Ondansetron Altpharm suppositories 16mg, No. 2

prevention and elimination of nausea and vomiting caused by cytostatic chemotherapy and radiotherapy.

Dosage regimen

The drug is used rectally. To remove the suppository from the cell packaging, break off one cell with the suppository along the notch and, after separating the edges of the tape, pull them in different directions. The suppository is inserted into the anus with a pointed end, as deep as possible. For a more convenient introduction of the suppository, it is recommended to bend down, squat down or lie on your side with your legs tucked in.

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

With moderate emetogenic chemotherapy or radiotherapy, 16 mg of ondansetron is prescribed 1-2 hours before the start of the main therapy.

With highly emetogenic chemotherapy, the recommended dose is 16 mg simultaneously with intravenous administration of 20 mg of 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, you should continue taking the drug at a dose of 16 mg 1 time / day for 5 days.

The drug is not recommended for use in children .

In elderly patients, dose changes are not required.

In patients with renal insufficiency , changes in dose, frequency of administration or route of administration are not required.

For patients with impaired liver function, the daily dose of ondansetron should not exceed 8 mg.

Patients with a slow metabolism of sparteine ??/ debrisoquine do not need to adjust the daily dose or frequency of taking ondansetron.

Rectal suppositories of white or white color with a creamy shade, torpedo-shaped, without visible inclusions on the longitudinal section.

1 supp. ondansetron 16 mg

Excipients : witepsol N-15.

1 PC. - contoured cell packaging (1) - cardboard inserts (2) - cardboard packs. Clinical and pharmacological group: Centrally acting antiemetic drug that blocks serotonin receptors

• pregnancy;

• lactation period (breastfeeding);

• childhood;

• hypersensitivity to ondansetron or any other component of the drug.

Rectal suppositories of white or white color with a creamy shade, torpedo-shaped, without visible inclusions on the longitudinal section.

1 supp. ondansetron 16 mg

Excipients : witepsol N-15.

1 PC. - contoured cell packaging (1) - cardboard inserts (2) - cardboard packs. Clinical and pharmacological group: Centrally acting antiemetic drug that blocks serotonin receptors

Pharmaco-therapeutic group: Antiemetic - serotonin receptor antagonist

pharmachologic effect

Centrally acting antiemetic drug. Selective antagonist of serotonin 5HT3 receptors.

Medicines for cytostatic chemotherapy and radiotherapy can cause an increase in serotonin levels, which, by activating the vagal afferent fibers containing serotonin 5HT3 receptors, induces the gag reflex. Ondansetron inhibits the appearance of the gag reflex by blocking serotonin 5HT3 receptors at the level of neurons in both the central and peripheral nervous systems. Apparently, this mechanism of action is the basis for the prevention and treatment of postoperative and induced by cytostatic chemotherapy and radiotherapy of nausea and vomiting.

Pharmacokinetics

The pharmacokinetic parameters of ondansetron do not change with repeated administration.

Suction

After rectal administration, ondansetron is determined in plasma after 15-60 minutes. The concentration of the active substance increases linearly, Cmax is reached after about 6 hours and is 20-30 ng / ml. Absolute bioavailability after rectal administration is approximately 60%. The decrease in plasma concentration occurs at a slower rate than after oral administration (due to continued absorption).

Withdrawal

T1 / 2 - 6 h.

Indications for Ondansetron-Altpharm

prevention and elimination of nausea and vomiting caused by cytostatic chemotherapy and radiotherapy.

Dosage regimen

The drug is used rectally. To remove the suppository from the cell packaging, break off one cell with the suppository along the notch and, after separating the edges of the tape, pull them in different directions. The suppository is inserted into the anus with a pointed end, as deep as possible. For a more convenient introduction of the suppository, it is recommended to bend down, squat down or lie on your side with your legs tucked in.

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

With moderate emetogenic chemotherapy or radiotherapy, 16 mg of ondansetron is prescribed 1-2 hours before the start of the main therapy.

With highly emetogenic chemotherapy, the recommended dose is 16 mg simultaneously with intravenous administration of 20 mg of 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, you should continue taking the drug at a dose of 16 mg 1 time / day for 5 days.

The drug is not recommended for use in children .

In elderly patients, dose changes are not required.

In patients with renal insufficiency , changes in dose, frequency of administration or route of administration are not required.

For patients with impaired liver function, the daily dose of ondansetron should not exceed 8 mg.

Patients with a slow metabolism of sparteine ??/ debrisoquine do not need to adjust the daily dose or frequency of taking ondansetron.

Side effect

From the digestive system: hiccups, dry mouth, constipation, diarrhea; sometimes - asymptomatic transient increase in serum aminotransferase activity.

From the side of the cardiovascular system: chest pain (sometimes with ST segment depression), arrhythmias, bradycardia, decreased blood pressure.

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

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

Local reactions: hyperemia, pain, burning sensation in the anus and rectum after the administration of the suppository.

Others: flushing of the skin of the face, a feeling of heat, temporary impairment of visual acuity, hypokalemia, hypercreatininemia.

Contraindications for use

• pregnancy;

• lactation period (breastfeeding);

• childhood;

• hypersensitivity to ondansetron or any other component of the drug.

Application during pregnancy and lactation

The drug is contraindicated during pregnancy and lactation (breastfeeding).

Application for violations of liver function

For patients with impaired liver function, the daily dose of ondansetron should not exceed 8 mg.

Application for impaired renal function

In patients with renal insufficiency , changes in dose, frequency of administration or route of administration are not required.

special instructions

Patients with a history of allergic reactions to other selective serotonin 5HT3 receptor blockers have an increased risk of developing them when taking ondansetron.

Ondansetron can slow down the motility of the large intestine, and therefore, its appointment to patients with symptoms of intestinal obstruction requires special monitoring.

Overdose

There is limited experience with ondansetron overdose. In most cases, the symptoms are similar to adverse reactions when using the drug in the recommended doses.

Treatment: symptomatic and supportive therapy. A specific antidote for ondansetron is not known.

Drug interactions

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 isoenzymes of the cytochrome P450 system (CYP3A4, CYP2D6 and CYP1A2). The inhibition or decrease in the activity of one of the isoenzymes is usually normally compensated by others, and therefore a significant decrease in the total clearance of ondansetron is unlikely. However, caution is required when used together:

• with inducers of isoenzymes of the cytochrome P450 system (CYP2D6 and CYP3A): barbiturates, carbamazepine, carisoprodol, glutethimide, griseofulvin, dinitrogen oxide, papaverine, phenylbutazone, phenytoin (probably other hydantoins), rifamampicin;

• with inhibitors of isoenzymes of the cytochrome P450 system (CYP2D6 and CYP3A): allopurinol, macrolide antibiotics, antidepressants (MAO inhibitors), chloramphenicol, cimetidine, oral contraceptives containing estrogens, diltiazem, disulfiram, valproiconiol, sodium issulfiram, valproiconiol , ketoconazole, lovastatin, metronidazole, omeprazole, propranolol, quinidine, quinine, verapamil.

Special studies have shown that ondansetron does not interact with ethanol, temazepam, furosemide, tramadol and propofol.

Storage conditions of the drug Ondansetron-Altpharm

The drug should be stored in a dry, protected from light, out of the reach of children at a temperature not exceeding 25 ? C.

Shelf life of the drug Ondansetron-Altpharm

Shelf life is 2 years.

Terms of sale

The drug is available with a prescription.