Queitoz-100 Davipharm medicine treatment of schizophrenia, bipolar disorder (4 blisters x 7 tablets)

Dosage form Box of 4 blisters x 7 tablets
Specifications Quetiapine

Ingredient

Composition information	Content
Quetiapine	100mg

Uses

indications

queitoz-100 pills are indicated in the following cases:

schizophrenia treatment.

Treatment of bipolar disorder:

Treatment of a strong manic attack in bipolar disorder.

Pharmacological group: Anti -psychotic drugs.

Quetiapin is an aligned anti -psychotic drug. Quetiapin and metabolites are active in plasma, N-Desalkyl Quetiapin, which works on many types of neurotransmitter receptors. Quetiapin and N-Desalkyl Quetiapin are affinity for serotonin receptors (5HT2) in the brain and with Dopamine D1 and D2 receptors. It is the selection with a higher Serotonin receptor (5HT2) in the brain with Dopamine D2 receptor that is believed to contribute to the clinical anti -psychotic properties and have little risk of unwanted effects on the outskirts of Quetiapin.

Quetiapin and Norquetiapin do not have significant affinity for the benzodiazepin receptor but have high affinity with the histaminergic receptor and adrenergic alpha1. Quetiapin does not have or have low affinity for muscarinic receptors, while Norquetiapin has a high average to high -to -high affinity with many Muscarinic receptors, which can explain the antigen effect (Muscarinic).

Norquetiapin inhibits Net and the owner partially at 5HT1A, which can contribute to Quetiapin's treatment effect as an antidepressant.

pharmacokinetics

absorption:

Quetiapin is well absorbed and completely metabolized after drinking. Quetiapin's bioavailability is not significantly affected when used with food. The peak concentration in the stable state of metabolites is 35% of the quetiapine concentration.

Dynamic pharmacokinetics of quetiapin and linear norquetiapine within the approved dose range.

distribution:

Quetiapin binds about 83% to plasma protein.

transformation:

quetiapin metabolized over the liver, after taking the radioactive mark, less than 5% of the original substance is eliminated in the form of non -metabolized in urine or feces.

In vitro research shows that CYP3A4 is an enzyme that plays a major role in quetiapin metabolism through cytochrom P450 intermediaries. Norquetiapin is formed and excreted mainly through CYP3A4.

quetiapin and many of its metabolites (including Norquetiapin) inhibit weak CYP 1A2, 2C9, 2C19, 2D6 and 3A4 In Vitro. This effect is only seen when used at concentrations about 5-50 times higher than 300 - 800 mg/day in humans. Based on in vitro information, quetiapin does not inhibit significant inhibitors clinically metabolism through the cytochrom P450 enzyme intermediate of other drugs. From animal research shows that quetiapin can touch Cytochrom P450 enzyme. However, in specific interactive studies conducted in psychotic patients, there is no increase in the activity of Cytochrom P450 seen after using Quetiapin.

excretion:

The sale time of Quetiapin and Norquetiapin corresponds to about 7 and 12 hours, respectively. About 73% of the dose marked radioactive excretion in urine and 21% in feces. Under 5% of free quantiapin and active metabolites in Norquetiapin plasma are eliminated in the urine.

Special subjects:

Sex:

The dynamic of Quetiapin is not different between men and women.

Elderly:

The average clearance of Quetiapin in the elderly is about 30-50% lower than adults aged 18 - 65 years old.

Patients with renal failure:

The average plasma clearance of Quetiapin decreases about 25% in severe renal failure (creatinine clearance

Patients with liver failure:

The average plasma clearance of Quetiapin decreases by about 25% in patients with hepatic failure (stable alcoholic cirrhosis). Because Quetiapin metabolizes the liver, the plasma concentration of Quetiapin is expected to increase in patients with liver failure. The dose may be needed in these patients.

