Emeset - Instructions For Use, Tablets, Price, Reviews, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Emeset

Emeset: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Emeset

ATX code: A04AA01

Active ingredient: ondansetron (Ondansetron)

Manufacturer: Tsipla Ltd. (Cipla, Ltd.) (India)

Description and photo update: 2019-09-07

Emeset is an antiemetic drug.

Release form and composition

Dosage forms of Emeset:

• solution for intravenous (intravenous) and intramuscular (intramuscular) administration: colorless, transparent liquid (2 and 4 ml in ampoules, 5 ampoules in plastic pallets, in a carton pack 1 pallet);
• film-coated tablets, 4 mg: round, biconvex, almost white or white, the number "4" is extruded on one side (6 pcs. in strips, 1 strip in a cardboard box);
• film-coated tablets, 8 mg: round, biconvex, almost white or white, the number "8" is squeezed out on one side, on the other there is a break line (6 pcs. in strips, 1 strip in a cardboard box).

Each pack also contains instructions for using Emeset.

Composition of 1 ml solution:

• active substance: ondansetron (in the form of dihydrate hydrochloride) - 2 mg;
• auxiliary components: trisodium citrate dihydrate, anhydrous citric acid, sodium chloride, water for injection.

Composition of 1 film-coated tablet:

• active substance: ondansetron (in the form of dihydrate hydrochloride) - 4 or 8 mg;
• auxiliary components: starch, hypromellose, lactose, microcrystalline cellulose, magnesium stearate.

Pharmacological properties

Pharmacodynamics

The active substance of Emeset is ondansetron, a selective antagonist of 5HT ₃ (serotonin) receptors.

The mechanism of action of the drug is determined by its ability to block 5-HT ₃ receptors at the level of neurons of the central and peripheral nervous system. This inhibits the appearance of the gag reflex, due to an increase in serotonin levels due to the use of drugs for radiotherapy and cytostatic chemotherapy, since it activates the vagal afferent fibers containing 5-HT ₃ receptors.

It is this mechanism of action of ondansetron that is thought to prevent and relieve postoperative and cytostatic chemotherapy / radiotherapy-induced nausea and vomiting (emetogenic effect).

Pharmacokinetics

After i / m administration of Emeset, the maximum plasma concentration (C _max) is reached within 10 minutes, after oral administration - 1.5 hours.

With intramuscular and intravenous administration, the distribution of ondansetron is the same.

About 70–76% of the dose is bound to plasma proteins. The absolute bioavailability of ondansetron is about 60%. The drug is metabolized in the liver. Less than 5% of ondansetron is excreted unchanged by the kidneys.

The half-life (T _1/2), regardless of the method of application of Emeset is approximately 3 hours. This period can increase up to 5 hours in the elderly, up to 15-20 hours in patients with severe hepatic insufficiency. T1 _{/ 2} increases for 4-5 hours in patients with kidney damage (renal clearance <15 ml / min), but this phenomenon has no clinical significance.

Indications for use

Emeset is used to prevent and eliminate nausea and vomiting in the postoperative period, as well as those caused by cytostatic chemotherapy and radiotherapy.

Contraindications

• children under 2 years old;
• period of pregnancy and lactation;
• known hypersensitivity to any component of Emeset.

Emeset, instructions for use: method and dosage

Nausea / vomiting during chemotherapy / radiotherapy

The dosage regimen of Emeset depends on the severity of the emetogenic effect of the anti-tumor therapy.

Regimens for moderate emetogenic chemotherapy / radiotherapy in adults:

• 8 mg intramuscularly or slowly intravenously jet immediately before starting therapy;
• 8 mg orally 1–2 hours before starting therapy and 8 mg orally 12 hours after starting therapy.

Treatment regimens used in adults for highly emetogenic chemotherapy:

• 16–32 mg, diluted in 50–100 ml of infusion solution, as a 15-minute infusion immediately before starting chemotherapy;
• 8 mg slowly intravenously jet immediately before the start of therapy, then two more intravenous jet injections of 8 mg at intervals of 2-4 hours;
• 24 mg as a continuous 24 hour infusion at a rate of 1 mg / h.

To dilute Emeset, the following solutions can be used: sodium chloride 0.9%, dextrose 5%, potassium chloride solution 0.3% with sodium chloride solution 0.9%, potassium chloride solution 0.3% with dextrose solution 5%, Ringer's solution …

With intravenous administration, the effect of ondansetron can be enhanced with a single intravenous administration of a glucocorticosteroid (for example, dexamethasone at a dose of 20 mg) prior to chemotherapy.

When taken orally, to enhance the effect, it is allowed to increase a single dose up to 24 hours and concomitantly prescribe dexamethasone at a dose of 12 mg 1-2 hours before chemotherapy.

To prevent delayed nausea / vomiting (occurring 24 hours after the start of radiotherapy / chemotherapy), it is recommended to take 8 mg Emeset tablets orally 2 times a day for 5 days.

Children from 2 years of age are prescribed an intravenous drug, immediately before the start of chemotherapy at 5 mg / m ^{2 of} the body surface, after 12 hours - 4 mg orally. After the end of chemotherapy, it is recommended to continue treatment for 5 days, taking Emeset orally 2 times a day, 4 mg.

