This page includes the following topics and synonyms. Zofran, zuplenz ondansetron dosing, indications, interactions. These highlights do not include all the information needed to. In normal volunteers, single intravenous doses of 0. A maximum initial dose of zofran16 mg iv infused over 15 minutes may be used. Zofran injection fda prescribing information, side.
A client is to receive chloramphenicole sodium succinate chloromycetin 1 g iv q 6 hours over 15 minutes. The efficacy and safety of ondansetron 8 mg bid compared with 8 mg tid for 3 days in the prevention of nausea and vomiting in 402 patients on cyclophosphamide or 500 mgm2based chemotherapy were evaluated in a multicenter, randomized, doubleblind, stratified study. In another study in six normal male volunteers, a 16mg dose infused over 5. Not many clinicians are aware that ondansetron 4 to 8 mg iv should be administered over 2 to 5 min and certainly not as a bolus or in less than 30 s. Zofran ondansetron side effects, dosage, interactions. Ondansetron oral route, oromucosal route description and. Subsequent breakthrough bolus of 50100% of hourly rate prn. Tablets, oral solution and injection ondansetron hydrochloride dihydrate 4 mg and 8 mg ondansetron hydrochloride dihydrate tablets 4 mg 5 ml ondansetron oral solution, usp.
Ondansetron may cause a condition that affects the heart rhythm qt prolongation. Ondansetron is available under the following different brand names. Monitor blood pressure before injection, 5 and 10 minutes after injection and routinely thereafter. Each 8 mg zofran tablet for oral administration contains. The risk of qtinterval prolongation appears to be dose related. This update is in followup to the fda drug safety communication. This medication is available as a generic drug and as the brandname drug zofran odt. Furthermore, the fda advised that that the weight based dose for intravenous ondansetron should not exceed 16 mg due to cardiac safety concerns 109 s. In 2 trials, the response rates to zofran 4 mg three times a day in patients younger than 12 years was similar to zofran 8 mg three times daily in patients 12 to 18 years. Data from clinical trials indicate that the drug ondansetron zofran increases the risk of a prolonged qt interval. The first dose should be administered 30 minutes before the start of chemotherapy. Adults and pediatric patients 6 months to 18 years. The first dose is infused over 15 minutes beginning 30 minutes before.
Zofran injection summary of product characteristics. Ondansetron 8 mg was injected as a bolus and 16 mg was added to the ivpca in the ondansetron group. The recommended dosage regimens for adult and pediatric patients are described in table 1 and table 2, respectively. Corresponding doses of zofran tablets, zofran odt orally disintegrating tablets and zofran oral solution may be used interchangeably. Because of this risk, single doses greater than 16 mg iv are not. Iv hydration with zofran and solucortef gastroenterology. However, no single intravenous dose of ondansetron should exceed 16 mg due to the risk of qt prolongation. Administer undiluted 2 mg ml immediately before induction of an esthesia or postoperatively if nausea and vomiting occur shortly after surgery. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication education rems cme, and. Learn about side effects, warnings, dosage, and more for the orally disintegrating tablet. Ondansetron ondansetron hydrochloride dose, indications.
This would include dilantin 100 mg doses, larger doses of dexamethasone greater than 10 mg and antiemetics like zofran and phenergan. The drug was sold premixed in solutions of either dextrose or sodium chloride in plastic containers. Subsequent doses are administered 4 and 8 hours after the first dose. Administer over at least 30 sec and preferably over 25 min. This book is distributed under the terms of the creative commons. Each 8 mg zofran odt orally disintegrating tablet for oral administration. The drug should be infused intravenously over 15 minutes. Auc from a 16 mg 73 tablet was 24% greater than predicted from an 8 mg tablet dose. This was followed by the oral administration of ondansetron ranging from 4 to 24 mg daily for 3 days. Przofran odt oral disintegrating tablets ondansetron 4 mg and 8 mg ondansetron orally disintegrating tablets, usp antiemetic 5ht 3 receptor antagonist novartis pharmaceuticals canada inc. Zofran ondansetron side effects, dosage, interactions drugs. Oct 28, 2016 zofran injection should be diluted in 50 ml of 5% dextrose injection or 0. Zofran injection 4 mg intravenous given over 2 to 5 minutes was significantly more effective than placebo.
