Zofran prescribing information |
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Zofran
Zofran acts by suppressing the sensation of nausea and vomiting reflex which is activated by release of serotonin (5HT) in the gut into the vomiting area.
About Zofran
An area exists in the brain called the vomiting center which is responsible for the sensation of nausea and vomiting. It is activated by nerve messages from another region in the brain known as the chemoreceptor trigger zone or CTZ. The vomiting center can also be activated by nerve messages from the gut. Serotonin (5HT) is released in the gut and it activates the 5HT receptors in the gut and when this happens, a nerve message is sent to the vomiting center. Serotonin is released during cancer treatments by chemotherapy, radiotherapy or surgery and this causes the nausea and vomiting. Zofran inhibits the action of the released serotonin by blocking the 5HT3 receptors in the brain thereby preventing the messages which cause sensation of nausea and vomiting from being sent to the vomiting center.
How to Take Zofran
Zofran is available as tablets or syrup which can be taken orally. They can also be administered via intramuscular or intravenous injection or drip. They are usually prescribed by the doctor for patients undergoing chemotherapy, radiotherapy or surgery for cancer treatment to prevent or treat nausea or vomiting that often occur as a side effect to cancer treatment drugs. This drug should be administered with care in people who might be allergic to 5HT antagonists, people with decreased liver function, intestinal obstruction, history of heart problems, irregular heartbeats and those with electrolyte (irregular levels of salts such as potassium, magnesium and sodium.
Possible Side Effects
Some side effects that have been associated with Zofran include flushing involuntary movement, abnormal heartbeats, chest pain, hiccups, constipation, headache, slowed heart rate and seizures. Other side effects may also occur that have not been listed here therefore if you notice any side effects seek medical attention.
Drug Interaction
It is advised to inform your doctor of any medicine you are taking or intend to take while taking Zofran to avoid any hazardous effects of the drugs interacting. Drugs such as rifampicin, phenytoin and carbamazepine may decrease the effectiveness of Zofran by increasing its rate of elimination from the body. Zofran can also reduce the activity of tramadol as a pain killer.
Pregnant and Breastfeeding
Zofran should not be taken by pregnant women as the effect on this group is not yet verified. Furthermore the drug could reach the breast milk therefore not recommended for those who are breast feeding.
Storage
The medicine should be stored in the packaged container away from intense heat and light. Liquid formulations should be stored in tightly closed bottles placed in an upright position.
Zofran notes:
Zofran generic equivalent Ondansetron prevents nausea and vomiting caused by cancer chemotherapy or after surgery. It works by blocking the hormone (serotonin) that causes vomiting.Ondansetron reduces the activity of the vagus nerve, which activates the vomiting center in the medulla oblongata.
It has little effect on vomiting caused by motion sickness, and does not have any effect on dopamine receptors or muscarinic receptors.
This medication may also be used to treat alcoholism.
Zofran side effects includes diarrhoea, headache, lightheadedness or drowsiness (uncommon), blurred vision, slow heart rate, anxiety, agitation, shivering, chest pain and urinating less than usual or not at all.It may impair thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
In the unlikely event allergic reaction to this drug may occur. Symptoms of an allergic reaction include rash, itching, swelling, severe dizziness, trouble breathing.It is recommended to consult doctor immediately if any of the side effects gets worsened.
Do not use this medication if you have liver disease or allergic to ondansetron hydrochloride, to similar medicines such as dolasetron (Anzemet), granisetron (Kytril), palonosetron(Aloxi) or a personal/family history of Long QT syndrome.
The recommended Zofran dosage is 8mg. It may be taken with or without food. It may also be taken with antacids. The first dose is usually taken 30 minutes before chemotherapy.
For maximum Zofran effect, it is necessary to take medication as prescribed by doctor. The Zofran orally disintegrating tablet can be taken with water/liquid or can be swallowed with saliva alone(Zofran odt). Allow it to dissolve in mouth without chewing.
Consult doctor regarding medical history, especially of stomach/intestinal problems, liver disease, any allergies. The effect of Zofran during pregnancy is not known, though consult doctor if you are pregnant before using this medication.Limit alcohol
intake, as it may intensify drug side effects. It is not known if this drug is excreted into breast milk.
Store Zofran at room temperature away from moisture and heat.
Zofran news:
The Food and Drug Administration in 2007 approved the first generic versions of zofran (Ondansetron) tablets, orally disintegrating tablets and oral solution which are indicated to prevent nausea and vomiting associated with surgery, radiotherapy and cancer chemotherapy. The approval is an important step in the agency's effort to increase the availability of lower-cost generic medications. In 2005, ondansetron was the 20th highest-selling brand-name drug in the United States Of America.
