Risperdal 2mg medicine Janssen treats 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
Risperdal 2 mg is indicated in the following cases:
Risperidone also attaches to the receptor α1 (Alpha 1 -adrenergic) and has lower affinity with H1 H1 receptor and α2-adrenergic receptor.
Risperidone has no affinity for the Cholinergic receptors. Although Risperidone is a strong antagonist with D2 receptor, which is considered to improve the positive symptoms of schizophrenia, but Risperidone is less inhibiting movement activities and is less likely to keep the posture of neurons.
When the antagonistic effect of dopamine and serotonin is balanced, it may reduce the risk of extrasic side effects and expand the treatment effects on negative symptoms and emotional symptoms in schizophrenia patients.
pharmacokinetic
absorption
Risperidone is completely absorbed after drinking, reaching the peak concentration of plasma within 1-2 hours. The absorption is not affected by food, so Risperidone can be used when full or hungry.
Distribution
Risperidone is quickly distributed. The distribution volume is 1 - 2 l/kg. In plasma, Risperidone is linked to albumin and alpha1-acid glycoprotein. The ratio of cohesion to plasma proteins of Risperidone is 88%, of 9-Hydroxy-Risperidone is 77%.
A week after drinking, 70% of oral dose is eliminated in urine and 14% in feces. In urine, Risperidone and 9-Hydroxy-Risperidone accounts for 35-45% of the dose. The rest are non -active metabolites.
Metabolism
Risperidone is converted by CYP2D6 to 9-hydroxy-risperidone, which has a pharmacological properties similar to Risperidone. Risperidone plus 9-hydroxy-risperidone creates a part of anti-psychotic activity.
Elimination
After taking orally for patients with psychosis, Risperidone is eliminated, the sale time is about 3 hours. The sale time of 9-Hydroxy-Risperidone and the substance with anti-psychotic activity is 24 hours.
The dose ratio:
Risperidone's constant state is achieved after 1 day in most patients. The status of 9-hydroxy-risperidone is achieved after 4-5 days of taking the drug. Plasma concentration of Risperidone is proportional to the dose within the scope of treatment.
Special population
Children: The pharmacokinetics of Risperidone, 9-Hydroxy-Risperidone and the small part of the anti-psychotic activity in children are the same as in adults.
Hepatic and renal failure:
A single dose study showed that the concentration was more active in plasma and the elimination of the drug with anti -psychotic activity was reduced by 30% in the elderly and 60% in patients with renal failure.
Risperidone plasma concentrations in patients with hepatic impairment are normal but the average concentration of the free risperidone part in plasma is about 35%.
Before taking Risperdal 2mg medicine Janssen treats schizophrenia (6 blisters x 10 tablets)
How to use
Risperdal medicine is in the form of oral tablets.
Dosage
schizophrenia
Switch from other anti -psychotic drugs to Risperdal: When appropriate treatment conditions, gradually stop the previous treatment while starting Risperdal treatment.
Also, under the appropriate treatment conditions when transferring patients who are taking anti -psychotic drugs that have a slow effect to Risperdal, it is advisable to start using Risperdal instead of the next injection. The need for continuing to use anti -Parkinson drugs should be re -evaluated periodically.
Adults: Risperdal can be used once a day or 2 times/day.
start using Risperdal at a dose of 2 mg/day. The dose should be increased to 4 mg on the second day and can be maintained with this dose, or the maintenance dose may vary depending on the patient if necessary. Most patients will respond well with a dose of 4 - 6 mg daily. In some patients, the dose adjustment stage is slower and the starting dose, the lower maintenance dose may be suitable.
The dose of over 10 mg/day is not more effective than lower doses and can cause foreign symptoms. Because the safety of the dose is over 16 mg/day has not been evaluated, so the dose should not be higher than this level.
benzodiazepine can be added with Risperdal if there is an additional sedative effect.
Special population:
Elderly (65 years or older): The starting dose should be used is 0.5 mg x 2 times/day. This dose can be adjusted by 0.5 mg 2 times/day depending on the patient until the dose of 1-2 mg x 2 times/day.
