Instruction for use: Zofran

Dosage form: Show all forms; Solution for intravenous and intramuscular injection; Syrup; Rectal suppositories; Tablets for absorption; Lyophilized tablets

Active substance: Ondansetron*

ATX

A04AA01 Ondansetron

Pharmacological groups:

Antiemetic

Serotonergic drugs

The nosological classification (ICD-10)

R11 Nausea and vomiting: Postoperative vomiting; Nausea; Vomiting; Vomiting in the postoperative period; Vomiting medication; Vomiting in the background of radiation therapy; Vomiting uncontrollable; Vomiting in radiation therapy; Persistent vomiting; Indomitable vomiting; Postoperative nausea; Vomiting with chemotherapy; Vomiting of the central genesis; Vomiting with cytotoxic chemotherapy; Persistent hiccups; Repeated vomiting

Y43.1 Adverse reactions in the therapeutic use of antitumor antimetabolites: Treatment with mercaptopurine

Y43.2 Adverse reactions in the therapeutic use of antineoplastic natural preparations

Y43.3 Adverse reactions in the therapeutic use of other antitumor drugs

Z100 * CLASS XXII Surgical practice: Abdominal surgery; adenomectomy; Amputation; Coronary angioplasty; Angioplasty of the carotid arteries; Antiseptic skin treatment for wounds; Antiseptic Hand; Appendectomy; atherectomy; Balloon coronary angioplasty; Vaginal hysterectomy; The coronary bypass; Interventions in the vagina and cervix; Interventions on the bladder; Intervention in the mouth; Restoration and reconstructive surgery; Hand hygiene of medical personnel; Gynecologic surgery; Gynecological intervention; Gynecological surgery; Hypovolemic shock during operations; Disinfection of purulent wounds; Disinfection of wounds edges; Diagnostic intervention; Diagnostic procedures; Cervical Diathermocoagulation; Long-surgery; Replacing the fistula catheters; Infection in orthopedic surgery; Artificial heart valve; cystectomy; Short-term outpatient surgery; Short-term operation; Short surgical procedures; Krikotireotomiya; Blood loss during surgery; Bleeding during surgery and in the postoperative period; Kuldotsentez; laser photocoagulation; laser coagulation; retinal laser coagulation; Laparoscopy; Laparoscopy in Gynecology; CSF fistula; Small gynecological operations; Small surgical procedures; Mastectomy and subsequent plastic; mediastinotomy; Microsurgical operations on the ear; Mukogingivalnye operation; suturing; Minor surgery; neurosurgical operation; Immobilization of the eyeball in ophthalmic surgery; testectomy; pancreatectomy; Perikardektomiya; The period of rehabilitation after surgery; The period of convalescence after surgery; Percutaneous transluminal coronary angioplasty; Pleural thoracentesis; Pneumonia postoperative and posttraumatic; Preparation for surgical procedures; Preparation for surgery; Preparation of the surgeon's hands before surgery; Preparation of the colon for surgical procedures; Postoperative aspiration pneumonia in neurosurgical and thoracic surgery; Postoperative nausea; Postoperative bleeding; postoperative granuloma; postoperative shock; The early postoperative period; myocardial revascularization; Radiectomy; gastric Resection; bowel resection; uterine Resection; liver Resection; enterectomy; Resection of part of the stomach; Reocclusion of the operated vessel; Bonding tissues during surgical procedures; Removal of sutures; Condition after eye surgery; Condition after surgery; Condition after surgery in the nasal cavity; Condition after gastrectomy; Status after resection of the small intestine; Condition after tonsillectomy; Condition after removal of the duodenum; Condition after phlebectomy; Vascular surgery; Splenectomy; Sterilization of surgical instruments; Sterilization of surgical instruments; sternotomy; Dental surgery; Dental intervention in periodontal tissues; strumectomy; Tonsillectomy; Thoracic surgery; Thoracic surgery; total gastrectomy; Transdermal intravascular coronary angioplasty; Transurethral resection; Turbinektomiya; Removal of a tooth; cataract surgery; Removal of cysts; tonsillectomy; Removal of fibroids; Removing the mobile primary teeth; Removing polyps; Removing broken tooth; Removal of the uterus body; Removal of sutures; Fistula likvoroprovodyaschih ways; Frontoetmoidogaymorotomiya; Surgical infection; Surgical treatment of chronic limb ulcers; Surgery; The surgery in the anal area; The surgery on the colon; Surgical practice; The surgical procedure; Surgical interventions; Surgery on the gastrointestinal tract; Surgical procedures on the urinary tract; Surgical procedures on the urinary system; Surgical intervention of the genitourinary system; Surgical procedures on the heart; Surgical manipulation; surgery; Surgery on the veins; Surgical intervention; Vascular surgery; Surgical treatment of thrombosis; Surgery; cholecystectomy; Partial gastric resection; hysterectomy; Percutaneous transluminal coronary angioplasty; Percutaneous transluminal angioplasty; Coronary artery bypass; tooth Extirpation; Extirpation of milk teeth; pulpectomy; pulsative cardiopulmonary bypass; tooth Extraction; teeth Extraction; cataract extraction; Electrocoagulation; endourological intervention; episiotomy; Etmoidotomiya; Complications after tooth extraction

