Olanzapine Tablets for Treatment of Severe Manic Episode

• Transport Package: Box
• Specification: 10mg*7tab/box
• Trademark: FUL
• Origin: China
• Model NO.: FC010-01
• Production Capacity: 10000PCS/

Product Description

Item Name:OLanzapine Tablets
Molecular Formula:C₁₇H₂₀N₄S

Item Description

Item nanme: OLanzapine Tablets
Item character: This product is white

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:10mg*7tab/box

Usage and dosage: Schizophrenia:
The recommended starting dose of olanzapine is 10mg / day, once a day, not related to food intake.
In the treatment of schizophrenia, the daily dose can be adjusted to 5 ~ 20mg / day according to the clinical status of patients. It is suggested that after appropriate clinical evaluation, the dose should be increased to more than 10mg / day of conventional dose, and the interval of dosing should not be less than 24 hours. The dosage of ornithromycin should be reduced gradually.
Manic episode:
The initial dose was 15mg per day for single drug and 10mg per day for combined treatment
To prevent recurrence of bipolar disorder:
The recommended starting dose is 10mg / day. For patients with manic episode treated with olanzapine, the continuous treatment dose to prevent recurrence is the same as before. Olanzapine therapy should be continued for new manic episode, mixed episode or depressive episode (the dosage should be adjusted when necessary), and the emotional symptoms should be treated with adjuvant drugs according to the clinical situation.
In the process of prevention and treatment of schizophrenia, manic episode and bipolar disorder, the daily dose can be adjusted in the range of 5-20mg / day according to the individual clinical conditions. It is suggested that the drugs exceeding the recommended dose can be used only after appropriate clinical re evaluation, and the interval of dosing should not be less than 24 hours. Olanzapine does not need to consider the factors of eating, and the food does not affect the absorption, The dosage of ornithromycin should be reduced gradually.
Patients with renal and / or liver dysfunction:
A lower initial dose (5mg) should be considered for these patients. In patients with moderate liver dysfunction (cirrhosis, child Pugh grade A or b), the initial dose is 5mg, and the dosage should be added carefully.
Female patients compared with male patients:
The initial dose and dose range of female patients generally need not be adjusted.
Non smoking patients compared with smoking patients:
The initial dose and dose range of non-smoking patients generally need not be adjusted.
When there is more than one factor (female, old age, non-smoking) to slow down the metabolism, we should consider reducing the initial dose, and we should also be conservative when we need to increase the dose.

Adverse reactions

Schizophrenia:
The recommended starting dose of olanzapine is 10mg / day, once a day, not related to food intake.
In the treatment of schizophrenia, the daily dose can be adjusted to 5 ~ 20mg / day according to the clinical status of patients. It is suggested that after appropriate clinical evaluation, the dose should be increased to more than 10mg / day of conventional dose, and the interval of dosing should not be less than 24 hours. The dosage of ornithromycin should be reduced gradually.
Manic episode:
The initial dose was 15mg per day for single drug and 10mg per day for combined treatment
To prevent recurrence of bipolar disorder:
The recommended starting dose is 10mg / day. For patients with manic episode treated with olanzapine, the continuous treatment dose to prevent recurrence is the same as before. Olanzapine therapy should be continued for new manic episode, mixed episode or depressive episode (the dosage should be adjusted when necessary), and the emotional symptoms should be treated with adjuvant drugs according to the clinical situation.
In the process of prevention and treatment of schizophrenia, manic episode and bipolar disorder, the daily dose can be adjusted in the range of 5-20mg / day according to the individual clinical conditions. It is suggested that the drugs exceeding the recommended dose can be used only after appropriate clinical re evaluation, and the interval of dosing should not be less than 24 hours. Olanzapine does not need to consider the factors of eating, and the food does not affect the absorption, The dosage of ornithromycin should be reduced gradually.
Patients with renal and / or liver dysfunction:
A lower initial dose (5mg) should be considered for these patients. In patients with moderate liver dysfunction (cirrhosis, child Pugh grade A or b), the initial dose is 5mg, and the dosage should be added carefully.
Female patients compared with male patients:
The initial dose and dose range of female patients generally need not be adjusted.
Non smoking patients compared with smoking patients:
The initial dose and dose range of non-smoking patients generally need not be adjusted.
When there is more than one factor (female, old age, non-smoking) to slow down the metabolism, we should consider reducing the initial dose, and we should also be conservative when we need to increase the dose.

