Latran, 4 mg 10 pcs

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 C_max 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 T_1/2 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 antitumor drugs or exposure to ionizing radiation;
prevention, prevention and elimination of nausea and vomiting in the postoperative period;
symptomatic treatment of alcohol withdrawal syndrome (especially mild and moderate severity).

Pharmacological effect

Latran – antiemetic, anti-withdrawal.

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.

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 creatinine1/2 increases by 4–5 hours, but this increase has no clinical significance.

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.

Active ingredient

Ondansetron

Composition

1 tablet contains:

Active substance:

ondansetron hydrochloride dihydrate (based on base) 4 mg;

Excipients:

MCC;

colloidal silicon dioxide (Aerosil);

potato starch;

magnesium stearate;

Shell composition:

hydroxypropylcellulose;

Tween 80 (polysorbate);

tropeolin O;

castor oil.

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).

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.

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, ketoconazole, 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.

Storage conditions

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

Shelf life

3 years

Manufacturer

FSUE Pharmzaschita NPC, Russia