Latran tablets p / o 4mg, No. 10

• Prevention of nausea and vomiting during anticancer chemotherapy or radiation therapy;

• prevention and treatment of nausea and vomiting in the postoperative period.

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

Individual, depending on the indications and treatment regimen, the patient's age and the dosage form used.

Film-coated tablets

1 tab.

Active ingredient: ondansetron (in the form of dihydrate hydrochloride) - 4 mg

Excipients: microcrystalline cellulose, colloidal silicon dioxide (aerosil), potato starch, magnesium stearate.

Shell composition: hyprolose (hydroxypropyl cellulose), polysorbate (tween-80), tropeolin O, castor oil

• Hypersensitivity to ondansetron;

• the simultaneous use of ondansetron with apomorphine;

• pregnancy, lactation (breastfeeding);

• children's age - depending on the indications and dosage form;

• congenital syndrome of prolongation of the QT interval.

With caution: in patients with hypersensitivity to other antagonists of 5HT3 receptors, with disturbances in the heart rhythm and conduction, with significant disturbances in the water-electrolyte balance; in patients with lengthening or at risk of lengthening the QTc interval, including patients with fluid and electrolyte imbalance, chronic heart failure, bradyarrhythmia, or in patients taking other medications that can cause QTc interval prolongation, fluid and electrolyte imbalance, or a decrease in heart rate; in patients receiving antiarrhythmics and beta-blockers; in patients with subacute bowel obstruction; with simultaneous use with other serotonergic drugs.

Clinical and pharmacological group: Centrally acting antiemetic drug that blocks serotonin receptors

Pharmaco-therapeutic group: Antiemetic - serotonin receptor antagonist

pharmachologic effect

Antiemetic. Effectively prevents and eliminates nausea and vomiting that occur during anticancer chemotherapy or radiation therapy, as well as in the postoperative period. The mechanism of action is due to the ability of ondansetron to selectively block serotonin 5-HT3 receptors. It is believed that stimulation of afferent fibers of the vagus nerve with serotonin released from enterochromaffin cells of the gastrointestinal mucosa plays an important role in the occurrence of nausea and vomiting during antitumor therapy. By blocking 5-HT3 receptors, ondansetron prevents the onset of the gag reflex. In addition, ondansetron inhibits the central links of the gag reflex by blocking 5-HT3 receptors in the floor of the IV ventricle (area postrema).

Pharmacokinetics

Ondansetron undergoes a 'first pass' effect through the liver. Protein binding is high (70-76%). Biotransformed in the liver, mainly by hydroxylation. The average T1 / 2 in adult patients is about 4 hours.

Indications

• Prevention of nausea and vomiting during anticancer chemotherapy or radiation therapy;

• prevention and treatment of nausea and vomiting in the postoperative period.

Dosage regimen

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

Individual, depending on the indications and treatment regimen, the patient's age and the dosage form used.

Side effect

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

From the nervous system: very often - headache; infrequently - seizures, movement disorders (including extrapyramidal symptoms such as dystonia, oculogyric crisis and dyskinesia); rarely - dizziness, mainly during rapid intravenous administration.

From the side of the organ of vision: rarely - transient visual disturbances (for example, blurred vision, transient blindness), mainly during intravenous administration.

From the side of the cardiovascular system: often - a feeling of heat or 'hot flashes'; infrequently - arrhythmia, chest pain, both accompanied and not accompanied by a decrease in the ST segment, bradycardia, a decrease in blood pressure; rarely - prolongation of the QT interval (including ventricular tachycardia of the 'pirouette' type).

From the digestive system: often - constipation; infrequently - hiccups, dryness of the oral mucosa; frequency unknown - diarrhea.

From the liver and biliary tract: infrequently - an asymptomatic increase in the activity of ALT, ACT (mainly in patients receiving chemotherapy with cisplatin).

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

From the side of metabolism: rarely - hypokalemia, hypercreatininemia.

Local reactions: with intravenous injection - burning at the injection site; when using suppositories - a burning sensation in the anus and rectum.

Contraindications for use

• Hypersensitivity to ondansetron;

• the simultaneous use of ondansetron with apomorphine;

• pregnancy, lactation (breastfeeding);

• children's age - depending on the indications and dosage form;

• congenital syndrome of prolongation of the QT interval.

With caution: in patients with hypersensitivity to other antagonists of 5HT3 receptors, with disturbances in the heart rhythm and conduction, with significant disturbances in the water-electrolyte balance; in patients with lengthening or at risk of lengthening the QTc interval, including patients with fluid and electrolyte imbalance, chronic heart failure, bradyarrhythmia, or in patients taking other medications that can cause QTc interval prolongation, fluid and electrolyte imbalance, or a decrease in heart rate; in patients receiving antiarrhythmics and beta-blockers; in patients with subacute bowel obstruction; with simultaneous use with other serotonergic drugs.

Application during pregnancy and lactation

Contraindicated for use during pregnancy and lactation (breastfeeding). If necessary, use during lactation should stop breastfeeding.

Application for violations of liver function

In patients with moderate to severe hepatic dysfunction, the clearance of ondansetron is significantly reduced, and the half-life is significantly increased.

Application in children

It is possible to use in children of the appropriate age categories strictly according to indications, in recommended doses and dosage forms. It is necessary to strictly follow the instructions in the instructions for ondansetron preparations on contraindications for the use of specific ondansetron dosage forms in children of different ages.

special instructions

There are reports of the occurrence of hypersensitivity reactions to ondansetron in patients with a history of hypersensitivity to other selective 5HT3 receptor antagonists.

It is known that ondansetron increases the transit time of the contents through the large intestine. When using ondansetron in patients with symptoms of subacute intestinal obstruction, regular monitoring of such patients is necessary.

Before using ondansetron, it is necessary to correct hypokalemia and hypomagnesemia.

It has been established that the combined use of ondansetron and other serotonergic drugs increases the risk of developing serotonin syndrome. If the use of such a combination is clinically justified, it is necessary to ensure regular monitoring of the patient's condition.

Influence on the ability to drive vehicles and mechanisms

During the period of ondansetron use, patients should be careful when driving vehicles and mechanisms, as well as when engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Drug interactions

Due to the fact that ondansetron is metabolized in the liver by isoenzymes of the cytochrome P450 system, with simultaneous use with drugs that are inducers or inhibitors of this enzyme system, changes in clearance and T1 / 2 of ondansetron are possible.

In patients receiving strong inducers of the isoenzyme CYP3A4 (phenytoin, carbamazepine and rifampicin), the clearance of ondansetron increases, and the concentration of ondansetron in the blood decreases.

There is evidence that ondansetron may reduce the analgesic effect of tramadol.

With the combined use of ondansetron and other serotonergic drugs, including selective serotonin reuptake inhibitors and norepinephrine and serotonin reuptake inhibitors, the risk of developing serotonin syndrome increases.