Savi Quetiapine 200 drugs treat schizophrenia (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Quetiapine
Ingredient
| Composition information | Content |
| Quetiapine | 200mg |
Uses
Indications
Savi Quetiapin 200 drugs are indicated in the following cases:
Treatment schizophrenia .
Treatment bipolar disorder includes:
Pharmacology
Pharmacological Therapy Group: Anti -Psychosis. Quetiapin is active through anti -psychotic effects, such as conditioned evanged evanged test.
Quetiapin also reverses the impact of homogeneous substances with dopamine, evaluated by behavior or physiological and increases the concentration of dopamine metabolites, the nerve chemical index of Dopamine receptor inhibitors D2.
In preclinical trials forecasting the possibility of low external symptoms (EPS: Extrapyramidal Symptoms), Quetiapin is not like typical anti -psychotic drugs and has no typical characteristics.
Quetiapin does not cause hypersensitivity to Dopamine D2 receptor, when used for long term. Quetiapin only causes weak effects on the cataleps in the doses of Dopamine D2 receptors. Quetiapin proves the selection on the edge of the brain through the reducing inhibition effect of dopamine neurons in the middle edge of the brain but does not impact on nigrostriatal neurons after long -term use. Immediately after taking the medication and in the long run, Quetiapin can cause very small tone of force on the cebus monkey sensitive to Haloperidol or not.
Mechanism of action
Quetiapin is an aligned anti -psychotic drug. Quetiapin and metabolites are active in human plasma, Norquetiapin has the effects on many types of neurotransmitter receptors. Quetiapin and Norquetiapin have a work of serotonin receptors (5HT2) in the brain and with Dopamine D1 and D2 receptors. It is the selection with the higher Serotonin receptor (5HT2) in the brain with the Dopamine D2 receptor that is believed to contribute to the clinical anti -psychotic properties and have little risk of side effects on the outsider system of Quetiapin.
In addition, Norquetiapin has high affinity with norepinephrin transportation. Quetiapin and Norquetiapin also have high affinity with histaminergic receptors and adrenergic alpha1, with lower affinity with adrenergic alpha2 receptors, and Serotonin 5HT1A. Quetiapin has negligible affinity for the Cholinergic Muscarinic or Benzodiazepin receptors.
Dynamic pharmacokinetics
Adults
The activity of Quetiapin Fumarat is mainly due to the original compound. Quetiapine multi -doses of pharmacokinetics are linearly in the clinical dose of proposed, and accumulating Quetiapin is predicted when used many times.Quetiapin elimination is mainly through the metabolism in the liver with the last half of the last 6 hours in the proposed clinical dose. The concentration in a stable state is expected to be achieved within 2 days of drug use, Quetiapin does not interfere with the metabolism of the drug transformed by the cytochrom P450 enzyme.
children and teenagers
Dynamic data in 9 children from 10 to 12 years old and 12 teenagers have stable treatment with 400 mg of quetiapin twice a day. In a stable state, Quetiapin plasma concentration in children and adolescents (10-17 years old) is similar in adults, although in children higher than adults. AUC (Area Under the Curve) and CMAX of metabolites are about 62% higher than 62% and 49% in children, 28% and 14% respectively in adolescents (13-17 years old) compared to adults.
absorption
Quetiapin Fumarat is quickly absorbed after drinking, reaching a plasma peak concentration after 1.5 hours. The bioavailability of Quetiapin is slightly affected when taken with food, whereby the value of CMAX and AUC increases 25% and 15%, respectively.
Distribution
Quetiapin is widely distributed throughout the body with an integral distribution of 10 ± 4 liters/kg. 83% of drugs are associated with plasma proteins at the concentration of treatment. In vitro test shows that Quetiapin does not affect the links of Warfarin or Diazepam with human serum albumin. In contrast, Warfarin or Diazepam also does not change the links of Quetiapin.
