Latran

General characteristics. Structure:

Active agent: an ondansetrona of a hydrochloride of a dihydrate in terms of the basis – 4 mg.

Excipients: cellulose of microcrystallic 101 – 60 mg, aerosil (silicon dioxide colloid) – 6 mg, potato starch – 28 mg, magnesium stearate – 1 mg.

Structure of a cover: hydroxypropyl cellulose (hypro rod) – 1 mg, the twin-80 (polysorbate) – 0,2 mg, tropeolin O – 0,01 mg, castor oil – 0,2 mg.

Pharmacological properties:

Pharmacodynamics. Has antiemetichesky and anxiolytic activity.
Ondansetron is the selection antagonist of 5-HT3-retseptorov (serotonin). Medicines for cytostatic chemotherapy and radiotheraphy can cause increase in concentration of serotonin which by activation of the afferent fibers of a vagus nerve containing 5-HT3-retseptory causes an emetic reflex. Selectively blocks serotoninovy 5HT3-receptors of neurons central (the emetic center) and peripheral (digestive tract) of a nervous system, regulating an emetic reflex. Does not break coordination of movements, does not cause sedation and decrease in working capacity. Does not change concentration of prolactin in plasma.

Pharmacokinetics. After intake the maximum concentration of an ondansetron in a blood plasma is reached approximately in 1,5 hours. Absolute bioavailability makes about 60%. Drug is exposed to metabolism in a liver with participation of enzymes of system of a microsomal oxidation. Linkng with proteins of plasma makes 70-76%. With urine in not changed look less than 5% of drug are allocated. The elimination half-life makes about 3 hours.

Features of pharmacokinetics at special groups of patients: the semi-allocation period at elderly patients can reach 5 hours, at pathology of a liver and kidneys – 15-32 hours.

Indications to use:

The prevention and elimination of nausea and vomiting, arising at cytostatic chemotherapy, radiotheraphy or other forms of beam influence, and also postoperative nausea and vomiting.

Route of administration and doses:

In oncological practice for prevention and stopping of an emetichesky syndrome when carrying out radio - and chemotherapy:
Cytostatic therapy
The choice of the mode of dosing is defined by an emetogennost of antineoplastic therapy.
For adults the daily dose makes 8-24 mg, the following modes are recommended:
At moderate expressiveness of emetogenny action himio-or radiotheraphy:
To adults and children 12 years are more senior appoint 8 mg of an ondansetron in 1-2 hours prior to performing the main therapy with the subsequent reception of 8 more mg inside in 12 hours.
To children from 4 to 11 years appoint 4 mg of an ondansetron in 30 minutes prior to performing the main therapy with the subsequent reception of 4 more mg in every 8 hours.
Data on use at radiotheraphy for children up to 12 years are absent.
At high expressiveness of emetogenny action himio-or radiotheraphy:
The recommended dose for adults (data on use for children are absent) makes 24 mg along with dexamethasone inside in a dose of 12 mg for 1-2 h prior to carrying out chemotherapy.

For prevention of late or long vomiting:
Adults should continue administration of drug inside in a dose of 8 mg 2 times a day within 5 days after the end of the main therapy.

To children drug is appointed in a dose of 5 mg/sq.m of a body surface intravenously within not less than 15 minutes just before the beginning of chemotherapy, with the subsequent intake of 4 mg of an ondansetron in 12 hours; treatment is recommended to continue in a dose 4 mg 2 times a day inside within 5 days.

In surgical practice for prevention and stopping of an emetichesky postoperative syndrome:
Prevention of postoperative nausea and vomiting
Adult appoint 16 mg inside in 1 hour prior to the beginning of an anesthesia of the general anesthesia.
To children to prevention and stopping of postoperative nausea and vomiting ондансетрон it is applied only parenterally.
Concerning prevention and treatment of postoperative nausea and vomiting children under 2 years have no sufficient experience.
At impact of ionizing radiation of ЛатранÒ accept inside in a single dose 8 mg (2 tablets) in 1 hour prior to or right after beam influence.

Elderly patients
Change of a dose is not required.

Patients with damages of kidneys and a liver
At pathology of kidneys it is not required to change a usual daily dose and frequency of administration of drug. At liver pathology the daily dose is reduced to 8 mg.

Patients with slow metabolism of sparteine/debrisoquine
Correction of a daily dose or frequency of reception of an ondansetron is not required.

