Latran, 2 mg/ml, solution for intravenous and intramuscular administration, 2 ml, 5 pcs.

Nosological classification (ICD-10)

• F10.3 Withdrawal state
• K21 Gastroesophageal reflux
• K21.0 Gastroesophageal reflux with esophagitis
• K25 Stomach ulcer
• K26 Duodenal ulcer
• K29.1 Other acute gastritis
• K29.5 Chronic gastritis, unspecified
• K91.3 Postoperative intestinal obstruction
• K94* Diagnosis of gastrointestinal diseases
• R11 Nausea and vomiting
• T51 Toxic effects of alcohol
• T90.5 Consequences of intracranial injury
• Z100* CLASS XXII Surgical practice
• Z51.0 Radiotherapy course
• Z51.1 Chemotherapy for neoplasm
• Z54 Convalescent period
• Z58.4 Exposure to radiation pollution

Composition and release form

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

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

Latran, 10 pcs., 4 mg, film-coated tablets

INSTRUCTIONS for using 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-imidazol-1-ylmethyl)-1,2,3,9-tetrahydrocarbazole-4

(H)-one hydrochloride dihydrate - white or off-white

crystalline powder. In medical practice it is used in the form of an injection solution 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, incl. in the neural centers that regulate the implementation of gag reflexes. The drug has anxiolytic activity and does not cause sedation, impaired coordination of movements or decreased activity and performance. Eliminates somatic and psychopathological symptoms of mild to moderate alcohol withdrawal syndrome.

Indications for use

Nausea and vomiting caused by X-ray 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

degree of severity).

Directions for use and doses

Latran solution 0.2% for injection is administered intravenously, Latran tablets are taken orally. For adults, Latran solution 0.2% is first administered once intravenously at a dose of 0.008–0.016 g over 15 minutes immediately before chemotherapy. After 2 hours, start taking Latran tablets orally in a single dose of 0.008 g every 8 hours, but not more than 5 days. For children over 4 years of age, Latran solution 0.2% 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 h, but not more than 5 days. When exposed to ionizing radiation, the drug is taken orally in a single dose of 0.008 g (2 tablets) 1 hour before or immediately after radiation exposure. For the symptomatic treatment of alcohol withdrawal syndrome, a dose of 0.008 g is administered intravenously in the form of a 0.2% solution in 400 ml of hemodez, chlosol or saline. If necessary, re-administration of the drug Latran is possible.

Contraindications

Hypersensitivity, pregnancy, breastfeeding period.

Side effect

From the side of the central nervous system:

headache; rarely - 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 in serum transaminases.

Allergic reactions:

rarely - bronchospasm, angioedema, urticaria; in some cases - anaphylactic reactions.

Other:

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

special instructions

When used in patients with moderate and severe liver dysfunction, it is not recommended to exceed a 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 of ondansetron change.

Release form

Solution 0.2% for injection in ampoules of 2 ml or 4 ml, 5 ampoules per box; tablets of 0.004 g, film-coated, 10 pcs. in blister packs, 1 pack in a box, or in jars of 60 or 100 pcs., or in jars of 0.5 kg.

Storage conditions

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

Best before date

3 years.

Dispensed by prescription.

Manufacturer - State Enterprise SPC "Pharmzashchita", 141400, Khimki, Moscow region, Vashutinskoe highway, 11

Pharmacokinetics

With intramuscular administration, Cmax in plasma is achieved within 10 minutes; after oral administration - after about 1.5 hours. The distribution of ondansetron is the same with oral, intramuscular and intravenous administration. Absolute bioavailability is about 60%. Plasma protein binding is 70–76%. Metabolized 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 liver failure - 15–32 hours. With kidney damage (Cl creatinine <15 ml/min) T1 /2 increases by 4–5 hours, but this increase is not clinically significant.

Latran 4 mg tablet p/o No. 10

Dosage

4 mg

Active substance

Ondansetron

Manufacturer

FSUE NPC Pharmzaschita FMBA (Russia)

Shelf life

3 years

Storage conditions

In a dry place, protected from light, at a temperature not exceeding 25 °C

Registration certificate number

LS-001889 dated 10/08/2018

Description of the dosage form

Solution:

colorless or almost colorless transparent liquid.