Adolescents: The starting dose should be used is 0.5 mg/day, once a day in the morning or evening. If necessary, this dose may be adjusted by 0.5 or 1 mg/day for a range of ≥ 24 hours, if tolerated, until the recommended dose is 3 mg/day. Effective doses have been shown in the range of 1 mg to 6 mg/day. Dosage higher than 6 mg/day has not been studied.
Patients with drowsy fields may be beneficial when taking half a daily dose, use 2 times/day.
No experience in schizophrenia treatment in children under 13 years old.
Treatment of the bipolar disorder
Adults: Risperdal should be taken once a day, starting at a dose of 2 or 3 mg. If the dose is needed, it is necessary to be done after 24 hours and an increase of 1 mg/day. The effect of the drug is recorded in the range of 1 - 6 mg/day.
Like all symptomatic treatments, the continued use of Risperdal must be evaluated and adjusted based on disease progression.
Children and teenagers: The starting dose should be used is 0.5 mg/day, once a day in the morning or evening. If necessary, this dose may be adjusted by 0.5 or 1 mg/day for about ≥ 24 hours, if tolerated, until the recommended dose is 2.5 mg/day. Effective doses have been shown in the range of 0.5 mg to 6 mg/day. Dosage higher than 6 mg/day has not been studied.
Patients with drowsy fields may be beneficial when taking half a daily dose, use 2 times/day.
Like all symptomatic treatments, the continued use of Risperdal must be evaluated and adjusted based on disease progression.
There is no experience of revalt treatment due to bipolar disorder in children under 10 years old.
Trial disorders in children from 5 years old and teenagers
For patients ≥ 50 kg: should start at a dose of 0.5 mg (1 time/day). When needed, depending on the patient can increase by 0.5 mg/day but not do the dose earlier than 48 hours. The optimal dose in most patients is 1 mg (1 time/day). However, in some patients may only need 0.5 mg (1 time/day) while others need 1.5 mg (1 time/day).
For patients
Like all symptomatic therapies, the continuous use of Risperdal must be evaluated and adjusted based on disease progression.
Inexperienced use of this drug for children under 5 years old.
irritability is easy to be related to autism
Children and adolescents: 1 mg and 2 mg film tablets are inadequate for initial treatment and dose adjustment for patients
Risperdal dose must be prescribed specifically according to the needs and responding to the treatment of each patient. Should start at a dose of 0.5 mg/day for patients weighing ≥ 20 kg.
On the 4th day of treatment may increase the dose of 0.5 mg for patients ≥ 20 kg.
This dose should be maintained and the response should be evaluated and around the 14th. Only consider increasing the treatment dose in patients who do not achieve a complete clinical response. The increase in the dose can be done each ≥ 2 weeks at 0.5 mg for patients with severe patients ≥ 20 kg.
In clinical studies, the maximum dosage of the day does not exceed 1.5 mg in patients with severe 45 kg. The dose below 0.25 mg/day does not show effective in clinical studies.
Risperdal's doses for children with autistic disorders (total doses mg/day)
DAY 1 - 3
DAY 4 - 14+
The level of dosage increase if necessary
Dosage
≥ 20 kg
0.5 mg
1.0 mg
+0.5 mg every> 2 weeks
1.0 - 2.5 mg*
For patients with drowsiness, it is possible to switch from 1 time/day to 1 time/day before sleeping or 2 times/day.
Once clinical response has achieved and maintained, it is possible to consider to gradually reduce the dose to achieve the optimal balance between efficiency and safety.
Not enough experience to use in children younger than 5 years old.
In patients with liver failure and renal failure: Patients with renal impairment have a decrease in the clearance of drugs that are more anti -psychotic activity in normal adults. In patients with impaired liver function, the concentration of free risperidone in plasma increases.
Regardless of any indications, the starting dose and the next dose must be half reduced, and the dose adjustment process must be slower in patients with liver failure, kidney failure.
Risperdal must be used carefully in these patients.
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? These symptoms include drowsiness and sedation, tachycardia, hypotension and pagoda symptoms.
In the case of overdose, prolonged QT segment, and convulsions have been reported.
When an overdose of Risperdal oral with paroxetine, the torsion phenomenon has been reported.
