Sunsizopin 25 Sun Pharma drugs treat schizophrenia (5 blisters x 10 tablets)
Dosage form Box of 5 blisters x 10 tablets
Specifications Clozapine
Ingredient
| Composition information | Content |
| Clozapine | 25mg |
Uses
Indications
Sunsizopin 25 is indicated in the following cases:
pharmacokinetic
absorption
Clozapine absorbed by oral is about 90 - 95%, the ratio and level of absorption are not affected by food.
Clozapine first metabolized through the liver average, resulting in absolute bioavailability of about 50 - 60%.
When taking the drug twice a day, in a stable state, the peak concentration in the blood achieved an average of 2.1 hours (about 0.4 - 4.2 hours) and the distribution volume was 1.61/kg.
Distribution
about 95% clozapine is connected to plasma proteins.
Metabolism mechanism
Clozapine metabolizes almost completely before elimination. Metabolic substances are mainly Demethylation products that are active. The pharmacological effect of metabolites is similar to clozapine, but weaker and only in a short time.
Elimination
Elimination through two stages, with an average 12 -hour disposal time (about 6 to 26 hours). After taking the dose of 75mg, the average selling time is 7.9 hours, the stable stability time increases to 14.2 hours when taking daily dose 75mg in at least 7 days.
Only a very small amount of drug in the form of unchanged is found in urine and feces, about 50% of the dose is excreted in the form of metabolites in urine and 30% in feces.
Linear/non -linear
Increase the dose gradually from 37.5mg to 75mg and 150mg 2 times/day showing the area below the concentration curve/plasma time (AUC), peak concentration and minimum concentration proportional to the dose.
Before taking Sunsizopin 25 Sun Pharma drugs treat schizophrenia (5 blisters x 10 tablets)
How to use
Take oral use.
Dosage
Treatment of schizophrenia patients
Initial: 12.5mg, 1 or 2 times/day on the first day, then 25mg once or twice on the 2nd day. If tolerated, increase the dose slowly from 25mg to 50mg until treatment or up to 300mg/day within 2-3 weeks.
Then, if necessary, the daily dose may increase to 50 to 100mg per week.
Older people
Starting for treatment with particularly low doses (12.5mg 1 time on the first day), increasing the next dose limit 25mg/day.
Used in children and teenagers
Clozapine is not recommended for children or adolescents at the age of 16 due to lack of data on safety and efficiency. Do not use drugs for this group of patients until more data.
Dosage of treatment
For most patients, anti -psychotic effects can be expected in the dose of 200 - 450mg/day, divided into several times. Total daily dose may be divided unevenly, with higher doses before bed. The maintenance dose, see below.
Maximum doseFor appropriate treatment effect, higher doses may be used for some patients, in this case, the appropriate dose may be increased (ie not more than 100mg), caution to 900mg/day. It should be noted that the likelihood of reaction increases (in seizures) occurs at a dose of over 450mg/day.
Maintenance dose
After achieving the maximum treatment effect, it can be maintained at lower doses for patients. Therefore, consider reducing the dose carefully.
should maintain treatment for at least 6 months. If the daily dose does not exceed 200mg, can be used 1 time/day in the evening.
End of treatment
In case of termination of clozapine treatment plan, gradually reducing the dose in a period of 1-2 weeks is recommended. If it is necessary to stop the drug suddenly, the patient needs to be carefully monitored.
Start treatment again
In patients with the time of stopping treatment from the last dose clozapine exceeding 2 days, it is recommended to start treatment at a dose of 12.5mg one or twice a day. If this dose is well tolerated, the dose can be considered until reaching the target compared to the starting dose. However, for any patient who has a history of respiratory arrest or cardiac arrest at the beginning of the treatment, which is later adjusted to 1 dose/time/day, consideration of very careful adjustment.
Conversion from a previous anti -psychotic therapy to treat clozapine
Clozapine is often recommended not to be used in combination with other anti -psychotic drugs.
When starting to treat clozapine for patients who are treating other oral anti -psychotic drugs, it is recommended to stop other anti -psychotic drugs first by gradually reducing lower doses.
