[drug name]

　　General name: Tandospirone Citrate Capsules

　　Product Name: Tandospirone Citrate Capsules 5mg*24 granule

　　Pinyin full code: LvKang ZuoZuoSuanTanDuLuoTongJiaoNang 5mg*24Li

　　[main ingredients]

　　The main ingredient of this product is tandospirone citrate. Its chemical name is (3a, 4b, 7a, 7a) - hexahydro-2 - [4 (4-(2-pyrimidine) - 1-piperazine) butyl]-4, 7-methylene-1-hydro-isoindole-1, 3 (2-hydro) - diketone dihydrocitrate.

　　[character]

　　This product is a hard capsule, and its contents are white powder.

　　Indications / indications

　　1. anxiety states caused by various neurosis, such as generalized anxiety disorder. 2. the anxiety state of essential hypertension, peptic ulcer and other somatic diseases.

　　[specification type]

　　5mg*24 granule (LV Kang)

　　[usage and dosage]

　　Usually adults take 10mg once a day, 3 times a day. Patients can be appropriately increased or decreased with age and symptoms. The maximum daily dose should not exceed 60mg or as prescribed by doctors.

　　[adverse reactions]

　　According to foreign reports, 150 of 1451 cases (10.3%) had adverse reactions and abnormal laboratory test values. The main adverse reactions were sleepiness in 43 cases (3.0%), hobble in 16 cases (1.1%), nausea in 13 cases (0.9%), burnout in 11 cases (0.8%), bad mood in 11 cases (0.8%) and loss of appetite in 10 cases (0.7%). The main laboratory tests showed abnormal values of AST (GOT) and ALT (GPT).

　　[taboo]

　　It is forbidden for any allergen in this product.

　　[note]

　　1. take the medicine carefully (the following patients should be treated with caution).

　　(1) patients with organic brain dysfunction may enhance the function of the drug.

　　(2) moderate or severe respiratory failure patients (which may worsen the symptoms);

　　(3) patients with cardiac dysfunction may aggravate the symptoms.

　　(4) patients with liver and kidney dysfunction may affect pharmacokinetics.

　　(5) the elderly (refer to "medication for elderly patients").

　　2. important points for attention

　　(1) For neurotic patients, if the patient has a long course of illness (more than 3 years), serious illness or other drugs (benzodiazepines) ineffective refractory anxiety patients, the drug may also be difficult to produce efficacy. When the dosage of 60 mg in one day is still not effective, the doctor should be contacted in time, and no long-term use should be allowed at will.

　　(2) when the drug is used for patients with severe anxiety symptoms, it is difficult to observe the symptoms when it is difficult to produce curative effect.

　　(3) This medicine can cause drowsiness, dizziness and so on. Therefore, patients should be advised to take this medicine because it can cause sleepiness and dizziness. Please be careful not to let the patients take this medicine engage in dangerous mechanical operations such as motor vehicle driving.

　　(4) Because there is no cross-dependence with benzodiazepine derivatives, when substituting benzodiazepine derivatives for cost products, the drug properties of benzodiazepine derivatives will be weakened and the symptoms will deteriorate. Please pay attention to the gradual reduction of dosage before discontinuation.

　　[drug interaction]

　　For example, there may be drug interactions when used with other drugs. Consult your physician or pharmacist for details.

　　[child medication]

　　There is no information about the safety of this medicine for premature infants, newborns, infants, children and children.

　　[medication for elderly patients]

　　According to foreign literatures, in the pharmacokinetic test of 90 mg/day (3 times of the commonly used clinical dose) for elderly patients, the blood concentration of the elderly is higher than that of the young people. Therefore, when used in the elderly, the pharmacokinetic test begins with a small dose (e.g., 5 mg per time).

　　[pregnancy and lactation medication]

　　1. It can only be used in pregnant women or women who are likely to become pregnant after judging that the benefits of treatment exceed the risks. (refer to "reproductive toxicity") 2. it is best not to be lactating women. (refer to "reproductive toxicity")

　　[drug overdose]

　　At present, there is no clinical data of this drug overdose.

　　[pharmacology and toxicology]

　　Pharmacological effects: tansspirone is an anti anxiety drug that selectively acts on 5-HT1A receptors in the brain. Animal tests showed that tandispirone had a rather anxiolytic effect on diazepam. Animal model tests of psychosomatic diseases showed that tandosterone could inhibit the increase of plasma renin activity induced by hypothalamic stimulation and shock stress load, the occurrence of gastric ulcer caused by psychological stress load and the loss of appetite caused by forced immersion stress load. Toxicological study: chronic toxicity SD rats were given oral administration for 3~140mg/kg12 months. Saliva, pupillary, protein and lipid parameters, weight gain limitation, brain and spinal cord nerve cells, lipofuscin like deposition of renal tubules and accumulation of pulmonary foam cells were observed. Genotoxicity: Tandosterone Ames test was negative, and chromosome aberration test was positive in mammalian cells with metabolic activation. Reproductive toxicity: In general reproductive toxicity test, SD rats showed abnormal estrous cycle, decreased fertility rate, reduced implantation rate, low fetal weight when the dosage was above 50 mg/kg, and no fetal and fetal death or deformity was observed. In teratogenic sensitive period test, when the dosage of 80 mg/kg or more was given to SD rats, the weight of fetuses and young babies was low, and when the dosage of 200 mg/kg or more, the wavy ribs were increased, and no fetal death was observed. When the dosage of 150mg/kg was above, the weight of the fetus was reduced, and no fetal death or malformation occurred. In the perinatal trial, the SD rats were more than 50mg/kg, indicating that the development of pups was inhibited. Carcinogenicity: ICR mice received oral administration of 20~180mg/kg for 18 consecutive times.