"Uninorm ®" injection solution is used for the following indications:
nausea and vomiting caused by cytotoxic chemotherapy and radiotherapy; prevention and treatment of postoperative nausea and vomiting.
Composition
The active substance is ondansetron (1 ml of solution contains ondansetron hydrochloride dihydrate equivalent to 2 mg of ondansetron).
Excipients: sodium chloride, citric acid anhydrous, sodium citrate, water for injections.
Contraindication
Hypersensitivity to the components of the drug; the use of ondansetron together with apomorphine hydrochloride is contraindicated, as cases of severe hypotension and loss of consciousness have been observed during joint use.
Method of application
Nausea and vomiting caused by chemotherapy and radiation therapy
The emetogenic potential of cancer therapy varies depending on the dose and combination of chemotherapy and radiotherapy regimens. The choice of dosing regimen depends on the severity of the emetogenic effect.
Nausea and vomiting caused by chemotherapy and radiotherapy (adults)
Emetogenic chemotherapy and radiotherapy. The recommended intravenous or intramuscular dose of Yunorm® is 8 mg as a slow injection over at least 30 seconds, immediately before treatment. For the prevention of delayed or prolonged vomiting after the first 24 hours, oral or rectal administration of the drug is recommended.
Highly emetogenic chemotherapy (e.g. high doses of ciplatin). The drug "Uninorm ®" can be administered as a single dose of 8 mg intravenously or intramuscularly immediately before chemotherapy. Doses greater than 8 mg (up to 16 mg) can only be administered as an intravenous infusion in 50-100 ml of 0.9% sodium chloride solution or other suitable diluent; the infusion should last at least 15 minutes. A single dose exceeding 16 mg cannot be used. For highly emetogenic chemotherapy, 8 mg of the drug "Uninorm ®" or a lower dose does not need to be diluted and can be administered by slow intravenous or intramuscular injection (at least 30 seconds). Immediately before chemotherapy followed by a double intravenous or intramuscular injection of 8 mg after 2 and 4 hours or a continuous infusion of 1 mg/h for 24 hours. The effectiveness of the drug "Unorm ®" in highly emetogenic chemotherapy can be increased by an additional single administration of dexamethasone at a dose of 20 mg before chemotherapy.
For the prevention of delayed or prolonged vomiting after the first 24 hours, oral or rectal administration of the drug is recommended.
Nausea and vomiting caused by chemotherapy and radiation therapy (children aged 6 months to 17 years)
In pediatric practice, the drug "Uninorm ®" should be administered by intravenous infusion in 25-50 ml of 0.9% sodium chloride solution or other suitable solvent for at least 15 minutes. The dose of the drug can be calculated based on body surface area or body weight.
Calculation of the dose according to the child's body surface area. The drug should be administered immediately before chemotherapy by a single intravenous injection at a dose of 5 mg / m, the intravenous dose should not exceed 8 mg. After 12 hours, oral administration of the drug can be started, which can continue for another 5 days. Do not exceed the adult dose.
Calculation of the dose according to the child's body weight. The drug should be administered immediately before chemotherapy by a single intravenous injection at a dose of 0.15 mg/kg. The intravenous dose should not exceed 8 mg. On the first day, two more intravenous doses can be administered with an interval of 4 hours. After 12 hours, oral administration of the drug can be started, which can last for another 5 days. Do not exceed the adult dose.
Postoperative nausea and vomiting (adults)
For the prevention of postoperative nausea and vomiting, the recommended dose of Yunorm ® is 4 mg as a single intramuscular or slow intravenous injection during induction of anesthesia.
For the treatment of postoperative nausea and vomiting, the recommended single dose of Yunorm® is 4 mg as an intramuscular or slow intravenous injection.
Postoperative nausea and vomiting (children aged 1 month to 17 years)
For the prevention and treatment of postoperative nausea and vomiting in children undergoing surgery under general anesthesia, the drug "Yunorm ®" can be administered at a dose of 0.1 mg/kg of body weight (maximum - up to 4 mg) by slow injection (at least 30 seconds) before, during, after induction of anesthesia or after surgery.
Application features
Pregnant women
"Unorm ®" is not recommended for use during pregnancy.
Experimental studies have shown that ondansetron passes into breast milk in animals. If necessary, breastfeeding should be discontinued.
There is no information on the effect of ondansetron on human fertility.
Drivers
Psychomotor tests have shown that ondansetron does not affect the ability to drive and does not cause sedation, but the side effect profile of the drug should be borne in mind when deciding whether to drive or operate machinery.
Overdose
The drug "Unorm ®" prolongs the QT interval in a dose-dependent manner. In case of overdose, ECG monitoring is recommended.
Symptoms of overdose have been reported to include visual disturbances, severe constipation, hypotension, and vasovagal reactions with transient second-degree atrioventricular block. In all cases, these symptoms resolved completely.
There have been reports of cases of serotonin syndrome in young children following overdose.
There is no specific antidote, therefore, in case of overdose, symptomatic and supportive therapy should be used.
The use of ipecacuanha to treat ondansetron overdose is not recommended, as its effect may not be manifested due to the antiemetic effect of the drug "Unorm ®".
Children: Serotonin syndrome has been reported in infants and children aged 12 months to 2 years following accidental overdose of the oral drug (doses exceeding the recommended level of 4 mg/kg).
Side effects
From the nervous system: very often (≥ 1/10) - headache.
Vascular disorders: common (≥ 1/100 and <1/10) - feeling of warmth or flushing.
Gastrointestinal tract: often (≥ 1/100 and <1/10) - constipation.
Interaction
The drug "Unorm ®" cannot be used in the same syringe or infusion solution together with other medications.
Storage conditions
Store at a temperature not exceeding 25 °C, protected from light. Do not freeze.
Shelf life - 2 years.
Solvent storage conditions: store in original packaging at a temperature not exceeding 25 °C.
