.
If you encounter any unwanted effects, including unwanted effects not listed in this section, notify your doctor or pharmacist.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
contraindicated
Risperidoni 2 drug contraindicated in the following cases:
Be cautious when used
When you want to stop the drug, you need to reduce the dose slowly. If the sudden stopping can cause reactions such as nausea, vomiting, sweating and insomnia (rare). There have been reports on recurrent mental symptoms and non -autonomous movement disorders such as: sitting restless, muscular disorders, movement disorders.
There is no special requirement on drug treatment after use.
Do not throw away drugs in wastewater or domestic waste. Consult the pharmacist how to quit unused. These measures will help protect the environment.
Precautions
Elderly people are in intellectual decline
Increase the mortality rate when taking Risperidon.
Increase the mortality rate when simultaneously use Risperidon with Furosemid compared to the elderly group only using Risperidon or Furosemid single therapy. Combining Risperidon with other diuretics (Thiazid) does not observe the increase in the above mortality rate, has not explained the mechanism of this effect, so it is necessary to be careful to use when coordinating risperidon with diuretics in elderly patients with intellectual decline.
Understanding blood vessel events
Random clinical trials with a placebuild output show that the group of patients dementia using non -typical anti -psychotic drugs (including risperidon) is 3 times higher than the adverse blood vessel events than the placebo group. Risperidon should be used carefully in patients with stroke risk factors. The risk of adverse blood vessel events increases significantly in patients with mixed intelligence or blood vessels compared to patients with Alzheimer. Therefore, Risperidon should not be treated in patients with other dementia Alzheimer.
Doctors should consider the risk and benefits of using Risperidon in patients with intellectual dementia, paying attention to predicting the risk of stroke for each patient. Patients/family members need to be warned of signs and symptoms of disadvantages of hidden brain vessels such as weakness, sudden paralysis on the face, arms or legs; Having speech or vision problems. Should be appropriate treatment as soon as these symptoms are detected, including stopping using Risperidon.
Risperidon should only be treated for short -term (up to 6 weeks) persistent revolt in patients with dementia Alzheimer does not respond to other non -pharmacological therapy, which are at risk of harming themselves or others, need to periodically evaluate the effectiveness of Risperidon's treatment.
Vertical blood pressure
Due to the α receptor blocker, Risperidon can cause hypotension, especially in the early stage of the dose adjustment. Clinical significant hypotension has been observed when used in combination of risperidon with lowering hypotension. Risperidon cautious use should be used in cardiovascular patients (heart failure, myocardial infarction, conduction disorders, dehydration, reduced blood volume or cerebrovascular disease) and should increase the dose slowly, consider reducing the dose of risperidon when there is hypotension.
leukopenia, neutrophils, granulocytes
Cases of leukopenia, neutropen leukocytes, granulocytes have been reported with rare frequency. Patients with a significant history of leukemia or leukopenia, neutrophils due to drugs should be monitored in the first few months of treatment and should stop Risperidon when there are signs of clinical leukopenia without other risks, closely monitoring and timely treatment of fever or infection occurs in patients with leukopen. Stop using Risperidon and monitor the number of white blood cells until recovery in patients with severe leukemia (absolute neutrophils
Late movement disorders/ Symptoms of foreign tower
Dopamine receptor receptor is associated with the onset of late movement disorders characterized by non -autonomous rhythmic movements, mainly on the tongue and/or on the face. The emergence of foreign symptoms is a risk factor for late movement disorders. If the signs and symptoms of late movement disorders appear, all anti -psychotic drugs should be discontinued.
Malangible neurological syndrome
characterized by high fever, muscular, unstable nerves, consciousness disorders and increased plasma creatinine levels have been reported with anti -psychotic drugs. The accompanying signs may include myoglobinuria (pattern) and acute renal failure. In this case, all anti -psychotic drugs, including Risperidon.