Postoperative nausea and vomiting

Recommended dosage of Emeset for adults:

• prophylaxis: 16 mg orally 1 hour before the onset of anesthesia or 4 mg intramuscularly or intravenously slowly in a stream at the beginning of anesthesia;
• Treatment: 4 mg IM or slow IV.

With the intramuscular use of Emeset, a dose of not more than 4 mg can be administered in one area of the body.

Recommended dosage for children from 2 years of age:

• prevention: 0.1 mg / kg (but not more than 4 mg) slowly intravenously before or after anesthesia;
• treatment: 0.1 mg / kg (but not more than 4 mg) slowly intravenously.

Dose adjustment

Elderly people and patients with functional impairment of the kidneys do not need to adjust the Emeset regimen.

In case of impaired liver function, the maximum daily dose should not exceed 8 mg.

Side effects

• from the digestive system: dry mouth, hiccups, constipation or diarrhea, asymptomatic, transient increase in serum aminotransferase levels;
• on the part of the cardiovascular system: bradycardia, arrhythmias, decreased blood pressure, chest pain (sometimes with ST segment depression);
• from the nervous system: dizziness, headache, spontaneous movement disorders, convulsions;
• allergic reactions: laryngospasm, bronchospasm, urticaria, anaphylaxis, angioedema;
• others: a feeling of heat, flushing of the face, hypokalemia, temporary visual impairment;
• local reactions with intramuscular and intravenous administration: redness, pain and burning at the injection site of Emeset.

Overdose

At the moment, there are no reports of overdose cases.

The specific antidote for ondansetron is unknown. Symptomatic therapy was recommended.

When taking an excessive dose of Emeset in the form of tablets, Ipecacuanu should not be used, since it is most likely not effective during the antiemetic period of ondansetron.

special instructions

Ondansetron slows down intestinal motility, which can be dangerous if you have an intestinal obstruction. Patients with signs of this disorder require careful monitoring.

In patients with a history of indications of the development of hypersensitivity reactions when using other selective 5HT ₃ receptor antagonists, there is a risk of developing similar reactions during therapy with ondansetron.

During the infusion of Emeset, it is not required to protect the solution from light. In natural and normal light, it remains stable for at least 24 hours.

It is recommended to dilute the solution immediately before administration, but if necessary, it can be stored at a temperature of 2-8 ° C for up to 24 hours.

Influence on the ability to drive vehicles and complex mechanisms

The degree of restriction is determined individually. It is recommended to refrain from performing potentially hazardous activities in patients who develop undesirable effects that can affect the speed of reactions and the ability to concentrate, for example, dizziness.

Application during pregnancy and lactation

Emeset is contraindicated during pregnancy and lactation.

Pediatric use

Emeset is not prescribed for children under 2 years of age, since they have not established the efficacy and degree of safety of ondansetron.

With impaired renal function

Renal function has practically no effect on the pharmacokinetics of Emeset. Correction of the dosage regimen for patients with impaired renal function is not required.

For violations of liver function

Since ondansetron is metabolized in the liver, when its function is impaired, clearance is significantly reduced and T _{1/2 of the} substance from the plasma increases. In this regard, with a functional disorder of the liver, the daily dose of Emeset 8 mg should not be exceeded.

Use in the elderly

In the elderly, no changes were found in the pharmacokinetics of the drug, therefore, no correction of the dosage regimen of Emeset is required.

Drug interactions

Ondansetron is metabolized with the participation of isoenzymes of the cytochrome P _{450 system}, therefore, it is important to be careful with the simultaneous use of drugs such as:

• enzymatic inducers of P ₄₅₀ (CYP2D6 and CYP3A): phenytoin (possibly other hydantoins), phenylbutazone, glutethimide, carbamazepine, rifampicin, griseofulvin, papaverine, carisoprodol, tolbutamide, nitrous oxide, barbiturates;
• inhibitors of P ₄₅₀ enzymes (CYP2D6 and CYP3A): oral contraceptives containing estrogens; antidepressants that are monoamine oxidase (MAO) inhibitors; macrolide antibiotics, fluoroquinolones, disulfiram, metronidazole, diltiazem, valproic acid, chloramphenicol, omeprazole, isoniazid, cimetidine, fluconazole, quinine, quinidine, ketoconazole, erythromycin, allopurinol, verapinol sodium, propylpurinol, verapinatol sodium

Analogs

The analogues of Emeset are Vero-ondansetron, Domegan, Zofran, Lazaran VM, Ondavell, Ondansetron, Ondantor, Onitsit, Osetron, Emetron, etc.

Terms and conditions of storage

Store in a dark place, out of reach of children. Storage temperature: coated tablets - up to 25 ° С, solution for intramuscular and intravenous administration - up to 30 ° С.

The shelf life of the drug in all dosage forms is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Emeset

Reviews about Emeset are few, but mostly positive. Patients note that while using the drug, cytostatic chemotherapy is tolerated much easier. Reports on the use of ondansetron in the postoperative period, including after appendicitis in children, are also favorable.

Side effects include thirst, dry mouth and hiccups.

Price for Emeset in pharmacies

The price of Emeset depends on the dosage form of the drug and the dosage. The approximate cost of coated tablets at a dosage of 4 mg (6 pieces per package) is 910 rubles, at a dosage of 8 mg (6 pieces per package) - 1290 rubles. A solution for intravenous and intramuscular administration of 2 mg / ml (5 ampoules of 4 ml in a package) can be bought for approximately 1800 rubles.

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!