Pills:

Film-coated tablets are yellow.

Pharmacokinetics

With intramuscular administration, Cmax in plasma is achieved within 10 minutes; after oral administration - after about 1.5 hours. The distribution of ondansetron is the same with oral, intramuscular and intravenous administration. Absolute bioavailability is about 60%. Plasma protein binding is 70–76%. Metabolized 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 liver failure - 15–32 hours. With kidney damage (Cl creatinine <15 ml/min) T1 /2 increases by 4–5 hours, but this increase is not clinically significant.

Pharmacodynamics

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

Instructions

INSTRUCTIONS for using 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-imidazol-1-ylmethyl)-1,2,3,9-tetrahydrocarbazole-4

(H)-one hydrochloride dihydrate - white or off-white

crystalline powder. In medical practice it is used in the form of an injection solution 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, incl. in the neural centers that regulate the implementation of gag reflexes. The drug has anxiolytic activity and does not cause sedation, impaired coordination of movements or decreased activity and performance. Eliminates somatic and psychopathological symptoms of mild to moderate alcohol withdrawal syndrome.

Indications for use

Nausea and vomiting caused by X-ray 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

degree of severity).

Directions for use and doses

Latran solution 0.2% for injection is administered intravenously, Latran tablets are taken orally. For adults, Latran solution 0.2% is first administered once intravenously at a dose of 0.008–0.016 g over 15 minutes immediately before chemotherapy. After 2 hours, start taking Latran tablets orally in a single dose of 0.008 g every 8 hours, but not more than 5 days. For children over 4 years of age, Latran solution 0.2% 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 h, but not more than 5 days. When exposed to ionizing radiation, the drug is taken orally in a single dose of 0.008 g (2 tablets) 1 hour before or immediately after radiation exposure. For the symptomatic treatment of alcohol withdrawal syndrome, a dose of 0.008 g is administered intravenously in the form of a 0.2% solution in 400 ml of hemodez, chlosol or saline. If necessary, re-administration of the drug Latran is possible.

Contraindications

Hypersensitivity, pregnancy, breastfeeding period.

Side effect

From the side of the central nervous system:

headache; rarely - 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 in serum transaminases.

Allergic reactions:

rarely - bronchospasm, angioedema, urticaria; in some cases - anaphylactic reactions.

Other:

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

special instructions

When used in patients with moderate and severe liver dysfunction, it is not recommended to exceed a 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 of ondansetron change.

Release form

Solution 0.2% for injection in ampoules of 2 ml or 4 ml, 5 ampoules per box; tablets of 0.004 g, film-coated, 10 pcs. in blister packs, 1 pack in a box, or in jars of 60 or 100 pcs., or in jars of 0.5 kg.

Storage conditions

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

Best before date

3 years.

Dispensed by prescription.

Manufacturer - State Enterprise SPC "Pharmzashchita", 141400, Khimki, Moscow region, Vashutinskoe highway, 11

Indications

INSTRUCTIONS for using 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-imidazol-1-ylmethyl)-1,2,3,9-tetrahydrocarbazole-4

(H)-one hydrochloride dihydrate - white or off-white

crystalline powder. In medical practice it is used in the form of an injection solution 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, incl. in the neural centers that regulate the implementation of gag reflexes. The drug has anxiolytic activity and does not cause sedation, impaired coordination of movements or decreased activity and performance. Eliminates somatic and psychopathological symptoms of mild to moderate alcohol withdrawal syndrome.

Indications for use

Nausea and vomiting caused by X-ray 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

degree of severity).

