Instruction for use: Emetron

Dosage form: Solution for intravenous and intramuscular administration; Film-coated tablets

Active substance: Ondansetron*

ATX

A04AA01 Ondansetron

Pharmacological groups:

Antiemetic, serotonin receptor antagonist [Antiemetic]

Antiemetic, serotonin receptor antagonist [Serotonergic drugs]

The nosological classification (ICD-10)

R11 Nausea and vomiting: Postoperative vomiting; Nausea; Vomiting; Vomiting in the postoperative period; Vomiting medication; Vomiting in the background of radiation therapy; Vomiting uncontrollable; Vomiting in radiation therapy; Persistent vomiting; Indomitable vomiting; Postoperative nausea; Vomiting with chemotherapy; Vomiting of the central genesis; Vomiting with cytotoxic chemotherapy; Persistent hiccups; Repeated vomiting

Z51.0 Radiotherapy course: Supplement to external radiation therapy; Local X-Ray Irradiation; Radiation therapy; Brain edema associated with radiation therapy; Lesion in radiation therapy; Radiotherapy

Z51.1 Chemotherapy for neoplasm: Cystitis hemorrhagic, caused by cytostatics; Urotoxicity of cytostatics

Z98.8 Other specified post-surgical conditions: Purulent complications in the postoperative period; Suppurative complications of surgery; Postoperative liver dysfunction; Postoperative vomiting; Postoperative complications; Postoperative period; Early postoperative period

Composition

Tablets, coated with a film membrane 1 tab.

active substance: Ondansetron 8 mg

(Equivalent to 10 mg ondansetron hydrochloride dihydrate)

Auxiliary substances: silicon colloidal dioxide - 0.6 mg; Magnesium stearate - 1.3 mg; Talc - 7.1 mg; Pregelatinized starch - 18 mg; MCC - 40 mg; Corn starch - 54.5 mg; Lactose anhydrous - 118.5 mg

Membrane film: silicon dioxide colloid - 0.07 mg; Ferric oxide yellow oxide - 0.12 mg; Titanium dioxide 0.27 mg; Macrogol 6000 - 0.79 mg; Sepifilm 003 (macrogol 40 stearate (mono- and diesters of stearic acid and PEG-40 - E431) 8-12%, MCC (E460) 35-45%, hypromellose (E464) 45-55%) 8.75 Mg

Pharmachologic effect

Mode of action - antiemetic.

Dosing and Administration

Inside.

Cytostatic therapy

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

The daily dose for adults, as a rule, is 8-24 mg.

With moderate emetogenic chemotherapy or radiotherapy. 8 mg orally for 1 to 2 hours before the start of therapy, then another 8 mg orally 12 hours after the start of therapy.

With highly emetogenic chemotherapy. The recommended adult dose (no data for use in children) is 24 mg concomitantly with dexamethasone orally at a dose of 12 mg 1-2 hours before the start of chemotherapy.

When ingested to enhance the effect of a single dose can be increased to 24 mg and is prescribed simultaneously with 12 mg of dexamethasone 1-2 hours before the start of chemotherapy.

Prevention of postoperative nausea and vomiting

Adults prescribe 16 mg orally for 1 hour before the start of general anesthesia.

To prevent and manage postoperative nausea and vomiting, ondansetron is used only parenterally.

Special patient groups

Patients of advanced age. Dosage adjustment is not required.

Patients with impaired liver function. The daily dose should not exceed 8 mg.

Patients with a slow metabolism of sparteine / debrisosin. Correction of a daily dose or frequency of admission of ondansetron is not required.

Release form

Tablets, film-coated, 8 mg. In a blister of PVC and aluminum foil for 10 pcs. 1 blister in a cardboard box.

Manufacturer

OJSC Gedeon Richter. 1103, Budapest, st. Demrei, 19-21, Hungary.

Terms of leave from pharmacies

On prescription.

Storage conditions of the drug Emetron

At a temperature not higher than 30 ° C.

Keep out of the reach of children.

The shelf life of the drug Emetron

3 years.

Do not use beyond the expiration date printed on the package.