Features of use:

Ondansetron children should not appoint less than 0,6 sq.m with body surface area. Ondansetron it is impossible to apply to prevention and treatment of postoperative nausea and vomiting at children after abdominal organs operations. In case of side reactions from a nervous system patients are recommended to refrain from driving and other mechanisms, and also occupations the types of activity demanding concentration of attention, tension of psychomotor functions.

Influence of medicine on ability to manage vehicles, mechanisms
Data on adverse influence of medicine Latran on ability to manage vehicles and mechanisms are absent.

Side reactions from a nervous system in the form of a headache are possible, dizzinesses, extrapyramidal disturbances, passing disturbance of visual acuity. It should be considered when performing the above-stated actions.

Side effects:

Allergic reactions: small tortoiseshell, bronchospasm, laryngospasm, Quincke's disease, anaphylaxis.
From a nervous system: headache, dizziness, extrapyramidal disturbances.
From the alimentary system: a hiccups, dryness in a mouth, diarrhea, a lock, asymptomatic passing increase in activity of aminotransferases in blood serum.
From cardiovascular system: thorax pains, depression of a segment of ST, arrhythmia, bradycardia, lowering of arterial pressure.
Others: "inflow" of blood to face skin, feeling of heat, temporary disturbance of visual acuity, a hypopotassemia (connection with administration of drug is unambiguously not established).
If any of the side effects specified in the instruction are aggravated, or you noticed any other side effects which are not specified in the instruction, report about it to the doctor.

Interaction with other medicines:

As ондансетрон it is metabolized by fermental system (P450 cytochrome) of a liver, care at combined use is required:

- with P450 cytochrome inductors (isoenzymes of CYP2D6 and CYP3A): barbiturates, carbamazepine, каризопродол, глютетимид, griseofulvin, a dinitrogene oxide, a papaverine, phenylbutazone, Phenytoinum (it is probable also other hydantoins), rifampicin, Tolbutamidum;

- with P450 cytochrome inhibitors (isoenzymes of CYP2D6 and CYP3A): Allopyrinolum, antibacterial drugs of group of macroleads, antidepressants – MAO inhibitors, chloramphenicol, Cimetidinum, the oral contraceptives containing estrogen, diltiazem, Disulfiramum, valproic acid drugs, erythromycin, флуконазол, ftorkhinolona, an isoniazid, кетоконазол, ловастатин, metronidazole, омепразол, propranolol, quinidine, quinine, verapamil.

Special researches showed what ондансетрон does not interact with alcohol, temazepam, furosemide and propofoly. Data of special researches indicate what ондансетрон can reduce analgesic effect of a tramadol.

If you take other medicine, before administration of drug surely consult with the doctor.

Contraindications:

- Hypersensitivity to any component of drug;
- I trimester of pregnancy and period of breastfeeding;
- Children's age up to 2 years (experience of use for children is younger than 2 years is absent therefore purpose of Latran® medicine at this category of patients is contraindicated);
- Children's age up to 3 years (for a dosage of 4 mg);
- Children's age up to 12 years (for a dosage of 8 mg).
If at you one of the listed states, before administration of drug surely consult with the doctor.

With care
Arrhythmias, electrolytic imbalance, concomitant use of antiarrhytmic medicines and beta adrenoblockers.
Use at pregnancy and during breastfeeding
Latran is contraindicated to use in the I trimester of pregnancy.
In need of use in the period of a lactation it is necessary to stop breastfeeding.

Overdose:

Symptoms: a vision disorder, a lock, a lowering of arterial pressure and a vazovagalny episode with a passing atrioventricular block of the II degree. In all cases of the phenomenon are completely reversible.
Treatment: carry out a symptomatic and maintenance therapy, the specific antidote is not known.

Storage conditions:

In the dry, protected from light place at a temperature not above 25 °C.
To store in the places unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Tablets, coated 4 mg. On 2, 4 or 10 tablets in a blister strip packaging from a film of the polyvinyl chloride and printing aluminum foil varnished.

On 1 blister strip packaging on 10 tablets together with the application instruction place in a pack from a cardboard.
On 2 or 4 tablets place in cases polyethylene. The free space in a case is filled with the hygroscopic medical cotton or mouthpieces filtering.
On 0,4 kg (4000 pieces) or 0,8 kg (8000 pieces) in banks (large bottles) of dark glass with the screwed plastic covers or in banks (bottles) from plastic. The free space in bank is filled with hygroscopic medical cotton.
Cases are polyethylene, banks and planimetric packagings on 2 or 4 tablets are intended for a special purpose.