Psychiatric disorders during the treatment of Parkinson's disease, in the case of standard treatment, failed
Start with a dose of no more than 12.5mg/day, used in the evening. After that, increase the dose gradually to 12.5mg/time, the number of times increased maximum twice a week, to the maximum dose of 50mg, should not increase to the maximum dose within 2 weeks. It is better to use a single dose/day in the evening.
Average effective dose is usually 25 to 37.5mg/day. If treatment is less than 1 week at a dose of 50mg without meeting the needs of treatment, it can be carefully increased by the dose every 12.5mg/week.
Only exceeds 50mg/day in special cases, and does not exceed the maximum dose of 100mg/day.
Limit or prolong increasing the dose if the posture, drowsiness or confusion occurs. Need to monitor blood pressure during the first weeks of treatment.
When mental symptoms decrease completely in just 2 weeks, Parkinson's supplement may be supplemented if indicated based on movement. If mental symptoms recur, clozapine can be increased every 12.5mg/week to a maximum of 100mg/day, one or two times (see above).
End of treatment: Should gradually reduce the dose every 12.5mg for at least a week (better than two weeks).
Immediately stop treatment in case of leukopenia or granulocytosis. In this case, careful monitoring of patients should be monitored because the symptoms may recur quickly.
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?
Signs and symptoms
Sleep, sleep, coma, confusion, hallucinations, excitement, delusion, symptoms of foreign tower, increased reflexes, seizures, secretion, pupils, blurred vision, lowering blood pressure, collapse, tachycardia, arrhythmia, pneumonia, shortness of breath, respiratory failure.
Treatment
There is no specific antidote for clozapine.
Gastroenta or activated carbon within the first 6 hours after taking the medication. Peritonics and dialysis are ineffective. Symptomatic treatment under continuous heart rate monitoring, respiratory monitoring, electrolytes and acid-base balance. Epinephrin should be avoided in the treatment of hypotension because of the effect of effectively reversing epinephrin.
Need to closely monitor at least 5 days because of the slow reaction.
What to do when forgetting 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.
Side Effects
When using Sunsizopin 25 , you may experience unwanted effects (ADR).
Side effects are arranged according to the following frequency: Very common (≥ 1/10), common (≥ 1/100 to
cardiovascular disorders
Very common: tachycardia.
Common: Change of electrocardiogram (ECG).
Rare: circulatory failure, arrhythmia , myocarditis, pericarditis/pericardium.
Very rare: myocardial disease, cardiac arrest.
Disorders of blood and lymphatic systems
Common: leukopenia/reduction of leukocytes/neutropen blood cells, acidic white blood cells (EOSIN), leukemia.
Not common: loss of granulocytes.
Rare: Anemia .
Very rare: platelet reduction, platelet creation.
Nervous system disorders
Very common: drowsiness/sedation, dizziness.
Common: blurred vision, headache, tremor, hardness, symptoms of foreign tapes, convulsions.
Rare: Confusion, delirium.
Very rare: late movement disorders, symptoms obsessive forced .
Respiratory, chest and mediastinum disorders
Rare: Pneumonia and lower respiratory infections can be fatal.
Very rare: respiratory failure .
Gastrointestinal disorders
Constipation is very common, increased salivation.
Common: Nausea, vomiting, anorexia, dry mouth.
Rare: Difficult to swallow.
Very rare: Blooming the ear gland, intestinal obstruction.
Kidney and urinary disorders
Common: uncontrolled, urinary retention.
interstitial nephritis: Very rare.
Skin and tissue disorders
Skin reaction: Very rare.
Metabolic and nutrition disorders
Common: weight gain.
Rare: reducing glucose tolerance, diabetes.
Very rare: acid ceton infection, osmotic pressure, severe hyperglycemia, hyper triglycerides, hypercholids of blood cholesterol
vascular disorders
Common: hypertension, posture hypotension, fainting.
Rare: thrombosis.
Unknown: venous thrombosis.
Systemic disorders and at treatment
Common: fatigue, fever, benign body temperature, sweat disorders/change body temperature.
Malignant neurological syndrome: Not common.
Very rare: Sudden death of unknown cause.
Liver disorders
Increased liver enzymes: common.
Rare: hepatitis, jaundice, pancreatitis.
Acute liver necrosis: Very rare.
System and breast disorders
Very rare: erection.
Mental disorders
Common: Disorder.
Uncommon: It is difficult to say.
Rare: restlessness, excitement.
