Ramosetron Hydrochloride Injection

15-HT3 receptor antagonism In the 5-HT-induced guinea pig isolated colon contraction test and rat and ferret heart rate slowing reflex (Bezold-Jarisch reflex) test, this drug showed 5-HT3 receptor antagonism; 2 Anti-malignant tumor drug-induced vomiting inhibition In the vomiting of ferrets induced by cisplatin, this drug was given before vomiting or after the first vomiting, and showed an inhibitory effect. Cisplatin and other anti-malignant tumor drugs can free 5-HT from enterochromaffin cells in the digestive tract. 5-HT binds to the 5-HT3 receptors present in the afferent vagus nerve endings in the digestive tract mucosa, thereby stimulating the vomiting center to induce vomiting. Ramosetron hydrochloride exerts its antiemetic effect by blocking this 5-HT3 receptor. Toxicology studies have been conducted on mice, rats and dogs by intravenous administration. Mice and rats can see a transient decrease in spontaneous movement after administration, and die after tremor and convulsion. The LD50 is 90-108 mg/kg for male mice, 108-130 mg/kg for female mice, 172 mg/kg for male rats, and 151 mg/kg for female rats. Dogs given 30 mg/kg can see vomiting, rapid breathing, increased heart rate, weight loss, etc., but no death. There is no obvious gender difference in either animal. 2. Subacute toxicity Animal experiments were conducted on rats and dogs for one month by intravenous administration. Rats (dosage: 0.1, 1.0, 10 mg/kg/day) showed a slight increase in GPT (about 1.2 times that of the control group) when administered with more than 1 mg/kg, and weight gain was inhibited (about 4%) when administered with 10 mg/kg. However, no pathological histological abnormalities were found in the organ tissues of any animal. The maximum non-toxic dose for rats was estimated to be 0.1 mg/kg/day. The highest dose for dogs was 3 mg/kg, and no toxic effects were observed. 3 Reproductive toxicity and carcinogenicity: When intravenously administered to rats and rabbits, no pregnancy toxicity, teratogenicity or fetal death were observed in rats at a dose of 10 mg/kg, and only the weight gain of newborn rats was inhibited. When the dose reached 20 mg/kg, the fetal weight of rabbits decreased and ossification was delayed, but no teratogenic effects were observed. Oral administration of the drug to rats and mice for 24 weeks showed that no tumors occurred.

Ramosetron hydrochloride. Chemical name: (-)-(R)-5-[(1-methyl-1H-indol-3-yl)carbonyl]-4,5,6,7-tetrahydro-1H-benzimidazole hydrochloride.

This product is a colorless clear liquid.

Prevent or treat gastrointestinal symptoms such as nausea and vomiting caused by chemotherapy drugs.

Use after dissolving in liquid. For adults, 0.3 mg is given intravenously once a day. The dosage can be appropriately increased or decreased according to age and symptoms, but the daily dosage should not exceed 0.6 mg.

Adverse reactions occurred in 7 of the 352 cases (2%) that underwent safety evaluation before marketing. The main adverse reactions were fever, headache, and heaviness of the head. Serious adverse reactions: People who are allergic to this product may experience allergic-like symptoms such as chest tightness, dyspnea, wheezing, facial flushing, redness, itching, cyanosis, hypotension, and even shock. The incidence is not clear. In addition, there are reports of epileptic seizures in foreign countries using other 5-HT3 receptor antagonist antiemetics.

Patients with a history of allergy to the ingredients of this drug are prohibited from using it.

Precautions for children: This product has not been tested and there is no reliable reference. Precautions for pregnancy and lactation: 1. The safety of the drug during pregnancy has not been established. For pregnant women or women who may become pregnant, the drug can only be administered when it is judged that the therapeutic benefits outweigh the risks. 2. Animal experiments on rats have shown that this drug can be secreted into breast milk. When using the drug in lactating women, they should stop breastfeeding. Precautions for the elderly: Elderly patients usually have low physiological functions, so the patient's condition should be closely observed and the drug should be administered with caution. If adverse reactions occur, they should be handled in a timely manner.

This drug may react with mannitol injection, bumetanide injection, furosemide injection, etc., so do not use them together. However, it can be used by adding 200 ml of normal saline to furosemide injection containing 20 mg of furanilamide and mixing with one ampoule of this drug.

Protect from light, store tightly closed at room temperature.

2ml:0.3mg

24 months

Penglai Nuokang Pharmaceutical Co., Ltd.

• Founded in:

  2002-06-07

• Address:

  No. 118, Jinchuang Road, Penglai City, Shandong Province

• Tax NO.:

  913706007392965167

• Registered Funds:

  92.7117 million yuan

• Email:

  Log in to view