Latran (Ondansetron) 4 mg, 10 pcs

1 tablet contains:

Active substance:

ondansetron hydrochloride dihydrate (in terms of base)4 mg;

Excipients:

MKC;

colloidal silicon dioxide (aerosil);

potato starch;

magnesium stearate;

Shell composition:

hydroxypropyl cellulose;

twin 80 (polysorbat);

tropeolin O;

castor oil.

Latran is antiemetic, antiabstinent.

Pharmacodynamics

Selective receptor antagonist 5-HT3 (serotonin). It inhibits the appearance of a vomiting effect by blocking 5-HT3 receptors at the neuronal level of both the central and peripheral nervous systems. It has anxiolytic activity, does not cause sedative effect, impaired coordination of movements or reduced activity and performance. Levels somatic and psychopathological symptoms in alcohol withdrawal syndrome.

Pharmacokinetics

When administered, Cmax in plasma is achieved within 10 minutes; after ingestion - after about 1.5 hours. The distribution of ondansetron is the same for oral, intramuscular and intravenous administration. Absolute bioavailability is about 60%. Plasma protein binding - 70-76%. Metabolized in the liver. Less than 5% of the drug is released unchanged with urine. Both after oral administration and parenteral administration, T1_/2 is about 3 hours, in elderly patients it can reach 5 hours, and in case of severe liver failure - 15–32 hours. In case of kidney damage (Cl creatinine1/2 increases by 4-5 hours, but this increase is not clinically important.

• nausea and vomiting caused by X-ray, radio or chemotherapy with antitumor drugs or exposure to ionizing radiation;
• prevention, prevention and elimination of nausea and vomiting in the postoperative period;
• symptomatic treatment of alcohol withdrawal syndrome (especially mild to moderate severity).

• hypersensitivity to any component of the drug;
• pregnancy;
• breastfeeding;
• children under 2 years of age (safety and effectiveness of use in Russia have not been studied).

From the nervous system: headache, dizziness, spontaneous motor disorders and seizures.

From the cardiovascular system: chest pain, in some cases with ST segment depression, bradycardia, arrhythmia, arterial hypotension.

From the gastrointestinal organs: hiccups, dry mouth, diarrhea, constipation, sometimes asymptomatic transient increase in serum aminotransferase levels.

Allergic reactions: hives, bronchospasm, laryngospasm, angioedema, anaphylaxism.

Others: local reactions (pain, burning and redness at the injection site), a surge of blood to the face, feeling of heat, temporary visual acuity disorders, hypokalemia.

Since ondansetron is metabolized by the liver enzyme system (cytochrome P450), caution is required when used together:

- with enzymatic inductors P450 (CYP2D6 and CYP3A) (barbiturates, carbamazepine, carisoprodol, glutetimide, griseofulvin, nitrogen oxide, papaverine, phenylbutasone, phenytoin and probably other hydrantoins, rifampicin, tolbutamide);

- with P450 enzyme inhibitors (CYP2D6 and CYP3A) (allopurinol, macrolide antibiotics, antidepressants - MAO inhibitors, chloramphenicol, cimetidine, estrogen-containing oral contraceptives, diltiazem, dis

Intravenously, intramuscularly, internally.

Cytostatic therapy: the choice of dosing mode is determined by the emetogenity of antitumor therapy. For adults, the daily dose is usually 8–32 mg, the following modes are recommended:

In moderate emetogenous chemotherapy or radiotherapy

• 8 mg in/in jet slowly or in/m immediately before therapy;
• 8 mg orally (2 tablets) 1-2 hours before the start of therapy, then another 8 mg (2 tablets) 12 hours after the start of therapy.

In highly emetogenic chemotherapy

• 8 mg in/in jet slowly immediately before the start of chemotherapy, and then another 2 in/injections of 8 mg at intervals of 2-4 hours;
• continuous 24-hour infusion at a dose of 24 mg at a speed of 1 mg/h;
• 16-32 mg diluted in 50-100 ml of the corresponding infusion solution, in the form of 15-minute infusion immediately before chemotherapy.

The effectiveness of Latran^® can be increased by a one-time administration of glucocorticoid (for example, 20 mg of dexamethasone) before chemotherapy begins.

To prevent delayed vomiting that occurs after the first 24 hours from the beginning of chemotherapy, it is recommended to continue taking the drug orally in the form of tablets, 8 mg 2 times a day for 5 days.

Children over 2 years of age are prescribed the drug at a dose of 5 mg/m2 in/in immediately before the start of chemotherapy with subsequent ingestion at a dose of 4 mg after 12 hours; after the end of chemotherapy, it is recommended to continue treatment at a dose of 4 mg orally 2 times a day for 5 days.

Prevention of postoperative nausea and vomiting: adults are administered a single dose of 8 mg in/miles in jet slowly at the beginning of anesthesia, or prescribed 16 mg 1 hour before anesthesia. To stop nausea and vomiting, it is recommended to intramuscate or slow administration of 8 mg of the drug. B/m in the same area of the Latran^® body can be administered at a dose not exceeding 8 mg.

To prevent postoperative nausea and vomiting, Latran^® is used exclusively parenterally at a single dose of 0.1 mg/kg (up to a maximum of 4 mg) in the form of slow/in injection before or after anesthesia. For the treatment of developed postoperative nausea and vomiting in children, a slow intravenous dose of 0.1 mg/kg (up to a maximum of 4 mg) is recommended. In Russia, there is not enough experience in using the drug to prevent and treat postoperative nausea and vomiting in children under 2 years of age.

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

For symptomatic treatment of alcohol withdrawal syndrome, the drug is administered into/dumpled at a dose of 8 mg (in the form of a solution of 2 mg/ml, 4 ml) in 400 ml of hemodesis, chlosole or physiological solution. If necessary, it is possible to re-inject the drug.

Elderly patients do not need to change the dosage.

Patients with kidney lesions do not need to change the usual daily dose and frequency of administration of the drug.

In case of liver damage, it is necessary to reduce the dose to 8 mg per day.

The following solutions can be used to dilute the injection solution: 0.9% sodium chloride solution; 5% glucose solution; Ringer solution; 0.3% potassium chloride solution and 0.9% sodium chloride solution; 0.3% potassium chloride solution and 5% glucose solution.

In cases of suspected overdose, symptomatic therapy is indicated.

When overdoseing, the use of ipecakuana is not recommended, as it is unlikely that this drug will be effective during the antiemetic effect of Latran^®.

A specific antidote is not known.

Hypersensitivity reactions when using Latran^® may occur in patients previously observed for similar reactions when using other selective 5-HT3 receptor antagonists.

Patients with signs of intestinal obstruction after use of the drug require regular observation, as ondansetron can cause constipation.

The infusion solution should be prepared immediately before use. If necessary, the finished infusion solution can be stored until use for a maximum of 24 hours at a temperature of 2-8 °C.

No light protection is required during infusion: the diluted injection solution remains stable for at least 24 hours in natural light or normal light.

Tablets