Latran solution for injection 2mg / ml, 4 ml No. 5

nausea and vomiting caused by X-ray, radio or chemotherapy, anticancer 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).

Cytostatic therapy

The choice of the dosage regimen is determined by the emetogenicity of anticancer therapy.
For adults, the daily dose is usually 8-32 mg, the following regimens are recommended.

For mild emetogenic chemotherapy or radiotherapy:

• 8 mg intravenously as a slow jet or intramuscularly, immediately before starting therapy;

• 8 mg orally (2 tablets) 1-2 hours before starting therapy, then another 8 mg (2 tablets) 12 hours after starting therapy.

With highly emetogenic chemotherapy:

• 8 mg intravenously in a stream slowly immediately before starting chemotherapy, followed by two more intravenous injections of 8 mg, each given 2-4 hours later;

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

• 16-32 mg, diluted in 50-100 ml of the corresponding infusion solution, as a 15-minute infusion, immediately before starting chemotherapy.

The effectiveness of LatranЃ can be increased by a single intravenous administration of a glucocorticoid (for example, 20 mg dexamegazone) prior to chemotherapy; when taken orally to enhance the effect, a single dose can be increased to 24 mg and administered simultaneously with 12 mg of dexamegazone 1-2 hours before the start of chemotherapy.
To prevent delayed vomiting that occurs after the first 24 hours from the start of chemotherapy, it is recommended to continue the use of LatranЃ orally in the form of 8 mg tablets (2 4 mg tablets) 2 times a day for 5 days.

Children

For children over 2 years of age, the drug is prescribed in a dose of 5 mg / m2 of body surface intravenously, immediately before the start of chemotherapy, followed by oral administration in a dose of 4 mg after 12 hours; after the end of chemotherapy, it is recommended to continue treatment with 4 mg twice a day by mouth for 5 days.

Prevention of postoperative nausea and vomiting

For adults, a single dose of 4 mg is administered intramuscularly or intravenously in a stream, slowly at the beginning of anesthesia, or 16 mg is administered orally 1 hour before the onset of anesthesia.

To relieve the nausea and vomiting that has arisen, intramuscular or slow intravenous administration of 4 mg of the drug is recommended.
Intramuscularly in the same area of ??the body, LatranЃ can be injected in a dose not exceeding 4 mg!

For children, to prevent postoperative nausea and vomiting, LatranЃ is used exclusively parenterally in a single dose of 0.1 mg / kg (up to a maximum of 4 mg) as a slow intravenous injection before or after anesthesia.

For the treatment of developed postoperative nausea and vomiting in children , a slow intravenous administration of a single dose of LatranЃ 0.1 mg / kg (up to a maximum of 4 mg) is recommended.

There is little experience in the prevention and treatment of postoperative nausea and vomiting in children under 2 years of age.

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

For the symptomatic treatment of alcohol withdrawal syndrome, the drug is administered intravenously at a dose of 8 mg in 400 ml of hemodez, chlosal or 0.9% sodium chloride solution. If necessary, it is possible to re-administer LatranЃ.

Elderly Patients
No dosage changes are required.

Patients with kidney and liver damage
In case of kidney damage, it is not necessary to change the usual daily dose and the frequency of administration of the drug. With liver damage, the clearance of ondansetron is significantly reduced, and the half-life of it from the plasma increases, so 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% 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.

1 ml of solution contains:

Active ingredient: ondansetron hydrochloride dihydrate calculated as base - 2 mg.

Excipients: sodium chloride, hydrochloric acid, water for injection.

• Hypersensitivity to any component of the drug

• Pregnancy and lactation.

• Children under 2 years of age (safety and efficacy have not been studied)

Trade name of the drug: LatranЃ

International non-proprietary name:

ondansetron

Dosage forms: solution for intravenous and intramuscular administration; film-coated tablets.

Composition

1 ml of solution contains:

Active ingredient: ondansetron hydrochloride dihydrate calculated as base 2 mg.

Excipients: sodium chloride, hydrochloric acid, water for injection.

