Ondansetron Hydrochloride Orally Disintegrating Tablets

This product is a potent, highly selective 5-HT3 receptor antagonist with a strong antiemetic effect. Chemotherapy drugs and radiotherapy can cause the small intestine to release 5-HT, which activates the afferent branch of the vagus nerve through the 5-HT3 receptor and triggers the vomiting reflex. This product can block the triggering of this reflex. The stimulation of the afferent branch of the vagus nerve can also cause the release of 5-HT in the Postrema area at the bottom of the fourth ventricle, thereby enhancing it through the central mechanism. This product is effective for nausea and vomiting caused by chemotherapy and radiotherapy. Therefore, this product exerts its antiemetic effect by antagonizing the 5-HT receptors of neurons located in the peripheral and central nervous systems. The mechanism of action of postoperative nausea and vomiting is unclear, but it may be induced by a common pathway similar to nausea and vomiting caused by cytotoxic drugs. This product can also inhibit nausea induced by opioids, and its

The main ingredient of this product is ondansetron hydrochloride, and its chemical name is: 2,3-dihydro-9-methyl-3-[(2-methylimidazol-1-yl)methyl]-4(1H)-carbazolone hydrochloride dihydrate. Chemical structure: Molecular formula: C18H19N3O·HCl·2H2O Molecular weight: 365.86

It is a white or off-white tablet.

Antiemetic. Applicable to: 1. Nausea and vomiting caused by cytotoxic chemotherapy and radiotherapy. 2. Prevention and treatment of postoperative nausea and vomiting.

1 For vomiting caused by highly emetic chemotherapy drugs: inject 8 mg of ondansetron injection intravenously 15 minutes before chemotherapy, 4 hours and 8 hours after chemotherapy, and take 8 mg of ondansetron tablets orally every 8 to 12 hours after stopping chemotherapy for 5 consecutive days. 2 For vomiting caused by chemotherapy drugs that are not too emetic: inject 8 mg of ondansetron injection intravenously 15 minutes before chemotherapy, and take 8 mg of ondansetron tablets orally every 8 to 12 hours thereafter for 5 consecutive days. 3 For vomiting caused by radiotherapy: the first dose must be taken orally as a tablet of 8 mg 1 to 2 hours before radiotherapy, and then take 8 mg orally every 8 hours. The course of treatment depends on the course of radiotherapy. 4 For prevention of nausea and vomiting after surgery

There may be headache, abdominal discomfort, constipation, dry mouth, rash, occasional bronchial asthma or allergic reactions, and transient asymptomatic increase in transaminase. The above reactions are mild and do not require special treatment. Some patients have epileptic seizures. There are also rare reports of chest pain, arrhythmia, hypotension, and bradycardia.

Those who are allergic to this product. Those with gastrointestinal obstruction.

Precautions for children: The dosage and method of use for patients over 12 years old are the same as those for adults. The dosage for children aged 4 to 11 years needs to be adjusted: 4 mg of ondansetron is taken orally 30 minutes before chemotherapy, and the first dose is repeated twice, 4 mg each time, 4 and 8 hours after the first dose. After the end of chemotherapy, take the drug once every 8 hours, 4 mg each time, for 5 consecutive days. This product has no clinical experience in children under 4 years old, and for vomiting caused by radiotherapy/surgery in children. Precautions for pregnancy and lactation: The safety of this product during human pregnancy has not been determined, and animal studies have not shown direct or indirect harm to the embryonic period, fetal formation period, pregnancy period, perinatal period and postpartum period. However, since animal studies cannot fully predict human reactions, it is not recommended for use during pregnancy, especially in the first 3 months of pregnancy. Experiments have shown that this product can be secreted in the milk of lactating animals, so breastfeeding should be suspended when using this product. Elderly precautions: Due to slow metabolism, the elimination half-life is prolonged (5 hours) and the oral bioavailability is increased (65%), but it has no clinical significance. In clinical trials, it was observed that the efficacy and tolerance of the drug in patients over 65 years old were the same as those of ordinary adults, and there was no need to adjust the dose, frequency and route of administration. There is limited experience in preventing and treating postoperative nausea and vomiting in elderly patients.

1. There is no evidence that this product will induce or inhibit the metabolism of other drugs taken at the same time. Special studies have shown that this product has no interaction with alcohol, temazepam, furosemide, tramadol and propofol. 2. Patients with poor metabolism of separteine and isoquine have no effect on the elimination half-life of this product. After repeated administration to such patients, the drug exposure level is no different from that of normal humans, so the dosage and frequency of medication do not need to be changed. 3. Combination with dexamethasone can enhance the antiemetic effect.

Store below 30℃ away from light. Valid for three years.

8mg (as ondansetron)

20 months

Sinopharm ChuanKang Pharmaceutical Co., Ltd.

• Founded in:

  2003-05-09

• Address:

  No. 2, Xinwen Road, West Park, Chengdu Hi-tech Zone

• Tax NO.:

  91510100749702784T

• Registered Funds:

  40 million yuan

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