Tropisetron Hydrochloride Injection

Pharmacological action: This product is a potent and highly selective competitive antagonist of 5-hydroxytryptamine 3 (5-HT3) receptors in peripheral neurons and the central nervous system. Certain substances, including some chemotherapy drugs, can stimulate the chromaffin cells of the visceral mucosa to release 5-hydroxytryptamine, thereby inducing vomiting reflexes accompanied by nausea. This product mainly inhibits the vomiting reflex by selectively blocking the presynaptic 5-HT3 receptors of peripheral neurons. In addition, its antiemetic effect may also be related to its inhibition of the stimulation of the vagus nerve in the last area by directly blocking the central 5-HT3 receptors. Toxicity study: Genetic toxicity: Literature reports that tropisetron hydrochloride has no significant effect on mouse bone marrow micronuclei, and no chromosomal aberrations and mutagenic effects were observed at high concentrations in vitro. Reproductive toxicity: Animal reproductive toxicity tests indicate that this product has potential embryotoxicity. It is not clear whether this product can enter breast milk, so breastfeeding women should not use this product.

Tropisetron

This product is a colorless clear liquid.

Used to prevent and treat nausea and vomiting caused by chemotherapy, and for nausea and vomiting after surgical procedures under general anesthesia.

Children: It is generally not recommended for children. If it must be used for medical conditions, the following dosage can be used: The dosage for children over 2 years old is 0.1 mg/kg, and the maximum dosage can reach 5 mg/day. Intravenous administration on the first day; rapid intravenous drip before chemotherapy, and oral administration on the 2nd to 6th day. Oral administration for children: Take an appropriate amount, dilute with orange juice or cola, and take it with water when getting up in the morning (at least 1 hour before breakfast). Adults: The recommended dosage for adults is 5 mg/day, once a day, for a course of 6 days. Intravenous administration on the first day: rapid intravenous drip before chemotherapy. On the 2nd to 6th day, it can be changed to oral 5mg capsules, taken with water when getting up in the morning (at least 1 hour before breakfast). Application for poor metabolizers: No dose reduction is required during the 6-day application. Application in patients with hepatic or renal insufficiency: The pharmacokinetics of tropisetron hydrochloride are changed in patients with acute hepatitis or fatty liver. However, the plasma drug concentration in patients with cirrhosis or hepatic insufficiency is about 50% higher than that in normal healthy volunteers. However, if a 5 mg/day dosing regimen is used for six days, there is no need to reduce the dose.

Tropisetron hydrochloride is usually well tolerated, and adverse reactions at the recommended dose are transient. Common adverse reactions include headache, dizziness, constipation, vertigo, fatigue, and gastrointestinal dysfunction such as abdominal pain and diarrhea. Very few patients may experience transient blood pressure changes or allergic reactions. The former does not require special treatment, and the latter can be improved after anti-allergic treatment.

It is contraindicated for patients who are allergic to tolazosetron hydrochloride and pregnant women.

Precautions during pregnancy and lactation: Pregnant women are prohibited from using

1. If tropisetron hydrochloride is used simultaneously with rifampicin or other liver enzyme inducing drugs (such as phenobarbital), the plasma concentration of tropisetron hydrochloride may be reduced, so those with normal metabolism need to increase the dose (poor metabolizers do not need to increase the dose). 2. Cytochrome P450 enzyme inhibitors such as cimetidine have little effect on the plasma concentration of tropisetron hydrochloride, and no dosage adjustment is required under normal use.

Store at room temperature, tightly closed.

5ml:5mg (based on tropisetron)

Zhejiang Zhenyuan Pharmaceutical Co., Ltd.

• Founded in:

  1997-11-19

• Address:

  No. 61, Yuedong North Road, Yuecheng District, Shaoxing City, Zhejiang Province

• Tax NO.:

  913306022547351704

• Registered Funds:

  300 million yuan

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