Generic Zofran is used for preventing nausea and vomiting due to cancer chemotherapy or surgery. It may also be used for other conditions.
Other names for this medication:
Also known as: Ondansetron.
Generic Zofran is used for preventing nausea and vomiting due to cancer chemotherapy or surgery. It may also be used for other conditions.
Generic Zofran is a serotonin 5-HT3 receptor blocker. It works by blocking a chemical thought to be a cause of nausea and vomiting in certain situations (e.g., chemotherapy).
Zofran is also known as Ondansetron, Vomiof, Danzetron, Ondaz.
Generic name of Generic Zofran is Ondansetron.
Brand name of Generic Zofran is Zofran.
Take each dose with a full glass of water.
Take Generic Zofran with food or an antacid to lessen stomach discomfort.
If you want to achieve most effective results do not stop taking Generic Zofran suddenly.
If you overdose Generic Zofran and you don't feel good you should visit your doctor or health care provider immediately.
Store at temperature between 2 and 30 degrees C (36 and 86 degrees F) away from moisture and heat. Throw away any unused medicine after the expiration date. Keep out of the reach of children.
The most common side effects associated with Zofran are:
Side effect occurrence does not only depend on medication you are taking, but also on your overall health and other factors.
Do not take Generic Zofran if you are allergic to Generic Zofran components.
Be careful with Generic Zofran if you're pregnant or you plan to have a baby, or you are a nursing mother.
Generic Zofran should be used with extreme caution in children younger than 4 months old. Safety and effectiveness in these children have not been confirmed.
Do not stop taking Generic Zofran suddenly.
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This column is the first in a two-part series exploring lessons for psychiatric drug development that can be learned from the development of six central nervous system drugs with novel mechanisms of action over the past 25 years. Part 1 presents a brief overview of the neuroscience that supported the development of each drug, including the rationale for selecting a) the target, which in each case was a receptor for a specific neurotransmitter system, and b) the indication, which was based on an understanding of the role that target played in a specific neural circuit in the brain. The neurotransmitter systems on which the development of these agents were based included serotonin for ondansetron and lorcaserin, dopamine for varenicline, substance P (or neurokinin) for aprepitant, melatonin for ramelteon, and orexin for suvorexant. The indications were chemotherapy-induced nausea and vomiting for ondansetron and aprepitant, smoking cessation for varenicline, weight loss for lorcaserin, and insomnia for suvorexant and ramelteon.
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Data for patients (n=159) receiving platinum-based chemotherapy regimens were retrospectively collected . Patients getting 5-HT(3) antagonists without steriods or those with known history of brain metastasis, gastroparesis, and intestinal obstruction were not eligible for the study. Patient characteristics including age, gender, primary diagnosis, history of heavy alcohol intake, chemotherapy regimen administered , number of cycles, and Eastern Cooperative Group performance status at the start of therapy were noted. Primary outcome was the complete control of platinum-induced acute nausea and vomiting. Secondary outcome measures included control of > or = grade 1 nausea or vomiting, comparison of two doses of dexamethasone, and antiemetic eficacy among various platinum drugs. National Cancer Institute Common Toxicity Criteria version 2.0 was used to assess toxicity.
To compare risk model-guided (RMG) antiemetic prophylaxis with physician's choice (PC) in patients receiving chemotherapy for early-stage breast cancer.
