Description
Latin name
Latranum
Packing
5 ampoules of 2 ml
Pharmacological action
Latran – antiemetic, anti-withdrawal.
Pharmacodynamics
Selective 5-HT3 (serotonin) receptor antagonist. It inhibits the appearance of an emetic effect by blocking 5-HT3 receptors at the level of neurons in both the central and peripheral nervous systems. It has anxiolytic activity, does not cause sedation, impaired coordination of movements or decreased activity and performance. It eliminates somatic and psychopathological symptoms in alcohol withdrawal symptoms.
Pharmacokinetics
With the intramuscular administration of Cmax in plasma, it is achieved within 10 minutes after oral administration – after about 1.5 hours. The distribution of ondansetron is the same when administered orally, intramuscularly and intravenously. Absolute bioavailability is about 60%. Binding to plasma proteins – 70 76%. It is metabolized in the liver. With urine, unchanged, less than 5% of the drug is excreted. Both after oral administration and 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 1/2 increases by 4 5 h, but this increase is not clinically significant.
Indications for
nausea and vomiting caused by X-ray, radiotherapy 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 moderate to severe alcohol withdrawal syndrome.
Use during pregnancy and lactation
Contraindicated.
Composition
1 ml of the solution contains:
Active ingredient: ondansetron hydrochloride dihydrate (in terms of base) 2 mg
Excipients: sodium chloride acid hydrochloric water for injection.
Dosage and administration of
Intravenously, intramuscularly.
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 slowly or IM immediately before the start of
therapy With highly emetogenic chemotherapy
– 8 mg iv intravenously slowly immediately before chemotherapy, and then another 2 iv injections of 8 mg with an interval of 2 4 hours
– continuous 24-hour infusion at a dose of 24 mg at a speed of 1 mg / h
– 16 32 mg, diluted in 50-100 ml of the appropriate infusion solution, in the form of a 15-minute in fusion immediately before chemotherapy.
The efficacy of Latran ® can be increased by a single intravenous administration of a glucocorticoid (eg 20 mg dexamethasone) before 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 by mouth 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 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 by mouth 2 times a day for 5 days.
Prevention of postoperative nausea and vomiting: adults are given a single dose of 8 mg IM / IV / jet slowly at the beginning of anesthesia, or 16 mg is prescribed orally 1 hour before the start of anesthesia. For the relief of nausea and vomiting that occurs, it is recommended that / m or a slow iv injection of 8 mg of the drug. V / m in the same part of the body Latran ® can be introduced 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 (up to 4 mg maximum) as a slow intravenous injection before or after anesthesia. For the treatment of postoperative nausea and vomiting in children, slow intravenous administration of a single dose of 0.1 mg / kg (up to 4 mg maximum) is recommended. In Russia, there is insufficient experience in the use of the drug to prevent and treat 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 tablets) 1 hour before or immediately after radiation exposure.
For the symptomatic treatment of alcohol withdrawal symptoms, 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, chlorosol or physiological saline. If necessary, re-administration of the drug is possible.
Elderly patients do not require dosage changes.
Patients with kidney damage do not need to change the usual daily dose and frequency of drug administration.
In case of liver damage, 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 cramps.
From the cardiovascular system: chest pain, in some cases with ST segment depression, bradycardia, arrhythmias, arterial hypotension.
From the digestive tract: hiccups, dry mouth, diarrhea, constipation, sometimes asymptomatic transient increase in serum aminotransferases.
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, a temporary violation of visual acuity, hypokalemia.
Drug Interaction
As ondansetron is metabolized by liver enzymes (cytochrome P450), p450 (CYP2D6, CYP3A) , phenytoin, and probably other phenytoin, phenytoin, phenytoin , fluconazole, fluoroquinolones, isoniazid, ketoconazole, lovastatin, metronidazole, omeprazole, propranolol, quinidine, quinine, verapamil).
Overdose
Symptomatic treatment is indicated in cases of suspected overdose.
Ipecacuanine is not recommended for overdosage because it is unlikely that this drug will be effective during the anti-emetic action of Latran ®.
No specific antidote known.
Storage conditions
In the dark place at a temperature of no higher than 25 ° C.
Shelf suitability
3 Year
Deystvuyuschee substances
ondansetron
pharmacy terms for prescription
Dosage Form A dosage form
injection and infusion
