Latran ampoules 0,2% 4ml №5

Injection

Composition

1 ml of a solution of 0.2% contains: Ondansetron hydrochloride dihydrate, calculated on the basis of 2 mg

Excipients: Sodium chloride, hydrochloric acid, water for injection

Packing

In the ampoule 4 ml solution. In a cardboard bundle 5 ampoules with an ampoule knife.

Mechanism of action

Latran is a selective 5-HT 3 receptor antagonist (serotonin).

Medicines 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, induces a gag reflex. Ondansetron inhibits the appearance of the gag reflex by blocking 5-HT 3 receptors at the level of the neurons of both the central and peripheral nervous systems. Apparently, the prevention and treatment of postoperative and cytostatic and chemo - and radio - induced therapy of vomiting and nausea is based on this mechanism of action.

LATRAN ® has anxiolytic activity, does not cause a sedative effect, impaired coordination of movements or a decrease in the activity and performance of LATRAN ® is used for the symptomatic treatment of alcohol withdrawal syndrome of mild and moderate severity, acting on somatic and psychopathological symptoms.

Indications and usage

- Prevention and elimination of nausea and vomiting arising from cytostatic chemotherapy, x-ray radiotherapy, or other forms of radiation exposure, as well as postoperative nausea and vomiting.
- Symptomatic treatment of alcohol withdrawal syndrome (mainly mild to moderate severity).

Contraindications

- Hypersensitivity to any component of the drug.
- Pregnancy and lactation period.
- Children's age up to 2 years (safety and efficacy have not been studied).

Pregnancy and Breastfeeding

Contraindicated in pregnancy and lactation.

Dosage and administration

Cytostatic therapy: The choice of dosing regimen is determined by the emethogenicity of antitumor therapy. For adults, the daily dose is usually 8-32 mg, the following regimens are recommended:
For moderate emetogenic chemotherapy or radiotherapy, 8 mg intravenously, in a slow, intravenous stream, or intramuscularly, immediately before the start of therapy.

With high emethogenic chemotherapy, 8 mg is administered intravenously in a slow-dose intravenous manner immediately before the start of chemotherapy, and then two more intravenous injections of 8 mg, each of which take 2-4 hours; - continuous 24 - hour infusion of the drug in a dose of 24 mg at a rate of 1 mg / hour; - 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 effectiveness of LATRANA® can be increased by a single intravenous administration of a glucocorticoid (for example, 20 mg of dexamethasone) before the start of chemotherapy.

For children over 2 years old, the drug is administered at a dose of 5 mg / m 2 of the body surface intravenously, immediately before the start of chemotherapy, followed by ingestion at a dose of 4 mg after 12 hours.

Prevention of postoperative nausea and vomiting: Adults are given a single dose of 4 mg intramuscularly or intravenously injected, slowly at the onset of anesthesia.

For the relief of nausea and vomiting: intramuscular or slow intravenous administration of 4 mg is recommended. Intramuscularly in the same part of the body LATRAN® can be administered in a dose not exceeding 4 mg!
Children For the prevention of postoperative nausea and vomiting, LATRAN® is used exclusively parenterally in a single dose of 0.1 mg / kg (up to 4 mg) as a slow intravenous injection before or after anesthesia. Slow intravenous administration of a single dose of LATRANA 0.1 mg / kg (maximum up to 4 mg) is recommended. With regard to the prevention and treatment of postoperative nausea and vomiting in children under 2 years of age, there is not enough experience.

For the symptomatic treatment of alcohol withdrawal syndrome, the drug is administered intravenously at a dose of 8 mg in 400 ml of hemodesis, chlorol or 0.9% sodium chloride solution. If necessary, repeated administration of LATRAN® is possible.

Use in elderly patients: Dosage change is not required.

Use in patients with impaired liver and / or kidney function: If kidney damage occurs, it is not necessary to change the usual daily dose and frequency of drug administration. If the liver is damaged, the clearance of ondansetron is significantly reduced, and its half-life from plasma increases, so you need to reduce the dose to 8 mg per day.

The following solutions can be used to dilute the injection solution:

- 0.9% solution of sodium chloride.
- 5% dextrose solution.
- Ringer's solution.
- 0.3% solution of potassium chloride and 0.9% sodium chloride solution.
- 0.3% solution of potassium chloride and 5% dextrose solution.

For ease of use, you can use the drug Latran tab.po. 4 mg pack. 10 Pharmaceutical NPC.

Special notes

In patients who previously used other selective 5HT 3 receptor antagonists, hypersensitivity reactions have been observed, and LATRAN® can also differ in similar reactions.

Since Ondansetron can cause constipation, patients with signs of intestinal obstruction after using the drug require regular monitoring. 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.

During the infusion, protection from light is not required, the diluted injection solution maintains its stability for at least 24 hours in natural light or normal lighting.

Drug Interactions

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

With enzymatic inducers of P450 (CYP2D6 and CYP3A) (barbiturates, Carbamazepine, carisoprodol, glyutetemid, Griseofulvin, dinitrogen oxide, papaverine, phenylbutazone, phenytoin (and probably other hydantoins), rifampicin, tolbutamide).

With P350 inhibitors (CYP2D) lovastatin, Metronidazole, Omeprazole, propranolol, quinidine, quinine, verapamil).

Overdosage

In cases of suspected overdose, symptomatic therapy is indicated.

With an overdose of LATRAN® tablets, the use of ipecac is not recommended, since it is unlikely that the drug will be effective during the antiemetic effect of ondansetron. The specific antidote is unknown.

In a dry, dark place, at a temperature not higher than 25 ° C.