In case of acute overdose, it is advisable to consider the possibility of a lot of drugs.
Treatment: Set and maintain respiratory circulation and ensure adequate oxygen and ventilation. Stomach washing (after the internal intubation, if the patient is unconscious) and should consider using activated carbon in combination with laxatives. It should be started to monitor cardiovascular immediately, including continuous monitoring of electrocardiograms to detect possible arrhythmia.
There is no specific antidote to Risperdal. Therefore, appropriate support measures should be applied. Hypotension and circulatory failure should be treated with appropriate measures such as intravenous infusion and/or drugs like sympathetic nerve. In case of severe foreign symptoms, cholinergic drugs should be used. Should continue to monitor and closely monitor medical until the patient recovers.
In an emergency, call the 115 emergency center immediately or go to the nearest local health station.
What to do when forgetting a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.
Side Effects
When using Risperdal 2 mg, you may experience unwanted effects (ADR).
The most common reactions of the drug (ADR) (the ratio of ≥ 10%) are reported: Parkinson's syndrome, sedation/drowsiness, headache and insomnia. The ADR appears related to the dose including Parkinson's syndrome and restlessness.
The following is all ADRs reported in clinical studies and after bringing Risperidone to the market with the estimated frequency from Risperdal clinical studies. The following terms and frequency are applied: Very popular (≥ 1/10), popular (≥ 1/100 to
In each frequency group, adultery effects are presented in the order of severity of severity.
Classification of agency systems
The harmful reaction of the drug
Very popular
popular
Not popular
Rare
Very rare
Respiratory infections, cystitis, eye infections, tonsillitis, nail mushrooms, local tissue inflammation, virus infections, dermatitis.
infection.
Loss of granulocytes.
Anaphylactic reaction.
In the urine.
Diabetes, hyperglycemia, thirst, weight loss, anorexia, hyperkemia.
Surprising toxicity, hypoglycemia, increased blood insulin, hyper triglyceride.
diabetes, ceton acidosis.
Mental disorders
Insomnia.
Sleep disorders, agitation, depression, anxiety.
Halfy, condition, decrease in libido, stress, nightmares.
Exampling emotions, loss of orgasm.
sedation/drowsiness, ParkinsonD syndrome, headache.
restlessness, muscle tone disorders, dizziness, dysplasia, tremor.
late dysplasia, ischemic ischemic, non -response to stimulation, loss of consciousness, impaired level of consciousness, convulsions, fainting, mental movement, balance disorders, abnormal coordination, posture, attention disorders, taste disorders, decreased sensation, abnormalities.
Malignant syndrome caused by psychotropic drugs, cerebrovascular disorders, coma due to diabetes, dizziness.
fear of light, dry eyes, increased tear secretion, eye congestion.
Glaucoma, eye movement disorders, eye rotation, eyelid stiffness, iris mushy syndrome (in surgery).
Atrial fibrillation, atrial block, conduction disorders, extending the QT interval on electrocardiograms, slow rhythms, electrocardiogram abnormalities, chest drums. Sinus arrhythmia. Hypertension. Hypotension, posture hypoglycemic, holy. Pulmonary embolism, venous thrombosis. Inhaled pneumonia, pulmonary congestion, respiratory trail, ran, wheezing, difficulty pronouncing, respiratory disorders. Difficulty syndrome when sleeping, increasing ventilation. Self -control, stool, gastritis, difficulty swallowing, flatulence. Pancreatitis, bowel obstruction, tongue swelling, lipitis. intestinal obstruction. urticaria, itching, hair loss, horn, eczema, dry skin, skin discoloration, acne, seborrheic dermatitis, skin disorders, skin damage. Rash due to drugs, dandruff. eagowns Hemorrhage, abnormal body, stiffness, swelling, muscle weakness, neck pain Demonstration. urinating, urinary retention, difficult urine. Penis, menstrual delay, blood stasis in the breast, big breasts, breast secretion. Facial edema, chills, increase body temperature, abnormal gait, thirst, discomfort in the chest, discomfort, abnormal feeling, uncomfortable. Reduce temperature, reduce body temperature, peripheral cold, cessation syndrome, hard bottle c. jaundice. Pain due to tricks.