Description
Solution: colorless or almost colorless transparent liquid.
Tablets: film-coated tablets, yellow.

Pharmacotherapeutic group:

antiemetic agent, antagonist of serotonin receptors.

ATX code: ј04јј01

Pharmacological properties
Pharmacodynamics
Ondansetron is a selective antagonist of 5-HT3 (serotonin) receptors. Medicines for cytostatic chemotherapy and radiotherapy can cause an increase in serotonin levels, which, by activating the vagal afferent fibers containing 5-HT3 receptors, induces the gag reflex. Ondansetron inhibits the appearance of the gag reflex by blocking 5-HT3 receptors at the neuronal level of both the central and peripheral nervous systems. Apparently, the prevention and treatment of postoperative and induced by cytostatic chemotherapy and radio therapy of vomiting and nausea is based on this mechanism of action. LatranЃ possesses anxiolytic activity, does not cause sedation, impaired coordination of movements or decreased activity and performance.LatranЃ is used for the symptomatic treatment of mild to moderate alcohol withdrawal symptoms, acting on somatic and psychopathological symptoms.
Pharmacokinetics
When administered intramuscularly, the peak plasma concentration is reached within 10 minutes. The distribution of ondansetron is the same for oral, intramuscular and intravenous administration. After oral administration, the maximum concentration of ondansetron in the blood plasma is reached after about 1.5 hours. The absolute bioavailability is about 60%.
The drug is metabolized in the liver. Plasma protein binding is 70-76%. Less than 5% of the drug is excreted in the urine unchanged.
Both after oral administration and with parenteral administration, the half-life is about 3 hours, in elderly patients it can reach 5 hours, and with severe hepatic insufficiency - 15-32 hours. With kidney damage (renal clearance less than 15 ml / min), the half-life increases by 4-5 hours, but this increase has no clinical significance.

Indications for use
Prevention and elimination of nausea and vomiting that occur during cytostatic chemotherapy, X-ray radiation therapy, or other forms of radiation exposure, as well as postoperative nausea and vomiting.
Symptomatic treatment of alcohol withdrawal syndrome (mostly mild and moderate).

Contraindications

• Hypersensitivity to any component of the drug

• Pregnancy and lactation.

• Children under 2 years of age (safety and efficacy have not been studied)

Method of administration and dosage

Cytostatic therapy

The choice of the dosage regimen is determined by the emetogenicity of anticancer therapy.
For adults, the daily dose is usually 8-32 mg, the following regimens are recommended.

For mild emetogenic chemotherapy or radiotherapy:

• 8 mg intravenously as a slow jet or intramuscularly, immediately before starting therapy;

• 8 mg orally (2 tablets) 1-2 hours before starting therapy, then another 8 mg (2 tablets) 12 hours after starting therapy.

With highly emetogenic chemotherapy:

• 8 mg intravenously in a stream slowly immediately before starting chemotherapy, followed by two more intravenous injections of 8 mg, each given 2-4 hours later;

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

• 16-32 mg, diluted in 50-100 ml of the corresponding infusion solution, as a 15-minute infusion, immediately before starting chemotherapy.

The effectiveness of LatranЃ can be increased by a single intravenous administration of a glucocorticoid (for example, 20 mg dexamegazone) prior to chemotherapy; when taken orally to enhance the effect, a single dose can be increased to 24 mg and administered simultaneously with 12 mg of dexamegazone 1-2 hours before the start of chemotherapy.
To prevent delayed vomiting that occurs after the first 24 hours from the start of chemotherapy, it is recommended to continue the use of LatranЃ orally in the form of 8 mg tablets (2 4 mg tablets) 2 times a day for 5 days.

Children

For children over 2 years of age, the drug is prescribed in a dose of 5 mg / m2 of body surface intravenously, immediately before the start of chemotherapy, followed by oral administration in a dose of 4 mg after 12 hours; after the end of chemotherapy, it is recommended to continue treatment with 4 mg twice a day by mouth for 5 days.

