Item nanme:OLanzapine Tablets Item character:White coated tablets, light yellow to yellow after removing coating
Indication: Olanzapine is used to treat schizophrenia.
Olanzapine can maintain the clinical effect in patients with effective initial treatment during maintenance treatment.
Olanzapine is used in the treatment of severe manic episode.
Olanzapine can be used to prevent the recurrence of bipolar disorder in manic episode patients with olanzapine treatment
Item specifications: 5mg*14tab/box
Usage and dosage:Schizophrenia:
The recommended starting dose of olanzapine is 10mg/ day, once a day, and is not related to eating.
In the treatment of schizophrenia, the daily dose can be adjusted to 5-20mg / day according to the clinical status of the patients. It is suggested that after proper clinical evaluation, the dosage should be increased to the normal dose of 10mg/ day, and the interval of dosing should not be less than 24 hours. The dosage should be gradually reduced when the nitrogen is stopped.
Manic episode:
The initial dose of single drug use was 15mg daily, and 10mg daily in combination with treatment
Prevention of recurrence of bipolar disorder:
The recommended starting dose is 10mg/ day. For patients with mania with olanzapine, the continuous dose of prevention and recurrence is the same as before. For new mania, mixed or depression, olanzapine should be continued (dosage adjusted if necessary), and emotional symptoms should be treated with auxiliary drugs according to clinical conditions.
In the prevention and treatment of schizophrenia, manic attack and bipolar disorder, the daily dose can be adjusted within the range of 5-20mg/ day according to the individual clinical condition. It is suggested that only drugs exceeding the recommended dose can be used only after proper clinical reevaluation, and the interval of dosing is not less than 24 hours. Olanzapine does not need to consider the eating factors, and the food does not affect absorption The dosage should be gradually reduced when the nitrogen is stopped.
Patients with renal and / or liver dysfunction:
The lower initial dose (5mg) should be considered for such patients. The primary dose of patients with moderate liver dysfunction (cirrhosis, child Pugh grade A or b) was 5mg, and should be added carefully.
Women compared to men:
The initial dose and dose range of female patients need not be adjusted.
Non smoking patients compared with smokers:
The initial dose and dose range of non-smoking patients need not be adjusted.
When more than one factor (female, old, non-smoking) is present, the initial dose should be reduced and should be conservative when increasing the dose.
Adverse reactions [u] Adults
weight
In clinical trials, olanzapine treated patients gained more weight than placebo treated patients. Clinically significant weight gain was observed in all baseline body mass index (BMI) classifications.
In the long-term clinical trial (at least 48 weeks), the degree of weight gain and the proportion of clinically significant weight gain in olanzapine group were higher than those in the short-term clinical trial. The percentage of patients who gain more than 25% of baseline weight (≥ 10%) during long-term medication is very common.
glucose
In the clinical trial (52 weeks), compared with the placebo group, the olanzapine group had a greater change in the mean glucose.
Compared with placebo, the mean change in glucose was increased in patients with evidence of baseline glucose imbalance (including those diagnosed with diabetes or who met the criteria for hyperglycemia), who had a greater increase in glycosylated hemoglobin (HbA1c) than placebo treated patients.
The proportion of patients whose blood glucose changes increased from normal or critical baseline levels to high levels increased over time. In an analysis of patients who completed olanzapine treatment for 9-12 months, the average blood glucose growth rate slowed down after about 6 months.
blood fat
In the 12 week clinical trial, olanzapine treated patients had greater mean increases in fasting total cholesterol, LDL cholesterol, and triglycerides than placebo treated patients.
Patients without evidence of baseline dyslipidemia had higher fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides).
Regarding fasting HDL cholesterol, no statistically significant difference was observed between olanzapine treated patients and placebo treated patients.
In the long-term clinical trials (at least 48 weeks), the proportion of patients with changes in total cholesterol, LDL cholesterol or triglyceride from normal or critical level to high level, or the proportion of patients with changes in HDL cholesterol from normal or critical level to low level, was greater than that in the short-term clinical trials. In an analysis of patients who completed 12 months of treatment, there was no further increase in mean non fasting total cholesterol after about 4-6 months.