Z51.0 Radiotherapy course: Supplement to external radiation therapy; Local X-Ray Irradiation; Radiation therapy; Brain edema associated with radiation therapy; Lesion in radiation therapy; Radiotherapy

Z51.1 Chemotherapy for neoplasm: Cystitis hemorrhagic, caused by cytostatics; Urotoxicity of cytostatics

Composition and release form

Solution for intravenous and intramuscular injection 1 ml

Ondansetron hydrochloride dihydrate 2.5 mg

(In terms of ondansetron 2 mg)

Auxiliary substances: acids of citric monohydrate; Sodium citrate; sodium chloride; water for injections

In ampoules of 2 or 4 ml, in a contour plastic packaging (pallet) 5 ampoules; In a pack of cardboard 1 package (pallet).

Tablets for resorption 1 table.

Ondansetron 4 mg; 8 mg

Auxiliary substances: gelatin; Mannitol; Aspartame; Sodium methylhydroxybenzoate; Sodium propyl hydroxybenzoate; Strawberry flavor; purified water

In the blister 10 pcs .; In a pack of cardboard 1 blister.

Syrup 5 ml

Ondansetron hydrochloride dihydrate 5 mg

(Equivalent to 4 mg ondansetron)

Auxiliary substances: citric anhydrous acid; Sodium citrate dihydrate; Sodium benzoate; A sorbitol solution; Strawberry flavor; purified water

In bottles of 50 ml, complete with a measuring spoon; In the box 1 set.

Suppositories for rectal administration 1 supp.

Ondansetron 16 mg

Excipients: Witepsol S58

In the strip 1 supp .; In a pack of cardboard 1 or 2 strip.

Description of dosage form

Solution for intravenous and IM introduction: a transparent colorless liquid, practically free from foreign inclusions.

The tablets for resorption: round, white, convex on one side and flat on the other.

Syrup: clear liquid from colorless to light yellow color with a characteristic smell of strawberry.

Suppositories: white, smooth, uniform, shaped like a cylinder with a pointed end.

Pharmachologic effect

Mode of action - antiemetic.

Pharmacodynamics

Ondansetron is a selective 5-HT3 receptor antagonist. Drugs for cytostatic chemotherapy and radiotherapy can cause an increase in the level of serotonin, which, by activating vagal afferent fibers containing 5-HT3 receptors, causes a vomiting reflex. Ondansetron inhibits the appearance of a vomiting reflex by blocking 5-HT3 receptors at the neuronal level of both the central nervous system and the peripheral nervous system.

Pharmacokinetics

Ondansetron is completely absorbed into the digestive tract after ingestion and is metabolized first pass through the liver. Cmax in plasma is achieved approximately 1.5 hours after administration. Bioavailability increases somewhat with simultaneous intake of food, but does not change when taking antacids.

Distribution of ondansetron is the same for oral administration, IM and IV the introduction; T1 / 2 is approximately 3 hours, in elderly patients can reach 5 hours, and with severe renal failure - 15-20 hours. The volume of distribution when equilibrium concentration is reached is about 140 liters. Binding to plasma proteins - 70-76%. After rectal administration, ondansetron is determined in plasma after 15-60 min. The concentration of the active substance increases linearly, Cmax is reached after about 6 hours and is 20-30 ng / ml. Reduction in plasma concentration occurs at a lower rate than after oral administration (due to continued absorption). T1 / 2 - 6 hours. Absolute bioavailability in rectal administration - 60%.

