Universal reference book for medicines
Product name: ONDANSETRON-LANTS ® (ONDANSETRON-LANS)

Active substance: ondansetron

Type: Antiemetic medication of central action blocking serotonin receptors

Manufacturer: ЛЭНС-ФАРМ (Russia)
Composition, form of production and packaging
Solution for intravenous and / m introduction
1 ml

ondansetron hydrochloride 2 mg

2 ml - bottles (1) - packs of cardboard.

4 ml - vials (1) - packs cardboard.

4 ml - bottles (5) - packs cardboard.

4 ml - bottles (10) - packs of cardboard.

4 ml - bottles (50) - cardboard boxes.

4 ml - bottles (85) - cardboard boxes.

4 ml - bottles (100) - cardboard boxes.

8 ml - bottles (1) - packs of cardboard.

8 ml - bottles (5) - packs cardboard.

8 ml - bottles (10) - packs of cardboard.

8 ml - bottles (50) - cardboard boxes.

8 ml - bottles (85) - cardboard boxes.

8 ml - bottles (100) - cardboard boxes.

Solution for injection 0.2% transparent, colorless or yellowish in color.

1 ml of 1 fl.

ondansetron hydrochloride 2 mg 4 mg

2 ml - bottles (1) - packs of cardboard.

Solution for injection 0.2% transparent, colorless or yellowish in color.

1 ml of 1 fl.

ondansetron hydrochloride 2 mg 8 mg

4 ml - vials (1) - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

Ondansetron is a selective 5-HT 3 receptor antagonist (serotonin).
Drugs for cytostatic chemotherapy and radiotherapy can cause an increase in the level of serotonin, which, by activating vagal afferent fibers containing 5-HT 3 receptors, causes a vomiting reflex. Selectively blocks serotonin 5-HT 3 -receptors of neurons of the central and peripheral nervous system, ending vagus in the intestine and in the centers of the central nervous system (mainly the bottom of the IV ventricle), regulating the implementation of vomitive reflexes. Does not disrupt the coordination of movements, does not cause sedation and reduced efficiency. Does not change the concentration of prolactin in the plasma.
PHARMACOKINETICS

After intramuscular injection, TC max -10 min.
Binding to plasma proteins is 70-76%. The volume of distribution is 140 liters. After parenteral administration, T 1/2 is 3 hours. The absence of the CYP2D6 isoenzyme (debrisoquine polymorphism) has no effect on the pharmacokinetics of ondansetron.
In unchanged form, less than 5% of the administered dose is excreted in the urine.
The pharmacokinetic parameters of ondansetron do not change with its repeated administration.
In patients with moderate renal failure (creatinine clearance 15-60 ml / min), both systemic clearance and volume of distribution are reduced, resulting in a small and clinically insignificant increase in T 1/2 .
The pharmacokinetics of ondansetron practically does not change in patients with severe renal dysfunction in chronic hemodialysis (studies were conducted in between hemodialysis sessions). In patients with severe impairment of liver function, the systemic clearance of ondansetron drastically decreases, resulting in a longer half-life of 15-20 hours. T 1/2 of ondansetron does not depend on the mode of administration.
In elderly patients after ingestion or parenteral administration, T 1/2 may increase to 5 hours.

INDICATIONS

- prevention and elimination of nausea and vomiting caused by cytostatic chemotherapy or radiotherapy;

- prevention and elimination of nausea and vomiting in the postoperative period.

DOSING MODE

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 8-32 mg, the following regimens are recommended:

With moderately-emetogenic chemotherapy or radiotherapy:

8 mg intravenously struino slowly or intramuscularly, immediately before the start of therapy;

With highly emeticogenic chemotherapy:

- 8 mg intravenously slowly before the start of chemotherapy, then two more intravenous injections of 8 mg, each administered 2-4 hours

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

- 16-32 mg, diluted in 50-100 ml of the appropriate infusion solution, in the form of a 15-minute infusion, immediately before the start of chemotherapy.
The efficacy of ondansetron can be increased by a single intravenous injection of glucocorticosteroids (eg, 20 mg dexamethasone) prior to chemotherapy.
To prevent delayed emesis that occurs after the first 24 hours from the beginning of chemotherapy or radiotherapy, both with the use of highly emetic therapy, and with moderately emetic therapy - it is recommended to continue the use of ondansetron inside within 5 days.

Children older than 2 years of the drug is prescribed at a dose of 5 mg / m 2 of the body surface intravenously, immediately before the start of chemotherapy, followed by ingestion of 4 mg after 12 hours;
treatment is recommended to continue at a dose of 4 mg 2 times a day inside for 5 days.
Prevention of postoperative nausea and vomiting

Adults injected a single dose of 4 mg intramuscularly or intravenously struino slowly at the beginning of anesthesia.

For relief of nausea and vomiting , intramuscular or slow intravenous administration of 4 mg of the drug is recommended.

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

For children to prevent postoperative nausea and vomiting, ondansetron is used exclusively parenterally in a single dose of 0.1 mg / kg (maximum to 4 mg) in the form of a slow intravenous injection before or after anesthesia.
To treat the development of postoperative nausea and vomiting in children, a slow intravenous injection of a single dose of the drug 0.1 mg / kg (maximum 4 mg) is recommended.
In the prevention and treatment of postoperative nausea and vomiting in children under 2 years of age, there is no sufficient experience.

Elderly patients

Dosage adjustments are not required.

Patients with impaired renal function

Change the usual daily dose and the frequency of administration of the drug is not required.

Patients with a violation of liver function

With moderate or severe impairment of liver function, the clearance of ondansetron is significantly reduced, while the half-life of it is increased from the plasma, so it is not recommended for such patients to prescribe more than 8 mg of ondansetron per day.

