Latran

General characteristics. Structure:

Active agent: an ondansetrona of a hydrochloride of a dihydrate in terms of the basis – 2,0 mg.

Excipients: sodium chloride – 9,0 mg, Acidum hydrochloricum solution of 0,1 M – to рН 3,5, water for injections – to 1 ml.

Pharmacological properties:

Pharmacodynamics. Has antiemetichesky and anxiolytic activity. Is the selection antagonist of receptors 5-НТ3® mediates antiemetichesky activity due to serotonin emission blockade by enterokhromaffinny cells of a mucous membrane of digestive tract and neurons of the Area postrema area of a bottom of the IV ventricle. (serotonin) of the central and peripheral nervous system.

Pharmacokinetics. At intramuscular introduction the maximum concentration in plasma is reached within 10 minutes. Distribution of an ondansetron is identical at peroral, intramuscular and intravenous administration. 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%. Kidneys in not changed look remove less than 5% of drug.

The elimination half-life makes about 3 hours, at elderly patients can reach 5 hours.

The pharmacokinetics of an ondansetron practically does not change at the patients with heavy renal failures who are on a chronic hemodialysis (researches were conducted in breaks between hemodialysis sessions). Patients with the expressed abnormal liver functions have an elimination half-life – 15-32 hours.

Indications to use:

The prevention and elimination of nausea and vomiting, arising at cytostatic chemotherapy, radiotheraphy, and also postoperative nausea and vomiting.
Symptomatic treatment of an alcoholic abstinence syndrome (generally easy and moderate severity).

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, as a rule, makes 8-32 mg, the following modes are recommended:
At moderate emetogenny chemotherapy or radiotheraphy:
- 8 mg intravenously struyno slowly or intramusculary, just before the beginning of therapy.
At vysokoemetogenny chemotherapy:
- 8 mg intravenously struyno slowly just before the beginning of chemotherapy, and then two more intravenous injections on 8 mg, each of which is carried out in 2-4 hours;
- continuous 24-hour infusion of drug in a dose of 24 mg with a speed of 1 mg/hour;
- 15-minute infusion of the drug in a dose of 16-32 mg divorced in
50-100 ml of the corresponding infusion solution, just before the beginning of chemotherapy.

Efficiency of ЛатранÒ medicine can be increased due to one-time intravenous administration of a glucocorticosteroid (for example, 20 mg of dexamethasone) prior to the beginning of chemotherapy.

To children is more senior than 2 years drug is appointed in a dose of 5 mg/sq.m of a body surface intravenously, just before the beginning of chemotherapy with the subsequent intake in a dose of 4 mg in 12 hours; after the termination of chemotherapy it is recommended to continue treatment on 4 mg twice a day inside within 5 days.

In surgical practice for prevention and stopping of an emetichesky postoperative syndrome:
Prevention of postoperative nausea and vomiting

The adult enter a single dose of 4 mg intramusculary or intravenously struyno, slowly at the beginning of an anesthesia, or appoint 16 mg inside in 1 hour prior to the beginning of an anesthesia.

For stopping of the arisen nausea and vomiting single intramuscular or slow intravenous administration of 4 mg of drug is recommended.

Intramusculary into the same body part of ЛатранÒ it can be entered in the dose which is not exceeding 4 mg!
To children to prevention of postoperative nausea and vomiting of ЛатранÒ it is applied exclusively parenterally in a single dose of 0,1 mg/kg (as much as possible to 4 mg) in the form of a slow intravenous injection to or after anesthesia.

For treatment of the developed postoperative nausea and vomiting at children slow intravenous administration of a single dose of ЛатранÒ 0,1 medicine of mg/kg is recommended (as much as possible to 4 mg).
Concerning prevention and treatment of postoperative nausea and vomiting children under 2 years have no sufficient experience.