Metabolism and elimination
After taking the only dose with 14C - Quetiapin radioactive, less than 1% of the dose is eliminated in a constant form, showing that Quetiapin is very strongly metabolized. About 73% and 20% of the dose is recovered in urine and feces, respectively.
quetiapin is metabolized in the liver. The main metabolic paths are sulfoxid chemicals with sulfoxid metabolites and oxidation of parent acid metabolites; Both of these metabolites are not active.
In In vitro studies using Human Liver Microsom shows that CYP3A4 has been involved mainly in the metabolism of quetiapin through cytochrom P450 intermediaries and Norquetiapin metabolites have the main activity formed and eliminated via CYP3A4.
Before taking Savi Quetiapine 200 drugs treat schizophrenia (3 blisters x 10 tablets)
How to use
oral medication. Drink during or outside meals.
Dosage
The dosage of drug used is calculated by quetiapin.
Every 28.79 mg of quetiapin fumarat is equivalent to 25 mg of quetiapin.
Adults
schizophrenia
quetiapin should drink 2 times/day. The total daily dose in the first 4 days of treatment respectively is 50 mg (day 1), 100 mg (dated 2), 200 mg (dated 3), 300 mg (dated 4). From the 4th day onwards, the dose should be mainly effective to the dose effectively, usually from 300 - 450 mg/day. Depending on the clinical response and tolerance of each patient, the dose can be adjusted in the range of 150 - 750 mg/day.
Treatment of average to severe revolutionary attacks related to bipolar disorders
quetiapin should drink 2 times/day. The total daily dose in the first 4 days of treatment respectively is 50 mg (day 1), 100 mg (dated 2), 200 mg (dated 3), 300 mg (dated 4). Increase the dose, reaching 800 mg/day on the 6th day, not more than 200 mg/day. Depending on the clinical response and tolerance of each patient, the dosage can be adjusted in the range of 200 - 800 mg/day. Effective doses are usually about 400 - 800 mg/day.
Treatment of depression related to bipolar disorder
quetiapin should drink 1 time/day before going to bed. The total daily dose in the first 4 days of treatment respectively is 50 mg (day 1), 100 mg (dated 2), 200 mg (dated 3), 300 mg (dated 4). The recommended daily dose is 300 mg. The larger dose of more than 300 mg should be started by experienced doctors in the treatment of bipolar disorder. In each case, clinical trials show that the dose can be reduced to 200 mg.
Room recurrence of emotional or depression in patients with bipolar disorder
In order to prevent relapse of high manual, depression or mixture in bipolar disorders, the patient has responded to treatment with Quetiapin in the treatment of acute bipolar disorders, so they continue to treat with the same dose. The dose can be adjusted depending on the clinical response and tolerance of each patient, in the range of 300 - 500 mg/day, 2 times/day. The most effective dose is used for maintenance treatment.
Elderly
Like other anti -psychotic drugs, should be cautious when using Quetiapin in the elderly, especially in the starting stage of using the drug. The frequency of adjusting the dose may need to be reduced and the daily dose is lower than young people, depending on the clinical response and tolerance of each patient. The clearance of Quetiapin in the elderly decreased by 30-50% compared to young people.
The effectiveness and safety of Quetiapin has not been evaluated in depression patients related to bipolar disorder over 65 years old.children and adolescents
Quetiapin is not recommended for children and teenagers under 18 years old.
kidney failure
No dose adjustment in kidney failure.
liver failure
quetiapin metabolizes in the liver. Therefore, the kidneys need to be used while using quetiapin in patients with hepatic failure, especially in the early stages of treatment. Patients with liver failure should start treatment at a dose of 25 mg/day. The daily dose should be increased daily about 25 - 50 mg/day until the dose is effective, depending on the clinical response and tolerance of each patient.
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?
Overdose can lead to extension of QT, convulsions, epilepsy, pattern, respiratory failure, urinary retention, confusion, delusion and/or agitation, coma and death. Patients with previous severe cardiovascular disease may increase the risk of overdose.
Handling
There is no specific detoxification for Quetiapin. In case of severe poisoning, it is necessary to consider the ability of many drugs, taking special care measures, including establishment and maintenance of airway, ensuring ventilation and adequate oxygen supply, monitoring and cardiovascular support.
