قرص ondansetron 4 - کامل (هلپ کده)

خواص دارویی و گیاهی

A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties. [PubChem]

Having been developed in the 1980s by GlaxoSmithKline and approved by the US FDA since January 1991, ondansetron has demonstrated a long history of use and efficacy. Commonly formulated as oral tablets, orally disintegrating tablets (ODT), and injections, and available as generic products as well, ondansetron continues to see contemporary innovations in its formulation and use, including the development of orally soluble films that are both discreet in administration and less of a burden in comparison to having patients attempt to swallow pills during emesis 7.

A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

A unique ID assigned by the FDA when a product is submitted for approval by the labeller.قرص ondansetron 4

A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

In the adult patient population:
i) orally administered ondansetron tablets and orally disintegrating tablets (ODT) are indicated for:
– the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, including high dose (ie. greater than or equal to 50 mg/m2) cisplatin therapy, and radiotherapy, and
– the prevention and treatment of postoperative nausea and vomiting

ii) intravenously administered ondansetron injection formulations are indicated for:
– the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, including high dose (ie. greater than or equal to 50 mg/m2) cisplatin therapy, and
– the prevention and treatment of postoperative nausea and vomiting

In the pediatric (4-18 years of age) patient population:
i) ondansetron was effective and well tolerated when given to children 4-12 years of age for the treatment of post-chemotherapy induced nausea and vomiting,
ii) ondansetron tablets, ondansetron ODT, ondansetron injection are not indicated for the treatment of children 3 years of age or younger,
iii) ondansetron tablets, ondansetron ODT, ondansetron injection are not indicated for use in any age group of the pediatric population for the treatment of post-radiotherapy induced nausea and vomiting, and
iV) ondansetron tablets, ondansetron ODT, ondansetron injection are not indicated for use in any age group of the pediatric population for the treatment of postoperative nausea and vomiting

In the geriatric (>65 years of age) patient population:
i) efficacy and tolerance of ondansetron were similar to that observed in younger adults for the treatment of post-chemotherapy and radiotherapy-induced nausea and vomiting, and
ii) clinical experience in the use of ondansetron in the prevention and treatment of postoperative nausea and vomiting is limited and is not indicated for use in the geriatric patient population

Ondansetron is a highly specific and selective serotonin 5-HT3 receptor antagonist, not shown to have activity at other known serotonin receptors and with low affinity for dopamine receptors Label, 3,4. The serotonin 5-HT3 receptors are located on the nerve terminals of the vagus in the periphery, and centrally in the chemoreceptor trigger zone of the area postrema Label, 3,4. The temporal relationship between the emetogenic action of emetogenic drugs and the release of serotonin, as well as the efficacy of antiemetic agents, suggest that chemotherapeutic agents release serotonin from the enterochromaffin cells of the small intestine by causing degenerative changes in the GI tract Label, 3,4. The serotonin then stimulates the vagal and splanchnic nerve receptors that project to the medullary vomiting center, as well as the 5-HT3 receptors in the area postrema, thus initiating the vomiting reflex, causing nausea and vomiting Label, 3,4.

Moreover, the effect of ondansetron on the QTc interval was evaluated in a double-blind, randomized, placebo and positive (moxifloxacin) controlled, crossover study in 58 healthy adult men and women 9,10. Ondansetron was tested at single doses of 8 mg and 32 mg infused intravenously over 15 minutes 9,10. At the highest tested dose of 32 mg, prolongation of the Fridericia-corrected QTc interval (QT/RR0.33=QTcF) was observed from 15 min to 4 h after the start of the 15 min infusion, with a maximum mean (upper limit of 90% CI) difference in QTcF from placebo after baseline-correction of 19.6 (21.5) msec at 20 min 9,10. At the lower tested dose of 8 mg, QTc prolongation was observed from 15 min to 1 h after the start of the 15-minute infusion, with a maximum mean (upper limit of 90% CI) difference in QTcF from placebo after baseline-correction of 5.8 (7.8) msec at 15 min 9,10. The magnitude of QTc prolongation with ondansetron is expected to be greater if the infusion rate is faster than 15 minutes 9,10. The 32 mg intravenous dose of ondansetron must not be administered 9,10. No treatment-related effects on the QRS duration or the PR interval were observed at either the 8 or 32 mg dose 9,10.

