Sizodon 1 Sunplay Treatment Treatment of schizophrenia (5 blisters x 10 tablets)

Dosage form Box of 5 blisters x 10 tablets
Specifications Risperidonum

Ingredient

Composition information	Content
Risperidonum	1mg

Uses

indications

Sizodon drugs are indicated in the following cases:

schizophrenia.

Treatment of average to severe revolting attacks in bipolar disorder.

Short -term treatment (up to 6 weeks) in patients with Alzheimer loss of memory from medium to severe, not responding to non -drug -free measures and taking harmful actions for themselves or others.

Treatment of short-term symptoms (up to 6 weeks) in prolonged behavioral disorders in children from 5 years old and adolescents with intellectual function below average or intellectual retardation that is diagnosed with DSM-IV, in which the severity of aggressive or causing disruptive behavior needs drug treatment.

Drug treatment is an integral part of a comprehensive treatment, including psychosocial and educational intervention. Risperidon is recommended to follow the nerve expert's instructions in children and psychologists in minors or doctors who have experience in treating prolonged behavioral disorders of children and adolescents.

Pharmacokic

Risperidon acting mechanism is a selective antagonist monoaminergic. Risperidon has a high affinity with HT2 serotonin receptor, and Dopamine D2 receptor.

Risperidon is also associated with Alpha 1 -Drenergic receptors, and lower affinity with H1 histamine receptors, and alpha 2-adrenergic receptors.

Risperidon has no affinity for the Cholinergic receptor.

Risperidon is a strong D2 antagonist, improving the positive symptoms of schizophrenic mental mental illness, causing less exercise and causing more prove to retain the position of anti -psychotic drugs.

Serotonin and central dopamine antagonism balance may reduce the extrasic side effects and expand the treatment of negative symptoms and symptoms of schizophrenia.

pharmacokinetics

absorption:

Risperidon absorption is completely absorbed after drinking, the peak of plasma is achieved within 1-2 hours.

absolute oral bioavailability of Risperidon 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.

Risperidon's stable state is achieved within 1 day. The stability of 9-Hydroxy-Resperidon is achieved within 4-5 days of medication.

Distribution:

Risperidon is quickly distributed. The distribution volume is 1 - 2 l/kg. In plasma, Risperidon is attached to albumin and glycoprotein alpha -acid.

The cohesion with the plasma protein of Risperidon is 90%, of 9-Hydroxyrisperidon is 77%.

Metabolism:

Risperidon is converted by CYP2D6 to 9-hydroxy-risperidon with pharmacological activity similar to Risperidon.

Risperidon and 9-Hydroxy-Risperidon are anti-psychotic active components. Another metabolic line of Risperidon is N-DEALYLation.

Era:

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.

Before taking Sizodon 1 Sunplay Treatment Treatment of schizophrenia (5 blisters x 10 tablets)

How to use

Sizodon uses oral. Food does not affect the absorption of sizodon.

Dosage

Senocine patient

Adults:

can be used once or twice daily, patients should start at a dose of 2 mg of risperidon/day. The dose may increase to 4 mg on the second day. In some patients, the dose adjustment stage is slower, suitable for starting and maintaining at low doses. The dose of over 10 mg/day has not been effective compared to the lower dose and may increase the incidence of foreign symptoms.

The recommended starting dose is 0.5 mg twice daily.

Risperidon is not recommended for children under 18 years of age with schizophrenia due to lack of data on effectiveness.

Adults:

Sizodon should be used once a day, starting at a dose of 2 mg of risperidon. If the dose adjustment is indicated, it is advisable to take a period of less than 24 hours and increase at a dose of 1 mg daily. The daily dose per 6 mg of Risperidon is not studied in patients with a manicular attack.

The recommended starting dose is 0.5 mg twice daily.

Risperidon is not recommended for children under 18 years of age who have a bipolar sensuality due to lack of data on efficiency. If necessary, the dose can be adjusted on each patient by increasing the dose of 0.25 mg twice daily, increasing the day.

