ZOFETRON Ondansetron tablets 8mg №10

ZOFETRON Ondansetron tablets 8mg №10

Product Code: 8213
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active substance: ondansetron

1 tablet contains 4 mg or 8 mg of ondansetron in the form of ondansetron hydrochloride dihydrate;

excipients:lactose, microcrystalline cellulose, sodium croscarmellose, corn starch, magnesium stearate

pill shell:alcohol polyvinyl, titanium dioxide (E 171), macrogol, talc, iron oxide yellow (e 172).


Dosage form

Tablet, film coated.


drug description

Antiemetic agents and drugs that eliminate nausea. Antagonists 5НТ3-receptors of serotoninovy. PBX code A04A A01.


Nausea and vomiting caused by cytotoxic chemotherapy or radiation therapy.

Prevention and treatment of postoperative nausea and vomiting.


hypersensitivity to the components of the drug and to other selective antagonists

5NT3receptors, serotonin.

Severe violations of liver function, surgery on the abdominal cavity.

Method of application and doses

the Drug is taken orally.

the choice of dosing regimen is determined by the severity of the emetogenic effect of antitumor therapy and is set individually.

Moderate Emetogenic chemotherapy and radiation therapy.

Appoint 8 mg 1-2 hours before treatment, followed by taking 8 mg every 12:00. To prevent late or prolonged nausea and vomiting after the first 24 hours should continue to use the drug at 8 mg every 12:00 for 5 days. When choosing a dose should take into account the severity of vomiting. With partial irradiation with high doses of the abdominal area, 8 mg is prescribed every 8: 00.

the Drug is taken throughout the course of chemo - and radiation therapy, as well as 1-2 days (3-5 days if necessary) after its completion.

highly Emetogenic chemotherapy.

Adultsinside appoint 24 mg of ondansetron (simultaneously with dexamethasone phosphate) for 1-2 hours before chemotherapy. To prevent late vomiting is recommended after the first 24 hours to take the drug inside 8 mg 2 times a day during the course of chemotherapy, as well as 5 days after its completion.

Children.in this dosage form, the drug is not prescribed to children under the age of 4 years. Doses to children are calculated based on the surface area of the body or body weight. If you need to use ondansetron at a dose of 2 mg should be used with the appropriate dosage.

calculation of the dose by the area of the body.

Directly before chemotherapy administered ondansetron (solution for injection) as a single injection at a dose of 5 mg/m2; the intravenous dose should not exceed 8 mg. Oral administration begin after 12:00 and continue to 5 days. The total daily dose ondansetron should not exceed 32 mg.

Calculation of dose according to body weight.

Directly before chemotherapy administered ondansetron (solution for injection) as a single injection at a dose of 0.15 mg/kg of body weight; the intravenous dose should not exceed 8 mg. In the future, the introduction of two intravenous injections with an interval of 4:00. The total daily dose ondansetron should not exceed 32 mg. Oral administration begin after 12:00 and continue to 5 days.

The The
body weight
day 1
day 2-6
& gt; 10 kg
up to 3 doses 0.15 mg/kg each 4:00 intravenously
Orally 4mg every 12: 00

Postoperative nausea and vomiting.

Adultsto prevent postoperative nausea and vomiting, the drug can be administered orally at 16 mg at 1:00 before anesthesia. The maximum daily dose of ondansetron is 32 mg.

Children.in this reading, it is recommended to use ondansetron as an injection solution.

for all types of therapy.

elderly Patients.

there is no need to change the dose in patients over 65 years of age.

patients with renal insufficiency.

there is no need to change the dosage regimen or the route of administration of the drug to patients with impaired renal function.

patients with moderate hepatic insufficiency.

in patients with moderate hepatic impairment, the clearance of ondansetron decreases significantly, and the half - life from blood serum increases. For such patients, the maximum daily dose should not exceed 8 mg.

Patients with a metabolic disorder sparteine/debrisoquine.

the half-life of ondansetron in patients with impaired metabolism sparteine and debrisoquine does not change. In such patients, repeated use leads to the same concentration of the drug in patients with intact metabolism. Therefore, there is no need to change the dosing regimen for this group of patients.

