Ondansetron-Teva pills 8mg, 10pcs

Composition

1 tablet contains:

Active ingredient:

 ondansetron.

Pharmacological action of the Pharmaceutical group

:  antiemetic agent-serotonin receptor blocker. Pharmaceutical action:  An antiemetic. Drugs for cytostatic chemotherapy and radiotherapy can cause an increase in the content of serotonin, which, by activating the afferent fibers of the vagus nerve containing serotonin 5-HT3 receptors, causes a gag reflex. Selectively blocks serotonin 5-HT3 receptors of neurons of the central (emetic center) and peripheral (gastrointestinal tract) nervous systems that regulate the gag reflex. It does not interfere with the coordination of movements, does not cause sedation and reduced performance. It does not change the concentration of prolactin in plasma. Pharmacokinetics:  After oral use, TCmax is 1.5 hours. After rectal use of 16 mg, ondansetron is detected in plasma after 15-60 minutes. The concentration of the Active ingredient increases linearly, TCmax is reached in about 6 hours and is 20-30 ng / ml. The decrease in plasma concentrations occurs at a slower rate than after oral use (due to continued absorption). Absolute bioavailability with rectal use is approximately 60% and does not depend on gender. After intravenous use, TCmax is 10 minutes. The volume of distribution after both oral and parenteral use is 140 liters. Plasma protein binding is 70-76%. It is metabolized in the liver with the participation of microsomal liver enzymes (mainly by the CYP2D6 isoenzyme). Both after oral use and after parenteral use, T1 / 2 is 3 hours. After rectal use, T1/2 is determined by the rate of absorption of ondansetron, and not by systemic clearance, and is approximately 6 hours. Less than 5% of the administered dose is excreted unchanged in the urine. The pharmacokinetic parameters of ondansetron do not change with repeated use. In patients with moderate renal insufficiency (creatinine clearance 15-60 ml/min), both systemic clearance and volume of distribution are reduced, resulting in a small and clinically insignificant increase in T1/2. The pharmacokinetics of ondansetron are virtually unchanged in patients with severe renal impairment who are on chronic hemodialysis (studies were conducted in between hemodialysis sessions). In patients with severe hepatic impairment, T1 / 2 – 15-20 h. T1 / 2 of ondansetron does not depend on the method of use. In elderly patients, after oral or parenteral use, T1/2 may increase up to 5 hours.

Indications

Nausea and vomiting caused by cytotoxic chemotherapy or radiotherapy; postoperative nausea and vomiting-prevention and treatment.

Symptomatic treatment of mild to moderate alcohol withdrawal syndrome (Latran only).

Contraindications

Hypersensitivity, pregnancy, lactation.

With caution. Children’s age (up to 2 years – lack of sufficient experience).

Side effects

Allergic reactions: urticaria, bronchospasm, laryngospasm, angioedema, anaphylaxis. Local reactions: hyperemia, pain, burning sensation at the injection site.

From the digestive system: hiccups, dry oral mucosa, constipation or diarrhea, asymptomatic transient increase in serum aminotransferase activity.

From the cardiovascular system: chest pain, in some cases with S-T depression, arrhythmia, bradycardia, decreased blood pressure.

Nervous system disorders: headache, dizziness, spontaneous movement disorders and seizures.

Others: a “rush” of blood to the skin of the face, a feeling of heat, a temporary violation of visual acuity, hypokalemia, hypercreatininemia.

Interaction

Caution is required when using together:

• with inducers of isoenzymes CYP2D6 and CYP3A – barbiturates, carbamazepine, carisoprodol, glutethimide, griseofulvin, dinitrogen oxide, papaverine, phenylbutazone, phenytoin (and probably other hydantoins), rifampicin, tolbutamide;
• inhibitors of the isoenzyme CYP2D6 and CYP3A – allopurinol, macrolide antibiotics, antidepressants (MAO inhibitors), chloramphenicol, cimetidine, estrogensoderjaschie oral contraceptives, diltiazem, disulfiram, valproic acid and its salts, erythromycin, fluconazole, fluoroquinolones, isoniazid, ketoconazole, lovastatin, metronidazole, omeprazole, propranolol, quinidine, quinine, verapamil.