For most optimal doses of 0.5 mg twice daily. However, some patients can respond to the dose up to 1 mg twice daily.

Sizodon should not use for more than 6 weeks in Alzheimer patients with memory loss with prolonged aggression. During the treatment period, the condition must be evaluated regularly and regularly, it is necessary to re -evaluate the need to continue treatment.

behavioral disorders

Children and teenagers 5 - 18 years old:

Patients with weight> 50kg, the starting dose is recommended by 0.5 mg once daily. If necessary, can be adjusted in each patient by increasing 0.5 mg once a day, increasing day by day. However, some patients may respond to a dose of 0.5 mg once daily, while others may need 1.5 mg once a day. If necessary, can be adjusted on each patient by increasing 0.25 mg once a day, increasing day by day. The optimal dose is 0.5 mg for most patients. However, some patients may respond to a dose of 0.25 mg once a day, while others may need 0.75 mg once a day.

Children:

Sizodon is not recommended in children under 5 years old, because there is no record of children under 5 years old with this disorder.

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. Symptoms of acute drug stops include nausea, vomiting, sweating, and insomnia are rarely described after stopping the anti -psychotic drug suddenly in high doses.

Recognized cases of recurrence of mental symptoms, and the appearance of non -autonomous movement disorders (such as restless sitting, muscle disorders and movement disorders).

Use Sizodon after other psychotic drugs:

When necessary, it is advisable to slowly stop the previous treatment therapy when starting with sizodon. 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 include drowsiness, fatigue, tachycardia and hypotension, and pagoda symptoms. When overdose, record the situation of prolonged QT and convulsions. The peak is also recorded when combining the overdose of Risperidon and Paroxetin.

Excessive algae, need to consider the ability of combined drugs. Treatment to keep airway airy, ensuring enough oxygen and ventilation. Stomach washing (after intubation, if the patient is unconscious) and the use of active carbon with laxatives 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 infusion and/or using sympathetic drugs.

In case of severe pagoda symptoms, an acetylcholin 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, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Systemic: Fever, fatigue, periphery, weakness, chest pain.

Testing: increased blood prolactin.

Disorders of metabolism and nutrition: Increasing appetite, reducing appetite.

Neurological: headache, Parkinson's syndrome, headache, restless, dizziness, disorders of force, drowsiness.

digestive: vomiting, diarrhea, constipation, nausea, abdominal pain, digestive disorders, dry mouth, stomach pain.

Skin and subcutaneous tissue: rash, erythema.

blood: leukemia with fever, eosinophilia, hemoglobin. Cardiovascular: extends the qt distance on the electrocardiogram, abnormal electrocardiograms.

eyes: blurred vision.

Respiratory, chest, mediastinum: pneumonia, influenza, bronchitis, upper respiratory tract infections, shortness of breath, nosebleeds, cough, stuffy nose, sore throat - laryngeal.

Urinary tract:

musculoskeletal: joint pain, back pain, extreme pain.

Uncommon, 1/1000

Systemic body: Facial edema, movement disorders, abnormal feeling, slow, flu disease, thirst, uncomfortable chest, chills.

Respiratory, chest, mediastinum: wheezing, inhaled pneumonia, pulmonary artery obstruction, respiratory disorders, ran, respiratory obstruction, difficult to pronounce.

urinary tract: urinary retention, difficulty urination, non -autonomous urine, urination. Neurological: does not respond to stimuli, loss of consciousness, fainting, depression, brain blood vessel events, fleeting anemia, difficult to pronounce, causing stirring, sleeping, dizziness posture, balanced disorders, late movement disorders, speech disorders, abnormal activity, emotional reduction. digestive: difficulty swallowing, gastritis. ears: ear pain, tinnitus.

Skin and subcutaneous tissue: Evana, skin damage, skin disorders, itching, acne, skin discoloration, hair loss, seborrheic dermatitis, dry skin, horns. Cardiovascular: lower blood pressure, posture hypotension, blushing. Blood: leukopenia, anemia, platelet decreased in granulocytes, granulocytes.

