Odyssey Business Park, Ares Block, West End Road, South Ruislip, Middlesex, HA4 6QD. Your doctor will write the number of refills authorized on your prescription. In individuals 65 years of age or older in the community, the prevalence is 26% for women and 16% for men. Mean weight-normalized clearance and volume of distribution values in these pediatric surgical patients were similar to those previously reported for young adults. How to tell if the drug is working: You should not have nausea or vomiting. Oculogyric crisis, appearing alone, as well as with other dystonic reactions. Thus, the effect of ondansetron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism of 5-HT3 receptors on neurons located both in the peripheral and central nervous system. The populations in Table 10 consisted mainly of females undergoing laparoscopic procedures. There is no information on the effects of ondansetron on human fertility. It is typically used after other antinausea drugs have failed. DOSAGE. Ondansetron should be administered immediately before chemotherapy as a single intravenous dose of 5 mg/m2. The magnitude of the change was age-related, with clearance falling from about 300mL/min at 12 years of age to 100mL/min at 3 years. The 5-HT3 receptor antagonists are the primary medications used to treat and prevent chemotherapy-induced nausea and vomiting and radiotherapy-induced nausea and vomiting. In the same trial, 56% of patients receiving a single 24 mg oral dose of Ondansetron experienced no nausea during the 24-hour trial period, compared with 36% of patients in the oral Ondansetron 8 mg twice-a-day group (P = 0.001) and 50% in the oral Ondansetron 32 mg once-a-day group. In the majority of cases symptoms were similar to those already reported in patients receiving recommended doses (see section 4.8 Undesirable Effects). Patients with Hepatic Impairment: In patients with mild-to-moderate hepatic impairment, clearance is reduced 2-fold and mean half-life is increased to 11.6 hours compared with 5.7 hours in those without hepatic impairment. It is unknown whether ondansetron exposure in utero in the cases of cleft palate occurred during the time of palate formation (the palate is formed between the 6th and 9th weeks of pregnancy). Cross-trial comparison indicate similar efficacy for both regimens (see section 5.1). There have been post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the concomitant use of ondansetron and other serotonergic drugs (including selective serotonin reuptake inhibitors (SSRI) and serotonin noradrenaline reuptake inhibitors (SNRIs)). Slower clearance in women, a smaller apparent volume of distribution (adjusted for weight), and higher absolute bioavailability resulted in higher plasma ondansetron concentrations. Patients were randomised to either single intravenous doses of ondansetron (0.1 mg/kg for paediatric patients weighing 40 kg or less, 4 mg for paediatric patients weighing more than 40 kg; number of patients = 735)) or placebo (number of patients = 734). There are no data on the use of ondansetron for the treatment of post-operative nausea and vomiting in children under 2 years of age. WebDosage . This speeds up the rate at which the stomach empties into the intestines and may help with nausea. Marinol may be habit-forming and should be used only by the person it was prescribed for. 3, 4, 6, 7, 10, 14, 15, 20, 28, 30, 40, 49, 50, 60, 90, 100, 200, 300 & 500 film-coated tablets. A significant exposure-response relationship was identified between ondansetron concentration and QTcF. Complete control of emesis was achieved in 56% of patients. Specific dosing information is provided for patients over 65 years of age and over 75 years of age for intravenous dosing. blurred vision) predominantly during rapid intravenous administration. Renal impairment is not expected to significantly influence the total clearance of ondansetron as renal clearance represents only 5% of the overall clearance. With the exception of a slight decrease in maternal body weight gain in the rabbits, there were no significant effects of ondansetron on the maternal animals or the development of the offspring. b Nausea measured as none, mild, or severe. [19][20], Ondansetron is in pregnancy category B in the US. Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). Inclusion of duplicate reports led to a 23% overestimation of ondansetron's antiemetic efficacy. (See Special warnings and precautions for use). Electrocardiogram (ECG) changes, including QT interval prolongation have been seen in patients receiving ondansetron. Debra Rose Wilson, Ph.D., MSN, R.N., IBCLC, AHN-BC, CHT. The role of ondansetron in opiate-induced emesis is not yet established. Instruct patients to immediately report any signs or symptoms consistent with a potential bowel obstruction to their healthcare provider [see Warnings and Precautions (5.5)]. [40] An earlier, smaller, open-label trial had found ondansetron to be useful in treating antipsychotic-induced tardive dyskinesia in people with schizophrenia, and the study patients also showed significant improvement in the disease's symptoms.