Based on the published document, patients with paranoid symptoms, agitation and acetylcholine resistance syndrome are clearly treated with physostigmin, 1 - 2 mg (continuous electrocardiogram tracking). This is not a standard treatment recommendation and has the potential negative effects of Physostigmin on the heart. Physostigmin can be used if there is no problem with electrocardiography (ECG: ElectrocardRam). Do not use physostigmin in case of arrhythmia (any level) or qRS widening.
Research and reduce the absorption of quetiapin during the overdose has not been conducted. In case of severe poisoning, the stomach may be done within an hour after overdose. Activated carbon can be used to reduce the absorption of Quetiapin.
In case of quetiapin overdose, hypotension should be treated with appropriate measures such as intravenous and/or sympathetic drugs: epinephrin and dopamine should be avoided because beta stimulation may lower blood pressure.
Need to continue monitoring and monitoring patients closely until complete recovery.
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 Savi Quetiapin 200 drugs , you may experience unwanted effects (ADR).
Sleep, dizziness, dry mouth, mild weakness, constipation, tachycardia, Hypotenary pressure vertical , and indigestion.
Fainting, malignant syndrome caused by sedation, leukopenia, neutropenia and peripheral edema may occur.
Very common, ADR ≥ 1/10
Common, ADR> 1/100
Subclinical: weight gain, serum transaminase (Alt: Alanine Aminotransferase, AST: Aspartate Aminotransferase). Neutral leukopenia. Uncommon, 1/1000 Nervous system dysfunction: convulsions, tremor syndrome. Rare, ADR Genital dysfunction: positiveness. Very rare, ADR 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
Savi Quetiapin 200 drugs contraindicated in the following cases:
Be cautious when using
Children
Quetiapin is not recommended for children and young people under 18 years of lack of data of drugs in this age group. Clinical trials show that some side effects have a higher frequency of children and adolescents in adults (increasing appetite, high serum prolactin, vomiting, rhinitis, asphyxiation) or may have different effects in children and young people (symptoms of foreign tower, stimulated) and hypertension. The effects on the thyroid function also observed.
Moreover, the safety in long -term treatment with quetiapin has not been studied for more than 26 weeks.In clinical trials in children and teenagers treat schizophrenia, bipolar and bipolar depression, the research results show that the towering symptoms increased in the group of patients treated with quetiapines compared to the group using Placeo.
suicide/intend to commit suicide
Depression is associated with an increase in the risk of suicide, self -destruction and suicide (suicidal events). This risk lasts until the disease is significantly reduced. Because the improvement of the disease may not appear in the first few weeks of treatment or longer, the patient should be closely monitored until the disease is significantly improved. Clinical experience shows that the risk of suicide may increase in the early stages of the recovery process. In addition, the doctor should consider the potential risk of suicide when stopping treatment suddenly with Quetiapin.
Patients with a history of suicide, or suicide thought before treatment may be at risk of suicide and highly suicidal thoughts and need to be closely monitored during treatment. Clinical research with placebo -controlled control of antidepressants in adult patients with mental disorders shows that in the treatment group with antidepressants, there is an increase in the risk of suicide in patients under 25 years older than the group using Placebo.
Monitoring patients, especially those at high risk of suicide, should be done with drug treatment, especially in the early stages of the treatment process and when changing the dose. Patients and patients should be warned of the need to monitor the deterioration, suicide behavior or abnormal changes in thinking and behavior. Find medical advice immediately if the symptoms appear.
Clinical studies in depression patients related to bipolar disorders show the risk of suicide in 25 -year -old patients who have been treated with quetiapin increased compared to those who treated with Placebo (equivalent to 3.0% compared to 0%).
Metabolism
Clinical studies show that the metabolism changes in the direction of worsening, including changes in weight, blood glucose and lipid. The patient's metabolic parameters should be evaluated at the start of treatment and parameters should be controlled regularly during treatment. These parameters should be monitored as a clinical sign.
