Latran, 4 mg 10 pcs
€11.52 €9.00
Latran is an antiemetic, antiabstinence.
Pharmacodynamics
A selective antagonist of 5-HT3 receptors (serotonin). Inhibits the emergence of gagging effect by blockade of 5-HT3 receptors at the neuronal level of both the central and peripheral nervous system. It has anxiolytic activity and does not cause sedation, impaired coordination of movements or decreased activity and performance. It smoothes somatic and psychopathological symptoms during alcohol withdrawal syndrome.
Pharmacokinetics
Injection Cmax in plasma is reached within 10 minutes; after oral administration, about 1.5 h. The distribution of ondansetron is the same when administered orally, intravenously and volumetrically. Absolute bioavailability is about 60%. Binding to plasma proteins is 70-76%. It is metabolized in the liver. Less than 5% of the drug is excreted unchanged in the urine. After oral intake and parenteral administration T1/2 is about 3 hours, in elderly patients it can be up to 5 hours, and in severe hepatic insufficiency 15-32 hours. In renal impairment (creatinine1/2 Cl increases by 4-5 h, but this increase is not clinically significant.
Indications
- nausea and vomiting caused by x-ray, radio- or chemotherapy with anti-tumor drugs or exposure to ionizing radiation;
- symptomatic treatment of alcohol withdrawal syndrome (especially mild and moderate severity).
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Active ingredient
Ondansetron
Composition
1 tablet contains:
The active ingredient:
ondansetron hydrochloride dihydrate (in terms of base)4 mg;
Associates:
MCC;
Silicon dioxide colloid (aerosil);
Potato starch;
Magnesium stearate;
Composition of the shell:
hydroxypropylcellulose;
tween 80 (polysorbate);
Tropeolin O;
Castor oil.
How to take, the dosage
Intravenously, intramuscularly, orally.
Cytostatic therapy: The choice of dosing regimen is determined by the emetogenicity of the antitumor therapy. For adults, the daily dose is usually 8-32 mg; the following regimens are recommended:
In moderate emetogenic chemotherapy or radiotherapy
- 8 mg w/v slow-acting or v/m immediately before starting therapy;
- 8 mg orally (2 tablets.1 to 2 hours before therapy, then another 8 mg (2 tablets) 12 hours after the start of therapy.
Highly emetogenic chemotherapy
- 8 mg by IV injection slowly just before the start of chemotherapy and then 2 more IV injections of 8 mg at 2-4 h intervals;
- 16-32 mg diluted in 50-100 ml of an appropriate infusion solution as a 15-minute infusion immediately before the start of chemotherapy.
The efficacy of Latran® may be increased by a single IV infusion of a glucocorticoid (e.g., 20 mg dexamethasone) prior to the start of chemotherapy.
In order to prevent delayed vomiting occurring after the first 24 hours from the start of chemotherapy, it is recommended that the drug be continued orally as tablets, 8 mg twice daily for 5 days.
In children over 2 years of age, the drug is administered in a dose of 5 mg/m2 by IV immediately before the start of chemotherapy followed by an oral dose of 4 mg 12 hours later; after completion of chemotherapy, we recommend continuing treatment at a dose of 4 mg orally 2 times daily for 5 days.
Prevention of postoperative nausea and vomiting: Adults are given a single dose of 8 mg v/mili by IV infusion slowly at the beginning of anesthesia, or 16 mg orally 1 hour before anesthesia. To relieve the resulting nausea and vomiting, an 8 mg dose is recommended in/m or slowly administered by injection. In/m to the same area of the body, Latran® may be administered in a dose not exceeding 8 mg.
In children to prevent postoperative nausea and vomiting, Latran® is used exclusively parenterally at a single dose of 0.1 mg/kg (up to a maximum of 4 mg) as a slow IV injection before or after anesthesia. For treatment of postoperative nausea and vomiting in children, a slow single dose of 0.1 mg/kg (max. up to 4 mg) by intravenous injection is recommended. In Russia, there is insufficient experience of using the drug for prevention and treatment of postoperative nausea and vomiting in children under 2 years of age.
In case of exposure 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 symptomatic treatment of alcohol withdrawal syndrome the drug is administered by IV infusion in a dose of 8 mg (as 2 mg/ml solution, 4 ml) in 400 ml of hemodesis, chlosol or physiological solution. Repeated administration of the drug is possible if necessary.
Elderly patients do not need to change the dosage.
Patients with renal impairment do not need to change the usual daily dose and frequency of administration of the drug.
In patients with liver damage, the dose should be reduced to 8 mg daily.
To dilute the injectable solution the following solutions can be used: 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.
Interaction
Because ondansetron is metabolized by the liver enzyme system (cytochrome P450), caution is required when used together:
– with enzymatic inducers of P450 (CYP2D6 and CYP3A) (barbiturates, carbamazepine, carisoprodol, glutethimide, griseofulvin, nitrous oxide, papaverine, phenylbutazone, phenytoin and probably other hydantoins, rifampicin, tolbutamide);
– with P450 enzyme inhibitors (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, ketoconazole, lovastatin, metronidazole, omeprazole, propranololol, quinidine, quinine, verapamil).
Special Instructions
Sensitivity reactions with Latran® may occur in patients previously observed for similar reactions with other selective 5-HT3 receptor antagonists.
Patients with signs of bowel obstruction after using the drug require regular monitoring because ondansetron may cause constipation.
The infusion solution should be prepared immediately prior to use. If necessary, the prepared infusion solution may be stored for a maximum of 24 h at 2-8 °C prior to use.
Protection from light is not required during infusion: the diluted infusion solution remains stable for at least 24 h in natural light or normal lighting.
Contraindications
- High sensitivity to any component of the drug
- Pregnancy
- Breast-feeding
- children under 2 years of age (safety and effectiveness has not been studied in Russia).
Side effects
Nervous system disorders: headache, dizziness, spontaneous motor disorders and convulsions.
Cardiovascular system: chest pain, in some cases with ST-segment depression, bradycardia, arrhythmias, arterial hypotension.
Gastrointestinal system disorders: hiccups, dry mouth, diarrhea, constipation, and sometimes asymptomatic transient elevation of serum aminotransferases.
Allergic reactions: urticaria, bronchospasm, laryngospasm, angioedema, anaphylaxis.
Others: local reactions (pain, burning and redness at the injection site), blood rush to the face, fever, temporary visual acuity impairment, hypokalemia.
Overdose
In cases of suspected overdose, symptomatic therapy is indicated.
In cases of overdose, the use of ipecacuana is not recommended, as it is unlikely that this drug will be effective during the anti-emetic effect of Latran®.
A specific antidote is not known.
Similarities
Ondansetron-Altfarm, Latran, Ondansetron
Weight | 0.015 kg |
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Shelf life | 3 years |
Conditions of storage | In a light-protected place, at a temperature not exceeding 25 °C |
Manufacturer | FGUP Pharmzaschita NPC, Russia |
Medication form | pills |
Brand | FGUP Pharmzaschita NPC |
Other forms…
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