An ECG assessment study has not been performed for orally administered ondansetron 9,10. On the basis of pharmacokinetic-pharmacodynamic modelling, an 8 mg oral dose of ondansetron is predicted to cause a mean QTcF increase of 0.7 ms (90% CI -2.1, 3.3) at steady-state, assuming a mean maximal plasma concentration of 24.7 ng/mL (95% CI 21.1, 29.0) 9,10. The magnitude of QTc prolongation at the recommended 5 mg/m2 dose in pediatrics has not been studied, but pharmacokinetic-pharmacodynamic modeling predicts a mean increase of 6.6 ms (90% CI 2.8, 10.7) at maximal plasma concentrations 9,10.

In healthy subjects, single intravenous doses of 0.15 mg/kg of ondansetron had no effect on esophageal motility, gastric motility, lower esophageal sphincter pressure, or small intestinal transit time 8. Multiday administration of ondansetron has been shown to slow colonic transit in healthy subjects 8. Ondansetron has no effect on plasma prolactin concentrations 8.

Ondansetron is a selective antagonist of the serotonin receptor subtype, 5-HT3 8,9,10.

Cytotoxic chemotherapy and radiotherapy are associated with the release of serotonin (5-HT) from enterochromaffin cells of the small intestine, presumably initiating a vomiting reflex through stimulation of 5-HT3 receptors located on vagal afferents 8,9,10. Ondansetron may block the initiation of this reflex. Activation of vagal afferents may also cause a central release of serotonin from the chemoreceptor trigger zone of the area postrema, located on the floor of the fourth ventricle 8,9,10. Thus, the antiemetic effect of ondansetron is probably due to the selective antagonism of 5-HT3 receptors on neurons located in either the peripheral or central nervous systems, or both 8,9,10.

Although the mechanisms of action of ondansetron in treating postoperative nausea and vomiting and cytotoxic induced nausea and vomiting may share similar pathways, the role of ondansetron in opiate-induced emesis has not yet been formally established 9,10.

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Structured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.

Structured data representing warnings from the black box section of drug labels. These warnings cover important and dangerous risks, contraindications, or adverse effects.

Ondansetron is absorbed from the gastrointestinal tract and undergoes some limited first-pass metabolism 8. Mean bioavailability in healthy subjects, following administration of a single 8-mg tablet, was recorded as being approximately 56% to 60% 8,9,10. Bioavailability is also slightly enhanced by the presence of food 8.

Ondansetron systemic exposure does not increase proportionately to dose 8. The AUC from a 16-mg tablet was 24% greater than predicted from an 8-mg tablet dose 8. This may reflect some reduction of first-pass metabolism at higher oral doses 8.

The volume of distribution of ondansetron has been recorded as being approximately 160L 5.

The plasma protein binding associated with ondansetron was documented as approximately 73% 9,10.

In vitro metabolism studies have shown that ondansetron is a substrate for human hepatic cytochrome P450 enzymes, including CYP1A2, CYP2D6 and CYP3A4 8,9,10. In terms of overall ondansetron turnover, CYP3A4 played the predominant role 8,9,10. Because of the multiplicity of metabolic enzymes capable of metabolizing ondansetron, it is likely that inhibition or loss of one enzyme (e.g. CYP2D6 enzyme deficiency) will be compensated by others and may result in little change in overall rates of ondansetron clearance 8,9,10.

Following oral or IV administration, ondansetron is extensively metabolised and excreted in the urine and faeces 8,9,10. In humans, less than 10% of the dose is excreted unchanged in the urine 8,9,10. The major urinary metabolites are glucuronide conjugates (45%), sulphate conjugates (20%) and hydroxylation products (10%) 8,9,10. The primary metabolic pathway is subsequently hydroxylation on the indole ring followed by subsequent glucuronide or sulfate conjugation 8,9,10. 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 8,9,10.

Following oral or IV administration, ondansetron is extensively metabolised and excreted in the urine and faeces 9,10.

The half-life of ondansetron after either an 8 mg oral dose or intravenous dose was approximately 3-4 hours and could be extended to 6-8 hours in the elderly 9,10.

The clearance values determined for ondansetron in various patient age groups were recorded as approximately 0.38 L/h/kg in normal adult volunteers aged 19-40 yrs, 0.32 L/h/kg in normal adult volunteers aged 61-74 yrs, 0.26 L/h/kg in normal adult volunteers aged >=75 yrs Label.

At present, there is little information concerning overdosage with ondansetron 8,9,10. Nevertheless, there have been certain cases of somewhat idiosyncratic adverse effects associated with particular dosages of ondansetron used 8,9,10.

