Latran

Latran is the antagonist of serotoninovy receptors; antiemetic, having anxiolytic activity, not causing lacks of coordination, sedation, decrease in working capacity and activity.

Form of release and structure

Drug is produced in the following dosage forms:

• Solution for intravenous and intramuscular administration: transparent liquid, almost colourless or colourless (on 2 ml or 4 ml in ampoules, in a strip packaging from PVC (polyvinyl chloride) film 1, 2 or 5 ampoules, 1 strip packaging in a pack cardboard);
• Tablets, coated: a cover of yellow color (on 10 pieces in a blister strip packaging, 1 packaging in a pack cardboard).

Contains in 1 ml of solution:

• Active ingredient: a dihydrate of a hydrochloride of an ondansetron (in terms of ондансетрон) – 2 mg;
• Auxiliary components: Acidum hydrochloricum, sodium chloride, water for injections.

In 1 tablet, coated, contains:

• Active ingredient: a dihydrate of a hydrochloride of an ondansetron (in terms of ондансетрон) – 4 mg;
• Auxiliary components: aerosil (colloid silicon dioxide), microcrystallic cellulose, magnesium stearate, potato starch;
• Cover: hydroxypropyl cellulose (hypro rod), tropeolin Oh, polysorbate (twin-80), castor oil.

Indications to use

Latran is shown to use for prevention or elimination of nausea and vomiting in the following cases:

• Cytostatic chemotherapy, X-ray radiotheraphy, other forms of beam influence;
• Postoperative period.

Drug is also used for symptomatic therapy of alcoholic abstinence easy and moderate severity.

Contraindications

• Pregnancy;
• Period of a lactation (breastfeeding);
• Children's age up to 2 years (efficiency and safety of use of drug in this age group were not studied);
• Hypersensitivity to an ondansetron and/or auxiliary components of drug.

Route of administration and dosage

Solution is entered intramusculary (in oil), intravenously (in/in) struyno slowly or kapelno. In one body part introduction of Latran in oil in a dose no more than 4 mg is allowed.

Tablets are intended for oral administration.

The mode of dosing of Latran at cytostatic therapy depends on an emetogennost of the antineoplastic procedure and age category of the patient.

Moderate emetogenny himio-or radiotheraphy, adult patients: a standard daily dose – 8-32 mg:

• Solution: just before the beginning of the procedure in/in struyno slowly or in oil – 8 mg;
• Tablets: in 1-2 hours prior to treatment of 2 pieces on 4 mg (8 mg), the following reception in the same dose 12 hours later from the beginning of a course.

Vysokoemetogenny chemotherapy, adult patients:

• In/in jet slow infusion – 8 mg just before the beginning of the procedure, 2 more in/in an injection on 8 mg with an interval between them from 2 to 4 hours;
• In/in continuous drop infusion – within a day in a dose of 24 mg with a speed of 1 mg/hour;
• In/in the 15th minute infusion, directly prior to the procedure – 16-32 mg divorced in 50-100 ml of the corresponding infusion solution.

Efficiency of solution Latran can be increased in the way of a glucocorticoid, single in/in introductions (for example, dexamethasone – 20 mg) prior to the procedure of chemotherapy. At oral administration about 24 mg for strengthening of effect are admissible to increase a single dose, and at the same time to appoint 12 mg of dexamethasone (for 1-2 h prior to the beginning of chemotherapy).

For the purpose of the prevention of the delayed vomiting which arises days (the first 24 hours) later from an initiation of treatment Latran's use is recommended to continue orally – 2 tablets on 4 mg (8 mg) 2 times a day for 5 days.

To children 2 years drug are more senior appoint directly prior to the beginning of chemotherapy, in/in in a dose of 5 ^mg/sq.m of a body surface. 12 hours later oral administration of drug – 1 tablet (4 mg) is recommended; upon termination of chemotherapy 2 times a day are recommended to take a pill for 5 days on 1 piece (4 mg).

