Active substanceOndansetronOndansetron
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  • Dosage form: & nbsp

    solution for intravenous and intramuscular administration.

    Composition:

    Active substance: Ondansetron hydrochloride dihydrate in terms of base - 2.0 mg.

    Excipients: sodium chloride - 9.0 mg, hydrochloric acid solution 0.1 M - to pH 3.5, water for injection - up to 1 ml.

    Description:Colorless or almost colorless transparent liquid.
    Pharmacotherapeutic group:antiemetics - serotonin receptor antagonist.
    ATX: & nbsp

    A.04.A.A.01   Ondansetron

    Pharmacodynamics:

    Has antiemetic and anxiolytic activity. Is an selective antagonist of 5-HT receptors3 (serotonin) of central and peripheral nervous system. Latran® mediates anti-emetic activity due to blockade of the release of serotonin by enterochromaffin cells of the gastrointestinal mucosa and neurons field of Area postrema bottom of the IV ventricle.

    Pharmacokinetics:

    With intramuscular injection, the maximum concentration in the plasma is reached within 10 minutes. The distribution of ondansetron is the same for oral, intramuscular and intravenous administration. Absolute bioavailability is about 60%. The drug is metabolized in the liver with the participation of enzymes of the system of microsomal oxidation.

    The binding with plasma proteins is 70-76%. Kidneys in unchanged less than 5% of the drug is excreted.

    The half-life is about 3 hours, in elderly patients it can be up to 5 hours.

    The pharmacokinetics of ondansetron practically does not change in patients with severe impairment of renal function on chronic Hemodialysis (studies were conducted in between sessions hemodialysis). In patients with severe impairment of liver function, the half-life period is 15-32 hours.

    Indications:

    Prevention and elimination of nausea and vomiting that occur when cytostatic chemotherapy, radiotherapy, as well as postoperative nausea and vomiting in mostly of mild and moderate severity).

    Contraindications:

    - Hypersensitivity to any component of the drug;

    - I trimester of pregnancy and the period of breastfeeding;

    - Children under 2 years of age (experience with children under 2 years of age is not available, so the appointment of the drug Latran® y this category of patients is contraindicated).

    If you have one of these conditions, before taking the drug always consult a doctor

    Carefully:

    Arrhythmias, electrolyte imbalance, simultaneous reception antiarrhythmic drugs and beta-blockers.

    Pregnancy and lactation:

    Latran® is contraindicated in the first trimester of pregnancy.

    The use of the drug in the II and III trimesters is not contraindicated in cases, if the use of the drug exceeds the risk of complications.

    If you need to use during lactation, you should stop

    breast-feeding.

    Dosing and Administration:

    In oncological practice for the prevention and reduction of the emetic syndrome in the conduct of radio and chemotherapy:

    Cytostatic therapy

    The choice of dosage regimen is determined by the emetogenicity of antitumor therapy.

    For of adults the daily dose, as a rule, is 8-32 mg, the following regimens are recommended:

    With moderate emetogenic chemotherapy or radiotherapy:

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

    With highly emeticogenic chemotherapy:

    - 8 mg intravenously struino slowly just before the start of chemotherapy, and then two more intravenous injections of 8 mg, each of which is carried out in 2-4 hours;

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

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

    The effectiveness of the drug Latran® can be enhanced by a single intravenous injection of a glucocorticosteroid (eg, 20 mg dexamethasone) prior to chemotherapy.

    Children over 2 years old the drug is given in a dose of 5 mg / m2 body surface intravenously, immediately before the start of chemotherapy, followed by oral administration at a dose of 4 mg after 12 hours; after the end of chemotherapy, it is recommended to continue treatment at 4 mg twice daily for 5 days.

    In surgical practice for prevention and cupping an emetic postoperative syndrome:

    Prevention of postoperative nausea and vomiting

    Adults inject a single dose of 4 mg intramuscularly or intravenously struino, slowly at the beginning of anesthesia, or prescribe 16 mg orally 1 hour prior to the onset of anesthesia.

    For relief of nausea and vomiting It is recommended a single intramuscular or slow intravenous injection of 4 mg of the drug.

    Intramuscularly in the same body area, Latran® can be administered at a dose not exceeding 4 mg!

    Children to prevent postoperative nausea and vomiting

    Latran® 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 single dose is recommended

    of the drug Latran® 0.1 mg / kg (maximum to 4 mg). With regard to the prevention and treatment of postoperative nausea and vomit in children under 2 years of age there is no sufficient experience.