“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 8,9,10. Hypotension (and faintness) occurred in another patient that took 48 mg of oral ondansetron 8,9,10. Following infusion of 32 mg over only a 4-minute period, a vasovagal episode with transient second-degree heart block was observed 8,9,10. Neuromuscular abnormalities, autonomic instability, somnolence, and a brief generalized tonic-clonic seizure (which resolved after a dose of benzodiazepine) were observed in a 12-month-old infant who ingested seven or eight 8-mg ondansetron tablets (approximately forty times the recommended 0.1-0.15 mg/kg dose for a pediatric patient) 8,9,10. In all instances, however, the events resolved completely 8,9,10.

The safety of ondansetron for use in human pregnancy has not been established 9,10. Ondansetron is not teratogenic in animals 9,10. However, as animal studies are not always predictive of human response, the use of ondansetron in pregnancy is not recommended 9,10.

Ondansetron is excreted in the milk of lactating rats 9,10. It is not known if it is excreted in human milk, however, nursing is not recommended during treatment with ondansetron 9,10.

Insufficient information is available to provide dosage recommendations for children 3 years of age or younger 9,10.

Extended description of the mechanism of action and particular properties of each drug interaction.

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A rating for the strength of the evidence supporting each drug interaction.

An effect category for each drug interaction. Know how this interaction affects the subject drug.

Peter Bod, Kalman Harsanyi, Ferenc Trischler, Eva Fekecs, Attila Csehi, Bela Hegedus, Eva Mersich nee Donat, Gyorgyi Szabo nee Komlosi, Erika Horvath nee Sziki, “Process for preparing ondansetron.” U.S. Patent US5478949, issued September, 1990.قرص ondansetron 4

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Drug created on June 13, 2005 07:24 / Updated on July 13, 2019 01:02

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Pronunciation: on DAN se tron

Brand: Zofran, Zofran ODT, Zuplenz

4 mg, round, white, imprinted with M, 315

قرص ondansetron 4

8 mg, round, orange, imprinted with M, 344

4 mg, round, white, imprinted with M, 732

8 mg, round, white, imprinted with M, 734

4 mg, round, white, imprinted with GG, 927

8 mg, round, yellow, imprinted with GG, 928

4 mg, round, white, imprinted with R, 153

8 mg, round, yellow, imprinted with R, 154

4 mg, round, white, imprinted with 5, E

4 mg, oval, white, imprinted with 130

8 mg, oval, yellow, imprinted with 131

8 mg, oval, white, imprinted with 241

8 mg, oval, yellow, imprinted with 8, NO

4 mg, round, white, strawberry, imprinted with 5, E

8 mg, round, white, strawberry, imprinted with 7, E

4 mg, oval, white, imprinted with 4, NO

4 mg, round, white, imprinted with G, 4

8 mg, round, white, imprinted with G, 8

4 mg, round, white, imprinted with 93, 7301

4 mg, round, white, imprinted with 93, 233

8 mg, round, white, imprinted with 93, 7302

8 mg, round, yellow, imprinted with 93, 7236

4 mg, round, white, imprinted with 5, E

4 mg, oval, white, strawberry, imprinted with 240

4 mg, oval, white, imprinted with Zofran, 4

8 mg, oval, yellow, imprinted with Zofran, 8

You should not use ondansetron if you are also using apomorphine (Apokyn).

Ondansetron blocks the actions of chemicals in the body that can trigger nausea and vomiting.

Ondansetron is used to prevent nausea and vomiting that may be caused by surgery, cancer chemotherapy, or radiation treatment.

Ondansetron may be used for purposes not listed in this medication guide.

You should not use ondansetron if:

To make sure ondansetron is safe for you, tell your doctor if you have:

Ondansetron is not expected to harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether ondansetron passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Ondansetron is not approved for use by anyone younger than 4 years old.

Ondansetron orally disintegrating tablets may contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).قرص ondansetron 4

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Ondansetron can be taken with or without food.

The first dose of ondansetron is usually taken before the start of your surgery, chemotherapy, or radiation treatment. Follow your doctor’s dosing instructions very carefully.

Take the ondansetron regular tablet with a full glass of water.

To take the orally disintegrating tablet (Zofran ODT):

To use ondansetron oral soluble film (strip) (Zuplenz):

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Store at room temperature away from moisture, heat, and light. Store liquid medicine in an upright position.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include sudden loss of vision, severe constipation, feeling light-headed, or fainting.