Directions for use and doses

Latran solution 0.2% for injection is administered intravenously, Latran tablets are taken orally. For adults, Latran solution 0.2% is first administered once intravenously at a dose of 0.008–0.016 g over 15 minutes immediately before chemotherapy. After 2 hours, start taking Latran tablets orally in a single dose of 0.008 g every 8 hours, but not more than 5 days. For children over 4 years of age, Latran solution 0.2% 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 h, but not more than 5 days. When exposed to ionizing radiation, the drug is taken orally in a single dose of 0.008 g (2 tablets) 1 hour before or immediately after radiation exposure. For the symptomatic treatment of alcohol withdrawal syndrome, a dose of 0.008 g is administered intravenously in the form of a 0.2% solution in 400 ml of hemodez, chlosol or saline. If necessary, re-administration of the drug Latran is possible.

Contraindications

Hypersensitivity, pregnancy, breastfeeding period.

Side effect

From the side of the central nervous system:

headache; rarely - 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 in serum transaminases.

Allergic reactions:

rarely - bronchospasm, angioedema, urticaria; in some cases - anaphylactic reactions.

Other:

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

special instructions

When used in patients with moderate and severe liver dysfunction, it is not recommended to exceed a 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 of ondansetron change.

Release form

Solution 0.2% for injection in ampoules of 2 ml or 4 ml, 5 ampoules per box; tablets of 0.004 g, film-coated, 10 pcs. in blister packs, 1 pack in a box, or in jars of 60 or 100 pcs., or in jars of 0.5 kg.

Storage conditions

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

Best before date

3 years.

Dispensed by prescription.

Manufacturer - State Enterprise SPC "Pharmzashchita", 141400, Khimki, Moscow region, Vashutinskoe highway, 11

Contraindications

hypersensitivity to any component of the drug;

pregnancy;

breast-feeding;

children under 2 years of age (safety and effectiveness of use in Russia have not been studied).

Directions for use and doses

IV, IM, 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 chemotherapy or radiotherapy

- 8 mg IV in a slow stream or IM immediately before starting 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.

With highly emetogenic chemotherapy

- 8 mg IV infusion slowly immediately before the start of chemotherapy, and then 2 more IV injections of 8 mg each with an interval 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, as 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 of dexamethasone) before starting 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 tablet form, 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 after 12 hours; after completion 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 IM or IV in a slow stream at the beginning of anesthesia, or 16 mg is prescribed orally 1 hour before the start of anesthesia. To relieve nausea and vomiting, it is recommended to administer 8 mg of the drug intramuscularly or slowly intravenously. Latran® can be administered intramuscularly into the same area of ​​the body in a dose not exceeding 8 mg.

For children, to prevent postoperative nausea and vomiting, Latran® is used exclusively parenterally in a single dose of 0.1 mg/kg (maximum 4 mg) as 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 (maximum up to 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 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 in a dose of 8 mg (in the form of a solution of 2 mg/ml, 4 ml) in 400 ml of hemodez, hlosol or saline solution. If necessary, the drug can be re-administered.

Elderly patients

no dosage change is required.

Patients with kidney damage

There is no need to change the usual daily dose or frequency of administration of the drug.

For 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.

Side effects

From the nervous system:

headache, dizziness, spontaneous movement disorders and convulsions.

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 asymptomatic transient increases in serum aminotransferase levels.

Allergic reactions:

urticaria, bronchospasm, laryngospasm, angioedema, anaphylaxis.

Other:

local reactions (pain, burning and redness at the injection site), flushing of the face, feeling of heat, temporary impairment of visual acuity, hypokalemia.

Interaction

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

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

- with inhibitors of P450 enzymes (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, ket okonazole, lovastatin , metronidazole, omeprazole, propranolol, quinidine, quinine, verapamil).

Overdose

In cases of suspected overdose, symptomatic therapy is indicated.

In case of overdose, the use of ipecac is not recommended, because It is unlikely that this drug will be effective during the period of antiemetic action of Latran®.

A specific antidote is not known.

special instructions

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 using the drug require regular monitoring, because ondansetron may cause constipation.

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

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

Pharmgroups

Serotonergic agents

Pharmaceutical actions

antiemetic, anti-withdrawal

Side effects

From the nervous system: headache, dizziness, spontaneous movement disorders and convulsions.