Ondansetron at a concentration of 16-160 µg/ml pharmaceutically compatible and can be administered through a Y-shaped injector/drip in conjunction with the following drugs:

• cisplastin (in a concentration of 0.48 mg/ml) for 1-8 h;
• fluorouracil (at a concentration of up to 0.8 mg/ml at a rate of 20 ml/h – higher levels can cause the precipitation of ondansetron);
• carboplatin (at a concentration of 0.18-9.9 mg/ml 10-60 min);
• etoposide (at a concentration of 0.14-0.25 mg/ml for 30-60 min);
• ceftazidime (at a dose of 0.25-2 g, in the form of in/bolus injection over 5 min);
• cyclophosphamide (at a dose of 0.1-1 g, in the form of in/bolus injection over 5 min);
• doxorubicin (dose of 10-100 mg, in the form of in/bolus injection over 5 min);
• dexamethasone: perhaps, in/in the introduction of 20 mg of dexamethasone sodium phosphate slowly for 2-5 min. The drug can be administered through a single dropper, while in the solution the concentrations of dexamethasone sodium phosphate can range from 32 to 2500 mcg/ml, ondansetron-from 8 to 100 mcg/ml.

How to take, course of use and dosage

The choice of dosage regimen is determined by the severity of the emetogenic effect of the antitumor therapy.

For adults, the daily dose is 8-32 mg / day, the following regimens are recommended.

With moderate emetogenic effects of chemotherapy or radiotherapy – 8 mg IV jet slowly or iv, immediately before the start of therapy. If the emetogenic effect of chemotherapy is significant: enter intravenous jet slowly 8 mg immediately before the start of chemotherapy, and then intravenous jet-8 mg every 2-4 hours; or intravenous drip continuously at a rate of 1 mg/h for 24 hours; or drip immediately before the start of chemotherapy at a dose of 16-32 mg, diluted in 50-100 ml of the appropriate infusion solution, for 15 minutes.

The effectiveness of odansetron can be increased by a single intravenous use of corticosteroids (for example,20 mg dexamethasone) before the start of chemotherapy. To prevent delayed vomiting that occurs 24 hours after the start of chemotherapy or radiotherapy, both with strong and moderate severity of the emetogenic effect of the therapy, it is recommended to take the drug in the form of tablets.

For oral use: adults, for the prevention of nausea and vomiting against the background of chemotherapy or radiotherapy, ondansetron is prescribed 8 mg 1-2 hours before the start of antitumor therapy, followed by another 8 mg orally after 12 hours.

To prevent late (after 24 hours) or prolonged vomiting, continue taking 8 mg 2 times a day for 5 days after the end of the course of antitumor therapy. To enhance the effect, a single dose can be increased to 24 mg and administered simultaneously with 12 mg of dexamethasone phosphate (in the form of sodium salt) 1-2 hours before the start of chemotherapy.

Children over 2 years of age: iv at a dose of 5 mg / sq. m of body surface immediately before chemotherapy, followed by oral use at a dose of 4 mg after 12 hours.

After the end of the course of chemotherapy, it is necessary to continue taking ondansetron at a dose of 4 mg 2 times a day for 5 days.

Prevention of postoperative nausea and vomiting:

Adults are administered during the period of introductory general anesthesia in / m or in / in (slowly) at a dose of 4 mg.

For the treatment of nausea and vomiting, intravenous or intravenous slow use of 4 mg of the drug is recommended.

Ondansetron can be administered intravenously in the same area of the body at a dose not exceeding 4 mg.

To prevent postoperative nausea and vomiting in children, ondansetron is used exclusively parenterally, in a single dose of 0.1 mg/kg (up to a maximum of 4 mg) slowly intravenously before or after anesthesia.

For the treatment of postoperative nausea and vomiting in children, slow intravenous use of a single dose of 0.1 mg/kg (up to a maximum of 4 mg) is recommended.

There is insufficient experience in the prevention and treatment of postoperative nausea and vomiting in children under 2 years of age.

In patients with kidney damage and in elderly patients, no adjustment of the usual daily dose and frequency of use of the drug is required.

With liver damage, the clearance of ondansetron is significantly reduced, its T1 / 2 from plasma increases, and a dose reduction to 8 mg/day is required.

Special instructions

Patients who have previously had allergic reactions to other selective 5-HT3 receptor blockers have an increased risk of developing them on the background of ondansetron.

Ondansetron can slow down the motility of the large intestine, and therefore its use to patients with signs of intestinal obstruction requires special monitoring. The infusion solution is prepared immediately before use. If necessary, it can be stored for 24 hours at

a temperature of 2-8 degrees. C in normal light conditions. During the infusion, no protection from light is required; the diluted injection solution remains stable for at least 24 hours in natural light or normal light.

For the preparation of an infusion solution, the following methods can be used: : 0.9% NaCl solution,5% dextrose solution,10% mannitol solution, Ringer’s solution,0.3% KCl solution and 0.9% NaCl solution,0.3% KCl solution and 5% dextrose.

Lingual tablets contain aspartame, this should be taken into account when prescribing to patients with phenylketonuria.

Storage conditions

In a dark place, at a temperature not exceeding 25 °C.

Shelf life

2 years

Active ingredient

Ondansetron

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

Children as prescribed by a doctor, Children over 2 years old, Adults as prescribed by a doctor