In these trials, 58% of the 170 evaluable patients had a complete response no emetic episodes on day 1. The 32 mg, single intravenous dose of ondansetron was subsequently withdrawn from the market due to cardiac safety concerns. The number needed to treat nnt to prevent vomiting within 24 hours was 9. Zofran odt oral disintegrating tablet 4mg drug medication dosage information. Researchers examined 84 trials, with 11,980 people receiving ondansetron, published between 1991 and september 1996. If used together, monitor patients for antiemetic efficacy. A maximum initial intravenous dose of 16 mg diluted in 50100 ml of saline or other compatible infusion fluid see section 6. Ondansetron, marketed under the brand name zofran, is a medication used to prevent nausea. Drugs were given as premedication, single or multiple doses, either on request from patients, in response to symptoms, or routinely. Older adults are usually prescribed a lower dose to decrease the risk of side effects. A single iv dose of 32 mg is no longer recommended for treating chemotherapyinduced nausea. To protect against delayed or prolonged emesis after the first 24 hours, oral or rectal treatment with zofran may be continued for up to 5 days after a course of treatment.
Updated information on 32 mg intravenous ondansetron dose. Intravenous infusion 16 minutes 31 minutes to 1 hour 90 minutes 30 minutes between ivp of same drug the infusion time the actual time over which the infusion is administered. Common and rare side effects for zofran intravenous. For chemotherapy, a typical adult dose of zofran can range from 16 to 24 mg daily. Zofran ondansetron hydrochloride tablets and solution. It is also used to prevent nausea and vomiting that may occur after surgery. In a pharmacokinetic study of 10 healthy subjects receiving a singledose intravenous dose of ondansetron 8 mg after 600 mg rifampin once daily for 5 days, the auc and the halflife of ondansetron were reduced by 48% and 46%, respectively. Zofran 10mg 325 is 8 mg of zofran safe in pregnancy board certified by the american academy of ophthalmology, j. Find patient medical information for zofran intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Learn about the reported side effects, related class drugs, and how these medications will affect your daily lifestyle.
Some of the dosage forms listed on this page may not apply to the brand name zofran. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic chemotherapy. If they are giving 8mg they just push two syringes instead of one, followed by 10cc of flush, others just draw up all 8mg straight up without dilution and push slowly bumping up the primary infusion fluid to 100cc for the brief time they are at bedside. Based on the population pharmacokinetic analysis, cancer patients aged 6 to 48 months who receive a dose of 0. Ondansetron works by blocking one of the bodys natural substances that causes vomiting. Oral ondansetron 8 mg twice daily is as effective as 8 mg. The patient receives therapy for the nausea and dehydration. Zofran injection should be diluted in 50 ml of 5% dextrose injection or 0. Using dry hands, carefully remove from blister pack immediately before use.
Common side effects of the drug are headaches and sometimes constipation. Case study you are transporting a 24 yo male who is. Perhaps slow administration of ondansetron as recommended over 25 min would decrease the incidence of potentially lifethreatening adverse effects associated with ondansetron. The nurse further dilutes desired dose to total volume of 20 ml and plans to administer medication over 4 minutes. Zofran side effects important safety information for. Nov 18, 2019 ondansetron should be administered immediately before chemotherapy as a single intravenous dose of 5 mg m 2. The initial dose of zofran may be followed by two additional 8 mg intravenous doses in not less than 30 seconds or intramuscular doses. Zofran reference guide for safe and effective use from the american society of. With the consistently rising value of highly skilled outpatient coders, numerous him departments are moving to a staffing model that employs coding professionals who are well versed in coding both inpatient and outpatient encounters. Ondansetron 2 mgml solution for injection summary of. Dec 04, 2012 the 32 mg single intravenous iv dose of the antinausea drug zofran ondansetron from glaxosmithkline will no longer be marketed because it poses a potential and serious cardiac risk, the us. As such, single doses of injectable ondansetron should not exceed 16 mg at one time. Find information about common, infrequent and rare side effects of zofran intravenous. Because of this, the cardiac safety concerns of ondansetron continue.
Ondansetron is used alone or with other medications to prevent nausea and vomiting caused by cancer drug treatment chemotherapy, radiation treatment, or drugs used to put you to sleep before surgery. The first dose is infused over 15 minutes beginning 30 minutes before the start of emetogenic. Normal ivp dosage for adults at least 50kg in weight. The rn administered ivp zofran at 10 am and d5normal saline was started at 10.
