Expiration date: 09/2025

Composition and form of release:

Solution for intravenous and intramuscular administration of 1 ml

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

excipients: sodium chloride acid hydrochloric water for injection

in ampoules of 2 or 4 ml in a pack of cardboard 1 2 or 5 pcs.

Coated tablets 1 table.

ondansetron hydrochloride dihydrate (in terms of base) 4 mg

excipients: MCC silicon dioxide colloidal (aerosil) potato starch magnesium stearate

shell composition: hydroxypropyl cellulose twin 80 (polysorbate) tropeolin O castor oil

in a contour cell pack of 10 pcs. in a pack of cardboard 1 pack, or in dark glass jars of 0.4 (4000) and 0.8 kg (8000 pcs.).

Description of the dosage form:

Solution: colorless or almost colorless transparent liquid.

Tablets: yellow coated tablets.

Pharmacokinetics:

With intravenous administration, Cmax in plasma is reached within 10 minutes after oral administration — approximately 1, 5 hours. The distribution of ondansetron is the same with oral, intravenous and intravenous administration. Absolute bioavailability is about 60%. Binding to plasma proteins is 70-76%. It undergoes metabolism in the liver. Less than 5% of the drug is excreted unchanged in the urine. Both after oral administration and with parenteral administration, T1 / 2 is about 3 hours, in elderly patients it can reach 5 hours, and with severe hepatic insufficiency — 15-32 hours. With kidney damage (creatinine Cl <15 ml/min), T1/2 increases by 4-5 hours, but this increase has no clinical significance.

Description of pharmacological action:

Selective antagonist of 5-HT3 (serotonin) receptors. Inhibits the appearance of an emetic effect by blocking 5-HT3 receptors at the level of neurons of both the central and peripheral nervous system. It has anxiolytic activity, does not cause sedation, impaired coordination of movements or decreased activity and performance. It levels somatic and psychopathological symptoms in alcohol withdrawal syndrome.

Dosage:

INSTRUCTIONS for use of LATRANUM (LATRANUM)

APPROVED:

Pharmacological State Committee of the Ministry of Health of the Russian Federation on March 23 , 2000 in return

instructions approved on April 11, July 6, 1995, March 28, 1996, 29

July 1998

Latran (ondansetron) — 9-methyl?3-(2-methyl?1H-imidazole?1-ilmetil)?1, 2, 3, 9-tetrahydrocarbazole?4

(H)-oh hydrochloride dihydrate — white or white with a creamy tint

crystalline powder. In medical practice, it is used as a solution for injection and tablets.

Pharmacological properties

Latran is an antiemetic from the group of serotonin antagonists. Pharmacodynamics. Selectively blocks 5-HT3 receptors of the central and peripheral nervous system, including in neural centers regulating the implementation of vomiting reflexes. The drug has anxiolytic activity, does not cause sedation, impaired coordination of movements or decreased activity and performance. Eliminates somatic and psychopathological symptoms in alcohol withdrawal syndrome of mild and moderate severity.

Indications for use

• Nausea and vomiting caused by radioradio or chemotherapy
• antitumor drugs or exposure to ionizing radiation.
• Prevention and treatment of vomiting in the postoperative period. Symptomatic
• treatment of alcohol withdrawal syndrome (especially mild and moderate severity).

Method of administration and dosage

A solution of Latran 0.2% for injection is injected intravenously, Latran tablets are taken orally. Adults, a 0.2% Latran solution is first administered once in / in at a dose of 0.008-0. 016 g for 15 minutes immediately before chemotherapy. After 2 hours, they begin to take Latran tablets orally in a single dose of 0.008 g every 8 hours, but no more than 5 days. For children over 4 years of age, a 0.2% Latran solution is administered once intravenously for 15 minutes immediately before chemotherapy at a dose determined at the rate of 0.005 g of the drug per 1 m2 of the child's body surface, after which Latran tablets are taken orally at 0.004 g every 8 hours, but no more than 5 days. When exposed to ionizing radiation, the drug is taken orally in a single dose of 0.008 g (2 tables). 1 hour before or immediately after radiation exposure. For the symptomatic treatment of alcohol withdrawal syndrome, an intravenous drip is administered at a dose of 0.008 g in the form of a 0.2% solution in 400 ml of hemodesis, chlosol or saline solution. If necessary, repeated administration of the drug Latran is possible.

Contraindications

Hypersensitivity, pregnancy, breastfeeding period.

Side effect

From the central nervous system: headache is rare — transient visual disturbances and dizziness (with rapid intravenous administration), involuntary movements.

From the cardiovascular system: chest pain, arrhythmias, bradycardia, arterial hypotension.

From the digestive system: constipation, diarrhea, transient increase of transaminases in blood serum.

