Latran, 2 mg/ml, solution for intravenous and intramuscular administration, 4 ml, 5 pcs.

Release form and composition

The drug is available in the following dosage forms:

• Solution for intravenous and intramuscular administration: clear liquid, almost colorless or colorless (2 ml or 4 ml in ampoules, 1, 2 or 5 ampoules in PVC (polyvinyl chloride) film, 1 blister in a cardboard pack);
• Film-coated tablets: yellow film (10 pieces in a strip pack, 1 pack in a cardboard box).

1 ml of solution contains:

• Active ingredient: ondansetron hydrochloride dihydrate (in terms of ondansetron) – 2 mg;
• Auxiliary components: hydrochloric acid, sodium chloride, water for injection.

1 film-coated tablet contains:

• Active ingredient: ondansetron hydrochloride dihydrate (in terms of ondansetron) – 4 mg;
• Auxiliary components: aerosil (colloidal silicon dioxide), microcrystalline cellulose, magnesium stearate, potato starch;
• Shell: hydroxypropylcellulose (hyprolose), tropeolin O, polysorbate (Tween-80), castor oil.

Instructions

The instructions contain information about the indications, method of administration, contraindications, as well as drug interactions. You need to familiarize yourself with this data to avoid unpleasant consequences in the future.

pharmachologic effect

The components of Latran act on certain receptors of the central and peripheral nervous system. The action is carried out at the neuronal level. Relief from conditions on the list of indications is observed within one hour after injection or taking tablets. The drug does not cause the effect of impaired coordination of movements or decreased performance. This nuance is explained by the lack of sedative action of the medication.

Pharmacological properties:

• 
  stimulation of afferent fibers of the vagus nerve;

• elimination of vomiting of various etiologies;
• restoration of the protective functions of the mucous membranes of the digestive tract;
• inhibition of the central part of the gag reflex;
• selective blocking of serotonin receptors.

Indications

The drug Latran is used in such cases as:

• Attacks of nausea, as well as vomiting, which are caused by x-ray, chemotherapy, radiotherapy;
• Alcohol syndrome.

Mode of application

The solution is administered intravenously or intramuscularly. Administration is carried out dropwise or in a slow stream. No more than 4 mg of Latran can be injected into one area of ​​the body. The tablets should be taken orally with plenty of water.

The doctor determines the required dosage based on the patient’s age and disease.

For chemotherapy, radiotherapy, and x-ray therapy, the drug is administered at a dosage of 32 mg:

• Tablets should be taken one hour before treatment, 2 tablets each. The next appointment should be 12 hours after the start of the course;
• The solution should be administered at 8 mg.

Chemotherapy is usually prescribed:

• The drug in a dosage of 8 mg for intravenous administration before the start of the procedure, then 8 mg is administered after 4 hours;
• The drug is administered intravenously at a dosage of 24 mg;
• The drug is administered intravenously within 15 minutes before the start of the procedure at a dosage of 16-32 mg. The drug is diluted in 50-100 ml of infusion solution.

In order to prevent vomiting, which may occur 24 hours after the start of therapy, Latran should be continued orally, i.e. 2 tablets of 4 or 8 mg 2 times a day. The course of therapy is no more than 5 days.

To eliminate attacks of nausea in the postoperative period, a single dosage should be 4 mg. The drug must be administered intravenously or intramuscularly before the onset of anesthesia, or 16 mg, i.e. 4 tablets one hour before anesthesia.

Children are prescribed the drug only in the form of a solution, which is administered before and also after anesthesia; a single dosage should not exceed 0.1 mg/kg (the maximum allowable dose is no more than 4 mg).

To eliminate vomiting and nausea that have already occurred, adults are prescribed intramuscular or intravenous administration of the drug in a dosage of 4 mg. For children, the medicine is administered intravenously at a dosage of 0.1 mg/kg body weight. The maximum permissible dosage is no more than 4 mg.

To treat alcohol withdrawal syndrome, the solution is administered intravenously at a dosage of 8 mg. If necessary, the medication may be repeated.

To dilute the medicine in solution form, the following can be used:

• Ringer's solution;
• Dextrose solution;
• Sodium chloride solution.