From the systemic blood flow, it is eliminated mainly as a result of metabolism in the liver, which occurs with the participation of several enzyme systems. The absence of the enzyme CYP2D6 (spartein-debrisoquine-type polymorphism) does not affect the pharmacokinetics of ondansetron. In unchanged form, less than 5% of the administered dose is excreted in the urine.

In doses exceeding 8 mg, the blood content increases disproportionately, because When high doses are administered orally, metabolism may decrease on the first passage through the liver.

Pharmacokinetic parameters of ondansetron do not change with repeated admission.

In patients with moderate renal insufficiency (Cl creatinine - 15-60 ml / min), both systemic clearance and volume distribution of ondansetron are reduced, which results in a small and clinically insignificant increase in its T1 / 2 (up to 5.4 h). The pharmacokinetics of ondansetron remains virtually unchanged in patients with severe renal dysfunction who are on chronic hemodialysis. In patients with severe impairment of liver function, the systemic clearance of ondansetron drastically decreases, resulting in an increase in its T1 / 2 (up to 15-32 h), and oral bioavailability reaches 100% due to a decrease in presystemic metabolism.

Special patient groups

Floor

The pharmacokinetics of ondansetron depends on the sex of the patients. Women have less systemic clearance and volume of distribution (the figures are corrected for body weight) than for men.

Children and adolescents (aged 1 month to 17 years)

In a clinical study, children aged 1 to 24 months (51 patients) received ondansetron at a dose of 0.1 mg / kg or 0.2 mg / kg before surgery. In patients aged 1 to 4 months, Cl was approximately 30% less than in patients aged 5 to 24 months, but comparable to that in patients aged 3 to 12 years (with correction according to the weight Body). T1 / 2 in the group of patients at the age of 1-4 months averaged 6.7 hours; In the age groups 5-24 months and 3-12 years - 2.9 hours. Patients aged from 1 to 4 months do not need dose adjustment, since once-daily intravenous ondansetron is used to treat postoperative nausea and vomiting in this category of patients . Differences in pharmacokinetic parameters are partly explained by a higher volume of distribution in patients aged 1 to 4 months.

In a study in children aged 3-12 years (21 patients) who underwent planned surgery under general anesthesia, the absolute Cl values and the volume distribution of ondansetron after a single IV injection at a dose of 2 mg (3 to 7 years) or 4 mg (From 8 to 12 years) were reduced in comparison with the values in adults. Both parameters increased linearly depending on the body weight, in patients aged 12 years, these values were close to those in adults. When adjusting the clearance values and volume of distribution, depending on body weight, these parameters were close in different age groups. The dose, calculated taking into account the body weight (0.1 mg / kg, maximum to 4 mg), compensates for these changes and system exposure of ondansetron in children.

A population pharmacokinetic analysis was performed in 74 patients aged 6 to 48 months who received IV / d ondansetron at a dose of 0.15 mg / kg every 4 hours in the amount of 3 doses for the reduction of nausea and vomiting caused by chemotherapy and in 41 patients At the age of 1 to 24 months after surgical interventions administered ondansetron in a single dose of 0.1 or 0.2 mg / kg. Based on pharmacokinetic parameters in this group for patients aged 1 to 48 months, the administration of ondansetron IV at a dose of 0.15 mg / kg every 4 hours in an amount of 3 doses should lead to a systemic exposure comparable to that observed in The use of the drug in the same doses in children aged 5 to 24 months with surgical interventions, as well as in previous studies in children with cancer (aged 4 to 18 years) and surgical intervention (aged 3 to 12 years ).

Patients of advanced age

Studies have shown a weak, clinically insignificant, age-dependent increase in T1 / 2 ondansetron.

Patients with impaired renal function

In patients with moderate renal impairment (Cl creatinine 15-60 ml / min) with ondansetron administration, both systemic clearance and ondansetron distribution volume were reduced, resulting in a small and clinically insignificant increase in T1 / 2 (up to 5.4 H). Ondansetron pharmacokinetics with intravenous administration remained virtually unchanged in patients with severe renal dysfunction in chronic hemodialysis (studies were conducted in between hemodialysis sessions).

