Solution for intravenous and intramuscular administration: colourless transparent liquid, practically without foreign inclusions (in ampoules on 2 or 4 ml, on 5 ampoules in planimetric plastic packagings (pallets), on 1 pallet in a cardboard pack);
Syrup: transparent liquid from light yellow color to colourless with a characteristic smell of strawberry (in dark glass bottles on 50 ml, on 1 bottle in a cardboard pack with a measured spoon in a set);
Suppositories rectal: white, homogeneous, smooth, in the form of the cylinder with the pointed end (in strips on 1 suppository, on 1 or 2 strips in a cardboard pack);
Tablets for a rassasyvaniye: white, round, on the one hand convex, with another – flat (in blisters on 10 pieces, on 1 blister in a cardboard pack).

For intravenous and intramuscular administration enters into structure of 1 ml of solution:

Active agent: ондансетрон – 2,5 mg (in the form of a dihydrate hydrochloride), in terms of ондансетрон – 2 mg;
Auxiliary components: monohydrate of citric acid, sodium citrate, sodium chloride, water for injections.

For a rassasyvaniye is a part of 1 tablet:

Active agent: ондансетрон – 4 or 8 mg;
Auxiliary components: aspartame, gelatin, Mannitolum, methylhydroxysodium benzoate, strawberry fragrance, пропилгидроксибензоат sodium, the purified water.

Is a part of 5 ml of syrup:

Active agent: ондансетрон – 5 mg (in the form of a dihydrate hydrochloride), in terms of ондансетрон – 4 mg;
Auxiliary components: anhydrous citric acid, a sodium citrate dihydrate, sodium benzoate, sorbite solution, strawberry fragrance, the purified water.

Rectal is a part of 1 suppository:

Active agent: ондансетрон – 16 mg;
Auxiliary component: витепсол S58.

Indications to use

Zofran appoint for the prevention and elimination of vomiting and sick which are made by the following reasons:

Cytostatic himio-or radiotheraphy;
Operative measures (tablets for a rassasyvaniye, solution for intravenous and intramuscular administration, syrup).

Contraindications

Pregnancy and period of a lactation;
Hypersensitivity to drug components.

Zofran in the form of suppositories it is contraindicated to apply at children's age, it is possible to take syrup and a pill for a rassasyvaniye from 2 years (efficiency and safety of use of drug for children of younger age was not studied).

Solution should be applied to intravenous and intramuscular administration with care along with antiarrhytmic means and beta adrenoblockers, and also the patient with disturbances of a cordial rhythm and conductivity and with considerable electrolytic disturbances (seldom or never at intravenous administration of Zofran development of tranzitorny changes of an ECG, including lengthening of an interval of QT is possible).

Route of administration and dosage

Zofran in the form of syrup accept inside, tablets for a rassasyvaniye should be placed on a tip of language and to swallow after dissolution.

The scheme of use of drug for the prevention and elimination of the vomiting and sick made by radiotheraphy or cytostatic chemotherapy is caused by an emetogennost of antineoplastic therapy.

As a rule, the adult daily dose at intake makes 8-32 mg.

It is recommended to apply the following modes:

Moderate emetogenny chemotherapy and radiotheraphy: 8 mg in 1-2 hours prior to performing the main therapy, repeatedly in 12 hours accept the same dose;
Vysokoemetogenny chemotherapy: 24 mg of an ondansetron along with 12 mg of dexamethasone in 1-2 hours prior to carrying out chemotherapy.

For prevention of the long or late vomiting arising in 24 hours for 5 days it is necessary to continue Zofran's reception in 2 times a day on 8 mg.

To children just before the beginning of carrying out chemotherapy Zofran once enter in the form of solution for injections intravenously in a dose 5 mg/m ². In 12 hours administration of drug inside (syrup, tablets for a rassasyvaniye) in a dose of 4 mg is shown. After the termination of a course of chemotherapy it is necessary to continue Zofran's reception for 5 days 2 times a day on 4 mg.

For the prevention and elimination of vomiting and nausea in the postoperative period Zofran's reception in the form of syrup or tablets for a rassasyvaniye in a dose of 16 mg in 1 hour prior to carrying out an anesthesia is shown to adults.

For stopping of postoperative vomiting and nausea apply Zofran's solution to injections.

To children for prevention and stopping of development of postoperative vomiting and nausea Zofran enter intravenously.

Change of a dosage for patients of advanced age and patients with a renal failure and slow metabolism of sparteine/debrisoquine is not required. The daily dose of an ondansetron for patients with functional disturbances of a liver should not be more than 8 mg.

Zofran in the form of suppositories apply rektalno.

The scheme of use of drug for the prevention and elimination of the vomiting and sick made by radiotheraphy or cytostatic chemotherapy is caused by an emetogennost of antineoplastic therapy. At moderate emetogenny chemotherapy or radiotheraphy appoint 1 suppository (16 mg of an ondansetron) in 1-2 hours prior to performing the main therapy. At vysokoemetogenny chemotherapy drug is used in the same dose along with intravenous administration 20 mg of dexamethasone.