[41][42]. The following adverse reactions have been reported in clinical trials of patients treated with ondansetron, the active ingredient of ZOFRAN. Table 9. This means you may need to take it with other medications. The majority of the blindness cases reported resolved within 20 minutes. Ondansetron is indicated for the management of chemotherapy-induced nausea and vomiting (CINV) in children aged 6 months, and for the prevention and treatment of PONV in children aged 1 month. Dosage; Side effects; Interactions; What is Reglan? This reduction in clearance is variable and was not consistent with an increase in half-life [see Use in Specific Populations (8.7 )]. Do not use marijuana while taking Marinol. Each film-coated tablet contains 4 mg ondansetron (as ondansetron hydrochloride dihydrate). Several studies have assessed ondansetron and the risk of oral clefts with inconsistent findings. In a crossover trial in 76 pediatric patients, intravenous ondansetron did not increase systemic concentrations of high-dose methotrexate. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. 8 mg (ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron), are yellow, oval, film-coated tablets engraved with Zofran on one side and 8 on the other in bottles of 30 tablets (NDC 0078-0676-15). In the US general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. [44] There is also some tentative evidence in those who are addicted to stimulants. Serotonin syndrome. Each tablet also contains the inactive ingredients hypromellose, iron oxide yellow (8-mg tablet only), lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, triacetin, and titanium dioxide. Ondansetron was significantly more effective than placebo in preventing further episodes of nausea and vomiting. Fifty-seven percent (57%) were females; 67% were white, 18% were American Hispanic, and 15% were black patients. [24], Ondansetron has rarely been studied in people under 4 years of age. In 2 randomized, double-blind, monotherapy trials, a single 24-mg oral dose of ZOFRAN was superior to a relevant historical placebo control in the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m. The recommended dose of ondansetron for chronic nausea is 48 mg given once or twice a day. To find similar products you must sign up and log in. Autonomic dysfunction occurred as a symptom of neuroleptic malignant syndrome. tired feeling, sleep problems (insomnia). A causal relationship to therapy with ZOFRAN was unclear in many cases. 4. Although some nonconjugated metabolites have pharmacologic activity, these are not found in plasma at concentrations likely to significantly contribute to the biological activity of ondansetron. Vomiting blood is the regurgitation of stomach contents mixed with blood or blood only. d Visual analog scale assessment of nausea: 0 = no nausea, 100 = nausea as bad as it can be. Its also available as a generic drug. We comply with the HONcode standard for trustworthy health information. Post-operative nausea and vomiting (PONV): Adults. In these trials, 58% of the 170 evaluable patients had a complete response (no emetic episodes) on Day 1. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk. To view the changes to a medicine you must sign up and log in. There is no specific antidote for ondansetron, therefore in all cases of suspected overdose, symptomatic and supportive therapy should be given as appropriate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. The background risk of major birth defects and miscarriage for the indicated population is unknown. Instruct patients not to remove ZOFRAN ODT orally disintegrating tablets from the blister until just prior to dosing. Table 3: Most Common Adverse Reactions in Adultsa for the Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Chemotherapy [Primarily Cyclophosphamide-based Regimens]. Ondansetron orally disintegrating tablet is available as the brand-name drug Zofran ODT. Our website services, content, and products are for informational purposes only. Follow your doctor's dosing instructions very carefully. Therapeutic Response in Prevention of Chemotherapy-Induced Nausea and, Table 8. Place the tablet on your tongue. Uncommon: Movement disorders (including extrapyramidal reactions (such as oculogyric crisis, dystonic reactions and dyskinesia) have been observed without definitive evidence of persistent clinical sequelae; seizures. Avoid driving or operating machinery until you know how this medicine will affect you. Learn about side effects, dosage, how it works, and more. Marinol causes effects that will impair your thinking or reactions. No emetic episodes occurred in 314 (79%) of the re-treatment courses, and only 1 to 2 emetic episodes occurred in 43 (11%) of the re-treatment courses. 