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:
There are few reports of hyperglycemia. Patients with diabetes history will be rare ketoacidosis or coma, and several deaths are reported. Some cases reported previous weight gain, which may be a contributing factor, and it is suggested that patients with diabetes and people with diabetes risk factors should be properly monitored.
When the nitrogenation was stopped suddenly, the following acute symptoms such as sweating, insomnia, tremor, anxiety, nausea or vomiting were rarely observed (< 0.01%). It is suggested that the amount of nitrogen should be reduced gradually.
Complications: in vitro experiments showed that olanzapine had anticholinergic activity, but the events related to anticholinergic effect in clinical trials were very low. However, olanzapine has limited clinical experience in the treatment of patients with complicated diseases. It is suggested that olanzapine should be used in patients with prostatic hypertrophy or paralytic ileus and related diseases.
Olanzapine is not recommended for Parkinson's disease and psychosis associated with dopamine agonists. In clinical trials, it has been reported that Parkinson's symptoms worsen or hallucinations are more common and frequent in patients with olanzapine than placebo (see adverse reactions), and olanzapine has the same efficacy as placebo for psychopathic symptoms in these patients. In these trials, patients were required to maintain a stable state of use of the lowest initial effective dose of anti Parkinson's drugs (dopamine agonists) and to maintain the same type and dose of anti Parkinson's drugs used throughout the trial. Olanzapine was 2.5mg/ day, and the maximum value was adjusted to 15mg / day according to the researchers' judgment.
Olanzapine was not approved for the treatment of dementia related mental and / or behavioral disorders and is not recommended for such special patients because of the increased risk of mortality and cerebrovascular events. In a placebo-controlled clinical trial (6-12 weeks), subjects were elderly people with dementia with mental and / or behavioral disorders (average age 78 years). Compared with placebo, the mortality rate of patients treated with olanzapine increased by twice (3.5% and 1.5% respectively). However, the incidence of death was not positively correlated with the dose of olanzapine (average daily dose of 4.4mg) or the treatment period. Risk factors for increased mortality include age over 65, dysphagia, sedation, malnutrition and dehydration, lung disease (such as inhalation or non inhalation pneumonia), or simultaneous administration of benzodiazepine. However, excluding these risk factors, patients treated with olanzapine still have a higher mortality rate than those who take placebo.
In the same clinical study, cerebrovascular adverse events (CVAE, i.e. stroke, transient ischemic attack) were reported, including deaths. The incidence of cerebrovascular adverse events in patients treated with olanzapine was 3 times higher than that of placebo (1.3%, 0.4%, respectively). All patients with cerebrovascular adverse events who were treated with olanzapine and placebo had existing risk factors. Risk factors associated with olanzapine treatment include age greater than 75 and vascular / mixed dementia. The effectiveness of olanzapine has not been demonstrated in these tests.
In the treatment of mental illness, it may take days or weeks for patients to improve their clinical condition. Patients should be closely monitored during this period.
Lactose: olanzapine tablets contain lactose.
During the treatment, patients often have transient and asymptomatic liver transaminase ALT and AST elevation, especially in the early stage of treatment. Therefore, olanzapine should be used carefully in patients with elevated ALT and / or ast, patients with liver dysfunction symptoms or signs, patients who have shown limited liver dysfunction and patients who have been treated with potential hepatotoxic drugs. If ALT and / or ast increase during treatment, attention should be paid to observation and consideration should be given to reducing the dosage. Olanzapine should be interrupted in cases where hepatitis has been diagnosed. After listing, few reports of hepatitis were received, and few reports of bile obstruction or mixed liver injury were reported.
Lipid Change: adverse lipid changes were found in patients treated with olanzapine in placebo-controlled clinical trials (see adverse reactions), and appropriate clinical monitoring is recommended.
Cardiovascular death: in a retrospective study, patients who were treated with atypical antipsychotics (including olanzapine) or typical antipsychotics had an increased risk of presumed sudden cardiac death, and were dose-related (the latter risk was almost twice as high as those who did not take antipsychotics). In the post market report of olanzapine, sudden cardiac death is rarely reported.