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 asymptomatic transient increases 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), flushing of the face, feeling of heat, temporary impairment of visual acuity, hypokalemia.

Latran tablets ppo 4 mg No. 10

Compound

Active substance: ondansetron hydrochloride dihydrate - 5 mg (in terms of ondansetron - 4 mg).
Excipients: microcrystalline cellulose - 57.0 mg, potato starch - 28.0 mg, colloidal silicon dioxide - 6.0 mg, magnesium stearate - 1.0 mg.

Pharmacokinetics

Ondansetron undergoes a first-pass effect through the liver. Protein binding is high (70-76%). Biotransformed in the liver, mainly by hydroxylation. The average T1/2 in adult patients is about 4 hours.

Indications for use

Prevention of nausea and vomiting during antitumor chemotherapy or radiation therapy; prevention and treatment of nausea and vomiting in the postoperative period.

Contraindications

Hypersensitivity to ondansetron; simultaneous use of ondansetron with apomorphine; pregnancy, lactation (breastfeeding); children's age - depending on the indications and dosage form; congenital long QT interval syndrome.

With caution: in patients with hypersensitivity to other 5HT3 receptor antagonists, with disturbances in heart rhythm and conduction, with significant disturbances in water and electrolyte balance; in patients with prolongation or risk of prolongation of the QTc interval, including patients with fluid and electrolyte imbalances, chronic heart failure, bradyarrhythmias, or in patients taking other drugs that may cause QTc prolongation, fluid and electrolyte imbalances, or a decrease in heart rate; in patients receiving antiarrhythmic drugs and beta-blockers; in patients with subacute intestinal obstruction; when used simultaneously with other serotonergic drugs.

Directions for use and doses

Inside.

• Prevention and treatment of nausea and vomiting caused by cytostatic chemotherapy and radiation therapy in adults

The choice of dosage regimen is determined by the emetogenicity of antitumor therapy and may differ depending on the dose and combinations of chemotherapy and radiation therapy regimens used.

Adults

The recommended dose is 8 mg of ondansetron 1-2 hours before the start of cytotoxic chemotherapy or radiation therapy, followed by 8 mg orally every 12 hours for no more than 5 days.

For highly emetogenic chemotherapy, a single dose of oral ondansetron is 24 mg simultaneously with oral dexamethasone at a dose of 12 mg 1-2 hours before the start of chemotherapy.

After the first 24 hours after chemotherapy or radiation therapy, you can continue taking Latran® orally for no more than 5 days.

It is recommended to take Latran® orally at a dose of 8 mg 2 times a day.

Special patient groups

• Elderly patients

No dose adjustment of Latran® in oral dosage form is required for elderly patients.

• Patients with impaired renal function

No adjustment is required in the daily dose, dosing frequency, or route of administration of ondansetron.

• Patients with liver dysfunction

In patients with moderate to severe liver dysfunction, the clearance of ondansetron is significantly reduced and the half-life is significantly increased.

In such patients, the daily dose of ondansetron should not exceed 8 mg.

• Patients with poor metabolism of sparteine-debrisoquine

In patients with poor metabolism of sparteine-debrisoquine, the half-life of ondansetron is unchanged. Therefore, when ondansetron is reintroduced to such patients, its plasma concentration will not differ from that in the general population. Therefore, no adjustment of the daily dose or dosing frequency of ondansetron is required in this case.

• Prevention and treatment of nausea and vomiting caused by other types of radiation exposure in adults

The drug Latran® is taken orally in a single dose of 8 mg (2 tablets) 1 hour before or immediately after radiation exposure.

• Prevention and treatment of nausea and vomiting caused by cytostatic chemotherapy in children

Dose calculation based on body surface area in children aged 3 years to 18 years for the prevention and treatment of chemotherapy-induced nausea and vomiting

The drug Latran®, a solution for intravenous and intramuscular administration, can be used as a single intravenous injection at a dose of 5 mg/m2 (not more than 8 mg) immediately before chemotherapy, followed by oral administration of the drug 12 hours later. Taking the drug Latran® in oral dosage form can be continued for another 5 days after the course of chemotherapy. Dosages used for adults should not be exceeded.