Release form

The drug Latran is available in the following forms:

• Film-coated tablets. The shell has a yellow tint;
• A solution intended for intramuscular and intravenous administration.

Interaction

Caution should be exercised when taking this substance together with such components as:

• With enzymatic inducers, for example, barbiturates, carisoprodol, griseofulvin, rifampicin, phenytoin, papaverine, tolbutamide;
• With P450 enzyme inhibitors, for example antidepressants, ketocanazole, omeprazole, quinidine, isoniazid, diltiazem, disulfires, chloramphenicol, cimetidine, fluconazole, lovastatin, propranolol, quinine.

Directions for use and dosage

The solution is administered intramuscularly (IM), intravenously (IV) in a slow stream or drip. IM administration of Latran in a dose of no more than 4 mg is allowed in one area of ​​the body.

The tablets are intended for oral use.

The Latran dosage regimen for cytostatic therapy depends on the emetogenicity of the antitumor procedure and the age category of the patient.

Moderate emetogenic chemotherapy or radiotherapy, adult patients: standard daily dose – 8-32 mg:

• Solution: immediately before the start of the procedure, i.v. in a slow stream or i.m. – 8 mg;
• Tablets: 1-2 hours before the start of treatment, 2 pcs. 4 mg (8 mg), the next dose at the same dose 12 hours after the start of the course.

Highly emetogenic chemotherapy, adult patients:

• IV jet slow infusion - 8 mg immediately before the start of the procedure, another 2 IV injections of 8 mg each with an interval between them of 2 to 4 hours;
• IV continuous drip infusion - during the day at a dose of 24 mg at a rate of 1 mg/hour;
• IV 15 minute infusion, immediately before the start of the procedure - 16-32 mg, diluted in 50-100 ml of the appropriate infusion solution.

The effectiveness of Latran solution can be increased by a single intravenous administration of a glucocorticoid (for example, dexamethasone - 20 mg) before the start of chemotherapy. When administered orally, the single dose can be increased to 24 mg to enhance the effect, and at the same time prescribe 12 mg of dexamethasone (1-2 hours before the start of chemotherapy).

In order to prevent delayed vomiting, which occurs after a day (the first 24 hours) from the start of treatment, it is recommended to continue the use of Latran orally - 2 tablets of 4 mg (8 mg) 2 times a day for 5 days.

For children over 2 years of age, the drug is prescribed immediately before the start of chemotherapy, intravenously at a dose of 5 mg/m2 of body surface. After 12 hours, oral administration of the drug is recommended - 1 tablet (4 mg); At the end of chemotherapy, it is recommended to take 1 tablet for 5 days. (4 mg) 2 times a day.

Preventing nausea and vomiting in the postoperative period:

• Adults: a single dose of 4 mg IM or IV in a slow stream at the beginning of anesthesia, or 16 mg (4 tablets) orally 1 hour before anesthesia;
• Children: exclusively in the form of a solution, slowly IV before or after anesthesia, single dose - 0.1 mg/kg (maximum - up to 4 mg).

Relief of existing nausea and vomiting:

• Adults: IM or slow IV – 4 mg;
• Children: slowly IV – 0.1 mg/kg (maximum – up to 4 mg).

In case of exposure to ionizing radiation, the drug is taken orally, a single dose is 2 tablets of 4 mg (8 mg) 1 hour before or immediately after irradiation.

For symptomatic treatment of alcohol withdrawal syndrome, the solution is administered intravenously in a dose of 8 mg (2 ampoules of 2 ml or 1 ampoule of 4 ml diluted in 400 ml of chlosol, hemodez or 0.9% sodium chloride solution). If necessary, repeated administration of Latran is allowed.

No dosage changes are required in the elderly and patients with kidney damage.

In case of liver dysfunction, the clearance of ondansetron is significantly reduced, and its half-life from plasma increases, so a correction (reduction) of the daily dose to 8 mg is required.

The following infusion solutions can be used to dilute Latran solution:

• Ringer's solution;
• 5% dextrose solution;
• 0.3% potassium chloride solution and 0.9% sodium chloride solution;
• 0.9% sodium chloride solution;
• 0.3% potassium chloride solution and 5% dextrose solution.

