Tropisetron Hydrochloride Injection

Tropisetron hydrochloride is used for a maximum of 6 days in any chemotherapy cycle. 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 chemotherapeutic 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 area by directly blocking the central 5-HT3 receptors. Toxicological studies Genetic toxicity: Literature reports that tropisetron hydrochloride has no obvious effect on mouse bone marrow micronuclei.

The main ingredient of this product is tropisetron hydrochloride, and its chemical name is: endo-1H-indole-3-carboxylic acid 8-methyl-8-azabicyclo[3,2,1]octan-3-yl ester hydrochloride.

This product is a colorless or slightly yellow 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 due to medical conditions, refer to the following dosage: The dosage for children over 2 years old is 0.2 mg/L, and the maximum dosage can reach 5 mg/day. Day 1 intravenous administration: Dissolve tropisetron hydrochloride in 100 ml of commonly used infusion solution (such as normal saline, Ringer's solution or 5% glucose solution) and quickly drip or slowly push intravenously before chemotherapy. It can be taken orally on days 2 to 6. Take an appropriate amount of tropisetron hydrochloride solution from the ampoule, dilute it with orange juice or cola, and take it immediately in the morning when you get up (at least 1 hour before breakfast). Adults: The recommended dose for adults is 5 mg/day, once a day, and the course of treatment is 6 days. Day 1 intravenous administration: Dissolve tropisetron hydrochloride in 100 ml of commonly used infusion solution (such as normal saline, Ringer's solution or 5% glucose solution) and quickly drip or slowly push intravenously before chemotherapy.

Tropisetron hydrochloride is generally well tolerated, and adverse reactions at the recommended dose are transient. The most commonly reported adverse reaction is constipation (11%) caused by the use of 5 mg, and these adverse reactions are more common in slow metabolizers than in normal metabolizers. Other common adverse reactions include headache, dizziness, vertigo, fatigue, and gastrointestinal disorders such as abdominal pain and diarrhea. There are also individual reports of collapse, syncope, and cardiac arrest, but the causal relationship with tropisetron hydrochloride cannot be determined. There are also individual reports of one or more of the following type I hypersensitivity reactions: facial flushing and/or systemic rash, chest tightness, dyspnea, acute bronchospasm, and hypotension.

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. Therefore, patients 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 affect the plasma concentration of tropisetron hydrochloride. Under normal use, no dose adjustment is required. 3 Clinically insignificant QTc prolongation has been observed in patients receiving high-dose (80 mg) intravenous tropisetron hydrochloride injection. Therefore, great care should be taken when using it in combination with other drugs that may cause QTc prolongation. 4 Patients with heart rate or conduction abnormalities and those taking anti-

Seal and store in a cool dark place. The validity period is tentatively 24 months.

5ml:5mg (calculated based on tropisetron)

Nanjing Hencer Pharmaceutical Co., Ltd.

• Founded in:

  1995-12-27

• Address:

  No. 18, Airport Road, Lishui Economic Development Zone, Nanjing

• Tax NO.:

  9132011713579053XB

• Registered Funds:

  32.142858 million yuan

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