Children:

In a stable state, the plasma concentration standardized the dose of quetiapin in children and adolescents (10-17 years) generally similar to adults, although CMAX in children at the upper limit of CMAX ranges in adults. AUC and CMAX of metabolites are higher than 62% and 49% in children (10 - 12 years old) and 28% and 14% in adolescents (13-17 years) compared to adults.

Before taking Queitoz-100 Davipharm medicine treatment of schizophrenia, bipolar disorder (4 blisters x 7 tablets)

How to use

oral tablets, or non -food. Take the tablet with a glass of water. Dosage

Different treatment process for each indication, so the patient certainly understood the appropriate dose information for his condition.

Adults:

schizophrenia treatment:

Should drink quetiapin 2 times/day. The total dose per day in the first 4 days of treatment is 50 mg (daily 1), 100 mg (daily 2), 200 mg (dated 3) and 300 mg (dated 4).

From the 4th day onwards, adjust to the usual dose is effective from 300 to 450 mg/day. Depending on the clinical response and tolerance of each patient, the dose can be adjusted in the range of 150 to 750 mg/day.

Treatment of emotional attacks that are severe in bipolar disorders:

Should take Quetiapin 2 times/day. The daily dose per day for the first 4 days of treatment is 100 mg (day 1), 200 mg (dated 2), 300 mg (dated 3) and 400 mg (dated 4). Dosage can be gradually adjusted to 800 mg/day on the 6th day but each increase should not exceed 200 mg/day.

Can adjust the dose depending on the clinical response and tolerance of each patient, between 200 to 800 mg/day. The usual dosage has a treatment effect of 400 - 800 mg/day.

Treatment of severe depression in bipolar disorders:

Should drink quetiapin once a day before going to bed. The total daily dose in the first 4 days of treatment is 50 mg (daily 1), 100 mg (dated 2), 200 mg (dated 3) and 300 mg (dated 4). The recommended daily dose is 300 mg.

There is no additional benefit when taking a dose of 600 mg compared to the dose of 300 mg except in some patients. The dose higher than 300 mg should be started by a doctor with experience in bipolar disorder treatment. In some patients, when concerned about tolerance complications, it is advisable to consider reducing to a minimum of 200 mg.

Prevention of recurrence in bipolar disorders:

To prevent relapse of the emotional, mixed or depression in bipolar disorders, patients have a response to Quetiapin when treating dipole acute dysfunction should continue to treat such a dose. The dose can be adjusted based on clinical response and tolerance of each patient, within 300 - 800 mg divided into 2 times/day. Should use the lowest dose effective in 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 dose growth rate may need to be slower and the daily dose is lower than when used for younger patients, depending on the clinical response and tolerance of each patient. The average plasma clearance of quetiapin decreased by 30-50% in the elderly when compared to younger patients.

Effective and safe in patients over 65 years of age with depression in bipolar disorder has not been evaluated.

Patients with renal failure:

No need to adjust the dose in patients with renal failure.

Patients with liver failure:

quetiapin metabolizes a lot through the liver. Therefore, be careful when using quetiapin in patients with liver failure, especially during the starting stage of drug use. Patients with liver failure should start with quetiapin 25 mg/day. Daily dose should be increased, each level of 25 to 50 mg, to the dose to achieve effective treatment, depending on the clinical response and tolerance of each patient.

Children:

It is not recommended to use Quetiapin for children and teenagers under 18 years old, due to lack of information on safety and efficiency in this age group.

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?

symptoms:

In general, the signs and symptoms are reported by increasing pharmacological effects of the drug, such as drowsiness and sedation, tachycardia, hypotension and anti -cholinergic effect. Overdose can lead to extension of QT, convulsions, epilepsy status, muscle prize, respiratory inhibition, urinary retention, coma and death. There may be an increase in the risk of overdose in patients with severe cardiovascular disease.

Management:

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.

Patients with delusion and excitement and anti -inergic syndrome can obviously be treated with physostigmin 1 - 2 mg (under continuous ECG monitoring). It is not recommended physostigmin as a standard treatment, because of the disadvantageous risk of physostigmin to heart transmission. Physostigmin can be used without ECG abnormalities. Do not use physostigmin in case of arrhythmia, heart block at any degree or wide QRS range.