Ondansetron may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Get emergency medical help if you have signs of an allergic reaction: rash, hives; fever, chills, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

Common side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ondansetron can cause a serious heart problem, especially if you use certain medicines at the same time, including antibiotics, antidepressants, heart rhythm medicine, antipsychotic medicines, and medicines to treat cancer, malaria, HIV or AIDS. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with ondansetron.

Taking ondansetron while you are using certain other medicines can cause high levels of serotonin to build up in your body, a condition called “serotonin syndrome,” which can be fatal. Tell your doctor if you also use:

This list is not complete and many other drugs can interact with ondansetron. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Your pharmacist can provide more information about ondansetron.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2019 Cerner Multum, Inc. Version: 13.01. Revision date: 10/21/2016.

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اندانسترون (به انگلیسی: Ondansetron)

نامهای تجارتی : Demitron – Zofran

رده درمانی: ضد استفراغ .

رده فارماکولوژیک: آنتاگونیست گیرنده سروتونین

قرص ondansetron 4

اشکال دارویی: قرص روکش دار ۴ میلی گرمی، محلول خوراکی ۴ میلی گرم در ۵ سی سی، آمپول ۲ میلی گرم در سی سی، ۲ سی سی، و ۴ سی سی.

اندانسترون اثرات ضد استفراغ خود را، با اثرات آنتاگونیستی گیرنده‎های سروتونین، در انتهای اعصاب واگ (عصب واگ) و گیرنده‌های مرکزی آن در مرکز استفراغ اعمال می‌کند و بدین طریق با مهار کردن رفلکس استفراغ، از تهوع و استفراغ جلوگیری می‌کند.

دربالغین و کودکان بزرگتر از ۴ سال : ۳۰ دقیقه قبل از شروع شیمی درمانی، ۰٫۱۵ میلی گرم به ازای هر کیلوگرم وزن بدن، از راه وریدی و در خلال ۱۵ دقیقه انفوزیون می‌شود و سپس ۰٫۱۵ میلی گرم به ازای هر کیلوگرم وزن بدن، ۴ و ۸ ساعت بعد از دوز اول تجویز می‌شود. همچنین می‌توان دارو را به صورت دوز واحد و به میزان، ۳۲ میلی گرم، ۳۰ دقیقه قبل از شیمی درمانی تجویز نمود.

روش دیگر: در بالغین و کودکان بزرگتر از ۱۲ سال : ۸ میلی گرم از راه خوراکی دو بار در روز تجویز می‌شود . دارو باید ۳۰ دقیقه قبل از شروع شیمی درمانی و سپس ۸ ساعت بعد از دوز اول تکرار شود و سپس ۸ میلی گرم هر ۱۲ ساعت تا دو روز بعد از اتمام شیمی درمانی تجویز می‌شود.

در کودکان سنین ۴ تا ۱۲ سال : ۴ میلی گرم از راه خوراکی، سه بار در روز تجویز می‌شود. ترتیب تجویز دارو، مشابه بالغین است.

دربالغین : ۸ میلی گرم، از راه خوراکی، سه بار در روز تجویز می‌شود.

در بالغین : ۱۶ میلی گرم، از راه خوراکی یک ساعت قبل از بیهوشی یا ۴ میلی گرم از راه وریدی بلافاصله قبل بیهوشی یا به فاصله کوتاهی بعد از عمل تجویز می‌شود.

نکته: در نارسایی کبد باید اندانسترون را، با احتیاط تجویز کرد.

Generic Name: ondansetron (oral) (on DAN se tron)Brand Names: Zofran, Zofran ODT, Zuplenz

Medically reviewed by Drugs.com. Last updated on Nov 5, 2018.

Ondansetron blocks the actions of chemicals in the body that can trigger nausea and vomiting.

Ondansetron is used to prevent nausea and vomiting that may be caused by surgery, cancer chemotherapy, or radiation treatment.

Ondansetron may be used for purposes not listed in this medication guide.

قرص ondansetron 4

You should not use ondansetron if you are also using apomorphine (Apokyn).

You should not use ondansetron if you are allergic to it or to similar medicines such as dolasetron (Anzemet), granisetron (Kytril), or palonosetron (Aloxi).

Before taking ondansetron, tell your doctor if you have liver disease, or a personal or family history of Long QT syndrome.

Ondansetron orally disintegrating tablets may contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).

Serious side effects of ondansetron include blurred vision or temporary vision loss (lasting from only a few minutes to several hours), slow heart rate, trouble breathing, anxiety, agitation, shivering, feeling like you might pass out, and urinating less than usual or not at all. Stop taking this medicine and call your doctor at once if you have any of these side effects. Ondansetron may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

You should not use ondansetron if:

you are also using apomorphine (Apokyn); or

you are allergic to ondansetron or similar medicines (dolasetron, granisetron, palonosetron).

