Seroquel XR 50mg Astrazeneca medicine for schizophrenia (3 blisters x 10 tablets)

The antagonism on these receptors and the selection with the serotonin receptor (5HT2) in the brain is higher than the Dopamine D2 receptor is considered to contribute to the clinical anti -psychotic properties and have little risk of side effects on the foreign tower system of Seroquel compared to typical anti -psychotic drugs. In addition, Norquetiapin has high affinity with norepinephrin transportation (net).

Quetiapin and Norquetiapin also have high affinity with histaminergic and adrenergic alpha1 receptors, with lower affinity with adrenergic alpha2 receptors and 5HT1A Serotonin. Quetiapin has negligible affinity for Muscarinic or Benzodiazepin receptors.

pharmacokinetic

quetiapin is well absorbed and completely transformed after drinking. Quetiapin binds to plasma proteins about 83%. The maximum molecular concentration in the stable state of metabolites has the activity of Norquetiapin equal to 35% of this concentration of Quetiapin.

Seroquel XR's peak concentration in plasma is about 6 hours after taking the drug (TMAX). The pharmacokinetics of Seroquel XR are proportional to the dose at doses of up to 800 mg x 1 time/day. The maximum concentration in plasma (CMAX) and the area under the Seroquel XR's concentration curve (AUC) used once a day equivalent to this value of Quetiapin Fumarat Fast release (Seroquel IR) used 2 times/day with the same daily daily dose.

Semi -selling time of quetiapin and norquetiapin in the order of about 7 and 12 hours.

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

The average clearance of quetiapin in plasma decreased by about 25% in patients with severe renal impairment (creatinine clearance

In vitro studies determine that CYP3A4 is the main enzyme responsible for the quetiapin metabolism through cytochrom P450 intermediaries. Norquetiapin is mainly formed and transformed through CYP3A4.

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.

Precautions for use

It is not recommended to use quetiapin for adolescents and minors under 18 years of age because there is no data to support the use of drugs for patients at this age. Clinical trials with Quetiapin show that in addition to safety data for adults has been identified, some adverse adverse events occur in children and adolescents with higher frequency than in adults (increasing appetite, increasing serum prolactin levels and foreign symptoms) and identifying a new adverse event (hypertension) has not been recorded through previous adult tests. Changes in thyroid function test are also recorded in children and adolescents.

suicide has suicide or clinical status.

Depression is associated with an increase in the risk of suicide, self -destruction and suicide (suicidal events). This risk persists until the remission is significantly reduced. Because there may not be improved in the first few weeks of treatment or longer, the patient should be carefully monitored until the disease is significantly improved. Clinical experience shows that the risk of suicide can increase in the early stages of disease recovery. In addition, therapist should consider risks that may occur suicide events after stopping the sudden treatment of Quetiapin treatment, due to the known risk factors of the disease being treated.

Other mental conditions that are indicated using Seroquel XR may also be associated with increased risk of suicide variables. In addition, these conditions can occur simultaneously with major depression. Therefore, be careful when treating patients with other mental disorders like when treating patients with large depression.

Combined with drug treatment, especially when starting treatment and when changing the dose, the most tightly monitoring of patients is that patients are at high risk. Patients (and patient caregivers) should be warned of the need to monitor all deteriorating clinical conditions, suicide behavior or thoughts or change in abnormal behaviors and finding medical support as soon as these symptoms appear.

Symptoms of foreign tower

Using Quetiapin can cause restlessness, manifested by subjective discomfort or restless restlessness and need to change the body position constantly accompanied by unable to sit or stand still. This symptom appears mainly during the first few weeks of treatment. In patients with these symptoms, it may be detrimental to the dose.

Tardive dyskinsesia

Late movement disorders are a syndrome of disorders, unintentional and non -recovery may occur in patients treated with anti -psychotic drugs, including Quetiapine. When there are any signs or symptoms of arbitrary movement disorders, it is advisable to consider reducing the dose or stopping Seroquel XR. Symptoms of late movement disorders may increase or worsen after treatment.

Sleep and dizziness

Treatment with quetiapin can cause drowsiness and related symptoms, such as jagged. In clinical studies on the treatment of depression patients due to bipolar disorders and mainly depression disorders, drowsiness often appears in the first 3 days of treatment and is mainly mild to medium. Patients with depression due to bipolar disorders and patients with major depression in depression disorders are mainly serious sleepiness may need to be re -examined more often, at least within two weeks from the symptoms of drowsiness or until this symptom is improved and may need to consider the stop treatment.

Treatment with quetiapin can cause vertical and dizziness lowering blood pressure often appears during the initial dose adjustment as for drowsiness. This may increase the risk of unexpected lesions (falling) especially in the elderly patients, so it is advisable to advise patients to be cautious until they get used to the possible effects of the drug.

On the heart

Seroquel XR should be used cautiously in patients with cardiovascular disease, cerebrovascular disease or conditions that can lead to hypotension. Quetiapin can cause vertical hypotension, especially during the initial dose adjustment and thus reducing the dose or adjusting the dose slowly if this condition occurs. It is possible to consider the slower dose mode for patients with cardiovascular disease.

convulsions

In control clinical trials, there is no difference in the frequency of seizures between patients using quetiapin and placebo groups.

malignant syndrome due to sedative

Clinical manifestations include overcrowding, changing mental state, muscle contraction, unstable autonomous nervous system and increased creatin phosphokinase. In this case, Seroquei XR should be stopped and has appropriate treatment.

