Omnivastin SPM drugs treat schizophrenia (5 blisters x 10 tablets)

Dosage form Box of 5 blisters x 10 tablets
Specifications Quetiapin

Ingredient

Composition informationContent
Quetiapin100mg

Uses

indications

omnivastin 100mg drug indicated schizophrenia.

Omnivastin 100mg drug is indicated to treat bipolar disorders:

  • Treatment of severe and moderate inductance in bipolar disorders
  • The major depression in bipolar disorders
  • Prevent the recurrence of bipolar disorders in patients where depression, hunger or depression and mangroves have responded to Quetiapine therapy. Anti -psychotic test, such as Conditailed Avoidance.

    Quetiapin also broke the impact of dopamine owners on behavioral or electrophysiological tests, and increased the concentration of metabolites of dopamine, a nerve index indicating the level of d2 receptor holder.

    In preclinical trials forecasting the possibility of foreign symptoms (EPS), Quetiapin is not the same as typical anti -psychotic drugs and not typical characteristics.

    Quetiapin does not cause too sensitive effects with dopamine D receptors after long -term use.

    Quetiapin only causes the weak effect (Catalepsy) in the doses of doses inhibiting Dopamin D3.

    Quetiapine proves a selective love on the edge of the brain through the reducing inhibitory effect of the neurons in the middle of the middle of the middle of the middle of the brain (mesolimbic) but does not affect the nermoneme (Nigrostriatal) after long -term use.

    Quetiapin can cause a minimum muscle disorder on the cebus monkey sensitive to Haloperidol or have never taken drugs (DRUG-Naive) after the medication immediately and long-term.

    Dynamic pharmacokinetics

    absorption

    Quetiapin is well absorbed and strongly metabolized after oral use.

    The bioavailability of Quetiapin is not significantly affected by food.

    The maximum molar concentration of the stable state of Norquetiapin metabolites is 35% of the observed concentration of Quetiapin.

    The pharmacokinetics of Quetiapin and Norquetiapin are linearly within the accepted dose range.

    distribution

    Quetiapin binds to plasma proteins about 83%.

    transformation

    quetiapin is strongly metabolized by the liver, with less than 5% of constant drugs detected in urine or feces after the use of radioactive quetiapin.

    In vitro tests determine that CYP3A4 is the initial enzyme responsible for the metabolism through Quetiapin's cytochrom P450.

    Norquetiapin is formed and eliminated first through CYP3A4.

    About 73% of radioactive substances are excreted in urine and 21% in feces.

    quetiapin and some of its metabolites (including norquetiapin) were discovered as weak inhibitors of Cytochrom P450 102, 2C9, 2C19, 2D6 and 3A4 in vitro.

    Inhibition in vitro CYP is only observed at concentrations of about 5-50 times higher than the specified dose observed in the range of 300 - 800 mg/day in humans.

    Based on these in vitro results, it is unlikely that the simultaneous use of quetiapin with other drugs will cause clinical inhibition of metabolism through the cytochrom P450 of other drugs.

    From animal studies shows that quetiapin can promote cytochrom P450 enzymes.

    However, in a special interactive study in mental patients, there is no increase in increased cytochrom P450 activity after using Quetiapin.

    Elimination

    The time for elimination of Quetiapin and Norquetiapin is about 7 and 12 hours respectively.

    The average ratio is calculated according to the molar concentration of free quetiapin and active metabolites in Norquetiapine plasma excreted through pepper water

  • Before taking Omnivastin SPM drugs treat schizophrenia (5 blisters x 10 tablets)

    How to use

    omnivastin 100mg of film tablets, can be used or not food.

    Dosage

    There are different dose modes for each indicator. Therefore, the patient must be clearly informed about the appropriate dose for his condition.

    Adults

    Dosage to treat schizophrenia:

  • To treat schizophrenia, Quetiapin should be used 2 times/day. Clinical and tolerance of each patient, the dose can be adjusted in the range of 150 - 750 mg per day.
  • In order to treat inductance in bipolar disorders, Quetiapin should be used 2 times/day. The can be adjusted depending on the clinical response and tolerance of each patient, about 200 - 800 mg per day.
  • quetiapin should be used 1 time/day at bedtime. dose 300 mg.