Oral dosing can commence twelve hours later and may be continued for up to 5 days table 1. Oct 24, 2019 ondansetron blocks the actions of chemicals in the body that can trigger nausea and vomiting. For the second time in less than a year, the food and drug administration fda has revised the label of. Oct 18, 2017 in these trials, 58% of the 170 evaluable patients had a complete response no emetic episodes on day 1. Zofran odt tablets are a freezedried, orally administered formulation of ondansetron which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing. The new information does not change any of the recommended oral dosing regimens for ondansetron, including the single oral dose of 24 mg for chemotherapy induced nausea and vomiting. Ondansetron is used to prevent nausea and vomiting that may be caused by surgery, cancer chemotherapy, or radiation treatment. Dosage may be repeated twice, administered 4 and 8 hours after the initial dose. Zofran ondansetron mchenry western lake county ems. Children ages 2 to 12 who weigh more than 40 kg 88 lb. The drug book states to reconstitute the drug with 10 ml of sterile water for injection to provide a concentration of 100 mgml and then to further dilute it in 50 ml of d5w for intermittent infusion.
Zofran odt oral disintegrating tablet 4mg drug medication. Zofran ondansetron hydrochloride injection, for intravenous or. This document contains side effect information about ondansetron. Updated information on 32 mg intravenous ondansetron zofran dose and premixed ondansetron products. Then theres an ivp of ondansetron for nausea and an ivp of solucortef steroid. The incidences of nausea, vomiting and side effects was recorded at 2 h, 24 h, 48 h and 72 h, postoperatively. Zofran is a brand name for the drug ondansetron, prescribed to treat or prevent nausea and vomiting. The total daily dose must not exceed adult dose of 32 mg.
Abnormal heart rhythms may be associated with use of zofran ondansetron on 9152011. The clearance of an 8 mg intravenous dose of zofran was significantly reduced and the serum halflife. In the three foreign trials, the initial dose of zofran injection ranged from 0. Auc from a 16 mg tablet was 24% greater than predicted from an 8 mg tablet dose. If they are giving 8mg they just push two syringes instead of one, followed by 10cc of flush, others just draw up all 8mg straight up without dilution and push slowly bumping up the primary. 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 three times a day every 8 hours for 1 to 2 days after completion of chemotherapy. The updated label will state that ondansetron can continue to be used in adults and children with chemotherapyinduced nausea and vomiting at the lower intravenous dose recommended in the drug label, a dose of 0. In june, 2012, the fda announced that ondansetron 32 mg iv single dose regimen is no longer indicated for chemotherapyinduced nauseavomiting cinv prophylaxis because of the risk of qt prolongation. Food and drug administration fda is notifying health care professionals that the 32 mg, single intravenous iv dose of the antinausea drug zofran ondansetron hydrochloride will no. Ondansetron has extreme utility as an antiemetic drug, and it is effective against nausea. For radiation therapy, a typical adult dose of zofran is 24 mg daily. Ondansetron is used to prevent nausea and vomiting that is caused by cancer medicines chemotherapy or radiation therapy. In clinical trials of patients taking 16 mg of zofran to prevent postsurgical nausea and vomiting, headache occurred in 9 percent of patients, fever in 8 percent, and dizziness in 7 percent.
Along with its needed effects, ondansetron the active ingredient contained in zofran may cause some unwanted effects. Comparison of palonosetron with ondansetron in prevention. Intravenous ondansetron 4 mg versus placebo was investigated in 16 reports and three further reports which had been duplicated a total of six times. The dosage is the same as for the general population. Sep 01, 2006 on the icu floor i work on several ivp meds are diluted in 50 ml bags of nacl and then infused via gravity over 1015 minutes. In rare cases, the drug can cause serious and potentially harmful side effects. Zofran injection ondansetron hydrochloride injection. Ondansetron may be used for purposes not listed in this medication guide. It metabolizes in the liver and has a shelflife of five to seven hours.
Odansetron zofran 16 mg ivp is ordered as a premed for patient undergoing chemotherapy. Each 5 ml of zofran oral solution contains 5 mg of ondansetron hcl dihydrate equivalent to 4 mg of ondansetron. Though zofran was originally created in 1984 to treat nausea and vomiting in cancer patients after receiving chemotherapy, the drug is most commonly used today by pregnant women. Ondansetron works in the stomach to block the signals to the brain that cause nausea and vomiting. Nursing dosage calculation test 1 flashcards quizlet. Dailymed ondansetron ondansetron hydrochloride injection. The recommended adult intravenous dosage of zofran is three 0. The info listed doesnt give stop times, which should definitely be documented, but based on the coding listed, it appears hydration ran for 1h 40 min. Doctors sometimes prescribe zofran to treat nausea and vomiting caused by cancer treatments. Ondansetron oral tablet 24mg drug medication dosage information. Ketorolac dosing, indications, interactions, adverse effects.
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