Side effects

a Side effect, as described below, qualified by organs and systems and frequency of occurrence. The frequency of occurrence divided into the following categories: very often (?1/10), often (?1/100 and<1/10), uncommon (?1/1000 and<1/100), rare (?1/10,000 and<1/1000), very rare (<1/10000).

in clinical studies it was found that the most frequent adverse reactions were:

headache, constipation, sensation of heat or hot flashes.

on the part of the immune system.

Rarely allergic reactions of immediate type, in some cases severe, including anaphylaxis, bronchospasm, vascular edema.

from the Central nervous system.

Very common: headache.

Often convulsions, motor disorders (including extrapyramidal reactions such as oculogyric crises, dystonic reactions and dyskinesia without persistent clinical consequences).

Rare: dizziness during rapid administration of the drug inhibition of the Central nervous system, paresthesia.

on the part of the visual organs.

Rare: visual impairment (blurred eyes), transient blindness, mainly during intravenous application.

on the part of the cardiovascular system.

not Often arrhythmias, heart pains (with or without St-segment depression), bradycardia, arterial hypotension, arterial hypertension, tachycardia.

Often feeling warm, tides.

from the respiratory system and the chest cavity.

infrequently hiccups, cough.

from the gastrointestinal tract.

often constipation, diarrhea, dry mouth.

from the digestive system.

Often asymptomatic increase in liver function tests, abnormal liver function.

Common disorders:weakness, fainting. These cases are observed mainly in patients who are treated with chemotherapy drugs containing cisplatin.


Symptoms:blurred vision, constipation, hypotension, atovaquone disorders with transient AV-block.

Treatment:drug withdrawal, symptomatic and supportive therapy. The use of antiemetic measures is not recommended from the antiemetic effect of the drug itself. There is no specific antidote.

use during pregnancy or lactation.

Ondansetron should not be prescribed during pregnancy. Unknown, penetrates ondansetron in breast milk, so feeding breast during the period of treatment should stop.



Children up to 4 years the drug in this dosage form is not used.

application Features

Ondansetron is not effective for the prevention of nausea and vomiting associated with motion sickness.

there is an experience of cross-hypersensitivity to various antagonists of 5NT3receptors therefore, in the presence of hypersensitivity to one of the antagonists of 5NT3receptors, a similar reaction to other antagonists may be more pronounced due to cross-reactions. In the presence of even a weak hypersensitivity reaction to one of the antagonist drugs

5NT3receptors it is not recommended to change it to another, given the possibility of increasing the hypersensitivity reaction.

Rarely during the use of ondansetron to meet transient ECG changes, including prolonged QT interval. The drug should be used with caution in the treatment of patients with cardiac arrhythmias or conduction, patients who are used in the treatment of antiarrhythmic drugs or ?-blockers, as well as in the treatment of patients with impaired electrolyte balance of high severity. According to postmarketing observations, there have been reports of cases of tremors/ventricular fibrillation in the application of ondansetron, so care should be taken in patients who have or may develop QT prolongation. This group includes patients with electrolyte imbalance disorders, with congenital Qt elongation syndrome, or who are treated with other drugs that can cause Qt interval elongation.

Ondansetron increases transit time through the colon, so in the presence of even weak signs of intestinal obstruction need constant supervision of the patient, if he uses the drug.

Ondansetron does not affect the cytochrome P450 system, but the use of other drugs that can affect the activity of these enzymes can lead to changes in clearance rates and half-life time of ondansetron.

in children who receive ondansetron together with hepatotoxic chemotherapy drugs, it is necessary to carefully monitor possible disorders of liver function.

since the tablets contain carbohydrates, including lactose, patients with impaired carbohydrate tolerance, with rare hereditary diseases, such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption, it is impossible to take the drug.


Ability to influence the reaction rate when driving motor transport or operating other mechanisms

Taking into account the possibility of adverse reactions from the nervous system, patients during treatment are advised to refrain from driving or working with other mechanisms.


Interaction with other medicinal products and other forms of interaction

Ondansetron is metabolized by enzymatic system of cytochrome P450, thus, inducers or inhibitors of microsomal enzymes may change the clearance and half-life of the drug caution should be used with enzyme inducers (barbiturates, carbamazepine, carisoprodol, glutethimide, griseofulvin, nitrous oxide, papaverine, phenylbutazone, phenytoin, rifampin, tolbutamide), enzyme inhibitors (allopurinol, macrolide antibiotics, MAOIs, chloramphenicol, cimetidine, ?strogensoder?a?imi contraceptives , diltiazem, disulfiram, valproic acid, sodium valproate, erythromycin, fuconazole, fluoroquinolones, isoniazide, ketoconazole, lovastatin, metronidazole, omeprazole, propranolol, quinidine, quinine, verapamil).

the Ondansetron does not interact with alcohol, temazepam, furosemide, tramadol and propofol. Carmustin, etoposide, cisplatin IS not injected into the pharmacokinetics of ondansetrona.