Dose calculation table based on body surface area in children aged 3 years to 18 years for the prevention and treatment of chemotherapy-induced nausea and vomiting

Dose calculation based on body weight in children aged 3 years to 18 years for the prevention and treatment of chemotherapy-induced nausea and vomiting

The drug Latran®, solution for intravenous and intramuscular administration should be administered once intravenously immediately before the start of chemotherapy (see instructions for use for the drug Latran®, solution for intravenous and intramuscular administration), followed by oral administration of the drug Latran 12 hours after the start of therapy.

Taking Latran® in oral dosage form can be continued for another 5 days after the course of chemotherapy. Dosages used for adults should not be exceeded.

Weight-Based Dose Calculation Chart in Children 3 Years to 18 Years of Age for the Prevention and Treatment of Chemotherapy-Induced Nausea and Vomiting

• Prevention of postoperative nausea and vomiting in adults

Adults

To prevent nausea and vomiting in the postoperative period, it is recommended to take 16 mg of Latran® orally 1 hour before anesthesia.

For the treatment of postoperative nausea and vomiting, the drug Latran® is used in the dosage form of a solution for intravenous and intramuscular administration.

Special patient groups

• Children aged 3 to 18 years

Studies of taking Latran® in oral dosage form for the prevention or treatment of nausea and vomiting in the postoperative period have not been conducted; for this purpose, it is recommended to use the drug Latran®, a solution for intravenous and intramuscular administration in the form of slow intravenous injections (lasting at least 30 seconds).

• Elderly patients

There is limited experience with ondansetron for the prevention of postoperative nausea and vomiting in elderly patients, although ondansetron is well tolerated in patients aged 65 years and older who have received chemotherapy.

• Patients with impaired renal function

No adjustment is required in the daily dose, dosing frequency, or route of administration of ondansetron.

• Patients with liver dysfunction

In patients with moderate to severe liver dysfunction, the clearance of ondansetron is significantly reduced and the half-life is significantly increased.

In such patients, the daily dose of ondansetron should not exceed 8 mg.

• Patients with poor metabolism of sparteine-debrisoquine

In patients with poor metabolism of sparteine-debrisoquine, the half-life of ondansetron is unchanged. Therefore, when ondansetron is reintroduced to such patients, its plasma concentration will not differ from that in the general population. Therefore, no adjustment of the daily dose or dosing frequency of ondansetron is required in this case.

Storage conditions

In a place protected from light, at a temperature not exceeding 25°C.

Keep out of the reach of children.

Best before date

3 years. Do not use after the expiration date.

special instructions

There are reports of hypersensitivity reactions to ondansetron in patients with a history of hypersensitivity to other selective 5HT3 receptor antagonists.

Ondansetron is known to increase the transit time of colonic contents. When using ondansetron in patients with symptoms of subacute intestinal obstruction, regular monitoring of such patients is necessary.

Hypokalemia and hypomagnesemia must be corrected before using ondansetron.

It has been established that with the combined use of ondansetron and other serotonergic drugs, the risk of developing serotonin syndrome increases. If the use of such a combination is clinically justified, it is necessary to ensure regular monitoring of the patient's condition.

Description

A centrally acting antiemetic drug that blocks serotonin receptors.

Dosage form

Round, biconvex, yellow film-coated tablets; On a cross section, the core is white or almost white.

Use in children

It can be used in children of the appropriate age categories strictly according to indications, in recommended doses and dosage forms. It is necessary to strictly follow the instructions in the instructions for ondansetron preparations regarding contraindications for the use of specific dosage forms of ondansetron in children of different ages.