Patients with impaired hepatic function

In patients with severe impairment of liver function, the systemic clearance of ondansetron decreases dramatically with an increase in T1 / 2 to 15-32 h.

Indication for the Zofran

Prevention and elimination of nausea and vomiting caused by cytostatic chemotherapy or radiotherapy;

Prevention and elimination of postoperative nausea and vomiting (rp for IV and / or injection, resorption tablets, syrup).

Contraindications

Hypersensitivity to any component of the drug;

pregnancy;

lactation;

Children's age (suppositories);

Children under 2 years of age (tablets for resorption, syrup - safety and efficacy have not been studied).

In addition for p-ra for iv and im administration

Use with caution in patients with cardiac rhythm and conduction abnormalities, patients receiving antiarrhythmics and beta-blockers and patients with significant electrolyte disorders (very rarely with intravenous administration of ZofranŽ transient ECG changes were recorded, including prolongation of the QT interval).

Side effects

Tablets for resorption, syrup, suppositories

Allergic reactions: urticaria, bronchospasm, laryngospasm, angioedema, anaphylaxis.

On the part of the digestive system: hiccough, dry mouth, constipation or diarrhea, a burning sensation in the anus and rectum after the introduction of the suppository; Sometimes - an asymptomatic transient increase in the activity of liver tests.

From the cardiovascular system: pain in the chest, in some cases - with depression of the ST segment, arrhythmia, bradycardia, lowering blood pressure.

From the nervous system: headache, dizziness, spontaneous movement disorders and convulsions.

Other: a rush of blood to the face, a feeling of heat, a temporary disturbance of visual acuity, hypokalemia, hypercreatininaemia.

RR for IV and IM

The adverse events presented below are classified according to the frequency of occurrence. Frequency of occurrence is defined as follows: very often - ≥1 / 10; Often - ≥1 / 100 and <1/10; Sometimes - ≥1 / 1000 and <1/100; Rarely - ≥1 / 10000 and <1/1000; Very rarely - <1/10000, including individual messages.

On the part of the immune system: rarely - immediate-type hypersensitivity reactions, in a number of severe cases, including anaphylaxis.

From the nervous system: very often - headache; Sometimes - convulsions, motor disorders (including extrapyramidal symptoms such as dystonia, oculogic crisis (spasm of the eye) and dyskinesia) in the absence of persistent clinical consequences; Rarely - dizziness during a rapid IV injection.

From the side of the eyes: rarely - transient visual disturbances (blurred vision), mainly during IV introduction; Very rarely - transient blindness, mainly during intravenous administration. Most cases of blindness were safely resolved within 20 minutes. Most patients received chemotherapy drugs containing cisplatin. In some cases, transient blindness was of a cortical genesis.

From the cardiovascular system: sometimes - arrhythmia, pain in the chest, as accompanied, and not accompanied by a decrease in the ST segment, bradycardia, lowering blood pressure; Often - a feeling of hot or hot flushes; Very rarely - transient changes in the ECG, including prolongation of the QT interval, mainly with IV introduction.

From the respiratory system, chest and mediastinum: sometimes - hiccups.

From the digestive tract: often - constipation.

From the liver and bile ducts: sometimes - asymptomatic increase in liver samples (mainly observed in patients receiving chemotherapy with cisplatin).

General and local reactions: often - local reactions in place in / in the introduction.

Interaction

There is no evidence that ondansetron induces or inhibits the metabolism of other drugs, often prescribed in combination with it.

Ondansetron is metabolized by several enzymes of the cytochrome P450 system (CYP3A4, CYP2D6 and CYP1A2). The inhibition or decrease in the activity of one of the enzymes is usually compensated by others, and therefore a significant reduction in overall clearance of ondansetron is unlikely. Nevertheless, caution is required when combined:

- with such enzymatic inducers P450 (CYP2D6 and CYP1A2), as barbiturates, carbamazepine, carisoprodol, glutetimide, griseofulvin, nitrous oxide, papaverine, phenylbutazone, phenytoin (probably other hydantoins), rifampicin, tolbutamide;

With such inhibitors of P450 enzymes (CYP2D6 and CYP1A2) as allopurinol, macrolide antibiotics, MAO antidepressants, chloramphenicol, cimetidine, oral contraceptives containing estrogens, diltiazem, disulfiram, valproic acid, sodium valproate, erythromycin, fluconazole, fluoroquinolones, isoniazid , Ketoconazole, lovastatin, metronidazole, omeprazole, propranolol, quinidine, quinine, verapamil.