Prevention of postoperative nausea and vomiting

For adults, a single dose of 4 mg is administered intramuscularly or intravenously in a stream, slowly at the beginning of anesthesia, or 16 mg is administered orally 1 hour before the onset of anesthesia.

To relieve the nausea and vomiting that has arisen, intramuscular or slow intravenous administration of 4 mg of the drug is recommended.
Intramuscularly in the same area of ??the body, LatranЃ can be injected in a dose not exceeding 4 mg!

For children, to prevent postoperative nausea and vomiting, LatranЃ is used exclusively parenterally in a single dose of 0.1 mg / kg (up to a maximum of 4 mg) as a slow intravenous injection before or after anesthesia.

For the treatment of developed postoperative nausea and vomiting in children , a slow intravenous administration of a single dose of LatranЃ 0.1 mg / kg (up to a maximum of 4 mg) is recommended.

There is little experience in the prevention and treatment of postoperative nausea and vomiting in children under 2 years of age.

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

For the symptomatic treatment of alcohol withdrawal syndrome, the drug is administered intravenously at a dose of 8 mg in 400 ml of hemodez, chlosal or 0.9% sodium chloride solution. If necessary, it is possible to re-administer LatranЃ.

Elderly Patients
No dosage changes are required.

Patients with kidney and liver damage
In case of kidney damage, it is not necessary to change the usual daily dose and the frequency of administration of the drug. With liver damage, the clearance of ondansetron is significantly reduced, and the half-life of it from the plasma increases, so 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% 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.

Side effect

Allergic reactions: urticaria, bronchospasm, laryngospasm, angioedema, anaphylaxis.
From the digestive system: hiccups, dry mouth, diarrhea, constipation, sometimes asymptomatic transient increase in serum aminotransferase levels.
From the side of the cardiovascular system: chest pains, in some cases with ST segment depression, arrhythmias, bradycardia, decreased blood pressure.
From the nervous system: headache, dizziness, spontaneous movement disorders and seizures.
Local reactions: pain, burning and redness at the injection site. Others: flush of blood to the face, feeling of heat, temporary impairment of visual acuity, rarely - hypokalemia (the connection with taking the drug has not been unequivocally established).

Interaction with other medicinal products

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

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

• with inhibitors of P450 enzymes (CYP2D6 and CYP3A) (allopurinol, macrolide antibiotics, antidepressants - MAO inhibitors, chloramphenicol, cimetidine, oral contraceptives containing estrogens, diltiazem, disulfiram, valproic acid, sodium elucidazolitone, phononichorone sodium lovastatin, metronidazole, omeprazole, propranolol, quinidine, quinine, verapamil).

Overdose

In cases of suspected overdose, symptomatic therapy is indicated.
In case of an overdose with Latran tablets, the use of ipecacuanha is not recommended, since it is unlikely that this drug will be effective during the period of antiemetic action of ondansetron.
No specific antidote is known.

special instructions

In patients who have previously been treated with other selective 5HT3 receptor antagonists. hypersensitivity reactions have been observed, with the use of LatranЃ, similar reactions may also develop.
Since Ondansetron can cause constipation, patients with signs of intestinal obstruction after using the drug require regular monitoring.
The infusion solution must be prepared just before use. If necessary, the ready-made infusion solution can be stored prior to use for a maximum of 24 hours at a temperature of 2-8 ? C.
No light protection is required during the infusion; The diluted injection solution is stable for at least 24 hours in natural light or normal light.

Release form

Solution for intravenous and intramuscular administration of 4 mg / 2 ml and 8 mg / 4 ml in ampoules. 1, 2 or 5 ampoules in a blister pack made of polyvinyl chloride film. One cell package together with instructions for use in a cardboard box.

Storage conditions

List B.
At a temperature not higher than + 25 ? C, in a dark place out of the reach of children.

Shelf life

Solution for intravenous and intramuscular administration - 3 years.
The drug should not be used after the expiration date printed on the package.

Conditions of dispensing from pharmacies

On prescription.