Symptoms of foreign tower
Clinical clinical studies in adult patients show that Quetiapin is associated with an increase in the incidence of low foreign symptoms compared to the placebo group in patients treating severe depression in bipolar disorders. The use of Quetiapin makes Akathisia's restless restlessness characterized by restlessness, subjective insecurity and must go on a regular trip to sit or stand still. This may occur in the first few weeks of treatment. In patients with this symptom, increased dose can be harmful.
Late movement disorders
If the signs and symptoms of late movement disorders appear, the dose reduction or quetiapine stops. Symptoms of movement disorders want to be serious or appear after stopping treatment.
Sleep and dizziness
Like sedatives, treatment with quetiapin can cause drowsiness and related symptoms. In clinical trials to treat bipolar depression patients, the onset is usually within the first three days of treatment and the primary level from mild to medium, the intensity of intensity must be loaded more often, at least 2 weeks from the beginning of sleepiness or until symptoms improved. Patients with severe intensity may have to stop treatment.
posture hypotension
quetiapin can cause vertical and dizziness. Hypotension posture usually starts at the starting dose and the dose adjustment stage. This may increase the risk of boredom due to an accident (fall), especially in the elderly. Therefore, patients should be cautious until they are familiar with the side effects of the drug.
Be cautious when using quetiapin in patients with cardiovascular disease, cerebrovascular disease, or other pathological conditions that can cause hypotension. If hypotension occurs, it is advisable to consider reducing the dose or increasing the dose slowly, especially in patients with cardiovascular disease.
Sleep apnea syndrome
Sleep apnea syndrome has been reported in patients using Quetiapin. In patients who use simultaneously with antidepressants and people with a history or a risk of sleep apnea, such as overweight/obesity or men, Quetiapin should be used carefully.
epilepsy
In control clinical trials, there is no difference in the rate of convulsions in patients treated with quetiapin or placebo. There is no data on convulsions in patients with convulsions. Like other anti -psychotic drugs, it is necessary to be cautious when using Quetiapin to treat patients with convulsions.
malignant syndrome due to sedative
Malignant syndrome caused by neuroleptic is related to the treatment of anti -psychotic drugs, including Quetiapin. Clinical manifestations include overcrowding, mental changes, muscle spasms, unstable autonomous nervous systems and increased creatin phosphokinase. In this case, Quetiapin should be discontinued and appropriate treatment.
Neutral leukemia and grain leukemia
Heavy neutropenia (
However, some cases occur in patients without risk factors. Quetiapin should be discontinued in patients with neutrophils
neutropenia should be considered in infections or fever patients, especially in the absence of clear causes, and must be clinically monitored.
Patients should be advised to report as soon as the signs/symptoms are related to granulocytes or infections (e.g. fever, weakness, indifference, or sore throat) whenever treatment with quetiapine.
Acetylcholin resistance effect
Norquetiapin, a metabolic substance of Quetiapin, has a strong average frustration with many types of Muscarinic receptors. This contributes to acetylcholine resistance when quetiapin is used in the recommended dose, when used simultaneously with other drugs with acetylcholine resistance, and in case of overdose.
Use Quetiapin cautious in patients taking anti -acetylcholine drugs (Muscarinic). Quetiapin should be used carefully in patients with current diagnosis or history of urinary retention, prostate hypertrophy with clinical significance, intestinal obstruction or related diseases, glaucoma or closed angle glaucoma.
Drug interaction
Simultaneous use of Quetiapin with strong liver enzyme drugs such as carbamazepine or phenytoin reduces the plasma concentration of quetiapin. This may affect Quetiapin's treatment effect. Patients who are taking liver enzyme drugs, only starting to treat Quetiapin when Quetiapin's treatment benefits are higher than the risk of liver enzyme stopping. The important thing is that any liver enzyme changes should be changed slowly, if necessary, it can be replaced with liver enzyme non -touch drugs (such as sodium valproat).
weight
Weight gain has been reported in patients treated with Quetiapin and should be monitored and clinically monitored as instructions for using anti -psychotic drugs.