B: In clinical studies with placebo, diabetes are reported by 0.18% in Risperidone treatment groups compared to the rate of 0.11% in the placebo group. The general ratio from all clinical studies is 0.43% in Risperidone treatment subjects.
C: Not recorded in Risperdal's clinical research but recorded in the stage after bringing the drug to the market with Risperidone.
d:
Periodic dysfunction may occur:
Parkinson's syndrome (increased salivation, stiff muscle muscle, Parkinson's syndrome, drooling, stiffness of serrated wheels, slow movement, reduction of motor function, stiff face such as masking, muscle tension, motor bile, stiff neck, stiff muscle, Parkinson's body and abnormal abnormal reflexes of-MI, Run Parkinson when resting), restlessness (restlessness (movement disorders, twisting muscles, twisting finger automatically, dancing and vibrating muscle), muscle disorders.
Muscle disorders include muscle hypertension, muscle tone, crew, automatic muscle contraction, muscle spasticity, eyelid spasms, eyeball rotation, tongue paralysis, face spasms, larynx spasms, muscle tone, curved bend, mouth spasms, stiffness on one side of the body, tongue spasms, and jaw hard.
Note that the symptoms are wider distributed, not necessarily from the foreign origin.
Insomnia includes: insomnia, insomnia in the middle of sleep; convulsions include: great epilepsy; Menstrual disorders include: irregular menstruation, sparse menstruation; Edema includes: full body edema, edema, concave edema.
Unwanted effects are recorded with the Paliperidone formula
Paliperidone is a metabolite that has the activity of risperidone. Therefore, the adverse reactions of these drugs (including oral form and injection form) are related to each other.
In addition to the aforementioned adverse reactions, the following adverse reactions listed have been recorded when using Paliperidone products and is expected to occur with Risperdal.
Cardiovascular disorders: Standing posture tachycardia syndrome.
Reactivation classification: Like other anti -psychotic drugs, there are very rare cases that extend the QT range that has been reported to Risperidone in the period after bringing the drug to the market.
Cardiovascular related reactions have been reported with anti -psychotic drugs that extend the QT range including ventricular arrhythmia, ventricular vibration, ventricular rhythm, sudden death, cardiac arrest and torsion.
Venous thrombosis: Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis, have been reported with anti -psychotic drugs (unknown frequency).
Weight gain:
The rate of weight gain ≥ 7%of the body weight comparison between adult patients using Risperdal and placebo used to treat schizophrenia is performed in the group of clinical trials with placebo-control tests for 6-8 weeks shows that the rate of increase has statistically significant weight gainer in the Risperdal group (18%) compared to the placebo group (9%).
In the group of clinical trials with a place of placeborn in 3 weeks in adult patients with acute Hung Cam Treatment, the weight gain rate of ≥ 7%at the end of the study is comparison in the Risperdal group (2.5%) and the placebo group (2.4%) and this rate is slightly higher in the control group using active drugs (3.5%).
In long -term studies in children and teenagers with behavioral disorders and vandalism, the average level of weight gain is 7.3 kg after 12 months of treatment. The average weight gain expected in children from 5 to 12 years old is 3 - 5 kg per year. In children from 12 to 16 years old, the level of weight gain reaches 3-5 kg per year is maintained in women, while male children gain about 5 kg per year.
More information about the special population group: the adverse reaction has been reported at a higher rate in older patients who dit in intelligence or in children more in the adult population described below:
Older patients have dementia:
A stroke due to transient anemia and a stroke is reported in clinical trials with the corresponding frequency of 1.4% and 1.5% in elderly patients who have dementia.
In addition, the following ADRs are reported at a frequency of ≥ 5% in older patients with dementia and at least twice the frequency of other adult populations: urinary tract infections, peripheral edema, lethargy and cough.
Pediatric patients:
In general, the types of adverse reactions in children are expected to be similar to adverse adult reactions.