Special studies have shown that ondansetron does not interact with alcohol, temazepam, furosemide, tramadol and propofol (diprivanom).

In addition for p-ra for iv and / m administration

Phenytoin, carbamazepine and rifampicin

In patients receiving powerful inducers CYP3A4 (phenytoin, carbamazepine and rifampicin), the concentration of ondansetron in the blood was decreased.

Tramadol

There are data from small studies indicating that ondansetron can reduce the analgesic effect of tramadol.

Pharmaceutical compatibility with other drugs

ZofranŽ at a concentration of 16 μg / ml and 160 μg / ml (corresponding to 8 mg / 500 ml and 8 mg / 50 ml, respectively) is pharmaceutically compatible and can be administered via the Y-shaped injector intravenously with the following drugs:

- cisplatin (at a concentration of up to 0.48 mg / ml) for 1-8 hours;

- 5-fluorouracil (at a concentration of up to 0.8 mg / ml at a rate of 20 ml / h - higher concentrations of 5-fluorouracil may cause precipitation of ZofranŽ);

- carboplatin (in a concentration of 0.18-9.9 mg / ml) for 10-60 minutes;

- etoposide (at a concentration of 0.144-0.25 mg / ml for 30-60 minutes);

- ceftazidime (in a dose of 0.25-2 g, as an IV bolus injection for 5 minutes);

- cyclophosphamide (in a dose of 0.1-1 g, as an IV bolus injection for 5 minutes);

- doxorubicin (at a dose of 10-100 mg, as an IV bolus injection for 5 minutes);

- dexamethasone: possible iv injection of 20 mg dexamethasone slowly, for 2-5 minutes. LS can be administered through a single dropper, while the concentration of dexamethasone sodium phosphate in the solution can range from 32 μg to 2.5 mg / ml, Zofran Ž from 8 μg to 1 mg / ml.

Dosing and Administration

Solution for IV and IM administration

Nausea and vomiting caused by chemotherapy and / or radiotherapy

The choice of dosage regimen is determined by the degree of emetogenicity of antitumor therapy.

Adults

Emetogenic chemotherapy and radiotherapy. The recommended dose is 8 mg, administered slowly IV or IM just before chemotherapy or radiotherapy.

Highly emetic chemotherapy. For patients receiving highly emeticogenic chemotherapy, for example cisplatin in high doses, ZofranŽ can be given as a single IV or IM injection at a dose of 8 mg just before chemotherapy. ZofranŽ in a dosage of 8 to 32 mg should be administered only by IV infusion after dissolving the drug in 50-100 ml of a 0.9% sodium chloride solution or other compatible infusion solution for 15 minutes or more. Another method is to administer ZofranŽ 8 mg slowly IV or IM immediately before chemotherapy, followed by the administration of two injections IV or IM at a dose of 8 mg at intervals of 2-4 hours or using a constant infusion of the drug At a rate of 1 mg / h for 24 hours.

In the case of highly emeticogenic antitumor therapy, the effectiveness of ZofranŽ can be enhanced by an additional single intravenous injection of dexamethasone sodium phosphate at a dose of 20 mg prior to chemotherapy. Oral or rectal dosage forms of ZofranŽ are recommended to prevent delayed or continued vomiting after the first day after the chemotherapy.

Children and adolescents (aged 6 months to 17 years). For children with a body surface area of less than 0.6 m2, an initial dose of 5 mg / m2 is given IV immediately before chemotherapy, followed by ZofranŽ inside at a dose of 2 mg (in the form of a syrup) after 12 hours. Within 5 days after the course Treatment therapy continues, taking ZofranŽ inside at a dose of 2 mg 2 times a day.

Children with a body surface area of 0.6-1.2 m2 ZofranŽ are administered iv once at a dose of 5 mg / m2 immediately before the chemotherapy, followed by taking the drug inside at a dose of 4 mg after 12 hours. Taking ZofranŽ orally at a dose 4 mg 2 times a day can be continued for another 5 days after the course of chemotherapy.

