Sunsizopin 100 Sun Pharma medicine treatment of schizophrenia (5 blisters x 10 tablets)
Dosage form Box of 5 blisters x 10 tablets
Specifications Clozapine
Ingredient
| Composition information | Content |
| Clozapine | 100mg |
Uses
Indications
Sunsizopin 100 is indicated in the following cases:
Control schizophrenia in serious patients does not respond to the treatment of standard anti -psychotic disorders.
Control of schizophrenia in serious patients in tolerance of unwanted effects of standard treatment.
Pharmacy
Clozapine is a new anti -psychotic drug different from other psychotic drugs in the affinity of the drug with different dopamine receptors. Clozapine has a weak effect in preventing dopamine attaching to D1, D2, D3 and D5 receptors, but has a high affinity with D4 receptor, in addition to Alpha-adrenergic resistance, cholinergic resistance, antihistamine and stimulating reflex inhibition effect, the drug also has serotonin resistance properties. Clozapine does not or less causing prolactin increase, thus avoiding side effects such as breast enlargement in men, amenorrhea, milk and helplessness.
pharmacokinetic
absorption
Clozapine absorbed by oral is about 90 - 95%, the ratio and level of absorption are not affected by food.
Clozapine first metabolizes 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 reaches an average of 2.1 hours (about 0.4 - 4.2 hours) and the distribution volume is 1.6L/kg.
Distribution
about 95% clozapine is connected to plasma proteins.
Metabolism
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 disposal time is 7.9 hours, the stable stable time increases to 14.2 hours when drinking daily materials 75mg for at least 7 days. Only a very small amount of drugs in the form of non -metabolic foundation 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 100 Sun Pharma medicine treatment of schizophrenia (5 blisters x 10 tablets)
How to use
Oral drugs.
Dosage
Treatment of schizophrenia patients
Start: 12.5mg, 1 or 2 times/day on the first day, then 25mg 1 or 2 times on Monday.
If tolerated, increasing the dose slowly 25mg to 50mg until treatment effects or up to 300mg/day for 2-3 weeks.
Then, if necessary, the daily dose may increase to 50 to 100 mg per week.
Used in the elderly
Starting for treatment with particularly low dose (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.
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 possibility of an increased reaction (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. Treatment should be maintained 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 for the drug condenser reaction.
Start treatment again
In patients with the time of stopping treatment from the last dose clozapine exceeding 2 days, it is advisable to start treating at a dose of 12.5mg 1 or 2 times 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 the 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 maximum increase of 2 times/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. The average dosage 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. The limit or prolonged increasing the dose if the posture, drowsiness or confusion occurs. Need to monitor blood pressure during the first weeks of treatment. When mental symptoms are completely reduced in just 2 weeks, Parkinson's anti -Parkins can be supplemented if indicated based on movement. If mental symptoms recur, clozapine dose may be increased every 12.5mg/week to a maximum of 100mg/day, 1 or 2 times (see above).
End of treatment: Should gradually reduce the dose every 12.5mg for at least 1 week (better than 2 weeks).
Immediately stop treatment in case of leukopenia or granulocytosis. In this case, careful mental monitoring of patients and 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? Steam.
Handling
There is no specific antidote for clozapine. Gastrointestinal lavage or activated carbon for 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 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 Sunsizopin 100 , you may experience unwanted effects (ADR).
cardiovascular disorders
Blood and lymphatic disorders
Respiratory, chest and mediastinum disorders
interstitial nephritis
Systemic disorders and at treatment
Mental disorders
Notify the doctor with unwanted effects when using the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Sunsizopin 100 contraindicated in the following cases:
Hypersensitivity to pharmaceutical substances or any excipients.
Patients can not test blood regularly.
There is a history of reduction or loss of granulocytes due to clozapine (except for reduction/loss of granulocytes due to chemotherapy).
History of clozapine causes grain leukopenia or granulocytes.
Bone marrow function impairment.
Unbelievable epilepsy.
Alcoholic and other nervous toxic drugs, poisoning, coma.
Circulation and/or central neurological inhibition due to all causes.
Severe heart disease dysfunction (eg myocarditis).
Liver disease accompanied by nausea, anorexia or jaundice, progressive liver disease, liver failure.
intestinal paralysis.
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.
Because of the risk of side effects of clozapine, the drug should only be used for patients as prescribed: Patients with normal number of white blood cells when they start treatment (WBC counting> 3500/mm (3.5x109/l) and A C> 2000/mm (2.0x109/l), and in patients with normal number of normal leukemia and can test ANC in the first week of the first week and at least the first 4 weeks. The treatment process and 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 disorders. Mobile risk, especially in high doses (> 600mg per day) and/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 before, history of electric shock treatment [ECT] jerk).
Avoid activities that cause sudden loss of consciousness because it can cause serious risks to 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; Consider the possibility of myocarditis in patients with unexplained fatigue, shortness of breath, fast breathing, fever, chest pain, chest drum, manifestation of heart failure, or ECG (for example, st-t wave abnormalities, arrhythmia). It is not known whether neutrophils are a reliable forecast factor 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 apnea, carefully adjusted leading to appropriate dose.
Lower blood pressure, with or without fainting; Most likely occur during the first treatment combined with rapid or even the first dose increase, but may continue to appear in some patients. Tachycardia, sometimes prolonged; It is not simply response to hypotension and present in all monitoring positions.
Can change the ECG extreme, including the ST segment and flatten or reverse T wave, normal | Back after stopping the drug.
Significant cardiovascular events (e.g. congestive heart failure, pericarditis, pericardial effusion, unstable ischemia, myocardial infarction, arrhythmia, sudden death) have been reported. Suddenly rarely occurs in mental patients, with or without anti -psychotic drugs; The relationship with anti -psychotic drugs is not known.
Increase mortality in elderly patients:
Significant 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 symptoms of foreign tower or suffer from severe serious drug -stopping symptoms and different occurrence time, including after birth. There have been reports of agitation, increasing tone, reducing force, 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.
Drug interaction
Contraindicated
Do not use clozapine simultaneously with drugs that risk significantly reducing bone marrow function.
Do not use the anti -psychotic drugs that have long -lasting effects (at risk of marrow inhibition) with clozapine because these drugs cannot be quickly eliminated 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
Caution includes adjusting the dose of clozapine may increase the effects of central neurological inhibitors such as anesthetic, 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 has the ability to cause plus effects, need to be cautious when used simultaneously with drugs with anti -cholin properties, hypotension, or respiratory inhibiting effects.
Due to the anti-alpha-adrenergic properties of the drug, clozapine may 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 CYP1A2 inhibitors such as caffeine (see below) and selective inhibitors of Serotonin Fluvoxamin.
Similarly, pharmacokinetic interaction with CYP3A4 inhibitors such as antifungal drugs 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, the plasma clozapine levels may increase, resulting in an increase in 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 cartridge drugs Cytochrom P450 enzymes may reduce the concentration of clozapine in the blood, leading to 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). Reports that are rare for serious attacks, including attacks 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. Precautions for patients treated in combination with other drugs inhibitors or cytochrom P450 liver enzymes. With three -round antidepressants, phenothiazine and anti -arrhythmia 1C that linked to Cytochrom P450 2D6, so far has not 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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