The following ADRs are reported at a frequency of ≥ 5% in children (5-17 years old) and at least twice the frequency recorded in clinical trials in adults; Sleep/sedation, fatigue, headache, increased appetite, vomiting, upper respiratory infection, stuffy nose, abdominal pain, dizziness, cough, fever, tremor, diarrhea and beams. The impact of long -term Risperidone treatment on sex maturity and height has not been fully studied.
Notify the doctor with unwanted effects when using the drug.
Instructions on how to handle ADR
Although risperidon is different from phenothiazin substances in chemicals, risperidon can cause multiple adr of phenothiazin, but not all.
ADR of risperidon and phenothiazine is abundant and may be related to most organs in the body. While these ADRs are often recovered when the dose reduction or stopping drugs, some ADR may not recover and rarer, may die.
The cause is mostly thought to be due to cardiac arrest or apnea due to losing reflexes, while some deaths do not clearly identify the cause of the drug.
If you see malignant neurolithic syndrome, a symptom complex that can be fatal with characteristic manifestations of reducing muscle tone, stunning state, fever, unstable blood pressure, blood myoglobin occurs, should stop immediately and treat dantrolen or bromocriptin.
If the patient needs to be treated with anti -psychotic drugs after the malignant neuroleptic syndrome, it is necessary to consider the use of the drug again. Must be monitored carefully, as this syndrome may recur. There is no therapy for late dysfunction, which can occur in patients treated with anti -psychotic drugs, although this syndrome may be partially or completely, if the drug is stopped.
If the signs and symptoms of late dysfunction occur in patients treated with risperidon, it is necessary to stop the drug. However, some patients may still need treatment with Risperidon, although this syndrome
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
Risperdal 2 mg contraindicated in the following cases:
Precautions when using
Older patients with dementia
General mortality rate: Elderly patients with dementia are treated with typical anti -psychotic drugs that increase the mortality rate compared to the placebo, under analysis of 17 clinical trials that are controlled with typical anti -psychotic drugs including Risperdal.
In Risperdal studies with a placebo, the mortality rate is 4.0% in the Risperdal treatment group, compared to 3.1% in the place of placebo. The average age of deaths is 86 years old (about 67 - 100 years old).
Use at the same time as Furosemide: Also in Risperdal studies compared to placebo in the elderly with intellectual dementia, patients treated with Furosemide and Risperidone, have higher mortality rates (7.3%, average age of 89 years old, about 75 - 97 years old) compared to Risperidone treatment for simple age (3.1%, age 85, age 85, 96) Furosemide alone (4.1%, average age 80, age 67 - 90).
Increased mortality in patients treated with Furosemide with Risperidone is recorded in 2 of 4 clinical trials.
There is no pathological mechanism that is clearly defined to explain this and there is no cause of death. However, caution must be set and the consideration between the risk and benefits of this combination of drugs must be carefully considered before deciding to use. There is no increase in the mortality rate in patients who are taking other diuretics in combination with Risperidone.
Regardless of treatment, dehydration is a high risk for death and thus should avoid dehydration carefully in older patients with dementia.
Side effects on cerebral vascular (CAE): In the trials compared to the placebo in the elderly, there is a dementia, the ratio of side effects on the cerebral vascular (stroke and transient ischemia) including deaths in patients treated with Risperdal higher than patients with placebo (average age of 85 years old: from 73 - 97 years old).
posture hypotension
Due to the Risperidone alpha blocker, hypotension (vertical posture) may occur, especially in the initial dose adjustment phase. Clinically implicitized hypotension has been recorded after bringing the drug to the market when Risperidone is used with drugs to treat hypertension.
Risperdal should be used carefully for patients who are known to have cardiovascular disease (such as heart failure, myocardial infarction, abnormalities in transmission, dehydration, reduced blood volume or cerebrovascular disease) and the dose should be adjusted slowly as recommended (see the dose and usage method). Should consider reducing the dose if hypotension occurs.
leukopenia, neutropenia and grain leukocytes
Clegen decreased, neutropenia and grain leukocytes have been reported with anti -psychotic drugs, including Risperdal. Grain leukemia is very rare (
Patients with a history of clinical leukemia or medications that cause neutropenia/neutropenia must be monitored in the first months of treatment and must be considered immediately to stop Risperdal when there are signs of clinical disruptive reduction of clinical significance without other causes.