For a symptomatic treatment of an alcoholic abstinence syndrome the drug is administered intravenously kapelno in a dose of 8 mg in 400 ml of solution of potassium of chloride + acetate sodium + sodium of chloride (Hlosol) or 0,9% of solution of sodium of chloride. In case of need perhaps repeated administration of the drug ЛатранÒ.

Elderly patients
Change of a dosage 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.

The following solutions can be applied to cultivation of injection solution:

- 0,9% chloride sodium solution,

- 5% dextrose solution,

- Ringer's solution,

- 0,3% solution of potassium of chloride and 0,9% chloride sodium solution,

- 0,3% solution of potassium of chloride and 5% dextrose solution.

Infusion solution has to be prepared just before use.

Features of use:

The patients who had earlier allergic reactions to other selection blockers of 5-HT3-retseptorov have the increased risk of their development against the background of reception of ЛатранÒ medicine. Ondansetron can slow down motility of a large intestine in this connection its appointment as the patient with signs of impassability of intestines demands special observation.

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

There are messages on a headache, dizziness, extrapyramidal disturbances, temporary 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.
Local reactions: pain, burning and reddening in an injection site.
From a nervous system: headache, dizziness, extrapyramidal disturbances, spasms.
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 with ST segment depression, lengthening of an interval of Q-T, arrhythmia, bradycardia, a lowering of arterial pressure.
Others: "inflow" of blood to face skin, feeling of heat, a tranzitorny blindness, 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 inductors of isoenzymes of CYP2D6 and CYP3A: barbiturates, carbamazepine, каризопродол, глутетимид, griseofulvin, a dinitrogene oxide, a papaverine, phenylbutazone, Phenytoinum (it is probable also other hydantoins), rifampicin, Tolbutamidum;
- with inhibitors of isoenzymes of CYP2D6 and CYP3A: Allopyrinolum, makrolidny antibiotics, antidepressants – inhibitors of monoaminooxidases, 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.

At simultaneous use with strong inductors of isoenzymes CYP3A decrease in concentration of an ondansetron in blood, with tramadoly – decrease in analgeziruyushchy effect of the last is possible. Ondansetron in concentration of 16-160 mkg/ml pharmaceutical is compatible and can be entered through a Y-shaped injector in/in kapelno jointly with the following medicines:
- Cisplates (in concentration to 0,48 mg/ml) within 1-8 hours;
- Ftoruratsil (in concentration to 0,8 mg/ml with a speed of 20 ml/h – higher concentration can cause precipitation of an ondansetron);
- Karboplatin (in concentration of 0,18-9,9 mg/ml within 10-60 minutes);
- Etopozid (in concentration of 0,14-0,25 mg/ml within 30-60 minutes);
- A ceftazidime (in a dose from 0,25-2 g, in a look in a bolyusny injection within 5 minutes);
- Doxorubicine (in a dose of 10-100 mg, in a look in a bolyusny injection within 5 minutes);
- Dexamethasone – 20 mg of dexamethasone of sodium of phosphate slowly, within 2-5 minutes are possible in/in introduction. Medicines can be entered through one dropper, at the same time in solution of concentration of dexamethasone of sodium of phosphate can make from 32 to 2500 mkg/ml, an ondansetron – from 8 to 100 mkg/ml.

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 medicine Latran at this category of patients is contraindicated).

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. Use of drug in II and III trimesters is not contraindicated in cases if the advantage of use of drug exceeds risk of development of complications.
In need of use in the period of a lactation it is necessary to stop breastfeeding.

Overdose:

There is a limited experience of overdose of an ondansetron. In most cases symptoms are similar to side reactions when using drug in the recommended doses.

In cases of alleged overdose symptomatic therapy is shown.
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:

Solution for intravenous and intramuscular administration of 2 mg/ml. On 2 ml or on 4 ml in ampoules of neutral glass. On 1, 2 or 5 ampoules in a blister strip packaging from a film polyvinyl chloride. One blister strip packaging together with the application instruction is placed in a pack from a cardboard.