    Some individual patients may have more benefits when using a dose of 600 mg.

    Dosage higher than 300mg should be started by experienced physicians in the treatment of bipolar disorder.

    Clinical trials show that it is possible to consider reducing the dose for some individual patients to minimum 200 mg when there is concern for drug tolerance.

    Using drugs in the treatment of depression in bipolar disorders should be started by a doctor who has experience in the treatment of bipolar disorders.

    In separate patients, there is a problem related to tolerance, clinical trials show that reducing the dose to a minimum of 200 mg may be considered.

    Dosage to prevent bipolar disorders:

    In the prophylaxis of relapse of colds, depression or depression and revival, the patient responded to Quetiapin in the treatment of bipolar disorder, so they continued to use the same dose before going to bed.

    Can adjust the dose depending on the response and intake of each patient in the level of 300 mg-800 mg/day. It is important to use the lowest dose effectively in maintenance treatment.

    Elderly

    As well as other anti -psychotic and antidepressants, need to be cautious when using Quetiapin in the elderly, especially in the beginning of treatment.

    Quetiapin dose adjustment speed may need to be slower and the total daily dose is lower than young patients.

    Average quetiapine in plasma clearance decreased by 30-50% in elderly patients compared to young patients.

    Effective in patients over 65 years old suffering from depression related to bipolar disorder has not been evaluated.

    Patients with renal failure

    Adjusting unnecessary dose in patients with renal failure.

    Patients with liver failure

    Quetiapin is strongly metabolized by the liver. Therefore, Quetiapin should be used to be carefully used for patients who know the liver failure, especially in the beginning of treatment.

    Patients are known to have liver failure, so they start at a dose of 25 mg daily. Dosage should be increased daily with an increase of 25 - 50 mg daily to effective dose, depending on the clinical response and tolerance of each patient.

    Children's patients

    Quetiapin is not recommended for children and teenagers under 18 years old.

    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 do

    do when overdose?

    Overdose can lead to extension of QT, convulsions, state epilepsy, pattern, respiratory arrest, urinary retention, confusion, delusion, and/or anxiety, coma and death. Patients who have suffered from severe cardiovascular disease may increase the risk of overdose.

    How to handle:

    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, according to
    and cardiovascular support.

    Based on publications, patients with delirium and anxiety and anti-cholinergic syndrome can be treated with physostigmin, 1-2 mg (continuous ECG monitoring).

    This is not recommended as the standard treatment, because the potential effect of physostigmin is transmitted in the heart. Physostigmin can be used without an extraordinary ECG.

    Do not use physostigmin in the event of a brain/heart wave disorder, any level of heart or open -end level.

    While there is no research to limit the absorption at an overdose, in case of severe poisoning, the stomach can be appointed for 1 hour after taking the drug if possible. Can consider using activated carbon.

    In case of quetiapin overdose, persistent hypotension should be treated with appropriate measures such as intravenous infusion and/or sympathetic nerve stimulants.

    Epinephrin and dopamine must be avoided, because beta stimulation can make blood pressure worse in alpha blockers driven by quetiapine.

    Need to continue monitoring and monitoring patients closely until complete recovery.

    In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

    What to do when you forget 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

    The side effects may be encountered when using the drug with the following frequency:

    Very popular:

  • Hemoglobin reduction. Meet:
  • leukopenia, neutrophils, eosinophilia Heart fast, brushed chest drum.
  • Neutral leukemia, platelet, anemia.
  • Hypersensitivity (including allergic reactions on the skin). Slow.
  • Rhinitis.
  • granulocytes.
  • Metabolic syndrome.
  • Sedative syndrome, hypothermia.
  • Anaphylaxis reaction.
  • Warnings

    Before using the drug you need to read the instructions carefully and refer to the information below.

    contraindicated

    omnivastin drug 100mg contraindicated in the following cases:

  • Hypersensitivity to any ingredients in the formula.

    Be cautious when using

    do not recommend using Quetiapin for children and teenagers under 18 years old.

    Therapist should consider risks that may occur suicide events after sudden stopping treatment of Quetiapine, due to the known risk factors of the disease being treated.