Gary J. Buehler, director, Office of Generic Drugs said that this approval will result in significant savings for the american public. He further added saying generic drugs are safe and effective alternatives to brand name drugs and undergo a thorough scientific and regulatory review.
The economic benefits of FDA's generic drug approval program will be significant because generic drug products which are used to fill over 50 percent of all prescriptions frequently cost a fraction of the price of the brand-name drugs. Such savings are likely to increase as more and more competitors will enter the market.
The office of Generic Drugs reviews and takes action on generic drug applications as expeditiously as possible. The same thorough and rigorously scientific review standards of safety, efficacy and quality are applied to generic drug applications as are applied to new drug applications. Consumers and health professionals can be assured that an approved generic drug is bioequivalent to a brand name drug and is its equal in dosage form, strength and performance characteristics.
Zofran story:
Zofran is a serotonin 5-HT3 receptor antagonist used mainly as an antiemetic to treat nausea and vomiting following chemotherapy. The recommended I.V. dosage of zofran for adults is a single 32-mg dose or three 0.15-mg/kg doses. A single 32-mg dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. The recommended infusion rate should not be exceeded beyond the recommended dosage.
The 5-HT3 receptor antagonists are the primary drugs used to treat and prevent chemotherapy-induced nausea and vomiting (CINV). As per the requirement they are given intravenously about 30 minutes before beginning therapy. It is also effective in controlling post-operative nausea and vomiting (PONV) and post-radiation nausea and vomiting. It is also a possible therapy for nausea and vomiting due to acute or chronic medical illness or acute gastroenteritis. This drug is highly effective in controlling PONV and CINV but its high cost had limited its use. It is also used off-label to treat hyperemesis gravidarum in pregnant women but there is no conclusive data available on its safety in pregnancy, especially during the first trimester.
Zofran is extensively metabolized in humans, with approximately 5% of a radiolabeled dose recovered as the parent compound from the urine. The primary metabolic pathway is hydroxylation on the indole ring followed by glucuronide or sulfate conjugation. Although some nonconjugated metabolites have pharmacologic activity, these are not found in plasma at concentrations likely to significantly contribute to the biological activity of zofran. In vitro metabolism studies have shown that zofran is a substrate for human hepatic cytochrome P-450 enzymes including CYP1A2, CYP2D6 and CYP3A4.
A 2006 double-blind, randomized controlled trial indicated that zofran can help in the treatment of schizophrenia subordinated by haloperidol. The study found that this combination improves negative schizophrenia symptoms upto a considerable level and people taking both drugs experienced fewer of the adverse effects commonly associated with haloperidol. Earlier a small open-label trial had found zofran to be useful in treating antipsychotic-induced tardive dyskinesia in people with schizophrenia and in the study patients also showed significant improvement in the disease's symptoms.
Researchers at the Stanford University School of Medicine have demonstrated that zofran might be useful and effective for treating withdrawal symptoms of opioid addictions. Unlike the existing treatments methadone and buprenorphine it is not an opioid and it doesn't require continued supervision like treatment with clonidine.
The study was undertaken using mice who were injected with increasing doses of morphine assayed with naloxone and then underwent haplotypic analysis to isolate a gene candidate. HTR3A which codes for the 5-HT3 receptor emerged as the primary candidate which suggested 5-HT3 antagonist zofran as a possible treatment. Then the researchers showed the efficacy in withdrawal symptom control in humans by an acute morphine administration model.
A study was carried out to investigate the effect of zofran in combination with dexamethasone in the prevention of higher incidence of postoperative nausea and vomiting(PONV) following strabismus repair in pediatric patients. Hundred healthy children of ASA class I and II aged 4-12 years who were scheduled for elective strabismus surgery were enrolled in this study. No premedications were given and anesthesia was induced by inhalational technique using sevoflurane, nitrous oxide and oxygen mixture. Fentanyl and atracurium were given and an endotracheal tube was inserted. Patients were randomly divided into four groups which received intravenously either placebo or a combination of zofran 50 microg/kg(-1) along with dexamethasone 0.5 mg/kg(-1) after induction of anesthesia and before start of surgery. All episodes of PONV during the first 24 hours after anesthesia were recorded. The incidence of postoperative nausea was 48%, 8%, 12% and 0% while the incidence of vomiting was 52%, 12%, 4% and 0% in placebo, zofran and dexamethasone which shows that prophylactic administration zofran combined with dexamethasone decreases the incidence of PONV following strabismus surgery in pediatrics.
Zofran review article...
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