Pharmacodynamics

Antiemetic. Effectively prevents and eliminates nausea and vomiting that occurs during antitumor chemotherapy or radiation therapy, as well as in the postoperative period. The mechanism of action is due to the ability of ondansetron to selectively block serotonin 5-HT3 receptors. It is believed that stimulation of the afferent fibers of the vagus nerve by serotonin released from the enterochromaffin cells of the gastrointestinal mucosa plays an important role in the occurrence of nausea and vomiting during antitumor therapy. By blocking 5-HT3 receptors, ondansetron prevents the gag reflex. In addition, ondansetron inhibits the central parts of the gag reflex, blocking 5-HT3 receptors in the bottom of the fourth ventricle (area postrema).

Side effects

The adverse reactions presented below are listed according to the damage to organs and organ systems and the frequency of occurrence. The frequency of occurrence is determined as follows: very often (≥1/10); often (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10000 to <1/1000); very rare (<1/10000, including isolated cases).

Adverse reactions observed as “very common,” “common,” and “uncommon” were generally defined from clinical trial data. The frequency of occurrence when taking placebo was also taken into account. Adverse reactions observed as “rare” and “very rare” were defined based on spontaneous reports obtained as part of post-marketing surveillance.

When taking standard recommended doses of ondansetron, the incidence rates shown below are established. The adverse reaction profile in children and adolescents was comparable to that observed in adults.

Immune system disorders

Rarely: immediate hypersensitivity reactions (urticaria, bronchospasm, laryngospasm, angioedema), in some cases severe, including anaphylaxis.

Nervous system disorders

Very common: headache.

Uncommon: seizures, movement disorders (including extrapyramidal symptoms such as dystonia, oculogyric crisis [convulsive gaze] and dyskinesia) in the absence of persistent clinical consequences.

Rare: dizziness, mainly during rapid intravenous administration.

Visual disorders

Rare: transient visual disturbances (eg, blurred vision), mainly during intravenous administration.

Very rare: transient blindness, mainly during intravenous administration.

Most cases of blindness resolved successfully within 20 minutes. Most patients received chemotherapy drugs containing cisplatin. In some cases, transient blindness was of cortical origin.

Heart disorders

Uncommon: arrhythmia, chest pain, both accompanied and not accompanied by a decrease in the ST segment, bradycardia.

Rare: QT interval prolongation (including torsade de pointes).

Vascular disorders

Common: feeling of heat or hot flashes.

Uncommon: decreased blood pressure.

Respiratory, thoracic and mediastinal disorders

Uncommon: hiccups.

Gastrointestinal disorders

Common: constipation.

Disorders of the liver and biliary tract

Uncommon: asymptomatic increase in the activity of the liver enzymes alanine aminotransferase (ALT), aspartate aminotransferase (AST) (mainly observed in patients receiving cisplatin chemotherapy).

Skin and subcutaneous tissue disorders

Very rare: toxic skin rash, including toxic epidermal necrolysis.

If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Use during pregnancy and breastfeeding

Contraindicated for use during pregnancy and lactation (breastfeeding). If necessary, use during lactation should stop breastfeeding.

Interaction

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

In patients receiving strong inducers of the CYP3A4 isoenzyme (phenytoin, carbamazepine and rifampicin), the clearance of ondansetron increases and the concentration of ondansetron in the blood decreases.

There is evidence that ondansetron may reduce the analgesic effect of tramadol.

When ondansetron is used concomitantly with other serotonergic drugs, including selective serotonin reuptake inhibitors and norepinephrine and serotonin reuptake inhibitors, the risk of developing serotonin syndrome increases.

Overdose

Symptoms

There is currently insufficient data regarding overdose with ondansetron. In most cases, symptoms of overdose were similar to adverse events reported in patients receiving recommended doses. Ondansetron causes a dose-dependent prolongation of the QT interval. It is recommended to monitor ECG in case of drug overdose. Symptoms suggestive of serotonin syndrome have been reported following oral overdose in children.

Treatment

There is no specific antidote for ondansetron, therefore, if an overdose is suspected, it is recommended to carry out appropriate symptomatic and supportive therapy. Further treatment should be carried out based on the clinical situation. The use of ipecac for the treatment of drug overdose is not recommended as patients are unlikely to respond to treatment with ipecac due to the opposite effects of ondansetron.