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 and 0.9% sodium chloride solution, 0.3% potassium chloride solution and 5% dextrose solution.

SIDE EFFECT

Side effects are classified according to organ systems.

Immune system: immediate hypersensitivity reactions (including severe, up to anaphylaxis)

Allergic reactions: urticaria, bronchospasm, laryngospasm, angioedema.

Nervous system: headache;
Extrapyramidal reactions, such as oculogic crisis, dystonic reactions without persistent clinical consequences, convulsions; dizziness during the period of rapid intravenous administration of the drug, dyskinesia.
Visual disturbances: transient visual disturbances (blurred vision), mainly during the period of intravenous administration;
blindness, mainly during intravenous use. In most cases of blindness it lasts for 20 minutes.
From the side of the cardiovascular system: a sensation of heat or a "tide" of blood;
arrhythmias, chest pain (with or without depression in the ST segment), bradycardia, arterial hypotension, prolongation of the QT interval.
On the part of the respiratory system: hiccough.

From the digestive system: constipation;
in isolated cases - an asymptomatic increase in hepatic samples.
Local reactions: pain, burning and redness at the injection site.

CONTRAINDICATIONS

- hypersensitivity to ondansetron or other components of the drug;

- pregnancy and the period of breastfeeding;

- Children's age up to 2 years.

With caution: in patients with heart rhythm and conduction disorders, patients receiving antiarrhythmics and beta-blockers and patients with significant electrolyte disorders (single cases of transient ECG changes, including QT interval prolongation)

PREGNANCY AND LACTATION

In connection with the lack of clinical data on safety, taking ondansetron during pregnancy and during difficult feeding is contraindicated.
If necessary, use during lactation should stop breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER

Change the usual daily dose and the frequency of administration of the drug is not required.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With moderate or severe impairment of liver function, the clearance of ondansetron is significantly reduced, while the half-life of it is increased from the plasma, so it is not recommended for such patients to prescribe more than 8 mg of ondansetron per day.

APPLICATION FOR CHILDREN

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

APPLICATION IN ELDERLY PATIENTS

Dosage adjustments are not required.

SPECIAL INSTRUCTIONS

Precautions for use

Patients who had previously had allergic reactions to other selective 5-HT3 receptor blockers have an increased risk of developing them against ondansetron.Ondansetron can slow the motility of the large intestine, and therefore its appointment to patients with signs of intestinal obstruction requires regular monitoring.

The infusion solution should be prepared immediately before use.
If necessary, the ready-made infusion solution can be stored for up to 24 hours at a temperature of 2-8 ° C at normal illumination.
During the infusion, protection from light is not required;
The diluted injection solution retains its stability for at least 24 hours under natural light or normal light.
Impact on the ability to drive vehicles and manage mechanisms

Studies to study the effect of the drug on the ability to drive and work with mechanisms were not conducted.
Given the safety profile, when taking ondansetron should be careful when driving a car and working with mechanisms.
OVERDOSE

Symptoms: the development of side effects in a more pronounced form.
In cases of suspected overdose, symptomatic therapy is indicated. The specific antidote is unknown. In case of an overdose of ondansetron, the use of ipecacuanas is not recommended, since it is unlikely that this drug will be effective during the antidepressive effect of ondansetron,
DRUG INTERACTION

Since ondansetron is metabolized by the enzyme system (isoenzyme cytochrome P450) of the liver, caution is required when combined:

- with inductors of isoenzymes P450 (CYP2D6 and CYP3A) - barbiturates, carbamazepine, carisoprodol, glutetimide, griseofulvin, dinitrogen oxide, papaverine, phenylbutazone, phenytoin (probably other hydantoins), rifampicin, tolbutamide;

- with inhibitors of isoenzymes P450 (CYP2D6 and CYP3A) - allopurinol, macrolide antibiotics, antidepressants (monoamine oxidase inhibitors), chloramphenicol, cimetidine, estrogen-containing oral contraceptives, diltiazem, disulfiram, valproic acid and its salts, erythromycin, fluconazole, fluoroquinolones, isoniazid, ketoconazole, lovastatin, metronidazole, omeprazole, propranolol, quinidine, quinine, verapamil.

Ondansetron at a concentration of 16-160 μg / ml is pharmaceutically compatible and can be injected through the Y-shaped injector intravenously with the following drugs:

- cisplastin (concentration up to 0.48 mg / ml) for 1-8 hours;

- fluorouracil (at a concentration of up to 0.8 mg / ml at a rate of 20 ml / h - higher concentrations may cause precipitation of ondansetron);

- carboplatin (in a concentration of 0.18-9.9 mg / ml for 10-60 min);

- etoposide (in a concentration of 0.14-0.25 mg / ml for 30-60 minutes);

- ceftazidime (in a dose of 0.25-2.0 g, as an intravenous bolus injection for 5 minutes);

- cyclophosphamide (in a dose of 0.1-1.0 g, as an intravenous bolus injection for 5 minutes);

- doxorubicin (in a dose of 10-100 mg, as an intravenous bolus injection for 5 minutes);

- dexamethasone: possible intravenous administration of 20 mg dexamethasone slowly, for 2-5 minutes.
The drug can be administered through a single dropper, while in the solution the concentrations of dexamethasone can range from 32 μg to 2.5 mg / ml, ondansetron - from 8 μg / ml to 0.1 mg / ml.
When used simultaneously with powerful inducers of CYP3A isoenzymes, a decrease in ondansetron concentration in the blood

With tramadol: there have been reports of a decrease in the analgesic effect of tramadol when combined with ondansstron.

TERMS OF RELEASE FROM PHARMACY

On prescription.

TERMS AND CONDITIONS OF STORAGE

Store at a temperature not exceeding 30 ° C.
Keep out of the reach of children. Shelf life - 3 years.
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