Tropisetron Hydrochloride Injection

Pharmacological action: Tropisetron hydrochloride 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-like cells of the visceral mucosa to release 5-hydroxytryptamine, thereby inducing a vomiting reflex 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 rear region by directly blocking the central 5-HT3 receptors. Toxicological studies: Genetic toxicity: Literature reports that tropisetron hydrochloride has no significant effect on mouse bone marrow micronuclei, and no chromosomal aberrations or mutagenic effects were observed at high concentrations in vitro. <br

Tropisetron hydrochloride. Excipients: water for injection.

This product is a colorless clear liquid.

Prevention and treatment of nausea and vomiting caused by cancer chemotherapy.

Children: It is generally not recommended for children. If it must be used for medical conditions, refer to the following dosage: The dosage for children over 2 years old is 0.1 mg/kg, and the maximum can reach 5 mg per day (based on tropisetron). Intravenous administration on the first day: Dissolve this product in 100 ml of commonly used infusion solution (such as normal saline, Green's solution or 5% glucose solution) and quickly drip or slowly push it intravenously before chemotherapy. Oral administration on the 2nd to 6th day. Oral administration for children: Take an appropriate amount of tropisetron hydrochloride injection from the ampoule, dilute it with orange juice or cola, and take it immediately when you get up in the morning (at least 1 hour before breakfast). Adults: The recommended dose is 5 mg per day (based on tropisetron), once a day, and a course of treatment is 6 days. Intravenous administration on the first day: Dissolve 1 vial of this product in 100 ml of commonly used infusion solution (such as normal saline, Green's solution or 5% glucose solution) and quickly drip or slowly push it intravenously before chemotherapy. On the 2nd to 6th day, it can be taken orally 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: In patients with acute hepatitis or fatty liver, the pharmacokinetics of tropisetron hydrochloride are unchanged, but the plasma drug concentration of patients with cirrhosis or renal insufficiency is about 50% higher than that of normal healthy volunteers. However, if a 5 mg per day, 6-day dosing regimen is used, no dose reduction is required.

Tropisetron hydrochloride is generally well tolerated, and adverse reactions at the recommended dose are transient. Common adverse reactions include headache, dizziness, constipation, vertigo, fatigue, and gastrointestinal disorders 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 in patients allergic to tropisetron and pregnant women.

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 normal metabolizers need to increase the dose (poor metabolizers do not need to increase the dose). 2. The effect of cytochrome P450 enzyme inhibitors such as cimetidine on the plasma concentration of tropisetron hydrochloride can be ignored, and no dose adjustment is required under normal use.

Sealed and stored in a cool dark place. The validity period is tentatively 18 months.

5ml: 5.64mg (equivalent to 5mg of Tropisetron)

Shanxi Zhendong Pharmaceutical Co., Ltd.

• Founded in:

  1995-11-15

• Address:

  Zhendong Science and Technology Park, Guangming South Road, Shangdang District, Changzhi City, Shanxi Province

• Tax NO.:

  91140400729655415C

• Registered Funds:

  1,005,319,756 yuan

• Website:

  Log in to view

• Email:

  Log in to view