For prevention of the long or late vomiting developing in 24 hours after the termination of radiotheraphy or chemotherapy it is necessary to continue therapy for 5 days on 1 suppository a day (administration of drug inside in the form of tablets for a rassasyvaniye or syrup is also possible).

Children and patients with functional disturbances of a liver are not recommended to apply Zofran in the form of suppositories. Change of a dosage for patients of advanced age and patients with a renal failure and slow metabolism of sparteine/debrisoquine is not required.

The drug dosing mode in the form of solution for injections for the prevention and elimination of the vomiting and sick made by radiotheraphy or cytostatic chemotherapy depends on an emetogennost of antineoplastic treatment.

The adult are recommended to apply the following modes:

Emetogenny radiotheraphy and chemotherapy: before performing therapy of 8 mg of Zofran enter intramusculary or slowly intravenously;
Vysokoemetogenny chemotherapy: just before the beginning of therapy of 8 mg of Zofran once enter intravenously or intramusculary. Use of higher doses (8-32 mg) is possible by intravenous infusion after Zofran's dissolution in 50-100 ml of 0,9% of solution of sodium of chloride or other compatible infusion solution within 15 minutes and more. Drug use in a different way is possible: 8 mg of solution enter slowly intravenously or intramusculary just before chemotherapy, then appoint 2 more intravenous or intramuscular injections in the same dose with an interval of 2-4 hours or for 24 hours use continuous infusion of drug with a speed of 1 mg an hour. Zofran's efficiency can be increased additional single intravenous administration prior to the beginning of chemotherapy of 20 mg of dexamethasone of sodium phosphate.

To children from 6 months to 17 years Zofran appoint proceeding from body surface area (the drug is administered intravenously just before carrying out chemotherapy):

Less than 0,6 m ²: an initial dose – 5 mg/m ²; in 12 hours accept in 2 mg of syrup;
0,6-1,2 m ²: an initial dose – 5 mg/m ²; in 12 hours accept in 4 mg of syrup;
More than 1,2 m ²: an initial dose – 8 mg; in 12 hours accept in 8 mg of syrup.

For 5 days after the termination of a course of treatment reception of syrup is continued by 2 times a day in the same dose (2, 4 or 8 mg respectively).

Children as an alternative Zofran can enter just before carrying out chemotherapy once intravenously in a dose 0,15 mg/kg (to 8 mg). Repeatedly this dose it is possible to enter each 4 hours (in total no more than three doses). Zofran's reception in 2 times a day on 4 mg can be continued within 5 days after end of a course of chemotherapy. Doses should not be higher recommended for adults.

For the prevention and elimination of vomiting and nausea in the postoperative period during an introduction anesthesia the single intramuscular or slow intravenous injection of 4 mg of Zofran is recommended to adults. For treatment of vomiting and nausea in the postoperative period of 4 mg of solution enter once intramusculary or slowly intravenously.

For the prevention and elimination of vomiting and nausea in the postoperative period (after operative measures under the general anesthesia) to children from 1 month to 17 years appoint 0,1 mg/kg (as much as possible – to 4 mg) in the form of a slow intravenous injection. The drug can be administered after operation or to, in time or after an introduction anesthesia. The same dose is shown for stopping of the vomiting and nausea which developed in the postoperative period.

Experience of use of Zofran for the purpose of prevention and stopping of postoperative vomiting and nausea at elderly patients is limited though drug, as a rule, is well transferred by the patients receiving chemotherapy 65 years are more senior.

Change of a dosage for patients with functional disturbances of kidneys and slow metabolism of sparteine/debrisoquine is not required. The daily dose of an ondansetron for patients with functional disturbances of a liver should not be more than 8 mg.

At cultivation of injection solution of Zofran it is possible to use the following solutions:

5% dextrose solution;
0,9% chloride sodium solution;
10% Mannitolum solution;
Ringer's solution;
0,9% solution of sodium of chloride and 0,3% chloride potassium solution;
5% solution of a dextrose and 0,3% chloride potassium solution.

Infusion solution should not be prepared in advance. If necessary ready solution can be stored for 24 hours at natural light or normal lighting at a temperature of 2-8 °C.

Side effects

Zofran in the form of tablets for a rassasyvaniye, syrup and suppositories can lead to development of the following side effects:

Cardiovascular system: thorax pains (sometimes with ST segment depression), bradycardia, arrhythmia, lowering of arterial pressure;
Alimentary system: dryness in a mouth, a hiccups, diarrhea or a lock, burning sensation in a rectum and an anus (after administration of suppositories); sometimes – asymptomatic passing increase in activity of hepatic tests;
Nervous system: dizziness, headache, spasms and spontaneous motive frustration;
Allergic reactions: bronchospasm, small tortoiseshell, laryngospasm, anaphylaxis, Quincke's disease;
Others: feeling of heat, rush of blood to the person, temporary disturbance of visual acuity, giperkreatininemiya, hypopotassemia.