Postoperative vomiting (POV) continues to be a common complication in children undergoing tonsillectomy with or without adenoidectomy. The incidence of POV is between 62% and 73% when no prophylactic antiemetic is given. Numerous antiemetics have been studied for the management of POV after pediatric tonsillectomy. As traditional antiemetics, benzamides (e.g., metoclopramide), butyrophenones (e.g., droperidol), phenothiazines (e.g., perphenazine), and antihistamines (e.g., dimenhydrinate) are used for POV. The available nontraditional antiemetics are propofol, dexamethasone, and midazolam. Serotonin receptor antagonists, which include ondansetron, granisetron, tropisetron, dolasetron, and ramosetron, are more effective than traditional antiemetics. However, these drugs are not entirely effective, perhaps because most of them act through the blockade on one type of receptor. Combination antiemetic therapy with a serotonin receptor antagonist (ondansetron, granisetron, tropisetron) plus droperidol or dexamethasone is highly effective for the prophylaxis against POV. Nonpharmacological techniques include acustimulation, acupressure, and acupuncture at P6 (Nei-Kuwan) point. Most of published trials indicate an improved antiemetic prophylaxis in children undergoing tonsillectomy with or without adenoidectomy when risk factors for POV would be avoided and/or effective antiemetic therapy would be performed. For the prevention of POV after pediatric tonsillectomy, baseline risk factors, including patient characteristics, surgical procedure, anesthetic techniques, and postoperative care, should be avoided, if possible. Clinicians should also consider these clinical strategies as mentioned above for the prevention of POV after tonsillectomy in children.
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Drug-induced nausea and vomiting, both post-operatively and following chemotherapy, is often distressing for the patients. Our clinical impression is that certain patients are not prone to but instead protected against both post-operative and chemotherapy-induced nausea and vomiting (CINV). If support for this hypothesis could be generated, it might be easier to identify such patients as low-risk patients and judge all other patients as high-risk patients by default.
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166 patients receiving moderately emetogenic chemotherapy were entered into a randomised prospective study in which the efficacy of single dose ondansetron 8 mg, tropisetron 5 mg and granisetron 3 mg in the prophylaxis of acute vomiting was evaluated. 130 patients were evaluable for analysis. During the 24 h following the start of chemotherapy complete control of vomiting was achieved in 80% [95% confidence interval (CI) 73.1; 86.9] of patients receiving granisetron compared with 75% (95% CI 67.1; 82.1) of those on tropisetron and 69% (95% CI 60.5; 76.5) on ondansetron. The patients experienced significantly fewer failures with granisetron (6.2%, 95% CI 2.1; 10.3) than with either ondansetron (14.6%, 95% CI 8.5; 20.6) or tropisetron (13.8%, 95% CI 7.9; 19.7). When asked, 34 (26%) patients out of 130 expressed no preference, 54 (42%) preferred granisetron, 22 (17%) preferred ondansetron and 20 (15%) preferred tropisetron. All the 5-HT3 receptor antagonists were highly effective in the prophylaxis of acute vomiting induced by moderately emetogenic chemotherapy. The observed differences in the control of emesis, although statistically significant, may not have clinical significance.
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The relation between pretreatment night-time urinary catecholamine excretion and chemotherapy-induced nausea and vomiting was studied. The first cohort included 17 women and three men with various cancer forms receiving low or moderately emetogenic chemotherapy. The second cohort included 42 women receiving cisplatinum (50 mg m-2) for ovarian cancer and ondansetron as an antiemetic (8 mg i.v. x 3 at chemotherapy and 8 mg p.o. x 3 for 5 days). Relatively higher noradrenaline, but not adrenaline, excretion was associated with an increased intensity of delayed nausea following treatment. Vomiting was not consistently related to the excretion of either catecholamine. The results indicate that noradrenaline modulates delayed nausea resulting from chemotherapy.
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All doses of oral casopitant as a 3-day regimen (and likely as a 150-mg single oral dose) in combination with Ond/Dex provided significant improvement in the prevention of cisplatin-induced emesis.
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Both ondansetron and cyclophosphamide are thought to be metabolized by hepatic microsomal processes. The purpose of this study was to evaluate the potential pharmacokinetic interactions between ondansetron and high-dose alkylating agent chemotherapy.
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Anesthesia department of an urban academic medical center.
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Emesis cessation, use of intravenous fluid for rehydration, hospital admission, return to care, and medication adverse effects.
