Universal reference book for medicines
Product name: ONDANSETRON-ALTHARM (ONDANSETRON-ALTPHARM)

Active substance: ondansetron

Type: Antiemetic medication of central action blocking serotonin receptors

Manufacturer: АЛЬТФАРМ (Russia)
Composition, form of production and packaging
Suppositories rectal
white or white with a creamy ottenkom color, torpedo-shaped, without visible impregnations on the longitudinal section.

1 supp.

ondansetron 4 mg

Auxiliary substances: Witepsol H-15.

5 pieces.
- packings of cellular contour (1) - packs cardboard.
Suppositories rectal white or white with a creamy ottenkom color, torpedo-shaped, without visible impregnations on the longitudinal section.

1 supp.

ondansetron 8 mg

Auxiliary substances: Witepsol H-15.

5 pieces.
- packings of cellular contour (1) - packs cardboard.
Suppositories rectal white or white with a creamy ottenkom color, torpedo-shaped, without visible impregnations on the longitudinal section.

1 supp.

ondansetron 16 mg

Auxiliary substances: Witepsol H-15.

1 PC.
- packings of cellular contour (1) - inserts from cardboard (2) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

Antiemetic drug of central action.
Selective antagonist of serotonin 5HT 3 receptors.
Drugs for cytostatic chemotherapy and radiotherapy can cause an increase in the level of serotonin, which, by activating vagal afferent fibers containing serotonin 5HT 3 receptors, causes a vomiting reflex.
Ondansetron inhibits the appearance of a vomiting reflex by blocking the serotonin 5HT 3 receptors at the neuronal level of both the central and peripheral nervous system. Apparently, this warning mechanism and the treatment of postoperative and induced by cytostatic chemotherapy and radiotherapy of nausea and vomiting are based on this mechanism of action.
PHARMACOKINETICS

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

Suction

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

T 1/2 - 6 hours.

INDICATIONS

- Prevention and elimination of nausea and vomiting caused by cytostatic chemotherapy and radiotherapy.

DOSING MODE

The drug is used rectally.
To remove the suppository from the cell package, one cell with a suppository must be broken off by notching and disconnecting the edges of the tape, pulling 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 or lie on one side, with your legs tucked.
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 concomitantly with IV administration of 20 mg 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, 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.

Patients with renal insufficiency do not require dose changes, frequency of administration or method of administration.

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 ondansetron.

SIDE EFFECT

On the part of the digestive system: hiccough, dry mouth, constipation, diarrhea;
sometimes - an asymptomatic transient increase in the activity of aminotransferases in the blood serum.
From the cardiovascular system: pain in the chest (sometimes with depression of the ST segment), arrhythmias, bradycardia, lowering 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 introduction of the suppository.

Other: hot flushes to the skin of the face, a feeling of heat, temporary disturbance of visual acuity, hypokalemia, hypercreatininaemia.

CONTRAINDICATIONS

- Pregnancy;

- lactation period (breastfeeding);

- childhood;

- Hypersensitivity to ondansetron or any other component of the drug.

PREGNANCY AND LACTATION

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

APPLICATION FOR FUNCTIONS OF THE LIVER

Patients with renal insufficiency do not require dose changes, frequency of administration or method of administration.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

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

SPECIAL INSTRUCTIONS

Patients who have a history of allergic reactions to other selective blockers of serotonin 5HT 3 receptors, have an increased risk of their development with ondansetron.

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

OVERDOSE

There is limited experience of overdose ondansetron.
In most cases, the symptoms are similar to adverse reactions when the drug is administered at recommended doses.
Treatment: symptomatic and supportive therapy.
The specific antidote for ondansetron is not known.
DRUG INTERACTION

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 reduction in the total clearance of ondansetron is unlikely. However, caution is required when using together:
- with inducers of cytochrome P450 isoenzymes (CYP2D6 and CYP3A): barbiturates, carbamazepine, carisoprodol, glutetimide, griseofulvin, dinitrogen oxide, papaverine, phenylbutazone, phenytoin (probably other hydantoins), rifampicin, tolbutamide;

with inhibitors of cytochrome P450 isoenzyme inhibitors (CYP2D6 and CYP3A): allopurinol, macrolide antibiotics, antidepressants (MAO inhibitors), chloramphenicol, cimetidine, oral contraceptives containing estrogens, diltiazem, disulfiram, valproic acid, sodium valproate, erythromycin, fluconazole, fluoroquinolones, isoniazid, ketoconazole, lovastatin, metronidazole, omeprazole, propranolol, quinidine, quinine, verapamil.

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

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored in a dry, protected from light, inaccessible to children at a temperature of no higher than 25 ° C.
Shelf life - 2 years.
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