2. The concentration of ondansetron in body tissues as opposed to plasma is also higher than in healthy people. The active ingredient in ZOFRAN ODT orally disintegrating tablets is ondansetron base, the racemic form of ondansetron, and a selective blocking agent of the serotonin 5-HT3 receptor type. Any unused medicinal product or waste material should be disposed off in accordance with local requirements. [9], A 2006 double-blind, randomized controlled trial indicated ondansetron may have value in the treatment of schizophrenia, as an adjunct to haloperidol. No detrimental effects on such activities are predicted from the pharmacology of ondansetron. Take this drug at evenly spaced intervals. These higher plasma levels may in part be explained by differences in body weight between men and women. WebConstipation is a common complaint and challenge for older adults. It is not known whether dronabinol will harm an unborn baby. In these trials, 58% of the 196 evaluable patients had a complete response (no emetic episodes) on Day 1. anthracyclines such as doxorubicin, daunorubicin or trastuzimab), antibiotics (such as erythromycin), antifungals (such as ketoconazole), antiarrhythmics (such as amiodarone) and beta blockers (such as atenolol or timolol) may increase the risk of arrhythmias. It should not be used in children of this age range. Visit the FDA MedWatch website or call 1-800-FDA-1088. Inform patients that ondansetron may cause myocardial ischemia during or after the administration. In a trial of 21 pediatric cancer patients (aged 4 to 18 years) who received three intravenous doses of 0.15 mg/kg of ondansetron at 4-hour intervals, patients older than 15 years exhibited ondansetron pharmacokinetic parameters similar to those of adults. In addition to the adverse reactions listed above, the following adverse reactions have been described in the setting of ondansetron overdose: Sudden blindness (amaurosis) of 2 to 3 minutes duration plus severe constipation occurred in one patient that was administered 72 mg of ondansetron intravenously as a single dose. Instructions for Use/Handling ZOFRAN ODT Orally Disintegrating Tablets [22] A retrospective review found it was used commonly for this purpose, being administered in over 58% of cases. Following oral administration, ondansetron is passively and completely absorbed from the gastrointestinal tract and undergoes first pass metabolism (bioavailability is about 60%). (2017). The patient should report any signs and symptoms of hypersensitivity reactions, including fever, chills, rash, or breathing problems [see Warnings and Precautions (5.1)]. Ondansetron has no or negligible influence on the ability to drive and use machines. Ondansetron comes in three forms that you take by mouth: a tablet, a disintegrating tablet, and a solution. Nonetheless, it did not have any antinociceptive activity. Geriatric Patients: A reduction in clearance and increase in elimination half-life are seen in patients older than75 years of age [see Use in Specific Populations (8.5)]. Ondansetron is extensively metabolized in humans, with approximately 5% of a radiolabeled dose recovered as the parent compound from the urine. When all 25 reports were combined, the apparent NNT improved to 4.9 (4.4 to 5.6). This form is only given by a healthcare professional. There is no experience beyond first-day administration of ondansetron. Little is known at present about overdosage with ondansetron, however, a limited number of patients received overdoses. The route of administration and dose of ondansetron should be flexible in the range of 8-32 mg a day and selected as shown below. Researchers examined 84 trials, with 11,980 people receiving ondansetron, published between 1991 and September 1996. Some may be better suited for you than others. Patients with poor sparteine/debrisoquine metabolism. feeling agitated or irritable. ZOFRAN 8 mg three times daily is not a recommended regimen for the treatment of moderately emetogenic chemotherapy [see DOSAGE AND ADMINISTRATION]. Common side effects of Zofran include headache, feeling unwell (malaise), fatigue, drowsiness, constipation, dizziness, and diarrhea. b: The total daily dose must not exceed adult dose of 32mg. At the 4-mg dosage, 59% of patients receiving ondansetron versus 45% receiving placebo in the first trial (P <0.001) and 41% of patients receiving ondansetron versus 30% receiving placebo in the second trial (P = 