Prolactin
In a controlled clinical trial (up to 12 weeks), prolactin was elevated in 10.5% of patients in the placebo group and in 30% of patients in the olanzapine group, with the vast majority of patients being mild. The level of prolactin in patients with schizophrenia decreased with the continuous treatment. Adverse events related to prolactin elevation 1 were more common in menstruation (incidence < 10%, ≥ 1%), while adverse events related to sexual function and breast were less common (incidence < 1%, ≥ 0.1%). The level of prolactin in patients with other mental diseases 2 continued to increase with the treatment. Prolactin related sexual function adverse events were more common (incidence < 10%, ≥ 1%), while breast and menstrual adverse events were less common (incidence < 1%, ≥ 0.1%).
(1) Tesses analysis lasted for 52 weeks.
(2) Bipolar depression, psychotic depression, refractory depression, borderline personality disorder and bipolar mania.
Liver transaminase
Asymptomatic transient elevation of liver transaminase, ALT / SGPT and AST / SGOT were occasionally seen.
Eosinophilia
Asymptomatic eosinophilia was occasionally seen.
Adverse reactions in special groups: in clinical trials conducted in patients with Alzheimer's disease, the most common adverse reactions associated with olanzapine treatment (≥ 10%) are abnormal gait and falls. In clinical trials in patients with dementia, the common (< 10% and ≥ 1%) adverse reactions associated with olanzapine treatment were urinary incontinence and pneumonia. In clinical trials of Parkinson's disease-related drugs (dopamine agonists) - induced psychotic patients, reports of worsening Parkinson's symptoms are common and more frequent than those in the placebo group. Hallucinations were also reported more frequently than in the placebo group. In these clinical trials, patients were required to take a fixed minimum dose of anti Parkinson's disease drugs (dopamine agonists) before the start of the study, and the dose was maintained throughout the study. The initial dose of olanzapine was 2.5mg/day, and the maximum dose was 15mg / day.
The following table summarizes the terms and frequency of adverse drug reactions of oral and intramuscular olanzapine during clinical trials and / or after marketing
Adverse drug reactions observed with olanzapine preparations
[u] Adolescents (13-17 years old) [/ u]
The types of adverse reactions observed in adolescent patients treated with olanzapine were similar to those observed in adult patients treated with olanzapine. Although there is no comparative clinical trial design between adolescents and adults, the adolescent clinical trial data and adult clinical trial data are compared.
The average weight gain of adolescents (median 3 weeks, 4.6kg) was higher than that of adults (median 7 weeks, 2.6kg).
In the long-term clinical trial (at least 24 weeks), the degree of weight gain and the proportion of clinically significant weight gain in the olanzapine treatment group were higher than those in the short-term clinical trial and adult group. About half of the adolescent patients gained more than 15% of the baseline weight and about one third of the adolescent patients gained more than 25% of the baseline weight. In adolescent patients, average weight gain was most significant in overweight or baseline obese patients.
The increase in fasting blood glucose levels was similar between olanzapine treated adolescents and adults; however, the difference between olanzapine treated adolescents and placebo treated adults was greater.
In long-term clinical trials (at least 24 weeks), the change of blood glucose from normal baseline level to high level is not common (the incidence rate is 0.1% - 1%).
Adolescents treated with olanzapine generally had greater increases in fasting total cholesterol, LDL cholesterol and triglycerides than adults; however, in short-term clinical trials, the differences between olanzapine and placebo groups were similar in adolescents and adults.
Compared with adults, olanzapine treatment caused a higher incidence of prolactin elevation in adolescent patients and a higher average of prolactin elevation
Taboo: Olanzapine should not be used in patients who are known to be allergic to any component of the product. Olanzapine should not be used in patients with known risk of narrow angle glaucoma
Matters needing attention: Olanzapine should not be used in patients who are known to be allergic to any component of the product. Olanzapine should not be used in patients with known risk of narrow angle glaucoma
Hyperglycemia is rarely reported. Ketoacidosis or coma is rare in patients with a history of diabetes. Several deaths have also been reported. Previous weight gain has been reported in some cases, which may be a predisposing factor. It is suggested that patients with diabetes and those with high risk factors for diabetes should be properly monitored.
