Zofran (ondansetron) solution for injections ampoules 2 mg/ml. 2 ml. №5

Description

Zofran (ondansetron) solution for injections ampoules 2 mg/ml. 2 ml. №5

Composition

active substance: ondansetron;

1 ml of solution contains 2 mg of ondansetron (in the form of dihydrate hydrochloride);

Excipients: citric acid monohydrate, sodium citrate, sodium chloride, water for injections.

Dosage form

Solution for injection.

Basic physical and chemical properties: transparent colorless solution, practically does not contain mechanical impurity.

Pharmacotherapeutic group

Antiemetics and drugs that eliminate nausea. Serotonin receptor antagonists (5HT3). ATX code A04A A01.

Pharmacological properties

Ondansetron is a potent highly selective 5HT3 (serotonin) receptor antagonist. The drug prevents or eliminates nausea and vomiting caused by cytotoxic chemotherapy and / or radiation therapy, as well as postoperative nausea and vomiting. The mechanism of action of ondansetron is not fully understood. It is possible that the drug blocks the onset of the gag reflex, exhibiting antagonistic action against 5HT3 receptors, which are localized in neurons of both peripheral and central nervous systems. The drug does not reduce the patient’s psychomotor activity and has no sedative effect.

Indication:

• nausea and vomiting caused by cytotoxic chemotherapy and radiation therapy;
• prevention and treatment of postoperative nausea and vomiting.

Contraindication:

• the use of ondansetron with apomorphine hydrochloride is contraindicated, as there have been cases of severe hypotension and loss of consciousness with concomitant use.
• hypersensitivity to any component of the drug.

Method of application and dosage

Nausea and vomiting caused by chemotherapy and radiation therapy

Adults:

• The emetogenic potential of cancer therapy varies depending on the dose and combination of chemotherapy and radiation therapy regimens. The choice of dosing regimen depends on the severity of the emetogenic effect. The dose of Zofran (range 8 to 32 mg per day) and method of administration are selected according to the following information.
• Emetogenic chemotherapy and radiation therapy
  The recommended intravenous or intramuscular dose of Zofran solution is 8 mg as a slow intravenous injection of at least 30 seconds or an intramuscular injection 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 for up to 5 days after the end of treatment.
• Highly emetogenic chemotherapy (eg high doses of cisplatin)
  Zofran can be given as a single dose of 8 mg intravenously or intramuscularly immediately before chemotherapy.
  For highly emetogenic chemotherapy, 8 mg of Zofran or less 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 two intravenous or intramuscular injections of 8 mg every 2 and 4 hours or constant infusion of 1 mg / h for 24 hours.
  Doses above 8 mg (up to 16 mg) should only be administered as an intravenous infusion of 50-100 ml of 0.9% sodium chloride solution or other appropriate solvent (see “Injection solution” below); the infusion should last at least 15 minutes.
  A single dose of more than 16 mg should not be used, as increasing the dose increases the risk of QT prolongation (see section 4.4).
  The choice of dosing regimen depends on the severity of the emetogenic effect. The efficacy of Zofran in highly emetogenic chemotherapy may be enhanced by additional single intravenous administration of dexamethasone sodium phosphate at a dose of 20 mg before chemotherapy.
• Oral or rectal administration of the drug is recommended to prevent delayed or prolonged vomiting after the first 24 hours.
• Postoperative nausea and vomiting
  For the prevention of postoperative nausea and vomiting, the recommended dose of Zofran is 4 mg as a single intramuscular or slow intravenous injection during anesthesia.
  For the treatment of postoperative nausea and vomiting, the recommended single dose of Zofran is 4 mg as an intramuscular or slow intravenous injection.

Children aged 6 months to 17 years

In pediatric practice, Zofran solution should be administered by intravenous infusion in 25-50 ml of 0.9% sodium chloride solution or other appropriate diluent for at least 15 minutes. The dose of the drug can be calculated by body surface area or body weight of the child.

Calculation of the dose according to the surface area of ​​the child’s body

Zofran solution should be administered immediately before chemotherapy by a single intravenous injection at a dose of 5 mg / m², the intravenous dose should not exceed 8 mg. After 12 hours, you can start taking the drug orally, which can last another 5 days. Do not exceed the adult dose.

Zofran should be diluted with 5% dextrose solution or 0.9% sodium chloride solution or other appropriate infusion solution and administered by intravenous infusion over at least 15 minutes.

There are no data from controlled clinical trials on the use of Zofran for the prevention of delayed or prolonged vomiting and nausea caused by chemotherapy (CINV). There are no data from controlled clinical trials regarding the use of Zofran in the treatment of nausea and vomiting caused by radiation therapy in children.

Calculation of the dose according to the child’s body weight

Zofran should be administered immediately before chemotherapy by a single intravenous injection of 0.15 mg / kg. The intravenous dose should not exceed 8 mg. On the first day, you can enter 2 more intravenous doses at 4-hour intervals.

After 12 hours, you can start taking the drug orally, which can last another 5 days. Do not exceed the adult dose.

Children aged 1 month to 17 years

For the prevention and treatment of postoperative nausea and vomiting in children operated on under general anesthesia, Zofran can be administered at a dose of 0.1 mg / kg body weight (maximum – up to 4 mg) by slow intravenous injection (at least 30 seconds) to , during, after anesthesia or after surgery.

Overdose

There are insufficient data on Zofran solution overdose. In most cases, the symptoms are similar to those described in patients given the recommended doses. Manifestations of overdose have been reported, such as visual disturbances, severe constipation, hypotension, vasovagal manifestations with transient atrioventricular block of the second degree. In all cases, these phenomena have completely disappeared. Ondansetron prolongs the QT interval in a dose-dependent manner. In case of overdose, ECG monitoring is recommended.
Cases of serotonin syndrome have been reported in young children after oral overdose.

Side effects:

From the nervous system: headache;

From the vessels: a feeling of heat or hot flashes;

From the digestive tract: constipation.