Prevention of nausea and vomiting in the postoperative period:

• Adults: a single dose of 4 mg in oil or in/in struyno slowly at the beginning of anesthesia, or 16 mg (4 tablets) orally in 1 hour prior to an anesthesia;
• Children: only in the form of solution, slowly in/in to or after an anesthesia, a single dose – 0,1 mg/kg (as much as possible – to 4 mg).

Stopping of already arisen nausea and vomiting:

• Adults: in oil or slowly in/in – 4 mg;
• Children: slowly in/in – 0,1 mg/kg (as much as possible – to 4 mg).

In case of impact of ionizing radiation drug is accepted orally, a single dose – 2 tablets on 4 mg (8 mg) in 1 hour prior to or right after radiation.

For symptomatic therapy of an alcoholic abstinence syndrome solution is entered in/in kapelno in a dose of 8 mg (2 ampoules on 2 ml or 1 ampoule on 4 ml part in 400 ml хлосоля, Haemodesum or 0,9% of solution of sodium of chloride). If necessary repeated introduction of Latran is allowed.

Change of a dosage with damage of kidneys is not required from elderly people and patients.

At abnormal liver functions the clearance of an ondansetron considerably decreases, and its elimination half-life from plasma increases therefore correction (decrease) of a daily dose to 8 mg is required.

For solution cultivation Latran the following infusion solutions can be used:

• Ringer's solution;
• 5% dextrose solution;
• 0,3% solution of potassium of chloride and 0,9% chloride sodium solution;
• 0,9% chloride sodium solution;
• 0,3% solution of potassium of chloride and 5% dextrose solution.

Side effects

• Alimentary system: dryness in a mouth, a hiccups, a lock, diarrhea, sometimes passing asymptomatic increase in blood serum of level of aminotransferases;
• Cardiovascular system: arrhythmias, a stethalgia (in a number of episodes with ST segment depression), a lowering of arterial pressure, bradycardia;
• Nervous system: dizziness, headache, spontaneous motive frustration, spasms;
• Allergic answers: Quincke's disease, small tortoiseshell, laryngospasm, bronchospasm, anaphylaxis;
• Local reactions (parenteral administration): pain, reddening and burning in the place of an injection;
• Another: the feeling of heat, rushes of blood to the person, temporary decrease in visual acuity, is rare – a hypopotassemia (unambiguous dependence on administration of drug is not established).

At alleged overdose symptomatic therapy is recommended.

There are no data on a specific antidote of an ondansetron.

At overdose by tablets Latran is not recommended to use an ipecacuanha (an emetic root) as efficiency of vomitive during braking of an emetic reflex under the influence of an ondansetron is improbable.

Special instructions

At the patients having data in the anamnesis on reactions of hypersensitivity on other selection antagonists of 5-HT3-retseptorov development of similar answers to Latran is possible.

In case of signs of impassability of intestines after use of drug regular observation of the patient as ондансетрон it is capable to cause a lock is required.

Infusion solution should be prepared just before use. It is possible to store ready infusion solution before use at a temperature from 2 to 8 °C no more days.

When performing infusion it is not required to protect solution from light, ready injection solution keeps the stability for 24 hours at lamp lighting or natural light.

Medicinal interaction

Ondansetron is metabolized in a liver by fermental system _{(P450 cytochrome)} therefore it is necessary to be careful in case of combined use of Latran and the following drugs / substances:

• The enzymatic _{inductors P450} (CYP2D6 and CYP3A) – carbamazepine, rifampicin, a carisoprodol, barbiturates, глютетимид, griseofulvin, a papaverine, a dinitrogene oxide, phenylbutazone, Phenytoinum (it is possible also other hydantoins), Tolbutamidum;
• Inhibitors _{of P450 enzymes} (CYP2D6 and CYP3A) – makrolidny antibiotics, Allopyrinolum, antidepressants (monoamine oxidase inhibitors), Cimetidinum, chloramphenicol, estrogensoderzhashchy oral contraceptives, Disulfiramum, diltiazem, sodium Valproatum, valproic acid, erythromycin, ftorkhinolona, флуконазол, an isoniazid, ловастатин, metronidazole, кетоконазол, омепразол, propranolol, quinine, quinidine, verapamil.

Terms and storage conditions

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

Period of validity – 3 years.