Very rare in ventricular tachycardia and prolonged QT can be associated with the vertex that has been reported although there is no related to the use of these drugs.
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
Sunsizopin 25 contraindicated in the following cases:
Clozapine treatment is not started with drugs with significant risks of grain leukemia, simultaneous use of anti -psychotic drugs that are not recommended.
Caution when using
Clozapine may cause granulocytes. Therefore, the following prevention measure is compulsory and must be implemented in accordance with the official regulations.
Vì nguy cơ tác dụng phụ của clozapine, chỉ nên sừ dụng thuốc cho những bệnh nhân theo chỉ định thuốc có: Bệnh nhân có số lượng bạch cầu bình thường khi bắt đầu điều trị (WBC đếm ≥ 3500/mm3 (3,5x109/l) và ANC ≥ 2000/mm3 (2,0x109/l), và ở bệnh nhân có số lượng bạch cầu bình thường và có thể xét nghiệm ANC mỗi tuần trong 18 tuần đầu tiên và ít nhất mỗi 4 tuần sau That. Continue to monitor the treatment process and for 4 weeks after stopping Clozapine.
Before starting to treat clozapine, patients should be tested for blood (see "loss of grain leukocytes") and check the patient's history and physical body. Patients with a history of heart disease or abnormal heart detection should see a specialist to check including electrocardiograms, and patients are only treated if the benefits are higher than the risk. Doctors should consider performing electrocardiogram before treatment. Doctors prescribing drugs should take all necessary safety measures.
Before the beginning of treatment, the doctor needs to know the previous patient history without harmful hematological reactions related to clozapine but to stop the drug. The drug should not be indicated for a longer time than the distance between the two blood counts.
The drug contains lactose monohydrate.
Patients with rare genetic diseases such as galactose intolerance, Lapp Lactase metabolic deficiency or Galactose should not use this drug.
Patients with myocarditis or myocarditis caused by clozapine should not reuse clozapine.
Mobile risks
Clozapine is contraindicated in patients with uncontrolled convulsions.
Mobile risk, especially in high doses (> 600 mg per day) or in patients with high plasma clozapine concentrations, should be used carefully in patients with a history of epilepsy or other influential factors (for example, no history of epilepsy but abnormal EEG, central neuropathic disease from advance, historical history of electric shock, or difficulty in the family, or biosome, or periodic use, jerk).
Avoid activities that cause sudden loss of consciousness because it can cause serious risks for patients or others (for example: heavy machinery, driving cars, swimming, climbing).
Myocarditis
Increased risk of death myocarditis, especially in the first month of treatment, but unlimited, considering the possibility of myocarditis in unexplained patients, shortness of breath, fast breathing, fever, chest pain, chest drum, manifestation of heart failure, or ECG (for example, ST-T wave abnormalities, arrhythmia). Do not know whether neutrophils are a reliable forecasting element of myocarditis.
Stop immediately if suspected of myocarditis, not reusable with patients with myocarditis related to Clozapine.
Tachycardia may be a sign that in patients with myocarditis, closely monitor patients with tachycardia in the first month of treating other signs of myocarditis.
Other effects on the heart and respiration
Use cautiously in patients with cardiovascular disease or lung disease due to the risk of tachycardia, hypotension, pulmonary collapse, and cardiac arrest or stop worship, carefully adjusting leading to appropriate dose.
Hypotension, with or without fainting, likely to occur during the first treatment combined with rapid dosage increase or even the first dose, but may continue to appear in some patients.
tachycardia, sometimes prolonged, it is not simply response to hypotension and presence in all monitoring positions.
may change the ECG pole, including the reduction of S-T and flatten or reverse T waves, normally returns after stopping the drug.
Significant cardiovascular events (for example: congestive heart failure, pericarditis, pericardial effusion, unstable ischemia, myocardial infarction, arrhythmia, sudden death) have been reported. Sudden death rarely occurs in mental patients, with or without treatment with anti -psychotic drugs, associated with anti -psychotic drugs is not known.
Increase mortality in elderly patients
Significant higher mortality rate (4.5%) in elderly patients with dementia related to neurological disorders are using typical anti -psychotic drugs (for example: Aripiprazole, olanzapine, quetiapine, risperidone) compared to placebo users (2.6%).