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Anxiolytic drugs, such as the benzodiazepines and the azapirones (ipsapirone, gepirone, buspirone), are well known to affect states of vigilance and to decrease the firing rate of serotoninergic neurones within the dorsal raphe nucleus in rats. In order to examine whether the newly developed 5-HT3 antagonists with potential anxiolytic properties act through similar mechanisms, the effects of several of such antagonists: MDL 72222, ICS 205-930, ondansetron and/or zacopride on both sleep-wakefulness and the discharge of serotoninergic neurones within the dorsal raphe nucleus were investigated in rats. When tested in a wide range of doses (0.05-10 mg/kg, i.p.), none of these drugs significantly affected the states of vigilance, except ondansetron, at 0.1 mg/kg, which increased paradoxical sleep for the first 2 hr after administration and MDL 72222, at 10 mg/kg, which reduced both paradoxical and slow wave sleep and increased wakefulness for the same initial period after treatment. In vivo, in chloral hydrate anaesthetized rats, as well as in vitro, in slices of brain stem, none of the 5-HT3 antagonists tested affected the firing rate of serotoninergic neurones. Similarly, no change in the electrical activity of serotoninergic neurones could be evoked in vitro by superfusion of the tissue with the 5-HT3 agonists, phenylbiguanide (10 microM) and 2-methyl-5-HT (1 microM). At a larger concentration (10 microM), the latter compound reduced the neuronal discharge probably through the stimulation of somatodendritic 5-HT1A autoreceptors since this effect, as that of ipsapirone, could be prevented by 10 microM l-propranolol. Comparison of these data with those obtained with benzodiazepines and 5-HT1A agonists of the azapirone series, supports the concept that different mechanisms are responsible for the anxiolytic-like properties of 5-HT3 agonists, compared to those of other anxiolytic drugs.
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Previous studies have demonstrated that alcohol use disorders (AUDs) are regulated by multiple mechanisms such as neurotransmitters and enzymes. The neurotransmitter, serotonin (5-hydroxytryptamine, 5-HT) may contribute to alcohol effects and serotonin receptors, including 5-HT3, play an important role in AUDs. Recent studies have also implicated histone deacetylases (HDACs) and acetyltransferases (HATS) in regulation of drug addiction, and HDAC inhibitors (HDACi) have been reported as transcriptional modulators of monoaminergic neurotransmission. Therefore, we hypothesize that HDACs may play a role in ethanol-induced serotonergic modulation. The effects of ethanol on serotonin and 5-HT3, and the role HDACs, HDAC activity and the HDACi, trichostatin A (TSA), play in alcohol-induced serotonergic effects were studied. Human SK-N-MC and neurons, were treated with ethanol (0.05, 0.1 and 0.2%), and/or TSA (50 nM), and 5-HT3 levels were assessed at 24-72 h. Gene expression was evaluated by qRT-PCR and protein by western blot and flow cytometry. Serotonin release was assessed by ELISA and HDAC activity by fluorometric assay. Our results show an increase in 5-HT3 gene after ethanol treatment. Further, ethanol significantly increased HDACs 1 and 3 genes accompanied by an increased in HDAC activity while TSA significantly inhibited HDACs. Studies with TSA show a significant upregulation of ethanol effects on 5-HT3, while surprisingly TSA inhibited ethanol-induced serotonin production. These results suggest that ethanol affects 5-HT3 and serotonin through mechanisms involving HDACs and HATs. In summary, our studies demonstrate some of the novel properties of HDAC inhibitors and contribute to the understanding of the mechanisms involve in alcohol-serotonergic modulation in the CNS.
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Inpatient clinical research center.
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In a randomised, controlled, double-blinded trial to study the effect of ondansetron pretreatment on the pain produced after intravenous injection of rocuronium and propofol in comparison with lidocaine, 60 patients were randomly assigned to one of three groups. Group 1 received 5 ml of intravenous 0.9% sodium chloride solution pretreatment, group 2 received ondansetron 4 mg (2 mg.ml-1 solution) diluted into a 5-ml solution, and group 3 received 50 mg lidocaine (5 ml 1% solution); this was followed 1 min later by rocuronium and propofol. Pain was reduced significantly in the ondansetron and lidocaine groups (p < 0.0001) compared with placebo, and significantly better with lidocaine than with ondansetron (p = 0.02). We conclude that ondansetron is effective in relieving the pain of rocuronium but is not as effective as lidocaine.
