Ondanset 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
Active ingredient: ondansetron (1 ml of solution contains ondansetron hydrochloride dihydrate equivalent to 2 mg of ondansetron).
Excipients: sodium chloride; citric acid, monohydrate; sodium citrate; water for injections.
Contraindication
The use of ondansetron together with apomorphine hydrochloride is contraindicated, as cases of severe hypotension and loss of consciousness have been observed during co-administration; hypersensitivity to the components of the drug.
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.
Adults. Emetogenic chemotherapy and radiotherapy The recommended intravenous or intramuscular dose of the drug 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 cisplatin). The drug 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 another suitable diluent; the infusion should last at least 15 minutes. A single dose of more than 16 mg cannot be used. For highly emetogenic chemotherapy, 8 mg or less of the drug does not require dilution and can be administered by slow intravenous or intramuscular injection (at least 30 seconds) immediately before chemotherapy, followed by two intravenous or intramuscular injections of 8 mg after 2 and 4 hours or by continuous infusion of 1 mg/h for 24 hours. The effectiveness of Ondanset in highly emetogenic chemotherapy can be increased by 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.
Children aged 6 months to 17 years In pediatric practice, Ondansetron should be administered by infusion in 25-50 ml of 0.9% sodium chloride solution or other suitable diluent over at least 15 minutes. The dose of the drug can be calculated by 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 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 dose for adults. Calculation of the dose according to the child's body weight. The drug should be administered immediately before chemotherapy by a single 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 continue for another 5 days. Do not exceed the dose for adults.
Postoperative nausea and vomiting
Adults. For the prevention of postoperative nausea and vomiting, the recommended dose 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 is 4 mg as a single intramuscular or slow intravenous injection.
Children aged one month to 17 years. For the prevention and treatment of postoperative nausea and vomiting in children undergoing surgery under general anesthesia, the drug can be administered at a dose of 0.1 mg/kg body weight (maximum - up to 4 mg) by slow intravenous injection (not less than 30 seconds) before, during, after induction of anesthesia or after surgery.
Application features
Pregnant women
The safety of the drug during pregnancy for humans has not been established. In experimental studies on animals, the drug did not disrupt the development of the embryo or fetus and did not affect the course of pregnancy, peri- and postnatal development. However, since animal studies are not always predictive for humans, the drug is not recommended for use during pregnancy.
In experimental studies, it has been 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.
Data on overdose of the drug "Ondansetron" is insufficient. In most cases, the symptoms are similar to those described in patients who were administered recommended doses. Ondansetron increases the QT interval in a dose-dependent manner. In case of overdose, ECG monitoring is recommended.
Among the manifestations of overdose, visual disturbances, severe constipation, hypotension, vasovagal manifestations with transient atrioventricular block of the second degree were reported. In all cases, these phenomena completely resolved. There are reports of cases of serotonin syndrome in young children after taking an overdose. There is no specific antidote, therefore, in cases of overdose, symptomatic and supportive therapy should be used.
Further management of patients should be based on clinical indications or, if possible, in accordance with the recommendations of the National Poisons Center.
The use of ipecacuanha to treat ondansetron overdose is not recommended because its effect may not be manifested due to the antiemetic effect of the drug "Ondansetron".
Children: Serotonin syndrome has been reported in infants and children aged 12 months to 2 years after accidental overdose of the oral drug (doses exceeding the recommended level of 4 mg/kg).
Side effects
The adverse reactions listed below are classified by system organ class and frequency. The frequency of occurrence of adverse reactions is defined as follows: very common (≥ 1/10), common (≥ 1/100 and <1/10), uncommon (≥ 1/1,000 and <1/100), rare (≥ 1/10,000 and <1/1,000), very rare (<1/10,000).
On the part of the immune system: rarely - immediate-type hypersensitivity reactions, sometimes severe, up to anaphylaxis.
From the nervous system: very often - headache; infrequently - convulsions, movement disorders (including extrapyramidal reactions such as oculogyric crisis, dystonic reactions and dyskinesia without persistent clinical consequences); rarely - dizziness, mainly during rapid administration of the drug.
On the part of the organs of vision: rarely - transient visual disturbances (clouding of the eyes), mainly with intravenous administration; very rarely - transient blindness, mainly during intravenous administration (in most cases, blindness disappears within 20 minutes).
Cardiac: infrequently - arrhythmia, chest pain (with or without ST segment depression), bradycardia; rarely - prolongation of the QT interval (including ventricular fibrillation/flutter (torsade de pointes)).
Vascular disorders: often - feeling of warmth or flushing; infrequently - arterial hypotension.
From the respiratory system and chest organs: infrequently - hiccups.
Gastrointestinal tract: often - constipation.
On the part of the digestive system: infrequently - asymptomatic increase in liver function tests (these cases are observed mainly in patients treated with chemotherapeutic drugs containing cisplatin).
Skin and subcutaneous tissue disorders: very rarely - toxic rashes, including toxic epidermal necrolysis.
From the cardiovascular system: chest pain and discomfort, extrasystoles, tachycardia, including ventricular and supraventricular tachycardia, atrial fibrillation, palpitations, fainting, ECG changes.
Hypersensitivity reactions: anaphylactic reactions, angioedema, bronchospasm, anaphylactic shock, itching, rash, urticaria.
Nervous system disorders: gait disturbance, chorea, myoclonus, restlessness, burning sensation, tongue protrusion, diplopia, paresthesia.
Storage conditions
Store in the original packaging at a temperature not exceeding 30 °C, out of the reach of children.
Shelf life - 3 years.