Patients with clinical neutropenia must be closely monitored by fever or signs of infection and immediately treated if these signs occur. Patients with severe neutropenia (the number of absolute neutrophils
Venous thrombosis
Cases of venous thrombosis (VTE) have been reported to anti -psychotic drugs. Because patients treat psychotic drugs often have risk factors for VTE, all possible risk factors of VTE must be detected before and during Risperdal treatment and have preventive measures.
Late movement disorders/Symptoms of foreign tower
Dopamine receptor -resistant drugs are associated with the fact that the late movement disorders are characterized by: The rhythmic movements are not arbitrary, mainly on the tongue and/or on the face. There has been a report that the appearance of foreign symptoms is a risk factor for the development of late movement disorders. If the signs and symptoms of late movement disorders occur, the stop use of all anti -psychotic drugs should be considered.
Malangular neuron syndrome
Malignant neuropular syndrome caused by neuroleptics, characterized by high fever, muscle spasticity, automatic neurological instability, consciousness disorders and increased serum creatine phosphokinase concentration that has 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 risperdal, should be discontinued.
Parkinson's disease and Lewy intellectual decline
Doctors need to consider the risk compared to the benefits of the drug when prescribing anti -psychotic drugs, including Risperdal, for Parkinson patients or Lewy intellectual dementia (DLB, Dementia Lewy Bodies) because both groups may be at high risk of malignant syndrome due to neuroleptic as well as increase sensitivity to anti -psychosis. Sensitive increase may include: confusion, drowsiness, and unstable posture with frequent falling, plus the symptoms of foreign tower.
Hyperborn and diabetes
Hyperglycemia, diabetes and worsening the available diabetes have been recorded during treatment with Risperdal. In some cases, the previous increase in body weight has been reported may be a promotional factor. The association with ketone acidosis has been reported very rare and rare for diabetes coma.
Adequate clinical monitoring is recommended in accordance with the instructions for using anti -psychotic drugs. The patient is treated with any typical anti -psychotic drugs, including Risperdal, which should be monitored with symptoms of hyperglycemia (such as eating a lot, drinking a lot, urinating and fatigue) and patients with diabetes must be monitored regularly to detect loss of blood sugar control.
weight gain
A lot of weight has been reported. Should track weight when using Risperdal.
About qt
Just like other anti -psychotic drugs, be careful when prescribing Risperdal for patients with a history of arrhythmia, patients with congenital QT syndrome, and patients who use it along with known drugs to extend the QT.
Penis erection
Alpha-adrenergic blockers have been reported to cause penis. This symptom has been reported in patients using Risperdal in surveys after bringing the drug to the market (see side effects).
Air conditioning body temperature
Integrity of reducing the center temperature of the body is the characteristic of anti -psychotic drugs. Appropriate care measures for patients are prescribed Risperdal in conditions may increase the center temperature of the body, for example: excessive exercise, exposure to excessive heat source, using anti -cholinergic drugs, or dehydrated patients.
Anti -vomiting effects
Anti -vomiting effects have been seen in preclinical studies with Risperidone. This impact, if occurring in humans, can obscure signs and overdose symptoms of certain drugs or diseases such as bowel obstruction, Reye syndrome and brain tumor.
convulsions
As well as other anti -psychotic drugs, Risperdal must be used carefully in patients with a history of convulsions or under conditions that can reduce seizures.
Surgery syndrome in surgery
IFIS moisture syndrome (ifis) is observed in cataract surgery in patients treated with drugs that have a disorder with α1 - adrenergic, including Risperdal (see the adverse effect).
iFIS may increase the risk of complications of eye and after surgery. The use of drugs has a contradiction with α1-adrenergic at the moment or previously needed by the surgeon to know before surgery.
The potential benefits of stopping treatment with α1 blockers before cataract surgery cannot be determined and should consider the benefits compared to the risk of the suspension of anti -psychotropic treatment.
