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Zofran Review Article

 

Zofran is a drug commonly used by cancer patients who underwent either chemotherapy or radiation therapy in order to avoid the occurrence of vomiting and nausea. Although there are also non-cancer patients who are given this drug, for the same purpose after a surgical procedure was done on them.

The human brain has a vomiting reception center; wherein this is the area that controls a person’s urge to vomit. Especially after a surgery, chemotherapy or radiation therapy, this vomiting center of the brain is triggered. However, with the intake of Zofran, the drug inhibits the vomiting reception center from being triggered, thus avoiding the sensation of being nauseous and inevitably the vomiting of the patient.

This drug comes in syrup, oral tablets or vials. Intake of the drug should be with doctor’s prescription as it is quite lethal to persons with the following conditions: electrolyte imbalance, cardiac problems, intestinal obstruction and liver problems.

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ZOFRAN AND EMESIS

ZOFRAN (Generic Name: Ondansetron, Ondansetron hydrochloride) was first developed and marketed by GlaxoSmithKline. It is used mainly as an antiemetic. There are a number of reasons by which emesis can occur but ondansetron is mainly used to prevent emesis that is induced by chemotherapy, radiotherapy, orsurgery. It can be given both orally and parentally. Ondansetron and ondansetron HCL (hydrochloride) belongs to the class of medications called 5-HT3 receptor antagonists.

Cancer is a disease characterized by uncontrolled multiplication of abnormal forms of body cells, which form tumors, and their invasion of different parts of the body by metastasis. There are also tumors that don’t metastasise, but these are not defined as cancerous. Cells can become cancerous due to a mutation in the DNA. DNA is present in each cell and directs all the functions of the cell but when it is damaged the cell tries to repair it, or the cell dies. In some cases cells neither die nor the damaged DNA gets repaired, leading towards the formation of cancerous cells.

When cancer is diagnosed by biopsy, or by a CT (computed tomography) scan, or by an MRI (magnetic resonance imaging) scan, then it can be treated by a number of methods like chemotherapy, or radiotherapy and surgery. Whatever the treatment option used for the treatment of cancer, nausea and vomiting are common side effects. To inhibit nausea and vomiting caused by cancer therapy we add antiemetics with the cancer therapy. There are a number of antiemetics used; ondansetron has unique importance in this regard.


Zofran

Zofran’s (ondansetron HCL) molecular formula is C18H19N3O•HCl•2H2O – its structural formula can be seen on the image below.

Zofran has been approved by FDA since January 1991 for the prevention of nausea and vomiting associated with cancer chemotherapy and surgery.


Mechanisms of action:

Ondansetron is a 5-HT3 receptor antagonist. 5-HT (5-hydroxytryptamine) is also known as serotonin). 5-HT3 (5-HT type 3) receptors are receptors that serotonin can bind to and stimulate. They are present in the gastrointestinal tract (GIT), central nervous system (CNS) and also in the other parts of the body. In the CNS, these receptors are present in a specific brain area called “area postrema” where the chemoreceptor trigger zone (CTZ) is present. The CTZ is a part in the brain involved in stimulating the vomiting reflex. One of the triggers for the CTZ is the binding of serotonin on 5-HT3 receptors. Ondansetron inhibits the binding of serotonin at 5-HT3 receptors, thus suppressing nausea and vomiting.


Zofran use in children

In 2001, a study was conducted which found that ondansetron has good efficacy in children as compared to metoclopramide, chlorpromazine and droperidol in preventing emesis induced by chemotherapy, radiotherapy and surgery. Thus, in children, ondansetron is considered as an effective first-line antiemetic agent. (Culy, et al., 2001)


Zofran compared to other antiemetic drugs

Nausea and vomiting are two important distressing side effects of chemotherapy. For the prevention of these side effects, 5-HT3 receptors antagonists are recommended. Among 5-HT3 receptor antagonists, ondansetron and granisetron are the most widely used. A study was conducted for the evaluation of effectiveness of ondansetron and granisetron. It was found by the studies that both ondansetron and granisetron have the same clinical effectiveness in the prevention of chemotherapy-induced emesis. (Vrabel, et al., 2007)

In 1993, a clinical study showed that ondansetron is clinically more effective as compared to metoclopramide and droperidol in preventing the chemotherapy-induced and postoperative nausea and vomiting. Other trials showed that the use of ondansetron with the dexamethasone is more effective against emesis than the ondansetron alone. (Markham, et al., 1993)


Dosage forms and administration

Zofran is available in different dosage forms; like tablets, oral solutions and injection. Zofran is used prophylactically for the prevention of emesis due to chemotherapy, radiotherapy and surgery. In spite of this prophylactic drug taking, additional doses are also taken during chemotherapy or radiation therapy and usually for one to two days after the end of therapy. In the case of injection it should be administered slowly, with an infusion rate of 2 - 5 minutes for the prevention of post operative emesis, or over 15 minutes for the prevention of emesis associated with the chemotherapy. (Richard et al., 2006). Always consult a pharmacist or physician before using Zofran.


Investigational and off-label indications of Zofran

A study was conducted on ondansetron which concluded that when the ondansetron is given in combination with haloperidol (an antipsychotic drug), the two work synergistically for the treatment of schizophrenia. The study also revealed that this combination also reduces the adverse effects of haloperidol. (Zhang, et al., 2006)

Another study was conducted for assessing the effectiveness of ondansetron against postanaesthetic shivering - a common occurrence after surgery. It was shown that ondansetron is as effective as pethidine when given as a single IV injection. (Generali and Cada, 2009)


Precautions and safety

Zofran should be used with caution as it may cause abnormal heart rhythms. This warning was given by FDA in September 2011. The FDA has also guided both the patients and medical professionals of how they can avoid the risk of arrhythmias associated with the use of ondansetron. (Richard et al., 2006). For the patients, some precautionary measures are given below:

• Don’t stop taking Zofran without consulting a health care professional.

• During the use of Zofran if you experience some irregular heart beat, breathlessness, or dizziness then immediately seek medical care.

• While taking Zofran, patients should be regularly monitored for their heart rate and rhythm by electrocardiography.



References

Culy CR, Bhana N, Plosker GL., 2001.Ondansetron: a review of its use as an antiemetic in children, Paediatr Drugs. ; 3(6):441-79.

Generali JA, Cada DJ., 2009. Off-label drug uses, Ondansetron: Postanesthetic Shivering, Hospital Pharmacy.; 44 (8): 670–1.

Rang H. P., Dale M. M., Ritter J. M., Flower R. J., 2007, Rang & Dale's Pharmacology (Sixth Edition), Churchill Livingstone.
Markham A, Sorkin EM., 1993.Ondansetron. An update of its therapeutic use in chemotherapy-induced and postoperative nausea and vomiting. Drugs.; 45(6):931-52.

Richard D. Howland, Mary J.Mycek., 2006. Lippincott’s Illustrated Reviews of Pharmacology (3rd Edition), Lippincott’s Williams & Wilkins.

Vrabel M., 2007.Is ondansetron more effective than granisetron for chemotherapy-induced nausea and vomiting? A review of comparative trials, Clin J Oncol Nurs.; 11(6):809-13.

Zhang ZJ, Kang WH, Li Q, Wang XY, Yao SM, Ma AQ., 2006.Beneficial effects of ondansetron as an adjunct to haloperidol for chronic, treatment-resistant schizophrenia: a double-blind, randomized, placebo-controlled study, Schizophr Res.; 88(1-3):102-10. Epub 2006 Sep 7.


 

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