Eyes: Conjunctivitis, congestion in the eyes, eye, swelling of the eyes, dry eyes, watery eyes, fear of light, vision decreasing, puffiness, glaucoma.

musculoskeletal: muscle weakness, muscle pain, neck pain, joint swelling, abnormal posture, numbness in joints, musculoskeletal chest, muscle pilot.

Testing: increased transaminase, increased blood phosphokinase.

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 drug is contraindicated in cases of sensitivity to pharmaceutical substances or any excipients of the drug.

Be cautious when using

Elderly patients with dementia: Increasing death rate in elderly people with dementia.

Unwanted effect on the blood vessel (CVAE): The risk of unwanted effects on the blood vessels increases about 3 times in random control clinical trials using placebo in patients with dementia treated with some typical anti -psychotic drugs.

Sizodon should be used carefully in patients at risk of stroke.

Sizodon should only be used short -term for persistent aggressive treatment in Alzheimer patients with average to severe dementia to support non -drug -free measures - often limited or ineffective 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.

Hypotension posture due to Risperidon's alpha blockers, hypotension may occur, especially during the initial dose adjustment period. Clinical hypotension significantly observed with simultaneous use of Risperidon and treating hypotension.

Sizodon should be used cautiously in patients with cardiovascular disease.

leukopenia, neutropenia has been recorded when using anti -psychotic agents including risperidon.

Late movement disorders/Symptoms of foreign tower (TD/EPS): The drug has a Dopamine receptor resistant to the onset of late movement disorders characterized by unconscious movement, mainly of the tongue or face.

Malignant syndrome caused by sedation is characterized by hyperthermia, muscle stiffness, plant instability, changing consciousness and increasing creatine phosphokinase has been reported to occur with anti -psychotic drugs.

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).

Hyperglycemia and diabetes: Record cases of hyperglycemia, diabetes and worsen diabetes during treatment with sizodon.

Sizodon should be used cautiously in patients with a history of hypertension blood prolactin and in patients with tumors dependent on prolactin.

Epilepsy: Sizodon should be used cautiously in patients with a history of epilepsy or other conditions with seizures.

Penis erection may occur when treated with sizodon due to the effect of blocking Alpha-adrenergic.

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.

Venous thrombosis (VTE): Cases of venous thrombosis (VTE) have been reported to anti -psychotic drugs.

Surgery syndrome in surgery has been recorded when cataract surgery in patients treated with drugs with alpha-adrenergic activity including risperidon, this syndrome may increase the risk of complications on the eye and after surgery.

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 ability to drive and operate machinery

sizodon may have a slight or medium effect on the ability to drive and use machines 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. Sizodon should not be used during pregnancy unless it is really necessary. If you need to stop the drug during pregnancy, do not stop suddenly.

The period of breastfeeding

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.

Interactive drug

as well as other anti -psychotic drugs, need to be cautious when prescribing Risperidon with drug products extending QT.

Sizodon's ability to affect other drugs: Risperidon should be used cautiously when combined with other central impact substances, notable including alcohol, opium, antihistamine and benzodiazepine due to an increase in the risk of sleep.

levodopa and dopamine owner: sizodon can impact against levodopa and other dopamine owners.

Paliperidon: It is not recommended to simultaneously use oral Risperidon with palipididon because paliperidon is a metabolic substance that is active of risperidon and the combination of these two drugs can lead to increased riseride concentration of risperidon.

Risperidon is metabolized mainly by CYP2D6 and CYP3A4. The substances that have the ability to change the activity of CYP2D6 or substances that have the ability to inhibit or touch CYP3A4 and/ or PGP activity, can affect the pharmacokinetics of the anti -psychotic activity of Risperidon.

Strongly linked drugs: When Risperidon is used simultaneously with strongly connected drugs with protein, there is no significant replacement between two drugs for plasma proteins. When combined with treatment, it is necessary to consider the corresponding information about the transformation and the appropriate dose adjustments.

Sertralin or fluvoxamine may increase the concentration of anti -psychotic activity of Risperidon.

Storage

Storage below 30 ° C. In the original packaging, avoid light.

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