Hyperglycemia
Hyperglycemia and/or hyperglycemia or acute hyperglycemia when combined with kerosen acid or coma rarely occur, including deaths. In some cases, previous weight gain has been reported, this may be a cause. Clinical monitoring should be monitored according to the instructions for using anti -psychotic drugs.
Patients who use any anti -psychotic drugs include Quetiapin should monitor signs and symptoms of hyperglycemia (such as drinking, urinating, eating a lot and fatigue), and patients with diabetes or having risk factors for diabetes should monitor blood sugar regularly. Should monitor regular weight.
lipid
Increase triglycerides, LDL (Low Density Lipoprotein) and total cholesterol, and HDL reduction (High Density Lipoprotein) cholesterol has been observed in clinical trials with quetiapin. Lipid changes should be clinically monitored.
extends the range of qt
In clinical studies and use of SPC statistical control (statistical process control), quetiapin has no side effects that extend the QT range. During the use of the drug, the Quetiapin report extends the QT range at the treatment dose and in case of overdose. Like other anti -psychotic drugs, using cautious quetiapin in patients with cardiovascular disease or family history that extends the QT range.
In addition, it is necessary to be cautious when using Quetiapin simultaneously with drugs that extend the QT or sedative, especially in the elderly, patients with congenital QT syndrome, congenital heart failure, heart hypertrophy, hypotension or hypoglycemia.
Myocarditis and myocarditis
Myocarditis and myocarditis have been reported. However, the causal relationship with Quetiapin has not been studied. Treatment with Quetiapin should be reviewed in patients suspected of myocardial or myocarditis.
Stop using drugs
Symptoms of acute cessation such as insomnia, nausea, headache, diarrhea, vomiting, dizziness and discomfort have been described after stopping the Quetiapin suddenly. Quetiapine should be stopped gradually for at least 1-2 weeks.
Elderly patients with mental disorders.
Quetiapin is not indicated to treat intellectual dementia associated with mental disorders. Random fatal control tests in patients with dementia with some typical anti -psychotic drugs show the risk of side effects of brain vascular complications increasing 3 times. The mechanism increases this risk unknown. This increased risk is not excluded in other anti -psychotic drugs or other patients. Should be cautious when using Quetiapin in patients with risk factors.
A study on non -typical anti -psychotic drugs shows that elderly patients who have dementia in mental disorders are at higher risk of death compared to the placebo group. In the two place to control the fugitive for 10 weeks with Quetiapin, there is the same group of patients (n = 710; age: 56 - 99 years old, an average of 83 years old), the mortality rate in patients treated with Quetiapin is 5.5% compared to 3.2% in the placebo group.
Difficult to swallow
Difficult to swallow has been reported to Quetiapin. Use cautious quetiapin in patients at risk of inhaling pneumonia.
Constipation and intestinal obstruction
Constipation is a risk factor for bowel obstruction. Constipation and intestinal obstruction have been reported to Quetiapin, including death reports in patients at high risk of intestinal obstruction, users simultaneously reducing intestinal peristalsis and/or may not report constipation symptoms. Patients with intestinal obstruction/intestinal obstruction must be closely monitored and special medical care.Venous thrombosis
Cases of venous thrombosis (VTE: Venous Thromboembolism) have been reported to anti -psychotic drugs. Because patients are treated with psychotic drugs, VTE risk factors often appear, all VTE risk factors need to be determined before and during treatment with quetiapine and take preventive measures.
Pancreatitis
Pancreatitis is reported in clinical trials and during the use of drugs.
Abuse and addiction
Cases of abuse and drug addiction have been reported. Precautions when prescribing Quetiapin for patients with a history of alcoholism or drug addiction.
Medicine combination
Data on Quetiapin combination with divalproex or lithium treatment of severe to severe sensitive goods. However, this combination therapy is effective. The effectiveness of treatment appears at the 3rd week.
lactose
Products contain lactose excipients. Patients have rare genetic problems such as galactose intolerance, lactase deficiency or Glucose-Galactose under absorption should not be taken.