Induscitation prevention has not been studied, gastric lavage may be indicated in case of severe poisoning and if possible, it should be done within 1 hour after overdose. Should consider using activated carbon.

In case of quetiapin overdose, anti -treatment hypotension should be treated with appropriate measures such as intravenous infusion and/ or sympathetic drugs. Epinephrin and dopamine should be avoided, because beta stimulates can aggravate blood pressure in the case of alpha blockers due to quetiapin.

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

In case of 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 doses to compensate for missed dose.

Side Effects

When using queitoz-100 drugs, you may experience unwanted effects (ADR) such as:

Safety information

Unwanted effects are most commonly reported when using Quetiapin (≥ 10%) is drowsiness, dizziness, headache, dry mouth, symptoms of quitting (when stopping the drug), increasing serum triglycerides, increasing cholesterol (mainly LDL cholesterol), reducing HDL cholesterol, weight gain, hemogobine loss and overspower symptoms.

Unwanted effects are separated by frequency and system

Very common, ADR ≥ 1/10

Blood and lymphatic system: Hemoglobin decrease. mouth.

Blood and lymphatic system: leukopenia, decreased number of neutrophils, eosinophilia Microscopic suicide. Aminotransferase (ALT) serum, increased gamma-GT concentration.

Blood and lymphatic system: neutral leukopenia, thrombocytopenia, anemia, platelet reduction. Vacuum, late movement disorders, unconscious. Genital and mammary glands: Genital dysfunction.

Rare, 1/10,000 ≤ ADR Blood and lymphatic system: granulocytes. liver.

The immune system: Anaphylaxis reaction.

Skin and subcutaneous tissue: Poisoned epidermal necrosis, diverse roses.

Unwanted effects in children and teenagers are similar to the above adults. In addition, children have unwanted effects that occur at higher frequency or unwanted effects only in children:

Very common, ADR ≥ 1/10

Endocrine: Increased prolactin.

Neurological: unconscious.

Warnings

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

Contraindicated

Queitoz-100 contraindications in the following cases:

Hypersensitivity to Quetiapin or any ingredients of the drug.

Be cautious when using

need to be very careful when taking the drug for patients in the following cases:

Because Quetiapin has many indications, safety information should be considered for the diagnosis of each patient and the dose in use.

Children:

It is not recommended to use Quetiapin for children and teenagers under 18 years old, due to lack of information on safety and effectiveness. Clinical trials show that unwanted effects have higher frequency in children and adolescents compared to adults (increasing appetite, increasing serum prolactin, vomiting, rhinitis and fainting) or may have other effects in children (symptoms of extravagant and uncomfortable) and have not seen in adults (hypertension). Change of thyroid function test is also seen in children and teenagers.

Moreover, Quetiapin's long -term safety on growth and maturity has not been studied for more than 26 weeks. Unknown long -term impact on cognitive and behavioral development.

Quetiapin increases the frequency of pagoda symptoms in children and adolescents during treatment

schizophrenia, bipolar and bipolar depression.

suicide/suicide thoughts or more severe clinical status:

Depression in bipolar disorder is associated with increased risk of suicide thoughts, self -harm and suicide (events related to suicide). These risks persist until there is a significant recovery. Because improvement may not occur in the first few weeks of treatment or more, closely monitor patients until improved clearly. According to the general clinical experience, the risk of suicide may increase in the healing phase.

In addition, the doctor should consider the risk of suicide events that may occur when suddenly stopped quetiapin due to risk factors of the disease.

Other mental conditions that Quetiapin are specified may also be associated with an increase in the risk of suicide -related events. In addition, these conditions may occur with severe depression. Caution in patients with severe depression should also be applied to patients with other mental disorders.

Patients with a history of suicide events, or patients show significant suicide thoughts before starting treatment is at higher risk of suicide or suicide thoughts, and should be carefully monitored during treatment.