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Strips of porcine urothelium and lamina propria were suspended in gassed Krebs-bicarbonate solution, and cumulative concentration-response curves for 5-HT were generated in the absence and presence of 5-HT antagonists, Nω-nitro-l-arginine and indomethacin. Responses to α-methyl-5-HT were also examined.
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Prospective, randomized, stratified, double-blind study.
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The incidence of postoperative emesis was 55% and 10% in placebo and ondansetron group respectively. As to the severity of emetic symptoms it was milder in the ondansetron group. There was no difference in the incidence of other complications between the two groups.
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When it was added to a standard regimen of intravenous ondansetron and oral dexamethasone in the current study, aprepitant reduced chemotherapy-induced nausea and vomiting and was generally well tolerated, although increases in infection were noted that were assumed to be due to elevated dexamethasone levels as a result of the pharmacokinetic interaction. The aprepitant 125/80-mg regimen had the most favorable benefit:risk profile.
The cost efficacy of various ondansetron regimens for the control of emesis induced by noncisplatin, moderately emetogenic chemotherapy was examined from a hospital perspective. Previous cost-efficacy analyses of ondansetron provide limited insight into the economic impact of ondansetron when used with moderately emetogenic chemotherapies. Clinical efficacy results of trials that used ondansetron to control emesis were retrieved from the biomedical literature published between January 1966 and December 2000. Only direct antiemetic treatment costs were considered. A total of 55 trials were analyzed, with a total of 22 regimens identified. Costs of antiemetic treatments were calculated by multiplying the milligrams of each product by the cost per milligram. For each injectable dose, the average cost of an administration device was Can$1.28. Pharmacy time required for preparing an i.v. dose was 2.5 minutes, at an average hourly rate of Can$25. Nursing time to administer each i.v. dose was estimated at one minute at an average rate of Can$23 per hour. The efficacy rate of the 22 regimens varied between 24.2% and 90.4%, while the cost varied from Can$20 to Can$413. A cost-efficacy analysis of ondansetron regimens for control of emesis caused by noncisplatin, moderately emetic antineoplastic treatment revealed regimens that should be avoided as well as regimens that are, in comparison, at least as efficacious and less expensive. The analysis supported the concomitant use of a corticosteroid, twice-daily administration of ondansetron, and limitation of ondansetron administration to a period not exceeding four days.
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Insignificant EGG changes during chemotherapy suggest that chemotherapy has a minimal direct effect on gastric pacemaker. Tachygastria seemed to be a secondary effect of vomiting rather than the cause of it. These preliminary findings suggest that efforts to modify gastric electrical rhythm as a means of management of chemotherapy-induced vomiting may be futile. Further studies to identify factors responsible for vomiting are warranted.
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Fifty-five cancer patients who received tropisetron for the prevention of acute chemotherapy-induced nausea and vomiting were enrolled into this single center, prospective study. Standard 12-lead ECG recordings were performed at baseline and 30 min after tropisetron (5 mg given over 1 min IV bolus) administration. P wave durations and corrected QT intervals were measured; P wave dispersion and QTc dispersion were calculated.
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A randomised, double-blinded study.
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The number of transient relaxations induced by a 1.7 kPa gastric distension (7.9 +/- 0.4/30 min) was dose-dependently reduced by ondansetron (1-100 micrograms/kg) and by granisetron (100 micrograms/kg). Ondansetron (100 micrograms/kg) did not modify the number of relaxations under a 1.0 kPa gastric pressure (2.7 +/- 0.4 vs 2.6 +/- 0.4/30 min) but reduced the increase of the occurrence of relaxations induced by CCK8S under a gastric pressure of 1.0 and 1.7 kPa.
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Ondansetron and meperidine have similar effects on shivering. We concluded that 8 mg of intravenous ondansetron can control shivering and this is the dose of choice, especially in patients with POS with nausea and vomiting.