At Zofran's use in the form of solution for intravenous and intramuscular administration development of the following disturbances is possible:

Cardiovascular system: sometimes – arrhythmia, thorax pain (can be followed by decrease in a segment of ST), lowering of arterial pressure, bradycardia; often – hot inflows or feeling of heat; very seldom – tranzitorny changes of an ECG, including lengthening of an interval of QT (usually at intravenous administration);
Nervous system: very often – a headache; sometimes – spasms, motive frustration (including such extrapyramidal symptoms as okulogirny crisis, dyskinesia and dystonia) without resistant clinical effects; seldom – the dizziness connected with bystry intravenous administration;
Immune system: seldom – reactions of immediate hypersensitivity (sometimes with a heavy current, including an anaphylaxis);
Digestive tract: often – a lock;
Respiratory system, bodies of a mediastinum and thorax: sometimes – a hiccups;
Liver and biliary tract: sometimes – asymptomatic increase in hepatic tests (it was more often observed at the patients receiving chemotherapy Cisplatinum);
Organ of sight: seldom – passing visual disturbances (in the form of the obscured sight), as a rule, at intravenous administration; very seldom – a tranzitorny blindness, as a rule, at intravenous administration (in most cases the blindness disappeared within 20 minutes; to many patients appointed chemotherapeutic drugs with the maintenance of Cisplatinum; in some cases the tranzitorny blindness was cortical genesis);
Local and general reactions: often – local reactions in places of intravenous administration.

Special instructions

At the patients having in the anamnesis of the instruction on hypersensitivity to other antagonists of 5HT3-receptors at Zofran's use allergic reactions can develop.

Ondansetron increases duration of passing of contents on a large intestine therefore with symptoms of impassability of intestines after Zofran's use it is required to patients regular observation.

Aspartame because of what they are recommended to be taken with caution the patient with a fenilketonuriya is a part of tablets for a rassasyvaniye.

In advance it is not necessary to squeeze out tablets for a rassasyvaniye from a foil.

Data about uses of an ondansetron in the form of solution for injections at children up to 1 month are limited.

It is not necessary to enter Zofran in one syringe or in one infusion solution with other medicines.

Medicinal interaction

Data that active agent of Zofran (ондансетрон) inhibits or induces metabolism of other medicines which are often appointed in a combination with it no.

It is necessary to be careful at combined use of Zofran with the following drugs:

The enzymatic inductors P450 (CYP2D6 and CYP1A2), such as rifampicin, carbamazepine, barbiturates, nitrous oxide, каризопродол, griseofulvin, глютетимид, phenylbutazone, a papaverine, Phenytoinum (it is probable also other hydantoins), Tolbutamidum;
Inhibitors of P450 enzymes (CYP2D6 and CYP1A2), such as antidepressants-monoamine oxidase inhibitors, Allopyrinolum, Cimetidinum, makrolidny antibiotics, chloramphenicol containing estrogen oral contraceptives, valproic acid, diltiazem, Disulfiramum, sodium Valproatum, флуконазол, erythromycin, an isoniazid, ftorkhinolona, ловастатин, кетоконазол, омепразол, metronidazole, propranolol, quinine, quinidine, verapamil.

With alcohol, furosemide, temazepam, propofoly (diprivany) and tramadoly Zofran does not interact.

At simultaneous use of Zofran in the form of solution for intravenous and intramuscular administration with some medicines there can be undesirable effects:

Phenytoinum, rifampicin and carbamazepine: decrease in concentration of an ondansetron in blood;
Tramadol: reduction of its analgeziruyushchy action.

Zofran in concentration of 0,016 mg/ml and 0,16 mg/ml (8 mg / 500 ml and 8 mg / 50 ml respectively) pharmaceutical is compatible and can be entered through a Y-shaped injector intravenously kapelno at the same time with the following medicines:

Doxorubicine: for 5 minutes (a dose – 10-100 mg, in the form of an intravenous bolyusny injection);
5-ftoruratsit: (concentration – 0,8 mg/ml with a speed of 20 ml an hour, higher concentration of a 5-ftoruratsil can lead to Zofran's loss in a deposit);
Cisplatinum: for 1-8 hours (concentration – to 0,48 mg/ml);
Etopozid: for 30-60 minutes (concentration – 0,144-0,25 mg/ml);
Karboplatin: for 10-60 minutes (concentration – 0,18-9,9 mg/ml);
Cyclophosphamide: for 5 minutes (a dose – 100-1000 mg, in the form of an intravenous bolyusny injection);
Ceftazidime: for 5 minutes (a dose – 250-2000 mg, in the form of an intravenous bolyusny injection);
Dexamethasone: perhaps intravenous administration of 20 mg of drug slowly, for 2-5 minutes. Administration of medicines through one dropper is possible, at the same time in solution of concentration of dexamethasone of sodium phosphate can make 0,032-2,5 mg/ml, Zofran – 0,008-1 mg/ml.