Most deaths are the result of heart -related agents (for example, heart failure, sudden death) or infection (mainly pneumonia).
Not typical anti -psychotic drugs are not approved to treat dementia related to neurological disorders.
The ability to drive and operate machinery
The drug can cause dizziness, patients should be warned to be cautious when driving or operating machinery.
Pregnancy
for clozapine, clinical data for pregnant women is limited. Be careful when indicated for pregnant women.
Infants are exposed to anti -psychotic drugs (including clozapine) in the last 3 months of pregnancy, there is a risk of side effects including pagoda symptoms or severe severity of severe drugs and different occurrence time, including after birth. There have been reports of agitation, increasing tone, reducing tone, tremor, drowsiness, respiratory failure, or eating disorders. Therefore, babies need to be carefully monitored.
Breastfeeding period
Animal research shows that clozapine is excreted through breast milk and has the effect of breastfed babies, so women who use clozapine should not be breastfeeding. Use appropriate contraception to protect women who are likely to become pregnant.
Drug interaction
Contraindicated
Unserted with clozapine with drugs that risk significantly reducing bone marrow function.
Do not simultaneously use anti -psychotic drugs that have a long -lasting effect (at risk of marrow inhibition) with clozapine because these drugs cannot quickly eliminate from the body as needed, such as neutropenia. Do not drink alcohol when using clozapine because of the sedative effect.
Caution includes the dose adjustment
Clozapine may increase the effects of central neurological inhibitors such as anesthesia, antihistamine and benzodiazepine sleeping pills. Especially cautious at the beginning of clozapine treatment for patients taking benzodiazepine or any other mental medicine. It may increase the risk of cardiovascular collapse in these patients, in rare cases that can lead to cardiac arrest or respiratory arrest. It is unknown whether it is possible to prevent cardiovascular or respiratory collapse by adjusting the dose or not.
Because it is likely to cause a combination effect, it is necessary to be cautious when used simultaneously with drugs with anti -cholin, hypotension, or respiratory inhibitor effects.
Due to the anti-alpha-adrenergic properties of the drug, clozapine can reduce the effect of norepinephrin's hypertension or other alpha-adrenergic drugs and reverse the hypertension of Epinephrine.
Used with the active inhibitors of some ISOzymes Cytochrom P450 may increase clozapine levels, and may need to reduce clozapine dose to prevent unwanted effects. It is important for CYP 1A2 inhibitors such as caffeine (see below) and selective inhibitors of Serotonin Fluvoxamin.
Similarly, pharmacokinetic interaction with CYP 3A4 inhibitors such as Azol, Cimetidin, erythromycin and protease inhibitors have been reported. Because the concentration of clozapine in the blood increases when shared caffeine and decreases nearly 50% after 5 -day caffeine elimination, clozapine dose should be changed when changing caffeine habits. In the case of sudden smoking stop, plasma clozapine levels may increase, leading to increased side effects.
There has been a case of interaction between citalopram and clozapine, which may increase the risk of side effects due to clozapine. The nature of this interaction has not been proven.
Concentrated use of drugs that induce cytochrom P450 enzymes may reduce the concentration of clozapine in the blood, resulting in reduced effects. Cytochrom P450 enzymes that interact with clozapine are reported, carbamazepin (not used simultaneously with clozapine due to the risk of marrow failure), phenytoin and rifampicin. CYP1A2 induction substances, like omeprazol, can lead to reduced clozapine levels. There is a risk of reducing the effect of clozapine when the drug is used in combination with these drugs.
Other interactions
Used with lithium or other central nervous effects may increase the risk of developing malignant neurological syndrome (NMS).
The reports are rare but serious during attacks, including stomach onset in epilepsy patients, and there are cases of coma when sharing clozapine with valproic acid. These effects may be due to pharmacokinetic interaction, unknown mechanism.
Be cautious for patients treated in combination with other drugs inhibitors or cytochrom P450 liver enzymes. With three -round antidepressants, phenothiazin and anti -arrhythmia 1C that linked to Cytochrom P450 2D6, so far has not been found clinical interactions.
With other anti -psychotic drugs, cautious should be used when using clozapine with drugs that cause increased QTC, or cause electrolyte imbalance.
Storage
Store in a cool place, below 30 ° C. Avoid light.
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