Parkinson's disease and Lewy intellectual decline
Doctors should consider the risk and benefits when prescribing anti -psychotic drugs, including Risperidon, Parkinson patients or patients with Lewy mental decline. Parkinson's disease may be worse when using Risperidon. Both groups are at high risk of malignant neurological syndrome as well as increased sensitivity to anti -psychotic drugs with signs: confusion, consciousness impairment, posture instability attached to regular falls and foreign symptoms.
Hyperborn and diabetes
Risperidon can cause hyperglycemia, diabetes, worsen the available diabetes. Rarely comatose due to diabetes and very rare metabolic keton infection. Should regularly monitor the symptoms of hyperglycemia (thirsty, urinate, eat a lot, weight loss) in patients with diabetes using Risperidon.
weight gain
Patients using risperidon with a lot of weight gain, need to monitor regular weight.
Hypertension hyperlactin
is an unwanted effect. Prolactin concentration should be measured in plasma when observing unwanted effects such as large breasts in men, menstrual disorders, no ovulation, reproductive disorders, reduced libido, erectile dysfunction, milk secretion. Caution should be used in patients with a history of hyperkemin and patients with tumors dependent on prolactin.
extends the range of qt
is unwanted effect very rare. Due to the increased risk of arrhythmia, caution should be used in patients with cardiovascular disease, patients with a history of a long -term QT family, slow heart rate or electrolyte disorders (hypotension, hypoglycemia) and patients taking the drug that lasts QT.
convulsions
Be cautious when using Risperidon in patients with a history of convulsions or patients with low seizures.
Prolonged erection
may occur due to the α receptor blocking effect of Risperidon.
Body temperature
It is necessary to take appropriate care in patients using Risperidon in a state of hyperthermia such as strong physical activity, a lot of sun exposure, used in combination with anti -cholinergic drugs, dehydration.
Anti -vomiting effect
observed in preclinical studies. This effect can hide the signs and symptoms of overdose of some drugs, bowel obstruction, Reye syndrome and brain tumor.
Patients with liver failure, kidney failure
The ability to eliminate ingredients with anti -psychotic activity in patients with less renal failure in adults with normal kidney function. The concentration of free risperidon in plasma increases in patients with liver failure.
Venous thrombosis
Cases of venous thrombosis have been reported when taking anti -psychotic drugs. Because patients treated with anti -psychotic drugs often have risk factors for venous thrombolytic embolism, it is necessary to identify risk factors before and during treatment with Risperidon and propose appropriate preventive measures.
Soft iris syndrome during surgery
has been reported in patients using drugs that have α1 receptor blockers, including risperidon during lens surgery. This syndrome increases the risk of eye complications during and after surgery. Patients need to notify the prehistoric doctor who uses the medication that has an α1 receptor blocker before eye surgery. The benefits of stopping the drug have an α1 receptor blocker before the lens surgery has not been established, it is necessary to consider the risk when stopping treatment with anti -psychotic drugs.
Children
Before prescribing Risperidon for children with behavioral disorders, it is necessary to fully assess the physical and social causes of aggression. Need to closely monitor the sedative effect of Risperidon in children due to the ability to study. Change the time of drinking Risperidon helps improve sedative effects on children's attention. Risperidon also causes weight gain and increased the BMI index in children, so it is necessary to monitor the child's weight before and during treatment.
Due to the hidden effects of increased blood prolactin growth and sexual development due to Risperidon, children need clinical monitoring periodically hormonal status, including: height, weight, sex development, reproductive function and other prolactin effects. Trong thời gian điều trị với risperidon, cũng nên thường xuyên kiểm tra các triệu chứng ngoại tháp và các rối loạn cử động khác.
Risperidon 2 contains lactose excipients. Patients with rare genetic problems in tolerance Galactose, Lapp Lactase deficiency or Glucose - Galactose should not use this drug.
The ability to drive and operate machinery
Risperidon has a slightly affected effect on the ability to drive and operate machinery due to the potential effect on the nervous and vision system. Therefore, patients who are using Risperidon 2 should not drive or operate machines until determining the effect of the drug on the patient.