Allergic reactions: rarely — bronchospasm, angioedema, urticaria in some cases — anaphylactic reactions.

Other: urinary retention, a feeling of warmth and a rush of blood to the head and epigastric region.

Special instructions

When used in patients with moderate and severe hepatic impairment, it is not recommended to exceed the dose of 8 mg / day.

Interaction with other drugs

Due to the fact that ondansetron is metabolized in the liver by enzymes of the cytochrome P450 system, it is possible that when used simultaneously with drugs that are inducers or inhibitors of this enzyme system, Cl and T1 /2 ondansetron change.

Release form

0.2% solution for injection in ampoules of 2 ml or 4 ml, 5 ampoules in a box of 0.004 g tablets, coated with 10 pcs. in a contour cell package, in a box of 1 package or in cans of 60 or 100 pcs., or in cans of 0.5 kg.

Storage conditions

Ampoules with the solution — in a place protected from light. Tablets — in a dry, protected from light place. List B.

Expiration date

3 years.

They are available by prescription.

Manufacturer — State enterprise SPC "Farmzashchita", 141400, Khimki, Moscow region, Vashutinskoe highway, 11

Indications:

• 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 and moderate severity).

Contraindications:

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

Side effect:

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, arrhythmias, arterial hypotension.

From the gastrointestinal tract: hiccups, dry mouth, diarrhea, constipation, sometimes an asymptomatic transient increase in the level of aminotransferases in the blood serum.

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

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

Drug interaction:

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

• with enzymatic inducers P450 (CYP2D6 and CYP3A) (barbiturates, carbamazepine, carisoprodol, glutetimide, griseofulvin, nitrous oxide, papaverine, phenylbutazone, phenytoin and probably other hydantoines, rifampicin, tolbutamide)
• with inhibitors of P450 enzymes (CYP2D6 and CYP3A) (allopurinol, macrolide antibiotics, antidepressant MAO inhibitors, chloramphenicol, cimetidine, estrogen—containing oral contraceptives, diltiazem, disulfiram, erythromycin, valproic acid, sodium valproate, fluconazole, fluoroquinolones, isoniazid, ketoconazole, lovastatin, metronidazole, omeprazole, propranolol, quinidine, quinine, verapamil).

Method of administration and dosage:

In/in, in/m, inside.

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

With moderate emetogenic chemo- or radiotherapy

- 8 mg i / v jet slowly or i / m immediately before the start of therapy

- 8 mg orally (2 tables) 1-2 hours before the start of therapy, then another 8 mg (2 tables). 12 hours after the start of therapy.

With highly emetogenic chemotherapy

- 8 mg intravenously slowly immediately before the start of chemotherapy, and then 2 more intravenous injections of 8 mg at intervals of 2-4 hours

- continuous 24-hour infusion at a dose of 24 mg at a rate of 1 mg /h

- 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 Latran can be increased by a single intravenous administration of a glucocorticoid (for example, 20 mg dexamethasone) 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 taking the drug orally in the form of tablets, 8 mg 2 times a day for 5 days.

For children over 2 years of age, the drug is prescribed at a dose of 5 mg / m2 IV immediately before the start of chemotherapy, followed by oral administration at a dose of 4 mg 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 given a single dose of 8 mg I / m or I / v jet slowly at the beginning of anesthesia, or prescribed orally 16 mg 1 hour before anesthesia. To relieve the nausea and vomiting that has arisen, it is recommended that an intravenous or slow intravenous administration of 8 mg of the drug. In / m, Latran can be injected into the same area of the body in a dose not exceeding 8 mg.

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

When exposed to ionizing radiation, Latran is taken orally in a single dose of 8 mg (2 tables). 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 the form of a solution of 2 mg / ml, 4 ml) in 400 ml of hemodesis, chlosol or saline solution. If necessary, repeated administration of the drug is possible.

Elderly patients do not need to change the dosage.

Patients with kidney damage 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's solution 0, 3% potassium chloride solution and 0.9% sodium chloride solution 0, 3% potassium chloride solution and 5% glucose solution.

Overdose:

In cases of suspected overdose, symptomatic therapy is indicated.

In case of overdose, the use of ipecacuanha is not recommended, because it is unlikely that this drug will be effective during the antiemetic action of Latran.

A specific antidote is not known.

Special instructions:

Hypersensitivity reactions with the use of Latran may occur in patients who have previously been observed for similar reactions with other selective 5-HT3 receptor antagonists.

Patients with signs of intestinal obstruction after using the drug require regular monitoring, because ondansetron can cause constipation.

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

During the infusion, no protection from light is required: the diluted injection solution remains stable for at least 24 hours in natural light or normal lighting.