For children with a body surface area of more than 1.2 m2, an initial dose of 8 mg is given IV immediately before chemotherapy, followed by taking the drug inside at a dose of 8 mg after 12 hours. ZofranŽ oral intake at a dose of 8 mg 2 times a day can be Continued for 5 days after the course of chemotherapy.

As an alternative to children aged 6 months and older, ZofranŽ is given IV once a dose of 0.15 mg / kg (not> 8 mg) immediately before chemotherapy. This dose can be administered repeatedly every 4 hours, not more than three doses in total. Taking ZofranŽ inside at a dose of 4 mg 2 times a day can be continued for another 5 days after the course of chemotherapy. Doses should not exceed recommended for adults.

Patients of advanced age. Correction of ZofranŽ is not required.

Patients with impaired renal function. Correction of ZofranŽ is not required.

Patients with impaired liver function. Clearance ZofranŽ is significantly reduced, the half-life is increased in patients with moderate and severe liver dysfunction. The daily dose of ZofranŽ should not exceed 8 mg.

Patients with a slow metabolism of sparteine / debrisoquine

In patients with a slow metabolism of sparteine and debrisoquine, the half-life of ondansetron is not changed. Consequently, with the repeated administration of ZofranŽ to such patients, its concentration in the plasma will not differ from that in the general population. Therefore, such patients do not need to adjust the daily dose or ondansetron frequency.

Postoperative nausea and vomiting

Adults. To prevent nausea and vomiting in the postoperative period, a single intravenous or slow intravenous injection of ZofranŽ at a dose of 4 mg is recommended during the induction anesthesia.

For the treatment of nausea and vomiting in the postoperative period ZofranŽ is administered once in a dose of 4 mg IM or slowly IV.

Children and adolescents (aged 1 month to 17 years). To prevent nausea and vomiting in the postoperative period in children undergoing surgical intervention under general anesthesia, ZofranŽ can be administered at a dose of 0.1 mg / kg (maximal to 4 mg) in the form of a slow intravenous injection before, during or after an introductory Anesthesia or after surgery. For the relief of nausea and vomiting that develops in the postoperative period, a slow intravenous injection of ZofranŽ at a dose of 0.1 mg / kg (maximum to 4 mg) is recommended.

Patients of advanced age. There is limited experience with ZofranŽ to prevent and arrest postoperative nausea and vomiting in the elderly, although ZofranŽ is well tolerated by patients over 65 years of age who are receiving chemotherapy.

Patients with impaired renal function. Correction of ZofranŽ is not required.

Patients with impaired liver function. Clearance ZofranŽ is significantly reduced, the half-life is increased in patients with moderate and severe liver dysfunction. The daily dose of ZofranŽ should not exceed 8 mg.

Patients with a slow metabolism of sparteine / debrisoquine. In patients with a slow metabolism of sparteine and debrisoquine, the half-life of ondansetron is not changed. Consequently, with repeated administration to such patients, its plasma concentration will not differ from that in the general population. Therefore, such patients do not need to adjust the daily dose or ondansetron frequency.

Pharmaceutical compatibility

To dilute the injection solution, the following solutions can be used:

- 0.9% solution of sodium chloride;

- 5% dextrose solution;

Ringer's solution;

- 10% mannitol solution;

- 0.3% potassium chloride solution and 0.9% sodium chloride solution;

- 0.3% potassium chloride solution and 5% dextrose solution.

The infusion solution should be prepared immediately before use. If necessary, the ready-made infusion solution can be stored for a maximum of 24 hours at a temperature of 2-8 ° C. During the infusion, protection from light is not required; The diluted injection solution retains its stability for at least 24 hours under natural light or normal light.

Tablets for resorption and syrup

The tablet for resorption is placed on the tip of the tongue, after dissolving it is swallowed.

Nausea and vomiting in cytostatic chemotherapy or radiotherapy

The choice of dosage regimen is determined by the emetogenicity of antitumor therapy.

Adults: The daily dose, as a rule, is 8-32 mg.

