Ondansetron-Borimed

General characteristics. Structure:

Active ingredient: 4 mg or 8 mg of an ondansetron (in the form of a hydrochloride) in each tablet.

Excipients: sodium krakhmalglikolit, cellulose microcrystallic, magnesium stearate, lactoses monohydrate, an advanti префед (a gipromelloza, кополивидон, polyethyleneglycol, caprylic capric triglyceride, polydextrose E 1200, titanium E 171 dioxide, ferrous oxide yellow E 172).

Pharmacological properties:

Pharmacodynamics. Antiemetic. Effectively warns and eliminates the nausea and vomiting arising against the background of antineoplastic chemotherapy or radiation therapy and also in the postoperative period. The mechanism of action is caused by ability of an ondansetron to selectively block serotoninovy 5-HT3-receptors.

Believe that in developing of nausea and vomiting when performing antineoplastic therapy an important role is played by stimulation of afferent fibers of a vagus nerve the serotonin which is emitted from enterokhromaffinny cells of a mucous membrane of a GIT.

Blocking 5-HT3-receptors, ондансетрон prevents emergence of an emetic reflex. Besides, ондансетрон oppresses the central links of an emetic reflex, blocking 5-HT3-receptors of a bottom of the IV ventricle (area postrema).

Indications to use:

- the prevention and elimination of nausea and vomiting, caused cytotoxic himio-or radiotheraphy;

- the prevention and elimination of nausea and vomiting in the postoperative period.

Route of administration and doses:

The choice of the mode of dosing is defined by expressiveness of emetogenny action of the carried-out antineoplastic therapy. The route of administration and doses of an ondansetron should be regulated in the range of 8 - 32 mg/days.

At the moderate nausea and vomiting caused himio-or radiotheraphy: inside for 1-2 h prior to performing antineoplastic therapy on 8 mg with the subsequent reception of 8 more mg inside in 12 h.

At the expressed nausea and the vomiting caused himio-or radiotheraphy: on 24 mg inside and 12 mg of dexamethasone of phosphate (in the form of sodium salt) intravenously for 1-2 h prior to carrying out himio-or radiotheraphy.

For the prevention of late or long vomiting in 24 h after the beginning himio-or radiotheraphy it is necessary to continue administration of drug inside on 8 mg 2 times a day within 5 days after the termination of a course.

For prevention of nausea and vomiting in the postoperative period: inside for 1 h before carrying out the general anesthesia on 16 mg or on 8 mg to anesthesia with the subsequent reception of two doses on 8 mg at an interval of 8 h.

At a renal failure: decrease in doses or transition to other dosage forms is not required.

At pochenochny insufficiency: the maximum daily dose should not exceed 8 mg.

Use for elderly patients: decrease in doses or transition to other dosage forms is not required.

Features of use:

At the patients receiving the previous treatment by other selection antagonists 5HT3 - receptors, being followed by hypersensitivity reactions, at use of an ondansetron hypersensitivity reactions are also possible.

As ондансетрон increases time of passing of contents on a large intestine, in case of use of an ondansetron for patients with symptoms of subacute intestinal impassability regular observation is necessary.

Patients of advanced age have an experience of use of an ondansetron for prevention and treatment of nausea and vomiting in the postoperative period is limited. Patients are more senior than 65 years receiving chemotherapy well transfer ондансетрон; special changes of a dose, frequency of reception or a way of administration of drug are not required.

At people with slow metabolism of sparteine and debrisoquine (lack of CYP2D6 enzyme) the elimination half-life of an ondansetron is not changed. Therefore, at repeated administration of drug to such patients of its concentration in plasma will not differ from those in the general population. Therefore it is not required to such patients of correction of a daily dose or frequency of reception of an ondansetron.

Influence on ability to driving of motor transport and to control of mechanisms. Ondansetron does not render sedation.

Pregnancy and lactation. Drug is not recommended to use at pregnancy. In need of purpose of drug in the period of a lactation it is necessary to stop breastfeeding.

Side effects:

Allergic reactions: small tortoiseshell, bronchospasm, Quincke's disease, anaphylaxis.

From cardiovascular system: bradycardia, tachycardia, stethalgias (anginous type), arrhythmia, arterial hypotonia.

From the alimentary system: a lock or diarrhea, a hiccups, dryness in a mouth, tranzitorny increase in level of aminotransaminases in blood serum.

From TsNS: the headache, dizziness, spontaneous motive frustration and spasms (passing afterwards).

Others: feeling of rush of blood to the person, feeling of heat, temporary disturbance of visual acuity.

Interaction with other medicines:

At simultaneous use with the drugs which are inductors (barbiturates, carbamazepine, rifampicin, Phenytoinum, phenylbutazone) or inhibitors (Cimetidinum, Allopyrinolum, Disulfiramum) of microsomal enzymes of a liver – P450 cytochrome isoenzymes, change of clearance of an ondansetron is possible.

Contraindications:

- hypersensitivity to drug, pregnancy, the lactation period, children's age up to 12 years.

Overdose:

Symptoms: dizziness, lock, vision disorder, arterial hypotension.

Treatment: symptomatic, podderzhivashchy therapy. The specific antidote is not known.

Storage conditions:

In the place protected from light and moisture, at a temperature not above 25 °C. To store in the place, unavailable to children. A period of validity - 2 years. Not to apply medicine after the termination of a period of validity.

Issue conditions:

According to the recipe

Packaging:

On 10 tablets in a blister strip packaging, in packaging No. 10х1.