0.001) experienced no emetic episodes. Pharmacokinetics in Pediatric Surgery Patients Aged 1 Month to 12 Years. ZOFRAN Tablets, 4 mg (ondansetron HCl dihydrate equivalent to 4 mg of ondansetron), are white, oval, film-coated tablets engraved with "Zofran" on one side and "4" on the other in daily unit dose packs of 3 tablets (NDC 0173-0446-04), bottles of 30 tablets (NDC 0173-0446-00), and unit dose packs of 100 tablets (NDC 0173-0446-02).Bottles:Store between 2and 30(36and 86Protect from light. The first or single dose was administered 30 minutes prior to chemotherapy. The use of ondansetron has not been studied in people older than 75 years of age, and it is not known if dosage should be adjusted for this group. Two further intravenous doses may be given in 4-hourly intervals. Since there is little experience to date of the use of ondansetron in cardiac patients, caution should be exercised if ondansetron is co-administered with anaesthetics to patients with arrhythmias or cardiac conduction disorders or to patients who are being treated with antiarrhythmic agents or beta-blockers. The initial dose of ZOFRAN injection ranged from 0.04 to 0.87 mg per kg (total dose of 2.16 mg to 12 mg) followed by the administration of oral doses of ZOFRAN ranging from 4 to 24 mg daily for 3 days. For highly emetogenic chemotherapy a single dose of up to 24 mg ondansetron taken with 12 mg oral dexamethasone sodium phosphate, 1 to 2 hours before chemotherapy, may be used. If you take too much: You could have dangerous levels of the drug in your body. Each 4-mg ZOFRAN tablet for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. On the days of chemotherapy, patients received either ondansetron 5 mg/m2 i.v. Because ondansetron is metabolized by hepatic cytochrome P450 drug-metabolizing enzymes (CYP3A4, CYP2D6, CYP1A2), inducers or inhibitors of these enzymes may change the clearance and, hence, the half-life of ondansetron. For the full list of excipients, see section 6.1. No alteration of daily dosage or frequency of dosing, or route of administration are required. In such patients a total daily dose of 8 mg should not be exceeded. Multiday administration of ondansetron has been shown to slow colonic transit in healthy subjects. To help avoid interactions, your doctor should manage all of your medications carefully. CAUTION: FOR CHEMOTHERAPY INDUCED NAUSEA AND VOMITING, DILUTION IS REQUIRED PRIOR TO ADMINISTRATION. The recommended dose for oral administration is 8 mg twice daily. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Acute dystonia and/or dyskinesia typically were transitory, occurring more frequently in children and young adults within the first 4 days of treatment or after dose changes. Table 11. The elimination half-life of ondansetron is not altered in subjects classified as poor metabolisers of sparteine and debrisoquine. Frequencies are defined as: Very rare (<1/10,000) not known (cannot be estimated from the available data). Therapeutic Response in Prevention of Vomiting Induced by Cisplatin ( 100 mg/m, Table 9. WebOndansetron, sold under the brand name Zofran among others, is a medication used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, or surgery. Product may also be stored in a refrigerator 2 to 8C (36 to 46F). The results of these trials are summarized in Table 12. Common promethazine side effects may include: drowsiness, dizziness; ringing in your ears; double vision; feeling nervous; dry mouth; or. In a trial of 21 pediatric patients (3 to 12 years) who were undergoing surgery requiring anesthesia for a duration of 45 minutes to 2 hours, a single intravenous dose of ondansetron, 2 mg (3 to 7 years) or 4 mg (8 to 12 years), was administered immediately prior to anesthesia induction. In patients treated with potent inducers of CYP3A4 (i.e., phenytoin, carbamazepine, and rifampin), the clearance of ondansetron was significantly increased and ondansetron blood concentrations were decreased. One 4-mg ZOFRAN Tablet or one 4-mg ZOFRAN ODT Tablet or 5 mL (1 teaspoonful equivalent to 4 mg of ondansetron) of ZOFRAN Oral Solution should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy. In patients with severe hepatic impairment (Child-Pugh score of 10 or greater), clearance is reduced 2-fold to 3-fold and apparent volume of distribution is increased with a resultant increase in half-life to 20 hours [see DOSAGE AND ADMINISTRATION, Use In Specific Populations]. In the subgroup of women who received both forms of administration, the RR was 1.07 (95% CI 0.59, 1.93). If radiotherapy was given in the morning, 8 mg of ZOFRAN or 10 mg of metoclopramide was administered in the late afternoon and repeated again before bedtime. Ondansetron is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, and for the prevention and