Latran - instructions for use, dose, side effects, contraindications

Ondansetron is a selective 5-HT antagonist₃-receptors (serotonin). Drugs for cytostatic chemotherapy and radiotherapy can cause an increase in serotonin concentration, which, by activation of the afferent fibers of the vagus nerve, containing 5-HT₃receptors, causes a vomitive reflex. Selectively blocks serotonin 5HT₃-receptors of central neurons (vomiting center) and peripheral (gastrointestinal tract) of the nervous system that regulate the gag reflex.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 oral administration, the maximum concentration of ondansetron in the blood plasma is reached after approximately 1.5 hours. Absolute bioavailability is about 60%. The drug is metabolized in the liver with the participation of enzymes of the microsomal oxidation system. The binding with plasma proteins is 70-76%. Less than 5% of the drug is excreted unchanged in urine. The half-life is about 3 hours.

Peculiarities of pharmacokinetics in special groups of patients: the half-life in elderly patients can reach 5 hours, with liver and kidney pathology - 15-32 hours.

Indications:

Prevention and elimination of nausea and vomiting that occur with cytostatic chemotherapy, radiotherapy or other forms of radiation exposure, as well as postoperative nausea and vomiting. Symptomatic treatment of alcohol abstinence syndrome (mainly 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 in children younger than 2 years is not available, therefore, the prescription of Latran® medicinal product in this category of patients is contraindicated);

- Children under 3 years of age (for a dosage of 4 mg);

- Children under 12 years (for a dosage of 8 mg).

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

Carefully:Arrhythmias, electrolyte imbalance, simultaneous administration of antiarrhythmic drugs and beta-blockers.

Pregnancy and lactation:

Latran® is contraindicated in the first trimester of pregnancy.

If necessary, use during lactation should stop breastfeeding.

Dosing and Administration:

Inside.

In oncologic practice for prevention and cupping 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 is 8-24 mg, the following regimens are recommended:

With moderate expression of the emetogenic effect of chemo- or radiotherapy:

Adults and children over 12 years of age are prescribed 8 mg of ondansetron 1-2 hours before the start of the main therapy, followed by another 8 mg inside after 12 hours.

Children from 4 to 11 years of age are prescribed 4 mg of ondansetron 30 minutes before the start of the main therapy, followed by taking another 4 mg orally every 8 hours.

Data on the use of radiotherapy in children under 12 years are absent.

If the emetogenic effect of chemotherapy or radiotherapy is high:

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.

For the prevention of late or prolonged vomiting:

Adults should continue taking the drug inside at a dose of 8 mg 2 times a day for 5 days after the end of the main therapy.

Children the drug is given in a dose of 5 mg / m² body surface intravenously for at least 15 minutes immediately before the start of chemotherapy, followed by oral administration of 4 mg ondansetron after 12 hours; treatment is recommended to continue at a dose of 4 mg 2 times a day inside for 5 days.

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

Prevention of postoperative nausea and vomiting

Adults appoint 16 mg inside for 1 hour before drugsza general anesthesia.

Children for preventing and arresting postoperative nausea and vomiting ondansetron only applied parenterally.

With regard to the prevention and treatment of postoperative nausea and vomiting in children under 2 years of age dthere is no residual experience.

When exposed to ionizing radiation Latran ® is taken orally in a single dose of 8 mg (2 tablets) 1 hour before or immediately after the radiation exposure.

Elderly patients

Dose changes are not required.

Patients with kidney and liver lesions

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

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

Side effects:

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

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

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

From the side of the cardiovascular system: chest pain, segment depression ST, arrhythmias, bradycardia, lowering blood pressure.

Other: "tide" of blood to the skin of the face, a feeling of heat, a temporary violation of visual acuity, hypokalemia (the connection with the drug intake is not unambiguously established).

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

Symptoms: visual impairment, constipation, lowering of arterial pressure and vasovagal episode with transient atrioventricular blockade of the II degree. In all cases, the phenomena are completely reversible.

Treatment: conduct symptomatic and maintenance therapy, a 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 cytochrome P450 (isozymes CYP2D6 and CYP3A): barbiturates, carbamazepine, carisoprodol, glutethimide, griseofulvin, dinitrogen oxide, papaverine, phenylbutazone, phenytoin (probably other hydantoins), rifampicin, tolbutamide;

- with inhibitors of cytochrome P450 (isozymes CYP2D6 and CYP3A): allopurinol, antibacterial drugs of the macrolide group, antidepressants - MAO inhibitors, chloramphenicol, cimetidine, oral contraceptives containing estrogens, diltiazem, disulfiram, preparations of valproic acid, erythromycin, fluconazole, fluoroquinolones, isoniazid, ketoconazole, lovastatin, metronidazole, omeprazole, propranolol, quinidine, quinine, verapamil.

Special studies have shown that ondansetron does not interact with alcohol, temazepam, furosemide and propofol. Data from special studies indicate that ondansetron can reduce the anesthetic effect of tramadol.

In the event that you are taking other medicines, be sure to consult a doctor before taking the drug.

Special instructions:

Ondansetron should not be given to children with a body surface area of less than 0.6 m². Ondansetron It can not be used to prevent and treat postoperative nausea and vomiting in children after surgery on the abdominal organs.In case of adverse reactions from the nervous system, patients are advised to refrain from controlling the car and other mechanisms, as well as activities that require concentration of attention, stress of psychomotor functions.

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

Information on the adverse effect of the drug Latran® on the ability to control vehicles and mechanisms is not available.

Possible adverse reactions from the nervous system in the form of headache, dizziness, extrapyramidal disorders, transient violation of visual acuity. This should be taken into account when carrying out the above actions.

Form release / dosage:The tablets covered with a cover of 4 mg.

Packaging:

2 or 4 tablets are placed in polyethylene containers. Free space in the pencil case is filled with cotton absorbent medical cotton or mouthpieces filtering.

For 50, 100, 4000 or 8000 tablets in cans or bottles of dark glass with screwed plastic caps or in cans or plastic bottles with screwed plastic caps. Free space in the bank is filled with cotton hygroscopic cotton.

On the jar or bottle stick a label of paper label.

For 1, 2, 4 or 10 tablets in a contour mesh box made of polyvinyl chloride film and aluminum foil.

Contoured cell packs without a secondary (consumer) package for 1, 2 or 4 tablets are intended for special purposes.

1 circuit cell pack for 1, 2, or 10 tablets together with instructions for use 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 expiry date indicated on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-001889

Date of registration:10.11.2011 / 26.08.2013

Expiration Date:Unlimited

The owner of the registration certificate:FARMZASCHITA NPC, FSUE FARMZASCHITA NPC, FSUE Russia

Manufacturer: & nbsp

FARMZASCHITA NPC, FSUE Russia

Information update date: & nbsp11.03.2018

Illustrated instructions

Instructions

Latran® (Latranum)