Zofran pills 8mg №10

Dosage form

Lozenges

Composition

1 tab. contains ondansetron 8 mg

Packing

10 pieces.

Mechanism of action

Antiemetic drug, selective serotonin 5HT3 receptor antagonist. The mechanism of action of Zofran is associated with the suppression of the gag reflex by blocking serotonin 5HT3 receptors at the level of neurons of both the central and peripheral nervous systems. The prevention and treatment of postoperative vomiting and nausea caused by cytostatic Chemotherapy and radiotherapy is associated with this mechanism of action, which is associated with an increase in serotonin levels, which, by activating vagal afferent fibers containing 5HT3 receptors, causes a gag reflex.

Indications and usage

- prevention and elimination of nausea and vomiting caused by cytotoxic chemotherapy or radiotherapy;
- prevention and elimination of nausea and vomiting in the postoperative period (this indication does not apply to suppositories).

Contraindications

Hypersensitivity to the drug Zofran.

Pregnancy and Breastfeeding

The safety of using ondansetron during pregnancy has not been established.
ATexperimental studies it was found that ondansetron does not have a direct or indirect adverse effect on the development of the embryo and fetus, during pregnancy, as well as on perinatal and postnatal development.However, since the results of studies in animals cannot always accurately predict the nature of the action in humans, the drug is not recommended for use during pregnancy.
If necessary, the appointment of the drug during lactation should stop breastfeeding.

Dosage and administration

A lozenge is placed on the tip of the tongue, after dissolving it is swallowed.

Nausea and vomiting with cytostatic chemotherapy or radiotherapy

The choice of dosing regimen is determined by the emethogenicity of antitumor therapy.

Adults: The daily dose, as a rule, is 8–32 mg.

The following modes are recommended:

- with moderate emetogenic chemotherapy and radiotherapy The recommended dose is 8 mg of ondansetron 1–2 hours before the start of the main therapy, followed by another 8 mg orally after 12 hours;

- with highly chemotherapeutic chemotherapy The recommended dose is 24 mg of ondansetron simultaneously with Dexamethasone at a dose of 12 mg 1–2 hours before the start of chemotherapy.

To prevent late or prolonged vomiting that occurs after 24 hours, Zofran should be taken orally at a dose of 8 mg 2 times a day for 5 days.

For children Zofran is usually administered as a solution for injection at a dose of 5 mg / m² once, in / in, immediately before the start of chemotherapy, followed by ingestion at a dose of 4 mg after 12 hours. After the end of chemotherapy, you must continue taking Zofran at a dose of 4 mg 2 times a day for 5 days.

Nausea and vomiting in the postoperative period

For adults for the prevention of nausea and vomiting in the postoperative period, 16 mg of Zofran is recommended orally for 1 hour before anesthesia.

For relief of postoperative nausea and vomiting, Zofran solution is used for injections.

For children to prevent and relieve postoperative nausea and vomiting, Zofran is administered as an intravenous injection.

Elderly patients. No change in dosage required.

Patients with renal failure. No special changes in dosage, frequency of administration or route of administration are required.

Patients with impaired liver function. The daily dose of ondansetron should not exceed 8 mg.

Patients with a slow metabolism of Spartein / Debrisoquine. Correction of the daily dose or frequency of receiving ondansetron is not required.

Adverse reactions

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

Gastrointestinal: hiccups, dry mouth, constipation or diarrhea, burning sensation in the region of the anus and rectum after the administration of the suppository; sometimes - asymptomatic transient increase in liver tests.

Cardiovascular: chest pain, in some cases with depression of the ST segment, arrhythmia, bradycardia, decrease in blood pressure.

Nervous system: headache, dizziness, spontaneous movement disorders and convulsions.

Other: rush of blood to the face, feeling of heat, temporary visual acuity, hypokalemia, hypercreatininemia.

Special notes

In patients receiving prior treatment with other selective 5HT antagonists₃-receptors accompanied by hypersensitivity reactions, hypersensitivity reactions are also possible with Zofran.
Since ondansetron increases the time it takes for the contents to pass through the large intestine, if Zofran is used in patients with symptoms of subacute intestinal obstruction, regular observation is necessary.
For the prevention and treatment of nausea and vomiting in the postoperative period, it is recommended to inject Zofran parenterally.
Zofran Lingual pills contain aspartame, so they should be used with caution in patients with phenylketonuria.
In elderly patients, experience with Zofran for the prevention and treatment of nausea and vomiting in the postoperative period is limited. Patients over 65 years of age who receive chemotherapy are well tolerated by Zofran; special changes in dose, frequency of administration or method of administration of the drug is not required.
In people with a slow metabolism of spartein and debrisoquine (lack of the CYP2D6 enzyme), the half-life of ondansertone is unchanged. Consequently, upon repeated administration of the drug in such patients, its plasma concentrations will not differ from those in the general population. Therefore, these patients do not need to adjust the daily dose or frequency of ondansteron.
Patients with impaired renal function do not need to adjust the daily dose, frequency or route of administration of Zofran.
Zofran ampoules should not be autoclaved.
Use in pediatrics
It is not recommended to prescribe a drug to children in the form of suppositories.
Influence on ability to drive motor transport and control mechanisms
Ondansetron has no sedative effect.

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

- with such enzymatic inducers of P450 (CYP2D6 and CYP1A2), as barbiturates, Carbamazepine, carisoprodol, glutetimid, Griseofulvin, nitrous oxide, papaverine, phenylbutazone, phenytoin (and probably other hydantoins), rifampicin, tolbutamide;

- with an inhibitor of enzymes p450, Ketoconazole, lovastatin, Metronidazole, Omeprazole, propranolol, quinidine, quinine, Verapamil.

Special studies have shown that ondansetron does not interact with alcohol, temazepam, Furosemide, tramadol and propofol (Diprivan).

Storage conditions

Store in a dark place at a temperature not exceeding 30 ° C.