Zofran candles 16 mg №1

Dosage form

Rectal suppositories

Composition

1 supp. contains ondansetron 16 mg

Packing

1 PC.

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.

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

Adults with nausea and vomiting associated with emetogenic chemotherapy or radiotherapyIt is recommended to prescribe 16 mg (1 suppository) for 1-2 hours before chemotherapy or radiotherapy. For the prevention of late or prolonged vomiting, 24 hours after the end of chemotherapy or radiotherapy, Zofran should be administered rectally in 16 mg (1 suppository) 1 time / day for 5 days. Instead of suppositories, Zofran can be administered orally in the form of pills or syrup.
Atnausea and vomiting associated with highly chemotherapeutic chemotherapy, the recommended dose is 16 mg (1 suppository) for 1-2 hours before chemotherapy. In the case of highly chemotherapeutic chemotherapy, the effect of Zofran may increase when it is administered along with Dexamethasone phosphate (in the form of sodium salt), which is administered intravenously in a single dose of 20 mg before the start of chemotherapy.
Forprevention of late or prolonged vomiting 24 hours after the end of chemotherapy or radiotherapy, treatment with the drug should be continued for 5 days at a dose of 16 mg (1 suppository) 1 time / day.

Adverse reactions

Cardiovascular: sensation of heat or rush of blood to the face and head; rarely - chest pain, arrhythmias, hypotension, bradycardia.
Gastrointestinal: constipation, hiccups, transient asymptomatic increase in transaminase activity in the blood plasma.
From the side of the central nervous system: headache, convulsions (passing afterwards).
Allergic reactions: rarely - allergic reactions of immediate type, in some cases - severe course, up to anaphylaxis.
Local reactions: rarely - a burning sensation in the anus and rectum after the administration of the suppository.

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

With simultaneous use with drugs that are inducers (barbiturates, Carbamazepine, rifampicin, phenytoin, phenylbutazone) or inhibitors (cimetidine, Allopurinol, disulfiram) microsomal liver enzymes - cytochrome P isoenzymes₄₅₀may change the clearance of ondansetron.

Storage conditions

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