Tandospirone Citrate Capsules

1. Pharmacological action Tandospirone is an antianxiety drug that selectively acts on the 5-HT1A receptor in the brain. Animal experiments have shown that tandospirone has comparable antianxiety effects to diazepam. Animal model experiments on psychosomatic diseases have shown that tandospirone can inhibit the pressor response caused by hypothalamic stimulation and the increase in plasma renin activity caused by electric shock stress, and inhibit the occurrence of gastric ulcers caused by psychological stress and the loss of appetite caused by forced immersion stress. 2. Toxicological studies (1) Chronic toxicity: When SD rats were orally administered 3-140 mg/kg for 12 months, salivation, miosis, changes in protein and blood lipid parameters, limited weight gain, deposition of lipofuscin-like substances in brain and spinal cord nerve cells and renal tubules, and accumulation of pulmonary foam cells were observed. (2) Genetic toxicity: The Ames test result of tandospirone was negative, and the chromosome aberration test result of mammalian cells was positive when metabolic activation was present. (3) Reproductive toxicity: In general reproductive toxicity tests, when the SD rats were given a dose of 50 mg/kg or more, they showed abnormal estrous cycles, decreased pregnancy rate, decreased implantation rate, and low fetal weight, but no embryonic death or fetal malformation was observed. In the teratogenic sensitive period test, when the SD rats were given a dose of 80 mg/kg or more, low fetal and pup weights were observed, and when the dose was above 200 mg/kg, an increase in wavy ribs was observed, but no fetal death was observed. When the rabbits were given a dose of 150 mg/kg or more, a decrease in fetal weight was observed, but no fetal death or malformation was observed. In the perinatal test, when the SD rats were given a dose of 50 mg/kg or more, postnatal development inhibition of the pups was observed. (4) Carcinogenicity: ICR mice were orally administered 20 to 180 mg/kg for 18 consecutive months, and SD rats were orally administered 10 to 90 mg/kg for 24 consecutive months, and no increase in tumor incidence was observed. (5) Dependence: A cross-dependence test of a single dose in monkeys under barbiturate dependence, a continuous self-administration test, and a dependence test of rats after oral administration for 4 consecutive weeks followed by 1 week of withdrawal showed no results of mental or physical dependence. Oral administration of 60 and 200 mg/day to rats had no inhibitory effect on the weight loss caused by continuous diazepam administration followed by withdrawal, indicating that there is no cross-dependence with benzodiazepines.

The main ingredient is tandospirone citrate.

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

1. Anxiety caused by various neuroses, such as generalized anxiety disorder. 2. Anxiety caused by physical complications such as primary hypertension and peptic ulcer.

Generally, adults take 10 mg orally 3 times a day. The dosage may be increased or decreased according to the patient's age, symptoms, etc. The maximum daily dosage should not exceed 60 mg or follow the doctor's advice.

According to foreign literature reports, 150 cases (10.3%) out of a total of 1,451 cases investigated had adverse reactions and abnormal laboratory test values. The main adverse reactions included drowsiness in 43 cases (3.0%), unsteady gait in 16 cases (1.1%), nausea in 13 cases (0.9%), fatigue in 11 cases (0.8%), bad mood in 11 cases (0.8%), and decreased appetite in 10 cases (0.7%). The main abnormal laboratory test values included elevated AST (GOT) and ALT (GPT). (1) Severe adverse reactions: abnormal liver function and jaundice (0.1%). Because of abnormal liver function and jaundice accompanied by elevated AST (GOT), ALT (GPT), AI-P, and -GTP, liver function tests should be performed regularly and the patient should be closely observed.

It is contraindicated for those who are allergic to any ingredient in this product.

Precautions for children: There is no safety data for premature infants, newborns, infants, young children and children. Precautions for pregnancy and lactation: 1. It can only be used for pregnant women or women who may become pregnant after judging that the benefits of treatment outweigh the risks. (See "Reproductive Toxicity") 2. It is best not to use it for breastfeeding women. If you have to take the medicine, you should avoid breastfeeding. (See "Reproductive Toxicity") Precautions for the elderly: According to foreign literature reports, in the pharmacokinetic test of elderly patients at 90 mg/day (3 times the commonly used clinical dose), the blood concentration of the elderly is higher than that of young people. Therefore, when used for the elderly, start with a small dose (e.g., 5 mg each time).

Drug name Clinical symptoms Mechanism, risk factors Butyrophenone drugs such as haloperidol, spiperone, etc. may enhance extrapyramidal symptoms. Due to the weak anti-dopamine effect of this drug, the pharmacological effects of butyryl drugs may be enhanced. Calcium antagonists such as nicardipine, amlodipine, nifedipine, etc. may enhance the antihypertensive effect. Due to the central antihypertensive effect mediated by 5-hydroxytryptamine receptors, this drug may enhance the antihypertensive effect.

Keep away from light and store in sealed container.

5mg

Tentatively 18 months.

Sichuan Credit Pharmaceutical Co., Ltd.

• Founded in:

  2000-04-20

• Address:

  Pharmaceutical Industrial Park, Luzhou National High-tech Zone, Sichuan Province

• Tax NO.:

  915105217144041624

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  27.214286 million yuan

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