Latran, 2 mg/ml 4 ml 5 pcs

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

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Active ingredient

Ondansetron

Composition

Active substance:

ondansetron hydrochloride dihydrate (in terms of base) 2 mg;

Auxiliary substances:

Sodium chloride;

Hydrochloric acid;

Water for injection;

How to take, the dosage

Intravenously, intramuscularly, orally.

Cytostatic therapy: The choice of dosing regimen is determined by the emetogenicity of the antitumor therapy. For adults, the daily dose is usually 8-32 mg; the following regimens are recommended:

In moderate emetogenic chemotherapy or radiotherapy

• 8 mg w/v slow-acting or v/m immediately before starting therapy;
• 8 mg orally (2 tablets.1 to 2 hours before therapy, then another 8 mg (2 tablets) 12 hours after the start of therapy.

Highly emetogenic chemotherapy

• 8 mg by IV injection slowly just before the start of chemotherapy and then 2 more IV injections of 8 mg at 2-4 h intervals;
• 16-32 mg diluted in 50-100 ml of an appropriate infusion solution as a 15-minute infusion immediately before the start of chemotherapy.

The efficacy of Latran^® may be increased by a single IV infusion of a glucocorticoid (e.g., 20 mg dexamethasone) prior to the start of chemotherapy.

In order to prevent delayed vomiting occurring after the first 24 hours from the start of chemotherapy, it is recommended that the drug be continued orally as tablets, 8 mg twice daily for 5 days.

In children over 2 years of age, the drug is administered in a dose of 5 mg/m² by IV immediately before the start of chemotherapy followed by an oral dose of 4 mg 12 hours later; after completion of chemotherapy, we recommend continuing treatment at a dose of 4 mg orally 2 times daily for 5 days.

Prevention of postoperative nausea and vomiting: Adults are given a single dose of 8 mg v/mili by IV infusion slowly at the beginning of anesthesia, or 16 mg orally 1 hour before anesthesia. To relieve the resulting nausea and vomiting, an 8 mg dose is recommended in/m or slowly administered by injection. In/m to the same area of the body, Latran^® may be administered in a dose not exceeding 8 mg.

In children 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) as a slow IV injection before or after anesthesia. For treatment of postoperative nausea and vomiting in children, a slow IV injection of a single dose of 0.1 mg/kg (max. up to 4 mg) is recommended. In Russia, there is insufficient experience of using the drug for prevention and treatment of postoperative nausea and vomiting in children under 2 years of age.

In case of exposure to ionizing radiation, Latran^® is taken orally in 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 by IV infusion in a dose of 8 mg (as 2 mg/ml solution, 4 ml) in 400 ml of hemodesis, chlosol or physiological solution. Repeated administration of the drug is possible if necessary.

Elderly patients do not need to change the dosage.

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

In patients with liver damage, the dose should be reduced to 8 mg daily.

To dilute the injectable solution the following solutions can be used: 0.9% sodium chloride solution; 5% glucose solution; Ringer’s solution; 0.3% potassium chloride solution and 0.9% sodium chloride solution; 0.3% potassium chloride solution and 5% glucose solution.

Interaction

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

– with enzymatic inducers of P450 (CYP2D6 and CYP3A) (barbiturates, carbamazepine, carisoprodol, glutethimide, griseofulvin, nitrous oxide, papaverine, phenylbutazone, phenytoin and probably other hydantoins, rifampicin, tolbutamide);

– with P450 enzyme inhibitors (CYP2D6 and CYP3A) (allopurinol, macrolide antibiotics, antidepressants – MAO inhibitors, chloramphenicol, cimetidine, estrogen-containing oral contraceptives, diltiazem, disulfiram, erythromycin, valproic acid, sodium valproate, fluconazole, fluoroquinolones, isoniazid, ketoconazole, lovastatin, metronidazole, omeprazole, propranololol, quinidine, quinine, verapamil).

Special Instructions

Patients with signs of bowel obstruction require regular monitoring after using the drug because ondansetron may cause constipation.

The infusion solution should be prepared immediately prior to use. If necessary, the prepared infusion solution may be stored for a maximum of 24 h at 2-8 °C prior to use.

The hypersensitivity reactions with Latran^® may occur in patients previously observed for similar reactions with other selective 5-HT₃ receptor antagonists.

At the time of infusion, protection from light is not required: the diluted injectable solution remains stable for at least 24 hours in natural light or normal light.

Contraindications

• Pregnancy
• Breast-feeding
• High sensitivity to any component of the drug
• Children under 2 years (safety and effectiveness has not been studied in Russia).

Side effects

Gastrointestinal organs: hiccups, dry mouth, diarrhea, constipation, sometimes asymptomatic transient increase in serum aminotransferases.

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

Nervous system disorders: headache, dizziness, spontaneous motor disorders and seizures.

Cardiovascular system: chest pain, in some cases with ST-segment depression, bradycardia, arrhythmias, arterial hypotension.

Others: local reactions (pain, burning and redness at the injection site), blood rush to the face, fever, temporary visual acuity impairment, hypokalemia.

Overdose

In cases of suspected overdose, symptomatic therapy is indicated.

In cases of overdose, the use of ipecacuana is not recommended, as it is unlikely that this drug will be effective during the anti-emetic effect of Latran^®.

A specific antidote is not known.

Similarities

Ondansetron-Altfarm, Latran, Ondansetron