Closely monitor patients, especially those at high risk, should be accompanied by drug treatment, especially in the early stages of treatment and after the dose changes. Patients (and caregivers) should be warned of the need to monitor any worse clinical condition, suicide behavior or thoughts, abnormal changes in behavior and need to go to the health center immediately if they have these symptoms.

Risk of metabolism:

In clinical research, the risk of metabolism is worse, including changes in weight, blood glucose and lipid, should assess the patient's metabolic parameters at the beginning of treatment and should regularly control the change of these parameters during treatment. Should manage the status worse when clinically suitable.

Symptoms of foreign tower:

Quetiapin is associated with an increase in the percentage of pagoda symptoms in patients with severe depression in bipolar disorders.

Use Quetiapin is related to restless sitting. This situation usually occurs during the first few weeks of treatment. In patients with this symptom, increasing the dose may be harmful.

Late movement disorders:

When signs or symptoms of late movement disorders should be considered, should consider reducing the dose or stop quetiapin. Symptoms of movement disorders want to get worse or even outbreak after treatment.

Sleep and dizziness:

Using Quetiapin can cause drowsiness and related symptoms, such as sedation. In clinical trials in patients with bipolar depression, symptoms often onset in the first 3 days of treatment with the main level of mild to medium. If the patient is severe, it may be necessary to contact more often for at least 2 weeks from the onset of drowsiness, or until the symptoms are improved and may consider stopping treatment.

Hypotension:

Quetiapin can cause vertical and dizzy hypotension, like drowsiness, these conditions often onset at the first stage of the dose adjustment. These conditions may increase the rate of injury due to an accident (falling), especially in the elderly. Therefore, it is advisable to advise patients to be cautious until they get used to the effects of the drug.

Quetiapin should be used carefully for patients who know that there is cardiovascular disease, cerebrovascular disease, or other pathological conditions that can cause hypotension. Dosage reduction should be considered more slowly if there is hypotension, especially in patients with hidden cardiovascular disease.

Sleep apnea syndrome:

Sleep apnea syndrome is reported in patients using Quetiapin. Caution should be careful in patients using the central nervous system inhibitors and patients with a history or risk of apnea, such as overweight/obesity or men.

convulsions:

In control clinical trials, there is no difference in the frequency of epilepsy between the group of patients using Quetiapin and the placebo group. Like other anti -psychotic drugs, should be careful when using drugs for patients with a history of epilepsy.

Malignant neuroleptic syndrome:

Malignant neuropular syndrome 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 heavy grain leukemia:

Heavy neutropenia (

Consider neutropenia in patients with symptoms of infection or fever, especially when there is a lack of clear causes, and should be treated when appropriate clinical.

Advice patients to immediately notify the appearance of signs/symptoms characteristic of granulocytes or infections (such as fever, weakness, coma or sore throat) at any time during treatment with quetiapin. The counting of white blood cells and white blood cells should be performed in time, especially without clear causes.

Anti -anti -anti -cholinergic effect (Muscarinic):

norquetiapin, metabolites that are active of quetiapin, have average affinity to strongly with many feces of Muscarinic receptors. This contributes to the undesirable effect of cholinergic resistance when using Quetiapin at the recommended dose, when used simultaneously with other drugs with anti -cholinergic effects, and in the case of overdose.

Be cautious when using quetiapin in patients taking drugs with anti -anti -anti -cholinergic effect (muscarinic). Should be cautious when using quetiapin in patients diagnosed or have a history of urinary retention, prostate hypertrophy with clinical significance, gastrointestinal obstruction or related conditions, increased intraocular pressure or closed angle Glaucom.

Interactive:

See more in the drug interaction.

