Instruction for use: Setronon

Dosage form: Solution for intravenous and intramuscular injection; Coated tablets

Active substance: Ondansetron*

ATX

A04AA01 Ondansetron

Pharmacological groups:

Antiemetic means and preparations

Serotonergic agents

Composition and release form

Solution for intravenous and intramuscular injection 1 ml

Ondansetron (as hydrochloride dihydrate) 2 mg

Auxiliary substances: sodium citrate; Citric acid monohydrate; sodium chloride; water for injections

In ampoules of 2 or 4 ml; In the packaging of the contour cell 5 ampoules.

Tablets, coated with a coating.

Ondansetron (as hydrochloride dihydrate) 4 mg; 8 mg

Auxiliary substances: magnesium stearate; MCC; corn starch; Lactose monohydrate

Composition of the shell: titanium dioxide; Macrogol / polyethylene glycol 4000; Hypromellose 15 cP; Lactose monohydrate; Sodium citrate dihydrate

In a planar cell pack of 10; In a pack of cardboard 1 package.

Pharmachologic effect

Mode of action - antiemetic.

Dosing and Administration

Cytostatic therapy

The choice of the dosage regimen is determined by the severity of the emetogenic effect of the antitumor therapy.

For adults, the daily dose is usually 8-32 mg. The following modes are recommended:

With moderately emetogenic chemotherapy or radiotherapy:

- IV jet (slow) or IM in a dose of 8 mg, immediately before the start of therapy;

- inside 8 mg for 1-2 hours before the start of therapy, then 8 mg after 12 hours after the start of therapy.

With highly emeticogenic chemotherapy:

- intravenous (slowly) immediately before the start of chemotherapy, and then - two more intravenous injections of 8 mg with an interval of 2-4 hours;

- continuous 24-hour infusion of the drug at a dose of 24 mg at a rate of 1 mg / h;

- 15-minute infusion, immediately before the start of chemotherapy in a dose of 16-32 mg (previously diluted in 50-100 ml of the appropriate infusion solution).

The efficacy of ondansetron can be increased by a single intravenous injection of glucocorticoid (dexamethasone 20 mg) prior to chemotherapy; When ingested to enhance the effect of a single dose can be increased to 24 mg and administered simultaneously with 12 mg of dexamethasone 1-2 hours before the start of chemotherapy.

To prevent delayed emesis, which occurs 24 hours after the initiation of chemotherapy or radiotherapy, it is recommended to continue using the drug inside at a dose of 8 mg 2 times a day for 5 days.

Children older than 2 years of the drug is administered IV in a dose of 5 mg / m2 immediately before the start of chemotherapy - followed by oral administration at a dose of 4 mg after 12 hours; After the end of chemotherapy - inside at a dose of 4 mg for 5 days.

Prevention of postoperative nausea and vomiting

Adults: IM or IV jet (slow) at a dose of 4 mg at the beginning of anesthesia or inside at a dose of 16 mg for 1 hour before the onset of anesthesia.

For relief of nausea and vomiting: IM or IV (slowly) in a dose of 4 mg.

IM in the same part of the body, ondansetron can be administered at a dose not exceeding 4 mg.

Children for the prevention of postoperative nausea and vomiting - only in / in (slowly) in a single dose of 0.1 mg / kg (maximum - up to 4 mg) during or after anesthesia.

For relief of postoperative nausea and vomiting - in / in (slowly) in a single dose of 0.1 mg / kg (maximum - up to 4 mg).

In the prevention and treatment of postoperative nausea and vomiting in children under 2 years of age, there is no sufficient experience.

Elderly patients do not need to change the dosage.

Patients with lesions of the kidneys and liver

When a kidney is affected, it is not necessary to change the usual daily dose.

When liver damage significantly decreases the clearance of ondansetron and increases the half-life of it from the plasma, so do not exceed the daily dose of 8 mg.

To dilute the ondansetron injection solution, the following solutions can be used: 0.9% sodium chloride solution, 5% dextrose solution, Ringer's solution, 0.3% potassium chloride solution in 0.9% sodium chloride solution, 0.3% potassium chloride solution in 5% solution of dextrose.

Storage conditions of the drug Setronon

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of the drug Setronon

Solution for intravenous and intramuscular injection 2 mg / ml - 2 years.

Coated tablets 4 mg - 3 years.

Tablets coated with 8 mg - 3 years.

Do not use after the expiry date printed on the package.