Instruction for use: Emeset

Dosage form: Solution for intravenous and intramuscular injection; Injection; Film-coated tablets

Active substance: Ondansetron*

Description of the active substance. The above scientific information is generalizing and cannot be used to decide on the feasibility of using a particular medicinal product.

Indications

For IV and IM injection and oral administration. Prevention and treatment of nausea and vomiting caused by cytostatic chemotherapy and radiotherapy in adults; Prevention and treatment of nausea and vomiting caused by cytostatic chemotherapy in children; Prevention and treatment of postoperative nausea and vomiting in adults and children.

Studies on the oral use of ondansetron for the prevention or treatment of postoperative nausea and vomiting in children have not been conducted. For this purpose, the use of ondansetron for intravenous and / or injection is recommended.

For rectal administration. Prevention and treatment of nausea and vomiting caused by cytostatic chemotherapy and radiotherapy.

Contraindications

For IV and IM. Hypersensitivity; Combined use with apomorphine; Congenital lengthening syndrome QT; Age to 6 months (prevention and treatment of nausea and vomiting caused by cytostatic chemotherapy in children); Age up to 1 month (prevention and treatment of postoperative nausea and vomiting in adults and children); Pregnancy and the period of breastfeeding.

For oral administration. Hypersensitivity; Pregnancy (tablets - I trimester of pregnancy); The period of breastfeeding; Children's age (tablets - up to 2 years (all dosages, experience in children under 2 years is absent), up to 3 years for a dosage of 4 mg and up to 12 years for a dosage of 8 mg, syrup for up to 6 months); Combined use with apomorphine; Congenital lengthening syndrome QT.

For rectal administration. Hypersensitivity; Combined use with apomorphine; Congenital lengthening syndrome QT; childhood; Pregnancy and the period of breastfeeding; liver failure.

Application in pregnancy and breastfeeding

The action category for fetus by FDA is B.

Contraindicated in pregnancy (tablets - in the first trimester of pregnancy).

If it is necessary to use ondansetron during lactation, breastfeeding should be discontinued.

Side effects

The undesirable phenomena presented below are listed according to the organs and systems of the body and in accordance with the frequency of occurrence when taking the standard recommended doses of ondansetron. Frequency of occurrence is defined as follows: very often (≥1 / 10); Often (≥1 / 100 and <1/10); Infrequently (≥1 / 1000 and <1/100); Rarely (≥1 / 10000 and <1/1000); Very rarely (<1/10000, including individual cases). Frequency categories were formed on the basis of clinical studies and post-registration surveillance.

The profile of adverse reactions in children and adolescents was comparable to the profile observed in adults.

From the side of the immune system: rarely - immediate reactions of hypersensitivity (urticaria, bronchospasm, laryngospasm, angioedema), in a number of cases of severe degree, including anaphylaxis.

From the nervous system: very often - headache; Infrequently - 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, mainly during a rapid IV injection.

From the side of the organ of vision: rarely - transient visual impairment (eg 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 CVS: often - a feeling of heat or hot flashes; Infrequent - arrhythmia, pain in the chest, as accompanied, and not accompanied by a decrease in the ST segment, bradycardia, lowering blood pressure; Rarely - prolongation of the QT interval (including bidirectional ventricular tachycardia).

From the respiratory system, chest and mediastinum: infrequently - hiccup.

From the digestive tract: often - constipation.

On the part of the liver and bile ducts: infrequently - an asymptomatic increase in the level of hepatic enzymes ALT, ACT (mainly observed in patients receiving chemotherapy with cisplatin).

From the skin and subcutaneous tissues: very rarely - toxic skin rash, including toxic epidermal necrolysis.

General and local reactions: often - local reactions (burning sensation at the injection site, a burning sensation in the anus and rectum after administration of a suppository).

In addition: the frequency is not established - dry mouth, diarrhea, hypokalemia (connection with ondansetron is not unambiguously established).

Precautionary measures

Patients who had previously had allergic reactions to other selective 5-HT3 receptor blockers have an increased risk of developing them against ondansetron. In patients with an increased risk of prolonging the QT interval, hypokalemia and hypomagnesemia should be adjusted. Ondansetron can slow the motility of the large intestine, and therefore its appointment to patients with signs of intestinal obstruction requires special observation.

Ondansetron clearance in children aged 1-4 months is reduced, and T1 / 2 is approximately 2.5 times greater than in children aged 5-24 months. Therefore, careful follow-up is recommended for patients receiving ondansetron at the age of 1-4 months.

When combined with ondansetron and other serotonergic drugs, including SSRIs and SSRIs, the risk of developing serotonin syndrome (altered state of consciousness, instability of the peripheral nervous system and neuromuscular disorders) increases; It is necessary to ensure regular monitoring of the patient's condition.

Pharmaceutical precautions. Ondansetron in the form of a solution should not be administered in the same syringe or in one infusion solution with other medicines, with the exception of those indicated in the instructions for medical use.

Influence on ability of management of vehicles and work with mechanisms. Ondansetron does not adversely affect the ability to drive vehicles and work with mechanisms.