treatment of post-operative nausea and vomiting (PONV). Reglan increases muscle contractions in the upper digestive tract. Examples of drugs that can cause interactions with ondansetron are listed below. An interaction is when a substance changes the way a drug works. Intramuscularly: inject undiluted syringe contents (4 mg). You may need to follow a special diet while using Marinol. Professional info; FAQ; Summary. As a result, a higher amount of a drug stays in your body for a longer time. Its precise antiemetic and antinauseal mechanism of action is not known. Cyclophosphamide-Based Chemotherapy: In a double-blind, placebo-controlled trial of Ondansetron Injection (three 0.15-mg/kg doses) in 20 patients receiving cyclophosphamide (500 to 600 mg/m2) chemotherapy, Ondansetron Injection was significantly more effective than placebo in preventing nausea and vomiting. A prescription for this medication is refillable. dizziness, drowsiness, thinking problems; This is not a complete list of side effects and others may occur. Excretion: In adult cancer patients, the mean ondansetron elimination half-life was 4.0 hours, and there was no difference in the multidose pharmacokinetics over a 4-day period. Each of the 3 treatment groups was shown to be statistically significantly superior to a historical placebo control. Keep the medication in a place where others cannot get to it. Ask your doctor how to safely stop using dronabinol. It is recommended that sexually active women of childbearing potential use effective contraception (methods resulting in less than 1% pregnancy rate) during treatment with ondansetron. When flying, never put it into a checked bag. CYP2D6 genetic deficiency) is normally compensated by other enzymes and should result in little or no significant change in overall ondansetron clearance or dose requirement. Ondansetron is metabolised by multiple hepatic cytochrome P-450 enzymes: CYP3A4, CYP2D6 and CYP1A2. There is no evidence that ondansetron either induces or inhibits the metabolism of other medicinal products commonly co-administered with it. Inform patients following abdominal surgery or those with chemotherapy-induced nausea and vomiting that ondansetron may mask signs and symptoms of bowel obstruction. However, no dosage adjustment for ondansetron is recommended Half-life: 2-7 hr (children . These drugs are often used to treat similar conditions. In some cases, they may not be available in every strength or form as the brand-name drug. Ondansetron hydrochloride - ondansetron solution. Pediatric Use Continue reading for a comprehensive list of adverse effects. People are cautioned to seek immediate medical care if symptoms such as irregular heartbeat/palpitations, shortness of breath, dizziness, or fainting occur while taking ondansetron. A class of drugs is a group of medications that work in a similar way. The absence of the enzyme CYP2D6 has no effect on ondansetron's pharmacokinetics. This article lists 17 natural ways to relieve nausea without medication. Do not use this medicine in larger or smaller amounts or for longer than recommended. Median time to first emetic episode (hours). As such, single doses of injectable ondansetron should not exceed 16mg at one time. It has not been established that this drug is safe and effective for this use in children. ZOFRAN does not alter the respiratory depressant effects produced by alfentanil or the degree of neuromuscular blockade produced by atracurium. There is no experience beyond first-day administration of ondansetron [see CLINICAL PHARMACOLOGY]. Taking it again could be fatal (cause death). Plasma protein binding of ondansetron as measured in vitro was 70% to 76% over the concentration range of 10 to 500 ng/mL. In a pharmacokinetic study of 10 healthy subjects receiving a single-dose intravenous dose of ondansetron 8 mg after 600 mg rifampin once daily for five days, the AUC and the t of ondansetron were reduced by 48% and 46%, respectively. Extrapyramidal reactions (less than 1% of patients). Reporting suspected adverse reactions after authorisation of the medicinal product is important. For the treatment of established PONV intravenous or intramuscular administration is recommended. b: The total daily dose must not exceed adult dose of 32 mg. Ondansetron is well tolerated by patients over 65 years and no alteration of dosage, dosing frequency or route of administration are required. Four open-label, noncomparative (one US, three foreign) trials have been performed with 209 pediatric cancer patients aged 4 to 18 years given a variety of cisplatin or noncisplatin regimens. Medically reviewed by Sanjai Sinha, MD. [38] Their analysis was a subject of an editorial in the Journal of the American Medical Association in 1999. Dont put this medication in