Other: See the "dosage and usage - schizophrenia" to know the specific dose in the elderly, the "Dosage and usage - Hung Cam due to bipolar disorder" in the elderly are managed by bipolar disorders, the "dosage and usage - behavioral disorders and other destructive behaviors" for children with behavioral disorders and destructive behaviors, self -use "
The ability to drive and operate machinery
Risperdal can affect activities that require mental alertness. Therefore, patients who are using Risperdal are recommended not to drive or operate machinery until they know their sensitivity.
Pregnancy
Risperdal's safety when used for pregnant women has not been determined. Despite the test on animal tests, Risperidone does not show direct toxicity on reproduction, some indirect effects through the intermediary of the prolactin and the central nervous system have been recorded. Risperidone's teratogenic effects are not recorded in any research.
Babies exposure to anti -psychotic drugs (including Risperdal) in the last 3 months of pregnancy, there is a risk of overseas symptoms and/or symptoms of "quitting" at different degrees of severe severity after birth. These symptoms in newborns include agitation, muscle tone, reducing muscle tone, tremor, drowsiness, shortness of breath, or difficulty sucking. Therefore, Risperdal should only be used during pregnancy if the benefit is more than the risk. If you need to stop the drug during pregnancy, do not stop suddenly.
Breastfeeding period
In animal studies, Risperidone and 9-Hydroxy-Risperidone are excreted in milk. This has also been identified on humans, Risperidone and 9-Hydroxy-Risperidone are excreted through breast milk. Therefore, women who are using Risperdal should not breastfeed.
Drug interaction
Interactions related to pharmacological energy
The drug acts on the central nervous system and Alcohol: Because Risperdal has the main effect on the central nervous system, so it should be cautious when used with drugs on the central nervous system or Alcohol.
levodopa and dopamine antagonist: Risperdal can fight the impact of levodopa and other dopamine homogens.
The drug has the effect of lowering blood pressure: After the drug is marketed, it is noticeable about clinical hypotension when used with drugs to treat hypertension.
The drug is known to extend the QT interval: Be cautious when prescribing Risperdal with drugs that are known to extend QT.
Interactions related to pharmacokinetics
Food does not affect the absorption of Risperdal: Risperidone is metabolized mainly through CYP2D6, and a small part via CYP3D4. Both Risperidone and metabolic active ingredients are also active 9-hydroxy-risperidone are the substrate of p-glycoprotein (P-GP). The substances that change the activity of CYP2D6, or strong inhibitors CYP3D4 and/or the activity of P-GP, can affect the pharmacokinetics of the Risperidone disorder.
CYP2D6 strong inhibitors: simultaneous use of Risperdal with strong CYP2D6 inhibitors may increase the plasma concentration of Risperidone, but less effects on the drug with anti -psychotic activity. The high doses of strong CYP2D6 inhibitors may increase the concentration of risperidone anti -dysplasia activity (for example: paroxetine, see below). When using Paroxetine simultaneously or other powerful CYP2D6 inhibitors, especially at high doses, at the beginning or when stopping in use, the doctor should re -evaluate the dose of Risperdal.
CYP3A4 inhibitors and or P-GP inhibitors: simultaneously use Risperdal with strong CYP3A4 and/or P-GP inhibitors that may increase the concentration in plasma parts that have anti-psychotic activity of risperidone. The doctor should re-evaluate the dose of Risperdal when using ITRACONAZole or strong inhibitor CYP3A4 and/or P-GP at the time of starting or stopping use.
CYP3A4 and/or P-GP touch substances: simultaneously use Risperdal with strong touch substances CYP3A4 and/or P-GP can reduce the concentration in plasma parts that have risperidone disorder. The doctor should re-evaluate the dose of risperdal when using Carbamazepine simultaneously or CYP3A4 and/or P-GP induction at the time of starting or stopping.
High -bound with protein: When Risperdal is taken with high -cohesive drugs with protein, there is no mutual position with clinical significance of any drug from plasma proteins.
When used simultaneously, information should be considered for the transformation path and can adjust the dose if necessary.
Children's subjects:
Research on drug interaction is only done in adults. The similar research results in the patient are not known.
Examples of drugs that are interactive or have been shown to have no interaction with Risperidone listed below:
Antibiotics: Erythromycine (average CYP3A4 inhibitor) does not change the pharmacokinetics of Risperidone and the anti -psychotic activity.