Severe neutropenia

Severe neutropenia (neutrophils

weight

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

Hyperglycemia

Recorded rare cases of hyperlem of blood glucose and/often appear or severe diabetes sometimes associated with keto-acid infection or coma, including some deaths. In some cases, previous weight gain has been recorded as risk factors. It is necessary to have appropriate clinical monitoring mode according to the instructions for the use of anti -psychotic drugs.

Patients treated with any anti -psychotic drugs including Quetiapin should be monitored with signs and symptoms of hyperglycemia (such as thirst, polyurges, eating a lot 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.

lipid

Increase triglycerides, LDL and cholesterol, and HDL cholesterol reduction have been recorded through clinical trials with quetiapin. Lipid changes need to be treated when clinical requirements.

Risk of metabolism

With changes in weight, blood glucose (seeing the "hyperlemia") and lipid has been recorded in clinical studies, patients (including people with normal initial index) may experience the risk of deterioration, so it should be appropriate clinical control.

extends the range of qt

In clinical trials and use in a summary of product characteristics, there is no relationship between Quetiapin and an increase in the absolute QT range. After the drug is circulated on the market, extending the QT period has been recorded when using Quetiapin at the treatment dose (see the "unwanted effect") and in the case of an overdose (see the stool "overdose"). As well as other anti -psychotic drugs, it is necessary to be cautious when prescribing Quetiapin for patients with cardiovascular disease or a family history showing signs of extending the QT.

Be careful when indicated Quetiapin along with drugs that extend QT, or use simultaneously with other sedatives, especially in the elderly, in patients with congenital QT syndrome, congenital heart failure, heart hypertrophy, potassium orgel hypertrophy.

Cowdown syndrome

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

Elderly patients with mental disorders related to intellectual decline

Seroquel XR has not been ratified to treat patients with mental disorders related to intellectual decline.

The impact on the liver

If jaundice occurs, Seroquel XR should be stopped.

Pathological accompanying

Difficult to swallow (see the "unwanted effect") and the inhaler coordination has been recorded when using Seroquel XR. Although the cause and effect of inhaled pneumonia has not been established, Seroquel XR should be used cautiously in patients at risk of inhaled pneumonia.

Venous venous embolism (VTE)

Cases of venous embolism caused by thrombosis (VTE) have been reported when using anti -psychotic drugs. Because patients treated with psychotic drugs often have risk factors for venous embolism caused by thrombosis, all vein -blocking risks should be identified before and during treatment with quetiapine and conduct preventive measures.

Pancreatitis

Pancreatitis has been recorded in clinical trials and after the drug circulates on the market. In the reports after the drug circulated on the market, not all cases were interfered by risk factors, many patients had known factors related to pancreatitis such as triglyceride (see lipid), gallstones and alcohol.

lactose

Seroquel XR tablets contain lactose. Patients with rare genetic disorders such as Nap Galactose disorders, Lapp Lactase deficiency, or abnormal absorption of Glucose-Galactose should not use this drug.

The ability to drive and operate machinery

Due to the main impact on the central nervous system, Quetiapin may affect the activities that need mental alertness. Therefore, it is necessary to recommend that patients should not drive or operate machinery until it is clearly determined by their own drug sensitivity.

Pregnancy

Reproductive toxicity is recorded in animal studies. Therefore, Quetiapin should only be used during pregnancy when the benefits are out of the risks that may occur.

Breastfeeding period

Due to the lack of data sources, the decision to breastfeed or stop using Sequequel XR should be considered based on the benefit of breastfeeding and mother treatment.

Medicinal interaction

quetiapin mainly acting on the central nervous system, so be careful when coordinating Seroquel XR with other medications on other central nervous systems and alcohol.

Cytochrom P450 CYP3A4 is the main enzyme responsible for quetiapin metabolism. 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 increase 5-8 times compared to normal. So contraindicated use of quetiapin 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 induction), simultaneous use of quetiapin with carbamazepine significantly increases the liquid of quetiapin. This increase in clearance reduces the average 13% rated quetiapin level (evaluated through AUC) compared to when using only quetiapin; Although some patients may be larger. Due to this interaction, the concentration of drugs in plasma may be lower, and therefore can affect the effectiveness of therapeutic therapy with Seroquel XR.

Simultaneous use of quetiapin with phenytoin (another liver -induced drug) also increases Quetiapin clearance about 450%. In patients who are using liver enzyme induction drugs, Seroquel XR should only be conducted after the treating doctor considers the benefits of Seroquel XR higher than the stopping of the liver enzyme induction. It is important to stop the drug that causes liver enzymes slowly, or if necessary, replace it with non -liver -induced drugs (such as sodium valproat).

Dynamic pharmacokinetics of sodium valproat and quetiapin do not change when used simultaneously. A rescue study on children and adolescents using Valproat, Quetiapin or both, the rate of leukopenia and neutropenia in the group using drugs combined higher than the single -treatment groups.

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

Be cautious when using Quetiapin at the same time with drugs that cause electrolyte imbalance or extend QT.

has recorded false positive results in methadon tests or three -round antidepressants by enzyme immune method in patients using Quetiapin. It is advisable to use an appropriate chromatography technique to confirm the results of implementation by suspected immune method.