your cars glove compartment or leave it in the car. Post-operative nausea and vomiting in children aged 1 months and adolescents: No studies have been conducted on the use of orally administered ondansetron in the prevention or treatment of post operative nausea and vomiting, slow i.v. Based on the population pharmacokinetic analysis, cancer patients aged 6 to 48 months who receive a dose of 0.15 mg/kg of intravenous ondansetron every 4 hours for 3 doses would be expected to achieve a systemic exposure (AUC) consistent with the exposure achieved in previous pediatric trials in cancer patients (4 to 18 years) at similar doses. Zofran - ondansetron hydrochloride tablet, film coated. Patients should be informed that the chances of developing severe cardiac arrhythmias, such as QT prolongation and Torsade de Pointes are higher in the following people: Ondansetron should be avoided in these patients, since they may be more at risk for cardiac arrhythmias, such as QT prolongation and Torsade de Pointes [see Warnings and Precautions (5.2)]. The recommended adult oral dosage is one 8-mg ZOFRAN Tablet or one 8-mg ZOFRAN ODT Tablet or 10 mL (2 teaspoonfuls equivalent to 8 mg of ondansetron) of ZOFRAN Oral Solution given twice a day. A single dose of ondansetron 0.1 mg/kg was administered within five minutes following induction of anaesthesia. Cases of myocardial ischemia have been reported in patients treated with ondansetron. The recommended dosage regimens for adult and pediatric patients are described in Table 1 and Table 2, respectively. Ondansetron blocks the initiation of this reflex. However, cytotoxic chemotherapy appears to be associated with release of serotonin from the enterochromaffin cells of the small intestine. Based on reports of profound hypotension and loss of consciousness when ondansetron was administered with apomorphine hydrochloride, concomitant use with apomorphine is contraindicated. In some patients, especially in the case of intravenous administration, symptoms appeared immediately after administration of ondansetron. No alteration of daily dosage or frequency of dosing is required. Chemotherapy -induced nausea and vomiting: The efficacy of ondansetron in the control of emesis and nausea induced by cancer chemotherapy was assessed in a double-blind randomised trial in 415 patients aged 1 to 18 years (S3AB3006). For prevention of PONV in paediatric patients having surgery performed under general anaesthesia, a single dose of ondansetron may be administered by slow intravenous injection (not less than 30 seconds) at a dose of 0.1 mg/kg up to a maximum of 4mg either prior to, at or after induction of anaesthesia. If you do, it should be less severe. Take Marinol exactly as it was prescribed for you. The metabolites are observed in the urine. Slower clearance in women, a smaller apparent volume of distribution (adjusted for weight), and higher absolute bioavailability resulted in higher plasma ondansetron levels. Manifestations that have been reported include visual disturbances, severe constipation, hypotension and a vasovagal episode with transient second-degree AV block. Each ZOFRAN ODT tablet also contains the inactive ingredients aspartame, gelatin, mannitol, methylparaben sodium, propylparaben sodium, and strawberry flavor. Call your doctor if your symptoms do not improve, or if they get worse while using Marinol. Marinol may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have ever had depression or mental illness. It's available as a generic drug, Whether from motion sickness, illness, or a hangover, vomiting can often be treated at home. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. To bookmark a medicine you must sign up and log in. Ondansetron orally disintegrating tablet is available as a brand-name drug and as a generic drug. In the same trial, 56% of patients receiving a single 24-mg oral dose of ondansetron experienced no nausea during the 24-hour trial period, compared with 36% of patients in the oral ondansetron 8-mg twice-a-day group (P = 0.001) and 50% in the oral ondansetron 32-mg once-a-day group. Concomitant use of apomorphine and ondansetron may cause a significant drop in blood pressure and loss of consciousness. Overdose symptoms may include changes in mood, memory problems, little or no urinating, constipation, loss of energy, problems with speech or coordination, or feeling light-headed. It can also cause other side effects. [9] It is also effective for treating gastroenteritis. Hypotension (and faintness) occurred in a patient that took 48 mg of ZOFRAN tablets. It comes with serious risks if you dont take it as prescribed. For children: This medication has not been studied in children younger than 4 years. Do not attempt to push ZOFRAN ODT orally disintegrating