The simultaneous use of Quetiapin with strong liver enzyme drugs such as carbamazepine or phenytoin significantly reduces the plasma concentration of quetiapin, which can affect the effectiveness of Quetiapin treatment. In patients using liver enzyme induction drugs, the beginning of treatment with Quetiapin should only be performed if the doctor considers the benefits of Quetiapin that is superior to the risk of giving up liver enzyme drugs. Any changes of induction drugs must be slowly, and replace it with non -touch drugs if needed (such as sodium valproat).

Weight:

Weight gain has been reported in patients using Quetiapin, and should be monitored and managed when clinical appropriate as instructions for using anti -psychotic drugs.

Hyperglycemia:

Hypoglycemia and/or progressive or worse than diabetes are often accompanied by ceton acidosis or coma which has been reported rare, including a number of deaths. In some cases, there is a previous weight gain, this may be a cause. Clinical monitoring should be appropriate according to the instructions for using anti -psychotic drugs. The signs and symptoms of hypoglycemia in patients using psychotic drugs include quetiapin, (such as drinking, urinating, eating a lot and weak) and patients with diabetes or risk factors for diabetes should be monitored due to more difficult monitoring of glucose control. Should track periodic weight.

lipid:

Increase triglycerides, LDL and total cholesterol, and reduce HDL cholesterol seen in clinical trials with quetiapin. Should handle lipid changes when appropriate clinical.

extends the QT range:

There has been a report that extends the QT period when using quetiapin at the dose of treatment and when overdose. Like other anti -psychotic drugs, should be cautious when using Quetiapin in patients with cardiovascular disease or family history extending the QT range. It is also advisable to use Quetiapine simultaneously with other drugs that can cause other QT interval, or with other anti -psychotic drugs, especially in the elderly, in patients with congenital QT syndrome, congestive heart failure, heart hypertrophy, hypotension or hypoglycemia.

Myocarditis and myocarditis:

There has been a report on myocarditis and myocarditis, but the causal relationship with Quetiapin has not been set. Treatment with quetiapin should be re -evaluated in patients suspected of having myocarditis or myocarditis.

Stop drugs:

Symptoms of acute cessation such as drowsiness, nausea, headache, diarrhea, vomiting, dizziness and discomfort have been reported after stopping the Quetiapin suddenly. Should stop the drug slowly within the period of at least 1-2 weeks.

Misregal use and abuse of drugs:

In case of wrong use and drug abuse have been reported. Should be cautious when using Quetiapin in patients with a history of alcohol or medicine abuse.

Elderly people with mental disorders related to memory loss:

Quetiapin has not been approved to treat patients with mental disorders related to memory loss.

There is an increase in the risk of unwanted events on the brain blood vessels seen in random trials to control the placebo in patients with dementia using some typical anti -psychotic drugs. The mechanism of increased risk is still unclear. The risk cannot be ruled out for other anti -psychotic drugs or other patient groups. Should be cautious when using Quetiapin in patients at risk of stroke.

In an integrated analysis for typical anti -psychotic drugs, there was a report on increased risk of death in elderly patients with psychotic disorders related to memory loss compared to placebo.

Difficult to swallow:

Difficult to swallow has been reported in patients using Quetiapin. Should be cautious when using quetiapin in patients at risk of choking pneumonia.

Constipation and intestinal obstruction:

constipation is a risk factor for intestinal obstruction. Constipation and intestinal obstruction have been reported when using Quetiapin, including deaths in patients with higher risk of intestinal obstruction, including patients who use simultaneously many drugs that reduce bowel motility and/or may not report constipation symptoms. Patients with intestinal obstruction should be treated by closely monitoring and emergency care.

venous thrombosis (VTE):

The case of VTE has been reported when using anti -psychotic drugs. Because patients treated with anti -psychotic drugs often have VTE risk factors, all VTE risk factors should be determined before and during treatment with quetiapin and should take preventive measures.

Pancreatitis:

Pancreatitis has been reported when using Quetiapin. In reports, not all but many patients have factors related to pancreatitis such as triglycerides, gallstones and drinking.

