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Dossier: | Ctd |
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Generic Name | Ondansetron Hydrochloride Suppositories 4mg |
Strength | 4mg |
Packing | 10suppositories/box |
Origin | China |
This product (crystallized from methanol) melting point 231 ~ 232ºC; Its hydrochloric acid dihydrate is a white crystalline solid (crystallized from water/isopropyl alcohol).
Antiemetic. For: nausea and vomiting caused by cytotoxic drug chemotherapy and radiotherapy; Prevention and treatment of postoperative malignant vomiting.
Usage and dosage:
1. Treatment of nausea and vomiting caused by chemotherapy and radiotherapy
(1) Adults: the route and dose of administration should vary from patient to patient. The dose is generally 8 ~ 32mg; For chemotherapy and radiotherapy, which can cause moderate vomiting, 8mg should be slowly administered intravenously before the patient receives treatment; Or 8mg orally 1 to 2 hours before treatment, then 8mg orally every 12 hours. For chemotherapy and radiotherapy that can cause severe vomiting, 8mg of this product can be injected slowly before treatment, and then 8mg at an interval of 2 to 4 hours, twice in total; It can also be added to 50 ~ 100ml normal saline for intravenous infusion before chemotherapy, and the infusion time is 15 minutes. For chemotherapy that may cause severe vomiting, this product can also be combined with 20mg dexamethasone sodium phosphate intravenous drip before treatment to enhance the efficacy of this product. In order to avoid nausea and vomiting 24 hours after treatment, patients should continue to take mg twice a day for 5 days.
(2) Children: calculated by body surface area before chemotherapy, 5mg per meter intravenous injection, then 4mg orally 12 hours later, after chemotherapy should continue to give 4mg orally, twice a day, for 5 days.
Matters needing attention:
There is no need to adjust the dosage, frequency and route of administration for patients with kidney damage. For patients with liver function impairment, patients with moderate or severe liver function impairment have a significantly reduced ability to clear this product, and the serum half-life is also significantly prolonged. Therefore, the dosage should not exceed 8mg per day; This product should not be used after abdominal surgery to avoid covering up the symptoms of ileal or gastric dilation; This injection and the ampoule or syringe containing this product do not contain preservatives, can only be used once after opening, any remaining solution should be discarded; The compatibility of this product with polyvinyl chloride infusion bag and polyvinyl chloride drug delivery device was studied, and it was found that this product also had considerable stability when using polyethylene infusion bag or type I glass bottle. Ondansetron diluent diluted with 0.9% W/V sodium chloride or 5% w/v glucose was stable in a polypropylene glycol ester syringe, so it was considered stable when mixed with other compatible infusion fluids in a polypropylene glycol ester syringe. Ampoules of this product cannot be sterilized under high pressure.