tablets through the foil backing. There is limited experience in the use of ondansetron in the prevention and treatment of post-operative nausea and vomiting (PONV) in the elderly, however ondansetron is well tolerated in patients over 65 years receiving chemotherapy. The populations in Table 12 consisted mainly of women undergoing laparoscopic procedures. Discover other causes such as food, sleep issues, and medication. Surgical procedures were unrestricted. Store upright between 15C and 30C (59F and 86F). In vitro metabolism studies have shown that ondansetron is a substrate for human hepatic cytochrome P-450 enzymes, including CYP1A2, CYP2D6, and CYP3A4. Administration with liquid is not necessary. In general, surgical and cancer pediatric patients younger than 18 years tend to have a higher ondansetron clearance compared with adults leading to a shorter half-life in most pediatric patients. Administration with liquid is not necessary. headache with chest pain and severe dizziness, highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m, initial and repeat courses of moderately emetogenic cancer chemotherapy, radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. Generic drugs usually cost less than the brand-name version. Inform patients following abdominal surgery or those with chemotherapy-induced nausea and vomiting that ZOFRAN may mask signs and symptoms of bowel obstruction. Very rarely transient ECG changes including QT interval prolongation have been reported. To stimulate appetite in people with AIDS, Marinol is usually taken 1 hour before lunch and 1 hour before dinner. Do not cut or crush the orally disintegrating tablets. [21], Trials in emergency department settings support the use of ondansetron to reduce vomiting associated with gastroenteritis and dehydration. In terms of overall ondansetron turnover, CYP3A4 plays a predominant role while formation of the major in vivo metabolites is apparently mediated by CYP1A2. Protect from light. The etiology of the liver failure is unclear. Ondansetron orally disintegrating tablet is used to prevent nausea and vomiting caused by certain medical treatments. Bioavailability, following oral administration, is slightly enhanced by the presence of food but unaffected by antacids. This activity reviews the FDA approved The single intravenous dose must not exceed 8mg. Dispense in tight, light-resistant container as defined in the USP. Not every pharmacy stocks this drug. Dont try to push the tablet through the foil. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. To make sure this medicine is safe for you, tell your doctor if you have ever had: heart problems, high or low blood pressure, fainting spells, fast heartbeats; depression, mental illness, or psychosis. As shown in Table 6, the 41 patients with pharmacokinetic data were divided into 2 groups, patients aged 1 month to 4 months and patients aged 5 to 24 months, and are compared with pediatric patients aged 3 to 12 years. Studies in healthy elderly volunteers have shown slight, but clinically insignificant, age-related increases in both oral bioavailability (65%) and half-life (5 hours) of ondansetron. Early Phase I studies in healthy elderly volunteers showed a slight age-related decrease in clearance, and an increase in half-life of ondansetron. The most common adverse reactions (greater than or equal to 2%) reported in patients receiving ZOFRAN and concurrent radiotherapy were similar to those reported in patients receiving ZOFRAN and concurrent chemotherapy and were headache, constipation, and diarrhea. Dont worry about airport X-ray machines. No emetic episodes occurred in 160 (59%), and two or fewer emetic episodes occurred in 217 (81%) re-treatment courses. There are no data from controlled clinical trials on the use of ondansetron in the prevention of chemotherapy-induced delayed or prolonged nausea and vomiting. Instruct the patient to report the use of all medications, especially apomorphine, to their healthcare provider. Follow all directions on your prescription label. rufinamide. Examples of these drugs include: Disclaimer: Our goal is to provide you with the most relevant and current information. A total of 66% of patients in the ondansetron 24-mg once-a-day group, 55% in the ondansetron 8-mg twice-aday group, and 55% in the ondansetron 32-mg once-a-day group, completed the 24-hour trial period with 0 emetic episodes and no rescue antiemetic medications, the primary endpoint of efficacy. Serotonergic Drugs (e.g. Ondansetron exposure in utero has not been associated with overall major congenital malformations in aggregate analyses. The risk is also higher in people taking other medicines that prolong the QT interval, as well as in people with congenital long QT syndrome, congestive heart