Rifampicin (strong inhibitor CYP3A4 and P-GP) reduces plasma concentrations of anti-psychotic activity.
Anticholinesterase: Donepezil and Galantamine (two metabolites through CYP2D6 and CYP3D4) are shown to not clinically related to Risperidone and anti -psychotic activity.
Anti-epileptic drugs: Carbamazepine (CYP3A4 and P-GP induction) have been shown to reduce the concentration in plasma parts with anti-psychotic activity of Risperidone.
Topiramate is a typical substance that reduces the bioavailability of Risperidone, but does not affect the anti -psychotic activity. So this interaction does not seem to have clinical significance
Risperidone does not show clinical related effects on pharmacokinetics of valproate or topiramate.
antifungal drugs: Itraconazole (strong inhibitor CYP3A4 and P-GP) at a dose of 200 mg/day increases plasma concentrations of the anti-psychotic activity about 70% when the dose of Risperidone from 2-8 mg/day.
Ketoconazole (strong inhibitor CYP3A4 and P-GP) at a dose of 200 mg/day increases risperidone plasma concentrations and reduces plasma concentrations in 9-hydroxy-risperidone.
Anti -psychotic drugs: Phenothiazine may increase the plasma concentration of risperidone but do not increase the anti -psychotic activity.
Aripiprazole (substrate of CYP2D6 and CYP3A4): Risperidone tablets or injections do not affect the pharmacokinetics of the total number of Aripiprazole and its active metabolites are Dehydraripipipipipipe.
Anti -viral drugs: Protease inhibitors: No official research is available; However, because Ritonavir is a strong CYP3A4 inhibitor and is a weak inhibitor CYP2D6, the Ritonavir and Ritonavir-Boosted Protease inhibitors have the potential to increase the concentration of risperidone disorder.
Beta blockers: Some beta blockers may increase the plasma concentration of risperidone but do not increase the concentration of risperidone disorder.
Calcium channel inhibitor: Verapamil (CYP3A4 average inhibitor and P-GP inhibitors) increase Risperidone plasma concentrations and the anti-psychotic activity.
Digitalis Glycoside: Risperidone does not show clinically related effects on pharmacokinetics of digoxin.
Diuretics: Furosemide: See the warning of increased mortality rates in older patients who are demented when taken at the same time with diuretics.
Gastroentric drugs: H2 receptor antagonists: cimetidine and ranitidine are two weak inhibitors CYP2D6 and CYP3A4, increasing the bioavailability of risperidone at negligible levels, only in the anti -psychotic activity.
Lithium: Risperidone does not show clinical effects on lithium pharmacokinetics.
SSRI and 3 -round antidepressants.
Fluoxetine (strong CYP2D6 inhibitor) increases the plasma concentration of risperidone but affects less levels of anti -psychotic activity.
Paroxetine (strong CYP2D6 inhibitor) increases risperidone plasma concentrations, but at a dose of up to 20 mg/day, less than the level of psychotic activity. However, higher paroxetine dose may increase the concentration of anti -psychotic activity Risperidone.
3 -round antidepressants may increase Risperidone levels but do not increase the anti -mental activity. Amitriptyline does not affect the pharmacokinetics of Risperidone or the anti -psychotic activity.
Sertraline (weak inhibitor CYP2D6) and Fluvoxamine (CYP3A4 weak inhibitor) at a dose of 100 mg/day is not related to any significant clinical changes to Risperidone anti -psychotic activity concentration. However, the dose higher than 100 mg/day of sertraline or fluvoxamine may increase the concentration of the active substance against Risperidone.
Storage
Store temperature not exceeding 30 ° C.
Expiry date: 36 months from the date of production.
Do not use overdue drugs indicated on the packaging.
Other drugs
- COLOMYCIN TABLETS
- ENANTYUM 25 MG ORAL SOLUTION
- MEBEVERINE 200MG MODIFIED RELEASE CAPSULES
- NOUBID 200MG FILM-COATED TABLETS
- NOOTROPIL 800MG TABLETS
- PROSTAMEN SOFT CAPSULES
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