    For symptomatic treatment of alcohol withdrawal syndrome the drug is administered intravenously drip in a dose of 8 mg in 400 ml of potassium solution chloride + sodium acetate + sodium chloride (Chlosol) or 0.9% solution sodium chloride. If necessary, repeated administration is possible preparation of Latran®.

    Elderly patients

    Dosage adjustments are not required.

    Patients with kidney and liver lesions

    In renal pathology, change the usual daily dose and frequency administration of the drug is not required.With liver pathology, the daily dose is reduced to 8 mg.

    For the dilution of the injection solution, the following solutions:

    - 0.9% solution of sodium chloride,

    - 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.

    The infusion solution should be prepared immediately before use.

    Side effects:

    Allergic reactions: urticaria, bronchospasm, laryngospasm, angioedema, anaphylaxis.

    Local reactions: pain, burning and redness at the injection site.

    From the nervous system: headache, dizziness, extrapyramidal disorders, convulsions.

    From the digestive system: hiccough, dry mouth, diarrhea, constipation, asymptomatic transient increase in aminotransferase activity in blood serum.

    From the cardiovascular system: pain in the chest with depression of the segment ST, lengthening the interval Q-T, arrhythmias, bradycardia, lowering blood pressure.

    Other: "tide" of blood to the skin of the face, a feeling of heat, transient blindness, hypokalemia (the connection with taking the drug is definitely not installed).If any of the side effects indicated in the instruction are aggravated, or if you notice any other side effects, do not specified in the instructions, inform the doctor about it.

    Overdose:

    There is limited experience of overdose ondansetron. AT most cases symptoms are similar to adverse reactions use of the drug at recommended doses.

    In cases of suspected overdose, symptomatic therapy is indicated.

    The specific antidote is not known.

    Interaction:

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

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

    - with inhibitors of isoenzymes CYP2D6 and CYP3A: allopurinol, macrolide antidepressants monoamine oxidases, chloramphenicol, antibiotics, inhibitors oral contraceptives, containing estrogens, diltiazem, disulfiram, preparations of valproic acid, erythromycin, fluconazole, fluoroquinolones, isoniazid, ketoconazole, lovastatin, metronidazole, omeprazole, propranolol, quinidine, quinine, verapamil.

    When used simultaneously with strong inducers isozymes CYP3A possible decrease in concentration ondansetron in the blood, with tramadol - decrease analgesic effect of the latter. Ondansetron at a concentration of 16-160 μg / ml is pharmaceutically compatible and can be administered via Y-injector in / in drip along with the following medicinal means:

    - Cisplastin (in concentrations 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 ondansetron);

    - Carboplatin (at a concentration of 0.18-

    9,9 mg / ml for 10-60 minutes);

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

    - Ceftazidime (in a dose of 0.25-2 g, as an IV bolus injection for 5 minutes);

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

    - Dexamethasone - maybe iv administration of 20 mg dexamethozone sodium phosphate slowly, for 2-5 minutes. Drugs can be administered through a single dropper, while the concentration of dexamethasone sodium phosphate in the solution can range from 32 to 2500 μg / ml, ondansetron - from 8 to 100 μg / ml.

    In the event that you take other medicines, before taking the drug always consult a doctor.
    Special instructions:

    Patients who had previously had allergic reactions to other selective blockers 5-HT3-receptors, have an increased risk of their development against the background of the drug Latran®. Ondansetron can slow the motility of the large intestine, in connection with which its appointment to patients with signs of intestinal obstruction requires special observation.

    Effect on the ability to drive transp. cf. and fur:

    Information on the adverse effect of the drug Latran® has no ability to manage vehicles and mechanisms.

    There are reports of headache, dizziness, extrapyramidal disorders, temporary violation of visual acuity. This should be taken into account when carrying out the above actions.

    Form release / dosage:

    Solution for intravenous and intramuscular injection 2 mg / ml.

    Packaging:

    By 2 ml or 4 ml per ampoule of neutral glass. By 1, 2 or 5 ampoules per contour cell pack of a polyvinyl chloride film.One contour mesh package together with the instruction for use is placed in a pack of cardboard.

    Storage conditions:

    In a dry, protected from light place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    The drug should not be used after the expiration date indicated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-001890
    Date of registration:06.12.2011
    The owner of the registration certificate:FARMZASCHITA NPC, FSUE FARMZASCHITA NPC, FSUE Russia
    Manufacturer: & nbsp
    Information update date: & nbsp27.02.2014
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