failure, and/or bradyarrhythmias. This resulted in a significant increase in the clearance of ondansetron. Marinol pregnancy and breastfeeding warnings. You dont need to take the tablet with liquid. As ondansetron is known to increase large bowel transit time, patients with signs of subacute intestinal obstruction should be monitored following administration. Ondansetron prolongs QT interval in a dose-dependent manner. Patients were randomized to either single intravenous dose of ondansetron (0.1 mg/kg for pediatric patients weighing 40 kg or less, 4 mg for pediatric patients weighing more than 40 kg) or placebo. Interactions with general or local anesthetics have not been studied. Chemotherapy and radiotherapy induced nausea and vomiting. In this study, there were no QTcF measurements greater than 480 msec and no QTcF prolongation was greater than 60 msec. It is not known whether these differences in ondansetron plasma half-life may result in differences in efficacy between adults and some young pediatric patients (see CLINICAL TRIALS: Pediatric Studies). [7][3] It is not known if ondansetron is excreted in breast milk. Ask your doctor if you have risk factors for arrhythmias. The released serotonin may stimulate the vagal afferents through the 5-HT3 receptors and initiate the vomiting reflex. There are no data on the effects of ZOFRAN on the breastfed infant or the effects on milk production. For oral dosage forms (oral disintegrating tablets, solution, or tablets): For prevention of moderate nausea and vomiting after treatment with cancer medicines: Adults and children 12 years of age and olderAt first, 8 milligrams (mg) taken 30 minutes before starting cancer treatment. Copyright 2022 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. More detailed pharmacokinetic information is contained in Tables 5 and 6. The number needed to treat (NNT) to prevent vomiting within 24 hours was 9.5, with 95% confidence interval 6.9 to 15, in the 16 nonduplicated reports. [28][29][30], Ondansetron (marketed under the brand name Zofran) was developed in the mid-1980s by GlaxoSmithKline in London. Zofran is a brand (trade) name for ondansetron which may be used to treat or prevent nausea and vomiting. In all instances, the adverse reactions resolved completely. The dosage recommendation is the same as for the general population. Its use was not found to mask serious diagnoses. Serotonin syndrome occurring with overdose of ZOFRAN alone has also been reported. Ondansetron doses included 8 mg and 32 mg infused intravenously over 15 minutes. of children n= 28). Dosage Adjustment for Patients With Impaired Renal Function Instruct patients to immediately report any signs or symptoms consistent with a potential bowel obstruction to their healthcare provider [see WARNINGS AND PRECAUTIONS]. In a placebo-controlled trail conducted in 468 males undergoing outpatient procedures, a single 4-mg intravenous ondansetron dose prevented postoperative vomiting over a 24-hour period in 79% of males receiving drug compared with 63% of males receiving placebo (P <0.001). Tramadol: Data from small studies indicate that ondansetron may reduce the analgesic effect of tramadol. Ondansetron may interact with other medications, Important considerations for taking ondansetron, dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=fa8c2931-35a7-4b4b-8be2-eda701b51079&type=display, dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=92c758a3-e749-4a15-be4b-ee30b364b2b0, dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=555f81bc-4ce0-4f77-b394-b974838c4440&type=display#ID, Stop Vomiting and Nausea: Remedies, Tips, and More, Hematemesis: Causes and Treatments for Vomiting Blood. The following clinically significant adverse reactions are described elsewhere in the labeling: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. 8 mg (as 8 mg ondansetron base) are white, round and plano-convex tablets debossed with a Z8 on one side in unit dose packs of 30 tablets (NDC 0078-0680-19). ECG monitoring is recommended in cases of overdose. It allows continued monitoring of the benefit/risk balance of the medicinal product. Do not attempt to push ZOFRAN ODT orally disintegrating tablets through the foil backing. In patients with adenotonsillar surgery prevention of nausea and vomiting with ondansetron may mask occult bleeding. Very common, common and uncommon events were generally determined from clinical trial data. Ondansetron should be administered with caution to patients who have or may develop prolongation of QTc, including patients with electrolyte abnormalities, congestive heart failure, bradyarrhythmias or patients taking other medicinal products that lead to QT prolongation or electrolyte abnormalities.

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