Latran is a drug with antiemetic and anti-abstinent action.
Release form and composition
- Solution for intramuscular and intravenous administration (2 or 4 ml in ampoules, in a cardboard bundle of 1, 2 or 5 ampoules);
- Yellow-coated tablets (10 each in a blister pack, in a carton pack 1 pack; 0.4 and 0.8 kg in dark glass jars).
The active substance is ondansetron hydrochloride dihydrate, its content in terms of base: in 1 ml of solution - 2 mg, in 1 tablet - 4 mg.
Auxiliary components of the solution: sodium chloride, water for injection, hydrochloric acid.
Additional components of tablets:
- Excipients: magnesium stearate, colloidal silicon dioxide (aerosil), microcrystalline cellulose;
- Shell composition: tropeolin O, tween 80 (polysorbate), hydroxypropylcellulose, castor oil.
Indications for use
- Prevention and elimination of nausea and vomiting in the postoperative period;
- Nausea and vomiting caused by anticancer drugs, chemo-, x-ray and radiotherapy, exposure to ionizing radiation;
- Symptomatic therapy of alcohol withdrawal syndrome (mainly mild to moderate severity).
Latran is contraindicated in the following cases:
- Children's age up to 2 years (due to lack of data on safety and efficacy of use);
- Lactation period;
- Increased sensitivity to components.
Dosing and Administration
Latran solution is administered intravenously (iv) or intramuscularly (im), the tablets are taken orally.
When conducting cytostatic therapy, the dosage of Latran is determined by the emethogenicity of antitumor agents. The daily dose for adults, as a rule, ranges from 8 to 32 mg.
Moderate emetogenic radio or chemotherapy:
- 8 mg intramuscularly or intravenously in a jet slowly, immediately before starting treatment;
- 8 mg orally (2 tablets) for 1-2 hours before the start of therapy, and then another 8 mg 12 hours after it began.
Highly Effective Chemotherapy:
- 24 mg in the form of a continuous 24-hour infusion at a rate of 1 mg / hour;
- 8 mg IV bolus slowly before starting chemotherapy, then another 2 injections of 8 mg at intervals of 2-4 hours;
- 16-32 mg, diluted with 50-100 ml of infusion solution, intravenously for 15 minutes immediately before the start of chemotherapy.
If necessary, the effectiveness of Latran can be increased by a single intravenous administration of a glucocorticoid (for example, dexamethasone at a dose of 20 mg) before the start of chemotherapy.
To prevent the development of delayed vomiting, which usually occurs after 24 hours from the start of chemotherapy, Latran is recommended to continue to take in the form of tablets - 2 pcs. 2 times a day for 5 days.
The dose for children older than 2 years is 5 mg / m 2 , the drug is administered intravenously immediately before the start of chemotherapy, and after 12 hours, it is administered orally at a dose of 4 mg. After the end of chemotherapy, it is also recommended to continue Latran 4 mg 2 times a day for 5 days.
Postoperative nausea and vomiting:
- Warning in adults: 8 mg IV bolus slowly or IM once at the beginning of anesthesia or 16 mg orally 1 hour before the onset of anesthesia;
- Relief in adults: 8 mg once a day or slowly in / in;
- Warning in children: exclusively in / in a dose of 0.1 mg / kg (but not more than 4 mg) once as a slow injection before or after anesthesia;
- Stopping in children: 0.1 mg / kg (but not more than 4 mg) once slowly in a / c.
With the introduction of the drug and to prevent, and for the relief of nausea and vomiting should be borne in mind that in the same area of the body, you can enter a dose not exceeding 8 mg.
When exposed to ionizing radiation, Latran is prescribed orally at a 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 iv drip in a dose of 8 mg, diluted in 400 ml of physiological saline, hemodesis or chloxol. If necessary, enter a repeated dose.
The maximum daily dose for patients with liver damage is 8 mg.
The following solutions can be used for dilution of Latran: 5% glucose, 0.9% sodium chloride, Ringer, 0.3% potassium chloride and 5% glucose, 0.3% potassium chloride, and 0.9% sodium chloride.
- Nervous system: dizziness, headache, spontaneous movement disorders, convulsions;
- Gastrointestinal: diarrhea or constipation, dry mouth, hiccups; rarely, asymptomatic and transient increases in serum aminotransferase levels;
- Cardiovascular system: arrhythmias, bradycardia, arterial hypotension, chest pain (sometimes with ST-segment depression);
- Allergic reactions: laryngism, bronchospasm, anaphylaxis, urticaria, angioedema;
- Others: temporary impairment of visual acuity, feeling of heat, flushing of the face, hypokalemia, local reactions (redness, burning, pain at the injection site).
Ondansetron can cause constipation, so patients with signs of intestinal obstruction after applying Latran should be under constant medical supervision.
Hypersensitivity reactions to the drug can occur in people who have a history of similar reactions to the development of other selective 5-HT 3 receptor antagonists.
Infusion solution is recommended to prepare immediately before the introduction. During the infusion, protection from light is not required, since It maintains its stability for 24 hours in normal or natural light.
Ondansetron is metabolized in the liver with the participation of the cytochrome P450 system, so care should be taken when it is necessary to use the following medicines at the same time:
- Enzymatic inducers of P450 (CYP2D6 and CYP3A): griseofulvin, glutethimide, nitrous oxide, carisoprodol, papaverine, carbamazepine, phenylbutazone, tolbutamide, rifampicin, barbiturates, phenytoin, and probably other hydantoins;
- Enzymes P450 , propranolol, quinine, fluconazole, omeprazole, verapamil.
Terms and conditions of storage
Store at a temperature up to 25 ºС in a dark place and out of reach of children.
Shelf life - 3 years.
The diluted injection solution can be stored for no more than 24 hours at a temperature of 2-8 ° C.