Hyperglycemia is rarely reported. Ketoacidosis or coma is rare in patients with a history of diabetes. Several deaths have also been reported. Previous weight gain has been reported in some cases, which may be a predisposing factor. It is suggested that patients with diabetes and those with high risk factors for diabetes should be properly monitored. The following acute symptoms, such as sweating, insomnia, tremor, anxiety, nausea or vomiting, are rarely found in patients with sudden withdrawal of ornithine (< 0 . 01
. 01
Hyperglycemia is rarely reported. Ketoacidosis or coma is rare in patients with a history of diabetes. Several deaths have also been reported. Previous weight gain has been reported in some cases, which may be a predisposing factor. It is suggested that patients with diabetes and those with high risk factors for diabetes should be properly monitored. The following acute symptoms, such as sweating, insomnia, tremor, anxiety, nausea or vomiting, are rarely found in patients with sudden withdrawal of ornithine (< 0 . 01 %). It is suggested to gradually reduce the amount of ornithine when it is stopped. Complications: olanzapine has anticholinergic activity in vitro, but the incidence of anticholinergic events in clinical trials is very low.
It is suggested to gradually reduce the amount of ornithine when it is stopped. Complications: olanzapine has anticholinergic activity in vitro, but the incidence of anticholinergic events in clinical trials is very low. However, the clinical experience of olanzapine in the treatment of patients with comorbid diseases is limited. It is recommended that olanzapine should be used cautiously in patients with prostatic hypertrophy or paralytic ileus and related diseases. Olanzapine is not recommended for Parkinson's disease and dopamine agonist related psychosis. In clinical trials, it has been reported that after taking olanzapine, Parkinson's symptoms worsened, or hallucinations were more common and frequent than placebo (see adverse reactions), and the efficacy of olanzapine on psychotic symptoms of these patients was equivalent to placebo. In these trials, patients were required to use the lowest initial effective dose of anti Parkinson drugs (dopamine agonists) to maintain a stable state, and the types and doses of anti Parkinson drugs used were consistent throughout the trial. Olanzapine started at 2 . 5mg / According to the judgment of the researchers, the maximum dosage was adjusted to 15mg / Day. Olanzapine is not approved for use as a treatment for dementia related psychosis and dementia / It is also not recommended for such special patients because of the increased risk of mortality and cerebrovascular events. In a placebo-controlled clinical trial (6 - At 12 weeks, the subjects were psychotic patients with dementia and normal controls / The average age was 78.
/ Day. Olanzapine is not approved for use as a treatment for dementia related psychosis and dementia / It is also not recommended for such special patients because of the increased risk of mortality and cerebrovascular events. In a placebo-controlled clinical trial (6 - At 12 weeks, the subjects were psychotic patients with dementia and normal controls / The average age was 78. Compared with placebo, patients treated with olanzapine had a 2-fold increase in mortality (3 . five % ,1 .
Olanzapine started at 2 .
Hyperglycemia is rarely reported. Ketoacidosis or coma is rare in patients with a history of diabetes. Several deaths have also been reported.
Olanzapine should not be used in patients with known risk of narrow angle glaucoma Hyperglycemia is rarely reported. Ketoacidosis or coma is rare in patients with a history of diabetes. Several deaths have also been reported. Previous weight gain has been reported in some cases, which may be a predisposing factor. It is suggested that patients with diabetes and those with high risk factors for diabetes should be properly monitored. The following acute symptoms, such as sweating, insomnia, tremor, anxiety, nausea or vomiting, are rarely found in patients with sudden withdrawal of ornithine (< 0 . 01 %).
Olanzapine should not be used in patients with known risk of narrow angle glaucoma Hyperglycemia is rarely reported. Ketoacidosis or coma is rare in patients with a history of diabetes. Several deaths have also been reported.