    Other mental conditions that are indicated using Quetiapin may also be associated with increased risk of suicide events.

    The worse risk of the patient's metabolic summary has been observed, including changes in weight, blood glucose (see hyperglycemia) and lipids, which have been seen in clinical studies.

    Patients' metabolic parameters must be evaluated at the beginning of treatment and changes in these parameters must be controlled regularly throughout the treatment.

    using Quetiapin can cause restlessness, manifested by subjective discomfort or restless restlessness and need to change the position that can be constantly accompanied by unable to sit or stand still.

    This symptom appears mainly in the first few weeks of treatment. In patients with these symptoms, it may be detrimental to the dose.

    Tardive dyskinsesia: If there is any sign or symptom of arbitrary movement disorders, should consider reducing the dose or stopping quetiapine.

    Quetiapin treatment can cause drowsiness and related symptoms, such as vaginal.

    Be careful when used to treat patients with a history of convulsions.

    Malignant syndrome caused by sedatives is related to the treatment of anti -psychotic drugs, including Quetiapin. Clinical manifestations include overcrowding, mental changes, muscle spasms, unstable nervous systems and increased creatine phosphokinase. In this case, Quetiapine should be discontinued and appropriate treatment.

    Neutral leukemia should be considered in patients with infections or fever, especially when there are no factors that are clearly affected, and are reasonably controlled in clinical.

    In patients taking liver enzyme promoting drugs, only starting to treat Quetiapin if the physician considers that the benefit of Quetiapin is beyond the risk of liver enzyme elimination.

    Weight gain has been recorded in patients treated with quetiapine, and should be monitored and controlled appropriately according to the instructions for use of psychotic drugs.

    Patients treated for any anti -psychotic drugs including Quetiapine should be monitored with signs and symptoms of hyperglycemia (such as thirst, multiple urinary, eating and fatigue) and patients with diabetes or having risk factors for diabetes should be monitored periodically to avoid worse glucose control. Should monitor the weight periodically.

    Increase triglycerides, LDL and total cholesterol, and decrease HDL cholesterol has been recorded through clinical trials with quetiapin.

    Be cautious when prescribing Quetiapin along with the drugs that extend QTC, or simultaneously used with other sedatives, especially in the elderly, in patients with congenital QT syndrome, congestive heart failure, heart hypertrophy, potassium orgel hypertrophy or magnesium.

    Quetiapin treatment should be re -evaluated for patients with suspected chronic heart disease for unknown cause and myocarditis.

    Symptoms of acute cessation such as nausea, vomiting, insomnia, diarrhea, dizziness and stimulation may occur after a sudden stop of high -dose Quetiapine. Therefore, it should be stopped slowly within a period of at least one to two weeks.

    Quetiapin has not been ratified to treat patients with mental disorders related to dementia.

    Difficulty swallowing has been reported to Quetiapin. Quetiapin should be used cautiously in patients with the risk of inhaled pneumonia.

    Constipation and intestinal obstruction have been reported to Quetiapin, including those who are taking a lot of medications at the same time that they reduce the peristalsis and/or cannot report constipation symptoms.

    Cases of venous embolism caused by thrombosis (VTE) have been reported when using psychotic drugs.

    Pancreatitis has been reported in clinical trials and experience in the circulation process.

    Products containing lactose, patients with rare genetic disorders such as galactose tolerance disorders, lapp lactase deficiency, or abnormal absorption of glucose-galactose should not use this drug.

    Women during pregnancy and lactation

    Pregnant women

    The first three months of pregnancy:

    Moderate amount of data published about pregnant women (for example, between 300-1000 pregnancy), including separate reports and some observatory studies do not give the risk of increased deformities due to treatment.

    However, based on all the available data, it is impossible to make a clear conclusion.

    Animal studies show reproductive toxicity. Therefore, Quetiapin is only used in pregnant women if the benefits proves superior risks.

    The third three months of pregnancy:

    The fetus is exposed to anti -psychotic drugs (including Quetiapin) in the 3rd 3 months of pregnancy that is at risk of harmful reactions including symptoms of foreign tower and/or stopping the drug may be severe and prolonged after birth. There are reports on anxiety, muscle monks, myasthenia gravis, tremor, drowsiness, respiratory arrest, or feeding disorders.

