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OLanzapine Tablets

作者:admin   时间:2018-11-21
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  [drug name]

  General name: Olanzapine Tablets

  Trade name: Oran Olanzapine Tablets 5mg*20

  Pinyin full code: AoLanZhi AoDanPingPian

  [main ingredients]

  The main ingredient of this product is olanzapine.

  [character]

  This product is made of blue oval film.

  Indications / indications

  Olanzapine is used in the treatment of schizophrenia. Olanzapine can maintain the basic clinical effect during the initial treatment. Olanzapine is used for treatment and severe manic episode. Olanzapine can be used to prevent the recurrence of bipolar disorder in manic episodes.

  [specification type]

  5mg*20 film (Oran)

  [usage and dosage]

  Schizophrenia:

  The starting dose of olanzapine is 10mg/ days, once a day, regardless of consumption.

  During the treatment of schizophrenia, the daily dosage can be adjusted to 5-20 mg/day according to the clinical condition. It is suggested that after proper clinical evaluation, the dosage should be increased to more than 10 mg/day, and the interval between dosage and medication should be no less than 24 hours. The dosage of nitrogen should be reduced gradually.

  Manic episode:

  The initial dose was 15mg per day, and 10mg daily.

  Prevention of bipolar disorder relapse:

  The recommended initial dose is 10 mg/day. For patients with manic episodes treated with olanzapine, the same continuous dose is given to prevent recurrence. For new manic, mixed or depressive episodes, olanzapine should be continued (dosage adjusted appropriately when needed) and adjuvant drugs should be used to treat emotional symptoms according to clinical conditions.

  In the course of prevention and treatment of schizophrenia, manic episode and bipolar disorder, the daily dose can be adjusted in the range of 5-20 mg/day according to the individual's clinical condition. It is suggested that more than the recommended dose should be used only after appropriate clinical reassessment, and the interval between dosing and dosing should be no less than 24 hours. Drugs should not be taken into account. Food does not affect absorption.

  Patients with kidney and / or liver function impairment:

  For such patients, a lower initial dose (5mg) should be considered. Patients with moderate hepatic insufficiency (cirrhosis, Child-pugh grade A or B) received a primary dose of 5 mg and should be carefully dosed.

  Female patients were compared with men:

  There is no need to adjust the initial dose and dose range of female patients.

  Non smoking patients were compared with smokers.

  There is no need to adjust the initial dose and dose range of non-smokers.

  When there is more than one metabolic slowing factor (female, elderly, non-smoking) occurring, we should consider reducing the initial dose and conservatively increasing the dose.

  [adverse reactions]

  In adult clinical trials, the most common adverse reactions associated with olanzapine (> 10%) were sleepiness and weight gain. Of the patients treated with olanzapine, 34% had elevated plasma prolactin levels, but these elevations were mild and short-lived (the mean endpoint did not exceed the normal upper limit, and there was no significant difference between placebo and olanzapine), with rare clinical manifestations (such as breast development, galactorrhea and breast enlargement in men). In most patients, the level of prolactin is returned to normal range without stopping treatment.

  In adult clinical trials, common adverse reactions associated with olanzapine (< 10%, > 1%) included dizziness, weakness, inability to sit, increased appetite, peripheral edema, orthostatic hypotension, dry mouth and constipation. Occasionally, transient and asymptomatic elevations of liver transaminase ALT/SGPT and AST/SGOT were seen. In clinical trials, patients with baseline values of random blood glucose levels (< 140 mg/dL) may occasionally see the phenomenon of random blood glucose levels (> 200 mg/dL) and random blood glucose levels (> 160 mg/dL) but < 200 mg/dL (suggesting that there may be hyperglycemia).

  In the 12-week adult clinical trial, fasting triglyceride increased by 22 mg/dL in olanzapine treatment group and decreased by 7 mg/dL in placebo treatment group. The difference was statistically significant. In olanzapine group, 8.1% of patients changed from normal to elevated, compared with 3.0% in placebo group, the difference was statistically significant.

  The average increase of fasting total cholesterol was 6 mg/dL in olanzapine group and 7 mg/dL in placebo group. The difference was statistically significant. In olanzapine group, 2.8% of patients changed from normal to elevated, compared with 1.6% in placebo group, the difference was statistically significant.

  Fasting LDL cholesterol, olanzapine treatment group increased 4 mg/dL on average, placebo treatment group decreased 5 mg/dL on average, the difference was statistically significant. There was no difference between olanzapine treatment group and placebo treatment group in the proportion of patients whose calibration values changed from normal to elevated.

  There was no significant difference in fasting HDL cholesterol between olanzapine and placebo groups.

  In placebo-controlled adolescents (ages 13-17), the results of fasting blood lipid were similar to those of adults.

  Occasionally asymptomatic eosinophilia occurs.

  Adverse reactions of special populations: clinical trials in elderly patients with dementia related mental disorders. The common adverse reactions associated with olanzapine (> 10%) were abnormal gait and falls, and the common adverse reactions associated with olanzapine (< 10% and (> 1%) were urinary incontinence and pneumonia. In patients with Parkinson's disease, drug-induced (dopamine agonists) psychotic patients.