Similar to other nerve blockers, olanzapine is used in patients with leucocyte and / or neutropenia, who are known to cause neutropenia, patients with drug-induced history of myelosuppression / toxicity, patients with myelosuppression caused by disease, radiotherapy or chemotherapy, and patients with eosinophilia or myelodysplasia. 32 patients with a history of clozapine related neutropenia or a lack of granulocyte had no neutropenia after olanzapine treatment, and a common neutropenia was found in combination with olanzapine and sodium valproate.
There is limited information on the combination of lithium salt and sodium valproate. There is no clinical data of olanzapine and carbamazepine, only pharmacokinetic studies have been carried out.
Neuroblocker malignant syndrome (NMS): NMS is a potentially lethal disease associated with antipsychotics. Patients treated with olanzapine rarely report NMS. The clinical features of NMS are high fever, myotonia, consciousness change and unstable function of plant nervous system (irregular pulse and blood pressure, tachycardia, sweating and cardiac rhythm disorder). Additional symptoms include increased creatine phosphate kinase, myoglobinuria (rhabdomyolysis) and acute renal failure. If the symptoms and signs of the patient indicate NMS, or are characterized by unexplained high fever without other clinical features of NMS, all antipsychotics, including ornithromide, should be discontinued on average.
Olanzapine was used in patients with a history of convulsion and a reduction in threshold of convulsion. There are few reports of convulsion caused by olanzapine. Most of these cases have convulsion history and risk factors.
Delayed motor disorders: in a one-year or shorter control study, olanzapine treatment had fewer motor disorders and had statistical significance. But long term medication will increase the risk of delayed motor disorders. Therefore, if the patients treated with olanzapine have symptoms and signs of delayed motor disorders, we should consider reducing the dosage or stopping the drug. These symptoms may have a sexual deterioration or even aggravation after the treatment is stopped.
Considering the basic effect of olanzapine on the central nervous system, it should be cautious when used in combination with other central active drugs or in drinking patients. Because of the dopamine antagonistic effect of olanzapine in vitro, it may antagonize the direct or indirect action of dopamine agonists.
In the clinical experiment of olanzapine in the treatment of elderly patients, there are occasionally reports of postural hypotension. As with other antipsychotics, it is recommended that patients over 65 years old be treated with olanzapine on a regular basis to monitor their blood pressure.
In clinical trials, patients treated with olanzapine had clinically significant QTc interval extension (baseline qtcf500 MS) was not common (0.1% - 1%), and there was no statistical difference compared with placebo. However, as with other antipsychotics, olanzapine should be used with other drugs known to extend QTc interval with caution, especially in elderly patients, patients with congenital long QT syndrome, patients with congestive heart failure, myocardial hypertrophy, hypokalemia or hypomagnesemia.
The transient relationship between olanzapine treatment and the occurrence of venous embolism was rarely reported (< 0.01%), and the relationship between the two was not confirmed. However, since schizophrenia patients often have the risk of acquired venous embolism, all risk factors (such as fixation of patients) that may be related to venous embolism should be considered and preventive measures should be taken.
As olanzapine may cause drowsiness, patients should be careful when operating dangerous machinery, including motor vehicles.

Company Profile

 

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 takes olanzapine, breast-feeding is not recommended


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Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd is a comprehensive enterprise which integrates R & D, production and construction of pharmaceutical production equipments, development and transfer of biotechnology, and cooperative production and sales of drugs and vaccines. The self-developed pharmaceutical production equipment branded FUL has been put into operation in many well-known pharmaceutical enterprises  CSPC and also cooperates with many well-known pharmaceutical enterprises in production and sales, including pharmaceutical intermediates, APIs and finished drug preparations.

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