Additional information:

Quetiapine combination information with divalproex or lithium in the acute imposition is both heavy and limited; However, the coordination of treatment is well tolerated. Information shows the impact of the contract at the 3rd week.

Authority warning:

Lactose, patients with rare genetic diseases Galactose, Lapp Lactase deficiency or Glucose-Galactose absorption disorders should not use this drug

The effect of drugs on driving and operating machinery

Because of the main effect on the central nervous system, Quetiapin can affect the activities that need mental focus. Therefore, patients should not drive or operate machinery until they know their sensitivity to the drug.

Using drugs for women during pregnancy and lactation

Using drugs for pregnant women

The first three months of pregnancy:

There has been no increased risk of birth defects due to the use of Quetiapin. However, there has not been a clear conclusion. Animal research shows toxicity on fertility. Therefore, Quetiapin should only be used during pregnancy if the benefits are out of risks that may occur.

The last three months of pregnancy:

Babies who are exposed to anti -psychotic drugs (including Quetiapin) in the last three months of pregnancy are at risk of unwanted effects including symptoms of outsider and/or symptoms of quitting drugs, may be at different severity and time after the onset. Should monitor babies carefully.

Using medicine for breastfeeding women

Based on the information that is very limited to published, Quetiapin secreted through breast milk, the irregular quetiapin secretion at the dose of treatment. Due to lack of information, it is necessary to decide to stop breastfeeding or stop using Quetiapin based on the benefit of breastfeeding for babies and the benefit of the drug for the mother.

fertility

There is no assessment of Quetiapin's influence on human fertility. Effects due to increased prolactin concentration in mice, although this is not directly related to people.

Drug interaction

Because Quetiapin acts mainly on the central nervous system, should be careful when combining Quetiapin with drugs that affect other central nervous systems and alcohol.

Be cautious when taking Quetiapin for patients who are taking other drugs with anti -anti -anti -cholinergic (Muscarinic) effects.

CYP3A4 is the enzyme that is mainly responsible for quetiapine metabolism through cytochrom P450 intermediaries. Contraindicated Quetiapin combination with CYP3A4 inhibitors, do not recommend the use of grapefruit juice while using Quetiapin.

Liver enzyme induction drugs such as carbamazepine and phenytoin significantly increase the clearance of quetiapin when used together. This may reduce Quetiapin's AUC, affecting the treatment effect. In patients using liver enzyme induction drugs, the beginning of treatment with Quetiapin should only be performed if the doctor considers the benefits of Quetiapin that is superior to the risk of giving up liver enzyme drugs. Any changes of induction drugs must be slowly, and replace it with non -touch drugs if needed (such as sodium valproat).

The pharmacokinetics of Quetiapin has not been significantly changed when used with imipramin antidepressants (CYP2D6 inhibitors) or fluoxetin (CYP3A4 and CYP2D6 inhibitors). The pharmacokinetics of Quetiapin is not significantly changed when used with anti -psychotic drugs Risperidon or Haloperidol. Thioridazin increases the clearance of Quetiapin about 70% when used simultaneously. The pharmacokinetics of Quetiapin is not changed after use with cimetidine. lithium pharmacokinetics are not changed when used with quetiapin.

In a study of lithium and quetiapin that released prolonged in adults, there is an acute mania, there is an increase in the percentage of outsider (namely tremor), drowsiness and weight gain in the group using additional lithium compared to the placebo group.

Dynamic pharmacokinetics of sodium valproat and quetiapin unchanged affect clinical effects when shared. In a study of rescue in children and adolescents, there is an increase in the rate of leukopenia and neutropenia in the group using Valproat and Quetiapin combination compared to the single -use group.

There is no official research on interaction with common cardiovascular medications.

Be cautious when using quetiapin with drugs that can cause electrolyte imbalance or increase in QT.

There is a false positive report in methadon's enzyme immune test and 3 -round antidepressants in patients using Quetiapin. The immunosuppressive results should be confirmed with the appropriate chromatography method.

Storage

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

To be out of reach of children, read the instructions carefully before use.

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