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Glioblastoma multiforme (GBM) represents an aggressive tumor type with poor prognosis. The majority of GBM patients cannot be cured. There is high willingness among patients for the compassionate use of non-approved medications, which might occasionally lead to profound toxicity. A 65-year-old patient with glioblastoma multiforme (GBM) has been treated with radiochemotherapy including temozolomide (TMZ) after surgery. The treatment outcome was evaluated as stable disease with a tendency to slow tumor progression. In addition to standard medication (ondansetron, valproic acid, levetiracetam, lorazepam, clobazam), the patient took the antimalarial drug artesunate (ART) and a decoction of Chinese herbs (Coptis chinensis, Siegesbeckia orientalis, Artemisia scoparia, Dictamnus dasycarpus). In consequence, the clinical status deteriorated. Elevated liver enzymes were noted with peak values of 238 U/L (GPT/ALAT), 226 U/L (GOT/ASAT), and 347 U/L (γ-GT), respectively. After cessation of ART and Chinese herbs, the values returned back to normal and the patient felt well again. In the literature, hepatotoxicity is well documented for TMZ, but is very rare for ART. Among the Chinese herbs used, Dictamnus dasycarpus has been reported to induce liver injury. Additional medication included valproic acid and levetiracetam, which are also reported to exert hepatotoxicity. While all drugs alone may bear a minor risk for hepatotoxicity, the combination treatment might have caused increased liver enzyme activities. It can be speculated that the combination of these drugs caused liver injury. We conclude that the compassionate use of ART and Chinese herbs is not recommended during standard radiochemotherapy with TMZ for GBM.
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The population model adequately described the differences in ondansetron pharmacokinetics between paediatric patients, young, elderly and aged volunteers. Different covariates were identified by the various methods. Weight was found to have a strong positive linear relationship with all four pharmacokinetic parameters. Clearance showed a weak negative relationship with age. Males were found to have a greater clearance than females after weight adjustment.
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Patients presenting with acetaminophen toxicity and vomiting are often treated with antiemetics so that orally administered N-acetylcysteine can be retained. The policy at the West Virginia Poison Center is to reserve ondansetron, an antiemetic with a higher cost than other antiemetics, as a second line agent for patients presenting within 8 hours of an acetaminophen ingestion.
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Intravenous NAC reduced antiemetic utilization, and it costs less than oral therapy. Furthermore, antiemetic use appeared to be determined by a combination of acetaminophen concentration and NAC administration route.
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1. Tritiated derivatives of the potent and selective 5-HT3 receptor antagonists GR65630 and LY278584 were used to identify 5-HT3 recognition sites in the rat gastrointestinal tract. 2. Binding studies were carried out in homogenates of the rat oesophagus, the cardia, fundus, body and antrum of the stomach, regions of the small intestine, caecum and large intestine. The specific binding of a single concentration of GR65630 (0.5 nM) defined by granisetron (10 microM) in these areas indicated that the density of 5-HT3 recognition sites varied from 2.4 +/- 1.0 to 10.1 +/- 1.0 fmol mg-1 protein. 3. Saturable binding of [3H]-GR65630 could only be demonstrated in the terminal regions of the small intestine (Bmax in the range of 13.83 +/- 4.54-21.19 +/- 0.89 fmol mg-1 protein; mean +/- s.e. mean) and of high affinity (Kd in the range of 0.42 +/- 0.18-0.79 +/- 0.24 nM). Use of [3H]-LY278584 revealed a similar binding density (Bmax 19.54 +/- 0.26 fmol mg-1 protein) and affinity (Kd 1.04 +/- 0.07 nM) in the terminal small intestine. 4. Binding of [3H]-GR65630 and [3H]-LY278584 to the terminal region of the small intestine was inhibited by 5-HT3 receptor ligands ondansetron and S-zacopride (and 5-hydroxytryptamine), but not by 5-HT1, 5-HT2, catecholamine, gamma-aminobutyric acid and opioid receptor ligands. 5. These data demonstrate that there are regional variations in the density of 5-HT3 recognition sites within the rat gastrointestinal tract. Such data are relevant to the potential use of 5-HT3 receptor ligands to modify secretory and contraction responses in the gastrointestinal system.
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