Hyperglycemia is rarely reported. Ketoacidosis or coma is rare in patients with a history of diabetes. Several deaths have also been reported. Previous weight gain has been reported in some cases, which may be a predisposing factor. It is suggested that patients with diabetes and those with high risk factors for diabetes should be properly monitored. The following acute symptoms, such as sweating, insomnia, tremor, anxiety, nausea or vomiting, are rarely found in patients with sudden withdrawal of ornithine (< 0 .
Hyperglycemia is rarely reported. Ketoacidosis or coma is rare in patients with a history of diabetes. Several deaths have also been reported. Previous weight gain has been reported in some cases, which may be a predisposing factor. It is suggested that patients with diabetes and those with high risk factors for diabetes should be properly monitored. The following acute symptoms, such as sweating, insomnia, tremor, anxiety, nausea or vomiting, are rarely found in patients with sudden withdrawal of ornithine (< 0 . 01 %). It is suggested to gradually reduce the amount of ornithine when it is stopped.
%). It is suggested to gradually reduce the amount of ornithine when it is stopped.
Hyperglycemia is rarely reported. Ketoacidosis or coma is rare in patients with a history of diabetes. Several deaths have also been reported. Previous weight gain has been reported in some cases, which may be a predisposing factor. It is suggested that patients with diabetes and those with high risk factors for diabetes should be properly monitored. The following acute symptoms, such as sweating, insomnia, tremor, anxiety, nausea or vomiting, are rarely found in patients with sudden withdrawal of ornithine (<
The following acute symptoms, such as sweating, insomnia, tremor, anxiety, nausea or vomiting, are rarely found in patients with sudden withdrawal of ornithine (<
Hyperglycemia is rarely reported. Ketoacidosis or coma is rare in patients with a history of diabetes. Several deaths have also been reported. Previous weight gain has been reported in some cases, which may be a predisposing factor. It is suggested that patients with diabetes and those with high risk factors for diabetes should be properly monitored.
Hyperglycemia is rarely reported. Ketoacidosis or coma is rare in patients with a history of diabetes. Several deaths have also been reported. Previous weight gain has been reported in some cases, which may be a predisposing factor. It is suggested that patients with diabetes and those with high risk factors for diabetes should be properly monitored. The following acute symptoms, such as sweating, insomnia, tremor, anxiety, nausea or vomiting, are rarely found in patients with sudden withdrawal of ornithine (< 0 . 01 %).
01 %). It is suggested to gradually reduce the amount of ornithine when it is stopped. Complications: olanzapine has anticholinergic activity in vitro, but the incidence of anticholinergic events in clinical trials is very low. However, the clinical experience of olanzapine in the treatment of patients with comorbid diseases is limited. It is recommended that olanzapine should be used cautiously in patients with prostatic hypertrophy or paralytic ileus and related diseases. Olanzapine is not recommended for Parkinson's disease and dopamine agonist related psychosis. In clinical trials, it has been reported that after taking olanzapine, Parkinson's symptoms worsened, or hallucinations were more common and frequent than placebo (see adverse reactions), and the efficacy of olanzapine on psychotic symptoms of these patients was equivalent to placebo. In these trials, patients were required to use the lowest initial effective dose of anti Parkinson drugs (dopamine agonists) to maintain a stable state, and the types and doses of anti Parkinson drugs used were consistent throughout the trial.
Medication for pregnant and lactating women: Pregnancy:
There are not enough controlled trials for pregnant women. Patients who are pregnant or are planning to be pregnant during olanzapine treatment should inform the doctor. Due to limited experience, this drug should only be used when the potential benefits outweigh the potential risks to the fetus.
Among the mothers who took olanzapine in the second 3 months of pregnancy, there were few spontaneous reports of tremor, high muscle tone, drowsiness and drowsiness.
Lactation:
In a lactation study of healthy women, olanzapine was excreted through milk. The mean steady-state infant exposure (mg / kg) was estimated to be 1.8% of the maternal olanzapine concentration (mg / kg). If the patient is taking olanzapine, breast-feeding is not recommended.
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