Ondansetron solution of oral 4mg/5ml 50 ml

General characteristics. Structure:

Active ingredient: ондансетрон; 5 ml of solution contain 4 mg of an ondansetron (in the form of an ondansetron of a hydrochloride of a dihydrate);
excipients: sorbite (Е 420), citric acid, monohydrate, Natrium benzoicum (Е 211), Strawberry fragrance, sodium citrate, the water purified.

Main physical and chemical properties: transparent colourless liquid with characteristic aroma of strawberry.

Pharmacological properties:

Pharmacodynamics. Ondansetron is the strong high-selection antagonist 5HT3 (serotoninovy) receptors. Drug warns or eliminates the nausea and vomiting caused by cytotoxic chemotherapy and/or radiation therapy and also postoperative nausea and vomiting. The mechanism of action of an ondansetron is up to the end not found out. Perhaps, drug blocks emergence of an emetic reflex, having antagonistic effect concerning 5HT3-receptors localized in neurons both peripheral and the central nervous system. Drug does not reduce psychomotor activity of the patient and does not render sedation.

Pharmacokinetics. The main part of the entered dose gives in to metabolism in a liver. With mochy in not changed state less than 5% of drug are removed. An elimination half-life – about 3 h (patients of advanced age have 5 h). Linkng with proteins of plasma – 70-76%.
In patients with a renal failure (clearance of creatinine of 15 - 60 ml/min.) both the system clearance, and volume of distribution of an ondansetron decreases, insignificant and clinically insignificant increase in an elimination half-life of drug is result of what. The pharmacokinetics of an ondansetron practically does not change in the patients with a renal failure of heavy degree who are on a constant hemodialysis. At patients with a chronic liver failure of heavy degree the system clearance of an ondansetron considerably decreases with increase in an elimination half-life (15-32 h).

Indications to use:

The nausea and vomiting caused by cytotoxic chemotherapy and radiation therapy.

Route of administration and doses:

Solution of an ondansetron is appointed inside.
For measuring off of a necessary dose use a measured spoon. One full measured spoon contains 5 ml of solution of an ondansetron.
Adults
For 1 – 2 h prior to the beginning of chemotherapy take 8 mg (10 ml – 2 measured spoons) solution of an ondansetron, the subsequent dose of 10 ml of solution – in 12 h.
For prevention of the delayed or long vomiting drug is appointed twice a day on 10 ml within 5 days daily after each cycle of treatment himio-or radiation therapy.
At continuous vomiting ондансетрон apply in the form of solution to injections. After improvement of a state continue treatment by oral solution of an ondansetron on 10 ml twice a day.
Children
Children aged from 4 years can appoint oral solution of an ondansetron as continuation of earlier begun treatment solution of an ondansetron for injections. Each 12 h (in the morning and in the evening) on 4 mg (5 ml) of solution of an ondansetron within 5 days after a chemotherapy course appoint.
Patients of advanced age
Ondansetron is well had by patients with age of 65 years which receive chemotherapy. To change a dose, the frequency and the scheme of treatment there is no need.
Patients with a renal failure
As Ondansetron does not influence function of kidneys, to change a dose and the scheme of treatment in this case there is no need.
Patients with a liver failure
For patients with moderate and heavy abnormal liver functions the clearance of an ondansetron considerably decreases, the elimination half-life from blood serum increases. The maximum daily dose should not exceed 8 mg of an ondansetron (in any combination).
In cases of untimely acceptance of drug reception of a double dose is not allowed.

Features of use:

At pernicious vomiting as a result of chemotherapy efficiency of drug can be increased by one-time intravenous administration of glucocorticoids (for example, 20 mg of dexamethasone) prior to the beginning of chemotherapy.
It is necessary to consider that 5 ml of solution contain 2,1 g of sorbitol that is equivalent to 0,175 BE.
At treatment of patients with manifestations of hypersensitivity to other selection antagonists 5HT3 (serotoninovy) receptors reaction of hypersensitivity and to an ondansetron was noted. Very seldom temporary changes of an ECG, including lengthening of an interval of QT meet.
As ондансетрон lowers an intestines peristaltics, careful observation of patients with signs of subacute impassability of intestines is necessary during drug use.

Ability to influence speed of response at control of motor transport or work with other mechanisms.
Does not influence.

Side effects:

Immune system: seldom – reactions of immediate hypersensitivity, sometimes heavy, up to an anaphylaxis.
Central nervous system: a headache, spasms, motive disturbances (including extrapyramidal reactions, such as okulogirny crisis, dystonic reactions and dyskinesia without resistant clinical effects).
Organs of sight: skoroprokhodyashchy visual disturbances, passing blindness.
Cardiovascular system: arrhythmia, pain in heart (with oppression of a segment of ST or without it), bradycardia, arterial hypotension, inflows.
Digestive tract and liver: a hiccups, dryness in a mouth, a lock or diarrhea, sometimes – tranzitorny increase in activity of aminotransferase, insufficiency of function of a liver.
Allergic reactions: small tortoiseshell, bronchospasm, laryngospasm, Quincke's disease.

Interaction with other medicines:

Ondansetron does not accelerate and does not slow down metabolism of other drugs at use, simultaneous with them. Drug does not interact with temazepam, furosemide, tramadoly and propofoly.
Ondansetron is metabolized by various enzymes of R-459 cytochrome of a liver: CYP3A4, CYP2D6 and CYP1A2. Thanks to variety of enzymes of metabolism of an ondansetron braking or reduction of activity of one of them (for example, genetic deficit of CYP2D6) in usual conditions is compensated by other enzymes and does not influence the general clearance of creatinine or influences slightly.
Phenytoinum, carbamazepine and rifampicin. At the patients who are treated the potential inductors CYP3A4 (for example, Phenytoinum, carbamazepine and rifampicin), the clearance of an ondansetron increases and its concentration in blood decreases.
Tramadol. According to a small amount of clinical trials, ондансетрон can reduce analgetichesky effect of a tramadol.

Contraindications:

Hypersensitivity to components of drug or to any antagonists of 5HT3-receptors. Pregnancy, the feeding period a breast, children's age up to 2 years. Intolerance of fructose (hereditary intolerance of fructose), and also disturbance of absorption (malabsorption) of glucose galactose or lack of sucrose-isomaltase.

Overdose:

In most cases symptoms are similar to those that are described at the patients using drug in the recommended doses (see the section "Side reactions"). The specific antidote does not exist therefore in cases of overdose the symptomatic or maintenance therapy is applied.
Use during pregnancy or feeding by a breast.
Use of drug during pregnancy and feeding is not recommended by a breast.
Children.
Drug is not used to children under 2 years.

Storage conditions:

To store in the place protected from light at a temperature from 15 °C to 25 °C in vertical position. To store in the place, unavailable to children! A period of validity - 3 years.

Issue conditions:

According to the recipe

Packaging:

On 50 ml in bottles with a measured spoon with a capacity of 5 ml.