Pregnancy
There is no enough data on the use of risperidon for pregnant women. Animal studies do not indicate the monster effects but observe other reproductive toxins. The potential risk in people has not been determined.
Infants are exposed to anti -psychotic drugs (including Rispendon) in the last 3 months of pregnancy, there is a risk of unwanted effect on the outskirts of the tower and/or symptoms of stopping after birth, severity and time may vary. There have been reports of agitation symptoms, increased muscle tone, reducing muscle tone, tremor, drowsiness, respiratory failure, or eating disorders in children, so careful monitoring should be monitored. Risperidon should not be used when pregnant unless necessary. If you have to stop taking the drug during pregnancy, it is necessary to reduce the dose slowly.
Lactation period
Risperidon and 9 - Hydroxy - Risperidon excreted in breast milk in small amounts. There is no data on unwanted effects of Risperidon and 9 - Hydroxy - Risperidon to the infant breastfeeding, so it is necessary to consider the risk and benefits when taking the drug.
Drug interaction
strong CYP 2D6 inhibitors (fluoxetin)
Increases the plasma risperidon levels but reduces the concentration of components with anti -psychotic activity. High doses of strong CYP 2D6 inhibitors (paroxetin, quinidin) may increase the concentration of components with anti -psychotic activity. When starting or stopping using CYP 2D6 inhibitors, Risperidon's dosage is required.
CYP 3A4 and P - Glycoprotein inhibitors (P - GP) (Itraconazol, Ketoconazol)
significantly increases the component concentration of Risperidon psychotic activity, especially when combined with high doses of CYP 3A4 and P - GP inhibitors. When starting or stopping using CYP 3 A4 and P - GP inhibitors, Risperidon's dosage is required.
CYP 3A4 and P-GP (Carbamazepin, Phenytoin and Phenobarbital, Rifampicin)
Reduce the component concentration with anti -psychotic activity Risperidon. When starting or stopping using CYP 3A4 and P - GP inhibitors, Risperidon's dose is re -evaluated. Risperidon takes at least 2 weeks to achieve the highest effect as well as need at least 2 weeks to stop using CYP 3 A4 touch agent when coordinated.
The drug is associated with high protein
does not cause clinical shifting one of two drugs from plasma proteins. When combined with high protein -mounted drugs, consider the transformation path of this drug and can adjust the dose if necessary.
Children
There is no pharmacokinetic interaction studying conducted in children. Combining Risperidon with nerve stimulants does not change the pharmacokinetics and effectiveness of the drug.
erythromycin (inhibitor CYP 3A4 and P - GP), Donepezil and Galantamin (resistant to cholininesterase - substrate of CYP 3A4 and 2D6)
Do not change the pharmacokinetics of Risperidon and the ingredient with anti -psychotic activity.
Topiramat
Reducing Risperidon's bioavailability but does not affect the effectiveness of Risperidon.
Phenothiazin, some beta blockers, 3 -round antidepressants and selective reabsorption inhibitors on serotonin (except amitryptylin)
Increases the plasma risperidon levels but does not increase the concentration of components with anti -psychotic activity.
Verapamil (Inhibition CYP 3A4 and P - GP - average GP), Ritonavir (strong inhibitor CYP 3A4 and weak inhibitors CYP 2D6)
Increases the level of Risperidon and the ingredient with anti -psychotic activity in plasma.
Sertralin, Fluvoxamin (weak inhibitors 2D6 and 3A4)
Increases the concentration of Risperidon activity at the dose> 100mg/day.
cimetidin, ranitidin (weak inhibitors 2D6 and 3A4)
Risperidon's bioavailability and a small part of anti -psychotic activity.
Tyeum of drugs
Due to the absence of studies on the correlation of the drug, not mixing this drug with other drugs.
Storage
Where dry, less than 30 ° C. Avoid light.
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