The following modes are recommended:

- with moderate emetogenic chemotherapy and radiotherapy, the recommended dose is 8 mg ondansetron 1-2 hours before the start of the main therapy with the subsequent intake of another 8 mg orally after 12 hours;

- with highly emetic chemotherapy, the recommended dose is 24 mg of ondansetron concomitantly with dexamethasone at a dose of 12 mg 1-2 hours before the start of chemotherapy.

To prevent late or prolonged vomiting that occurs after 24 hours, ZofranŽ should be taken internally at a dose of 8 mg twice daily for 5 days.

Children ZofranŽ is usually administered as an injection for 5 mg / m2 once, IV, immediately before the start of chemotherapy, followed by ingestion at a dose of 4 mg after 12 hours. After completing the course of chemotherapy, it is necessary to continue taking ZofranŽ at a dose 4 mg 2 times a day for 5 days.

Nausea and vomiting in the postoperative period

Adults to prevent nausea and vomiting in the postoperative period is recommended 16 mg ZofranŽ inside 1 hour before anesthesia.

To stop postoperative nausea and vomiting, ZofranŽ solution for injections is used.

Children to prevent and stop postoperative nausea and vomiting ZofranŽ is given as an IV injection.

Patients of advanced age. Dosage adjustments are not required.

Patients with renal insufficiency. No special changes in dosage, frequency or method of administration are required.

Patients with impaired liver function. The daily dose of ondansetron should not exceed 8 mg.

Patients with a slow metabolism of sparteine / debrisoquine. Correction of a daily dose or frequency of ondansetron is not required.

Suppositories

Nausea and vomiting in cytostatic chemotherapy or radiotherapy

The choice of dosage regimen is determined by the emetogenicity of antitumor therapy.

For adults, the following modes are recommended:

- with moderate emetogenic chemotherapy or radiotherapy 16 mg ondansetron (1 supp.) 1-2 hours before the start of the main therapy.

- with highly emetic chemotherapy, the recommended dose is 16 mg (1 supp.) Concurrently with IV injection of 20 mg dexamethasone 1-2 hours before the start of chemotherapy.

To prevent late or prolonged vomiting that occurs 24 hours after the end of chemotherapy or radiotherapy, continue taking the drug at a dose of 16 mg (1 soup.) Once a day for 5 days. Instead of suppositories, ZofranŽ can also be administered orally in the form of tablets or syrup.

Children. ZofranŽ in suppositories is not recommended for use in children.

Children ZofranŽ is prescribed in other dosage forms: tablets or syrup for oral administration or solution for parenteral administration.

Patients of advanced age. Dosage adjustments are not required.

Patients with renal insufficiency. No special changes in dosage, frequency or method of administration are required.

Patients with impaired liver function. The use of suppositories is not recommended, because The daily dose of ondansetron for this category of patients should not exceed 8 mg / day.

Patients with a slow metabolism of sparteine / debrisoquine. Correction of a daily dose or frequency of ondansetron is not required.

Overdose

Symptoms: in most cases, they are similar to adverse reactions when the drug is used in the recommended doses. There is limited experience of overdose ondansetron.

Treatment: there is no specific antidote for ZofranŽ, so it is recommended that symptomatic and supportive therapy be provided for suspected overdose. Use ipecacuanum in case of ZofranŽ overdose should not be taken. Its effectiveness is unlikely in connection with the antiemetic effect of ZofranŽ.

Special instructions

Allergic reactions to ondansetron in patients with a history of hypersensitivity to other 5HT3 receptor antagonists have been noted.

Since ondansetron increases the time of passage of the contents along the thick intestine, patients with signs of intestinal obstruction after the use of the drug require regular observation.

Tablets for resorption contain aspartame, and therefore they should be taken with caution to patients with phenylketonuria.

Tablets for resorption should not be squeezed out in advance from the foil, they are taken immediately before use.

At present, there are limited data on the use of ondansetron (rp for IV and I / O administration) in children younger than 1 month.

Pharmaceutical Precautions

ZofranŽ should not be administered in the same syringe or in one infusion solution with other medications.

Influence on the ability to drive and work with moving machinery

ZofranŽ does not have a sedative effect and does not affect the ability of patients to drive vehicles or engage in other potentially hazardous activities requiring increased concentration and speed of psychomotor reactions.

Storage conditions of the drug Zofran

In the dark place at a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life of the drug Zofran

3 years.

Do not use after the expiry date printed on the package.