Ondansetron may reduce the analgesic effect of tramadol.

the use of ondansetron with drugs that extend THE Qt interval may result in an additional prolongation of THE Qt interval. The simultaneous use of ondansetron with cardiac drugs (for example anthracyclines) can increase the risk of arrhythmias.


Pharmacological properties


Ondansetron hydrochloride is an antagonist of the serotonin receptor subtype 5NT3. The mechanisms of antiemetic action are not fully established. It is known that the use of radiation and cytotoxic chemotherapy leads to the release of serotonin (5NT) with enterochromafinnyh cells of the small intestine. The initiation of the gag reflex is associated with the interaction of serotonin with 5NT3receptors located on the afferent extremities of the vagus nerve. Activation of the afferent limbs of the vagus nerve can cause the release of serotonin in the Central nervous system from the chemoreceptorial trigger zone located in the area of the bottom of the fourth ventricle of the brain. It is believed that ondansetron blocks the initiation of gag reflex at the level of both afferent limbs of the vagus nerve and serotonin receptors located in the Central parts of the nervous system.

Ondansetron has a sedative effect, but without changing prolactin in blood plasma, does not reduce psychomotor activity of the patient.

with regard to the mechanisms of antiemetic action of ondansetron in the postoperative period, this issue has not been sufficiently studied.


the Bioavailability of ondansetron after administration is 60%. In the body, it is actively metabolized, metabolites are excreted with feces and urine. After taking the maximum concentration is achieved in an hour and a half. The connection with plasma proteins is about 73%. Most of the administered dose is metabolized in the liver.

half - life - 3-4 hours; elderly persons-up to 6-8 hours. Less than 10% of the active substance is excreted in the urine unchanged.

these studies of metabolism in vitro ondansetron testify that he is the substrate of enzymes of cytochrome P450human liver, including CYP1A2, CYP2D6, and

CYP3A4. Metabolism of ondansetron is carried out more often by the enzyme CYP3A4. Since the metabolism of ondansetron can be carried out by several enzymes of the cytochrome P450 system, in the absence of one of the enzymes, the total clearance of ondansetron does not change significantly, since the lack of one of the enzymes will be compensated by other enzymes of the metabolism system.

Basic physical and chemical properties

4 mg oval coated tablets, yellow-beige, with an impression of "P" on one side and "4" on the other;

tablets 8 mg oval, film-coated yellow-beige color, with the imprint "OD" on one side and "8".


shelf Life

5 years

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

storage Conditions

Keep out of reach of children at temperatures not exceeding 30 ° C.



5 tablets in a blister; 2 blisters in a cardboard box.


Category vacation

According to the recipe.



Pharmaceuticals Inc./Pharmascience Inc.



6111 Royalmount Avenue 100, Montreal, QC Н4Р 2Т4, Canada.

6111 Royalmount Avenue, 100, Montreal, Quebec H4P 2T4 Canada.


Safetran tablets 8 mg №10 – specialized pharmaceuticals, which is aimed at suppressing the nausea and gag reflex. Pharmacological effect is due to the suppression of serotonin receptors. The main active component-ondasetron, has a pronounced sedative effect. The medication is used for vomiting, nausea, radiation and cytotoxic chemotherapy, as well as as as the prevention of such disorders in the postoperative period.

application Features

the Drug is designed for oral use. Selection of dosing regimen is performed depending on the severity of emetogenic action of antitumor agents. At a moderate emetogenic activity is assigned to 8 mg 60 minutes prior to the start of treatment. In the future, a similar dosage is taken every 12 hours. In case of high-emetogenic chemotherapy, 24 mg (once) is prescribed. Pharmaceutical products contraindicated in:

  • the Pathologies of the liver and kidneys.
  • increased activity of histamine receptors in relation to selective antagonists 5NT3.
  • surgical interventions on the abdominal cavity.

it is not recommended to take the medicine simultaneously with Furosemide, Fluconazole, Propofol, as well as to combine it with alcoholic beverages.

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