Latran, 2 mg/ml, solution for intravenous and intramuscular administration, 4 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

Side effects

• Digestive system: dry mouth, hiccups, constipation, diarrhea, sometimes transient asymptomatic increases in serum aminotransferase levels;
• Cardiovascular system: arrhythmias, chest pain (in some episodes with ST segment depression), decreased blood pressure, bradycardia;
• Nervous system: dizziness, headache, spontaneous movement disorders, convulsions;
• Allergic responses: angioedema, urticaria, laryngospasm, bronchospasm, anaphylaxis;
• Local reactions (parenteral administration): pain, redness and burning at the injection site;
• Other: feeling of heat, flushing of the face, temporary decrease in visual acuity, rarely - hypokalemia (a clear dependence on the drug has not been established).

In case of suspected overdose, symptomatic therapy is recommended.

There is no data on a specific antidote for ondansetron.

In case of an overdose of Latran tablets, the use of ipecac (emetic root) is not recommended, since the effectiveness of the emetic during the period of inhibition of the gag reflex under the influence of ondansetron is unlikely.

Side effects

The use of the medicine may cause side effects, which can be expressed in conditions such as:

• Dizziness, convulsions, blurred vision, headache;
• Diarrhea, dry mouth, constipation, and hiccups;
• Arrhythmia, chest pain, bradycardia, hypotension;
• Bronchospasm, urticaria, laryngospasm, anaphylaxis;
• Feeling of heat, redness, pain at the injection site, hypokalemia.

Overdose

Exceeding dosages of Latran can provoke serious pathological conditions. If side symptoms appear as a result of an overdose, ipecac should not be used. The emetic root will intensify the negative reaction of the body and cause additional pathological manifestations.

There is no specific antidote against side symptoms from an overdose of Latran. Treatment is prescribed in accordance with the clinical picture of the patient’s health condition.

Severe consequences of overdose:

• 
  

  manifestations of bradycardia;
• angioedema;
• decreased blood pressure;
• convulsive conditions;
• decreased visual acuity;
• bronchospasm;
• anaphylactic shock.

Contraindications

It is not recommended to prescribe this drug for conditions such as:

• Allergy to the components of the medicine;
• human age up to 2 years.

In addition, the drug Latran can be cautiously prescribed during abdominal surgery.

Pregnancy

This medication is not recommended for use in the first trimester of pregnancy. This is due to the fact that the drug Latran can have a negative effect not only on the girl’s body, but also on the fetus.

In addition, it is also better to avoid taking this medication while breastfeeding.

special instructions

Patients with a history of hypersensitivity reactions to other selective 5-HT3 receptor antagonists may develop similar responses to Latran.

In case of signs of intestinal obstruction after using the drug, regular monitoring of the patient is required, since ondansetron can cause constipation.

The infusion solution should be prepared immediately before use. Before use, the prepared infusion solution can be stored at a temperature of 2 to 8 °C for no more than a day.

When carrying out the infusion, there is no need to protect the solution from light; the prepared injection solution remains stable for 24 hours under lamp lighting or natural light.

Drug interactions

Ondansetron is metabolized in the liver by an enzyme system (cytochrome P450), so caution must be exercised when using Latran and the following drugs/substances together:

• Enzymatic inducers of P450 (CYP2D6 and CYP3A) - carbamazepine, rifampicin, carisoprodol, barbiturates, glutethimide, griseofulvin, papaverine, dinitrogen oxide, phenylbutazone, phenytoin (possibly other hydantoins), tolbutamide;
• P450 enzyme inhibitors (CYP2D6 and CYP3A) - macrolide antibiotics, allopurinol, antidepressants (monoamine oxidase inhibitors), cimetidine, chloramphenicol, estrogen-containing oral contraceptives, disulfiram, diltiazem, sodium valproate, valproic acid, erythromycin, fluoroquinolones, fluconazole, isoniasis id, lovastatin, metronidazole, ketoconazole, omeprazole, propranolol, quinine, quinidine, verapamil.