    Therefore, newborns must be carefully supervised.

    breastfeeding women

    Based on very limited data from the published reports of the excretion of Quetiapin into human milk, the excretion of Quetiapin at the dose of treatment appears in contrast. Due to the lack of raw data, decisions or stop breastfeeding or stopping treatment with Quetiapin based on considering the benefits of breastfeeding or the maternal treatment benefits.

    fertility

    The effect of quetiapin on fertility in humans has not been evaluated. The effects related to prolactin secretion have been seen in rats, although this is not directly related to people.

    The ability to drive and operate machinery

    Due to the main impact on the central nervous system, Quetiapine may affect the activities that need mental alertness. Therefore, it is necessary to advise patients not to drive or operate the machine until it is clearly identified by their own drugs.

    Drug interaction

    Quetiapin is mainly impacted on the central nervous system, so be careful when coordinating Quetiapin with other medications on other central nervous systems and alcohol.

    Cytochrom P450 (CYP3A4) is the main enzyme responsible for quetiapine transformation. In an interactive study on a healthy volunteer, the simultaneous use of Quetiapin (dose of 25 mg) with ketoconazole, a CYP3A4 inhibitor, causes the AUC value of Quetiapin to an increase of 5-8 times higher than usual. So contraindicated use of quetiapine simultaneously with CYP3A4 inhibitors. In addition, Quetiapin is also recommended not to use grapefruit juice during treatment with Quetiapin.

    In a multi -dose test to evaluate the pharmacokinetics of Quetiapin used before and during treatment with carbamazepin (considered as a liver enzyme promotion), simultaneous use of quetiapin with carbamazepine significantly increases the clearance of quetiapine.

    This clearance increases reducing the average 13% rating quetiapin level (evaluation through AUC) compared to when using only quetiapine, although in some patients that can be greater.

    Due to this interaction, the concentration of plasma drugs may be lower, and therefore can affect the effectiveness of therapeutic therapy. Simultaneous use of quetiapin with phenytoin (another liver -induced drug also increases Quetiapine clearance about 450%.

    In patients who are taking drugs that promote liver enzymes, the beginning of the quetiapin therapy should only be conducted after the doctor considers the benefits of Quetiapin than stopping the use of the liver enzyme.

    It is important to stop the drug that promotes liver enzymes slowly, or if necessary, replaced with drugs that do not promote liver enzymes (like Sodium Valproat).

    The pharmacokinetics of Quetiapin does not change significantly when used simultaneously with imipramine antidepressants (a CYP 2D6 inhibitor) or fluoxetin (a CYP 3A4 and CYP2D6 inhibitors). The pharmacokinetics of Quetiapin does not change significantly when used simultaneously with Risperidon or Haloperidol psychotic drugs. Simultaneous use with thioridazin increases the clearance of Quetiapin about 70%. The pharmacokinetics of Quetiapin does not change when used simultaneously with cimetidine. lithium pharmacokinetics does not change when used simultaneously with quetiapin.

    In a random study, 6 weeks on the prolonged release of lithium and quetiapin opposite to the prolonged release of pharmaceutical prices and quetiapin in adult patients with acute anemia, a higher rate of extracurricular events (especially tremor), drowsiness, and weight gain that are observed in the lithu supplementary group compared to the placebo.

    Dynamic pharmacokinetics of Valproat sodium and quetiapin does not change when used simultaneously.

    A rescue study in children and adolescents used Valproat, Quetiapin, or both, showing a higher rate of leukopenia and neutropenia in the group combined against the monotherapy group.

    Official studies on drug interaction with common cardiovascular drugs have not been conducted.

    Be cautious when using Quetiapine simultaneously with drugs that cause electrolyte imbalance or extend QT.

    Has recorded a false positive result in methadone tests or three -round antidepressants by enzyme immune method in patients using Quetiapine.

    Should use an appropriate chromatography technique to confirm the results of implementation by suspected immune method.

  • Storage

    Leave a cool place, avoid light, temperature below 30⁰C.

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