Impact on the ability to drive vehicles and operate machinery

During the period of use of ondansetron, patients should be careful when driving vehicles and machinery, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Interaction

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

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

- with inhibitors of P450 enzymes (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, ket okonazole, lovastatin , metronidazole, omeprazole, propranolol, quinidine, quinine, verapamil).

Directions for use and doses

IV, IM, 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 chemotherapy or radiotherapy

- 8 mg IV in a slow stream or IM immediately before starting 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.

With highly emetogenic chemotherapy

- 8 mg IV infusion slowly immediately before the start of chemotherapy, and then 2 more IV injections of 8 mg each with an interval 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, as 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 of dexamethasone) before starting 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 tablet form, 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 after 12 hours; after completion 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 IM or IV in a slow stream at the beginning of anesthesia, or 16 mg is prescribed orally 1 hour before the start of anesthesia. To relieve nausea and vomiting, it is recommended to administer 8 mg of the drug intramuscularly or slowly intravenously. Latran® can be administered intramuscularly into the same area of ​​the body in a dose not exceeding 8 mg.

For children, to prevent postoperative nausea and vomiting, Latran® is used exclusively parenterally in a single dose of 0.1 mg/kg (maximum 4 mg) as 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 (maximum up to 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 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 in a dose of 8 mg (in the form of a solution of 2 mg/ml, 4 ml) in 400 ml of hemodez, chlorsol or saline solution. If necessary, the drug can be re-administered.

Elderly patients do not need to change the dosage.

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

If there is liver damage, the dose should be reduced 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.

Latran, 2 mg/ml, solution for intravenous and intramuscular administration, 2 ml, 5 pcs.

INSTRUCTIONS for using 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-imidazol-1-ylmethyl)-1,2,3,9-tetrahydrocarbazole-4

(H)-one hydrochloride dihydrate - white or off-white

crystalline powder. In medical practice it is used in the form of an injection solution 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, incl. in the neural centers that regulate the implementation of gag reflexes. The drug has anxiolytic activity and does not cause sedation, impaired coordination of movements or decreased activity and performance. Eliminates somatic and psychopathological symptoms of mild to moderate alcohol withdrawal syndrome.

Indications for use

Nausea and vomiting caused by X-ray 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

degree of severity).

Directions for use and doses

Latran solution 0.2% for injection is administered intravenously, Latran tablets are taken orally. For adults, Latran solution 0.2% is first administered once intravenously at a dose of 0.008–0.016 g over 15 minutes immediately before chemotherapy. After 2 hours, start taking Latran tablets orally in a single dose of 0.008 g every 8 hours, but not more than 5 days. For children over 4 years of age, Latran solution 0.2% 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 h, but not more than 5 days. When exposed to ionizing radiation, the drug is taken orally in a single dose of 0.008 g (2 tablets) 1 hour before or immediately after radiation exposure. For the symptomatic treatment of alcohol withdrawal syndrome, a dose of 0.008 g is administered intravenously in the form of a 0.2% solution in 400 ml of hemodez, chlosol or saline. If necessary, re-administration of the drug Latran is possible.

Contraindications

Hypersensitivity, pregnancy, breastfeeding period.

Side effect

From the side of the central nervous system:

headache; rarely - 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 in serum transaminases.

Allergic reactions:

rarely - bronchospasm, angioedema, urticaria; in some cases - anaphylactic reactions.

Other:

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

special instructions

When used in patients with moderate and severe liver dysfunction, it is not recommended to exceed a 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 of ondansetron change.

Release form

Solution 0.2% for injection in ampoules of 2 ml or 4 ml, 5 ampoules per box; tablets of 0.004 g, film-coated, 10 pcs. in blister packs, 1 pack in a box, or in jars of 60 or 100 pcs., or in jars of 0.5 kg.

Storage conditions

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

Best before date

3 years.

Dispensed by prescription.

Manufacturer - State Enterprise SPC "Pharmzashchita", 141400, Khimki, Moscow region, Vashutinskoe highway, 11

special instructions

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 using the drug require regular monitoring, because ondansetron may cause constipation.

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

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