The ability to drive and operate machinery
Because Quetiapin can cause drowsiness, patients need to be cautious when driving and operating machinery.
Pregnancy
First three months
Based on the results of some individual reports and some observation studies, Quetiapin does not increase the risk of fetal defects. However, the data is limited, so it is not possible to make an accurate conclusion. So Quetiapin is only for pregnant women when the treatment benefits are higher than the potential risk.
The last three months of pregnancy
Infants are exposed to anti -psychotic drugs (including Quetiapin) during the last three months of pregnancy, there is a risk of extrasic side effects and/or symptoms of cessation after birth. There has been a report of inciting side effects, increasing muscle tone, reducing muscle tone, tremor, drowsiness, respiratory failure or eating disorders. Therefore, closely monitoring babies.
The period of breastfeeding
so far, information about quetiapin excretion into human milk is limited. Based on the published information, Quetiapin does not excrete on breast milk at the treatment dose. However, due to lack of trust, the decision to stop breastfeeding or stop treatment with Quetiapin depends on the importance of the drug for the mother.
Drug interaction
quetiapin mainly acting on the central nervous system, so be careful when coordinating Quetiapin with drugs on other central nervous systems and alcohol.
Be cautious when using quetiapin for patients being treated with acetylcholin anti -acetylcholin (mucarinic) drugs.
Quetiapin metabolizes mainly thanks to the cytochrom P450 enzyme (CYP) 3A4, Cytochrom P450 enzyme system. In a study in a healthy volunteer, simultaneously used Quetiapin (dose of 25 mg) with ketoconazole, a CYP3A4 inhibitor, increasing 5-8 times the area under the curve of Quetiapin (AUC: Area Under the Curve). On this basis, contraindicated use of Quetiapin with CYP3A4 inhibitors. Grapefruit juice is also not recommended during treatment with Quetiapin.
In a multi -drug test to evaluate the kinetics of Quetiapin before and during treatment with carbamazepin (a liver enzyme induction), the results showed simultaneous use with carbamazepine significantly increasing the clearance of quetiapin. Increasing clearance reduces Quetiapin exposure (measured by AUC) on average 13% compared to the solitary quetiapin, in some cases of this actor greater.
This interaction may reduce the plasma concentration of Quetiapin, which leads to a reduction in the effectiveness of Quetiapin's treatment. Simultaneous use of quetiapin with phenytoin (another enzyme induction drug) increases the clearance of quetiapin about 45%. Patients who are taking liver enzyme drugs, only starting to treat Quetiapin when Quetiapin's treatment benefits are higher than the risk of liver enzyme stopping (such as sodium valproat).
The pharmacokinetics of Quetiapin does not change significantly when combined with imipramine antidepressants (CYP2D6 inhibitors) or fluoxetin (CYP3A4 and CYP2D6 inhibitors).Quetiapin's pharmacokinetics does not change significantly when combined with Risperidon or Nadoperidon anti -dysplasia drugs. However, the combination of quetiapin and thioridazin increases the clearance of Quetiapin about 70%. The pharmacokinetics of Quetiapin does not change when combined with cimetidine. lithium pharmacokinetics does not change when combined with quetiapin.In a 6 -week random study, Lithi and Quetiapin release the prolonged release of Placebo and Quetiapin released in the adult patient with acute Hung Cam. The results showed that the percentage of symptoms of foreign tapes was low, drowsiness and weight gain, observed in the lithium and quetiapin group, which lasted higher than the Placebo group.
Dynamic pharmacokinetics of sodium valproat and quetiapin clinically unchanged when used in combination. A recovery study in children and teenagers treated with Valproat, Quetiapin or both, research showed a high percentage of neutrophils and neutrophils in the group used to combine compared to the single -treatment group.
Quetiapin interaction with cardiovascular medications is not used yet.
Be careful when using Quetiapin and three -round antidepressants that can give a fake positive result in patients being treated with Quetiapin.Storage
Store in a dry place, temperatures below 30 ° C.
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