Tropisetron Hydrochloride Capsules

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 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.

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.

The content of this product is white or off-white granular powder.

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. 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 for patients who are allergic to tropisetron hydrochloride or any of its components.

Precautions for children: Children over 2 years old tolerate this product well. Precautions for pregnancy and lactation: Reproductive studies in animals have shown that tropisetron is embryotoxic. This study has not been conducted in pregnant women. This product should not be used in pregnant women. Animal studies using radiolabeled tropisetron have shown that radioactivity can be detected in breast milk. Since it is not clear whether tropisetron enters human breast milk, this product should not be used in breastfeeding women. Precautions for the elderly: The dosage does not need to be changed for the elderly, and there are no special side effects.

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.

Store in a light-proof, sealed, dry place. The validity period is tentatively 18 months.

5 mg (as tropisetron)

24 months

Shandong Yikang Pharmaceutical Co., Ltd.

• Founded in:

  1999-01-26

• Address:

  No. 3288, Yikang Avenue, Tengzhou City

• Tax NO.:

  91370400169901867G

• Registered Funds:

  34.56 million yuan

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