To make sure ondansetron is safe for you, tell your doctor if you have:

liver disease;

an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

congestive heart failure, slow heartbeats;

a personal or family history of long QT syndrome; or

a blockage in your digestive tract (stomach or intestines).

Ondansetron is not expected to harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether ondansetron passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Ondansetron is not approved for use by anyone younger than 4 years old.

Ondansetron orally disintegrating tablets may contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).

Take ondansetron exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Ondansetron can be taken with or without food.

The first dose is usually taken before the start of your surgery, chemotherapy, or radiation treatment. Follow your doctor’s dosing instructions very carefully.

Take the ondansetron regular tablet with a full glass of water.

To take the orally disintegrating tablet (Zofran ODT):

Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil. Do not push a tablet through the foil or you may damage the tablet.

Use dry hands to remove the tablet and place it in your mouth.

Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

Swallow several times as the tablet dissolves.

To use ondansetron oral soluble film (strip) (Zuplenz):

Keep the strip in the foil pouch until you are ready to use the medicine.

Using dry hands, remove the strip and place it on your tongue. It will begin to dissolve right away.

Do not swallow the strip whole. Allow it to dissolve in your mouth without chewing.

Swallow several times after the strip dissolves. If desired, you may drink liquid to help swallow the dissolved strip.

Wash your hands after using Zuplenz.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Store at room temperature away from moisture, heat, and light. Store liquid medicine in an upright position.قرص ondansetron 4

Ondansetron dosage information (in more detail)

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include sudden loss of vision, severe constipation, feeling light-headed, or fainting.

Ondansetron may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Get emergency medical help if you have signs of an allergic reaction to ondansetron: rash, hives; fever, chills, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

severe constipation, stomach pain, or bloating;

headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

fast or pounding heartbeats;

jaundice (yellowing of the skin or eyes);

blurred vision or temporary vision loss (lasting from only a few minutes to several hours);

high levels of serotonin in the body–agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Common ondansetron side effects may include:

diarrhea or constipation;

headache;

drowsiness; or

tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ondansetron side effects (in more detail)

Usual Adult Dose of Ondansetron for Nausea/Vomiting — Chemotherapy Induced:

Oral:
Highly Emetogenic Cancer Chemotherapy (HEC):
-Recommended dose: 24 mg orally 30 minutes before the start of single-day HEC (including cisplatin doses of 50 mg/m2 or greater)

Moderately Emetogenic Cancer Chemotherapy (MEC):
-Recommended dose: 8 mg orally twice a day, with the first dose administered 30 minutes before the start of chemotherapy and the subsequent dose 8 hours later; then 8 mg orally 2 times a day (every 12 hours) for 1 to 2 days after the completion of chemotherapy

Parenteral:
-Recommended dose: 0.15 mg/kg IV, with the first dose (infused over 15 minutes) 30 minutes before the start of emetogenic chemotherapy and subsequent doses given 4 and 8 hours after the first dose.
-Maximum dose: 16 mg per dose

Comments:
-Multi-day, single-dose administration of 24 mg orally for HEC has not been studied.
-The injection formulation should be diluted prior to IV administration.

Uses:
-Prevention of nausea and vomiting associated with HEC or MEC
-Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic chemotherapy

Usual Adult Dose of Ondansetron for Nausea/Vomiting:

Oral:
Highly Emetogenic Cancer Chemotherapy (HEC):
-Recommended dose: 24 mg orally 30 minutes before the start of single-day HEC (including cisplatin doses of 50 mg/m2 or greater)

Comments:
-Multi-day, single-dose administration of 24 mg orally for HEC has not been studied.
-The injection formulation should be diluted prior to IV administration.

Uses:
-Prevention of nausea and vomiting associated with HEC or MEC
-Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic chemotherapy

Usual Adult Dose of Ondansetron for Nausea/Vomiting — Postoperative:

Oral:
-Recommended dose: 16 mg orally 1 hour before the induction of anesthesia

Parenteral:
-Recommended dose: 4 mg IV (undiluted) immediately before induction of anesthesia or postoperatively (nausea and/or vomiting within 2 hours after surgery)
-Alternative route: 4 mg IM (undiluted)

Comment:
-Administration of a second dose does not provide additional control of nausea and vomiting.

Use:
-Prevention of postoperative nausea and vomiting

Usual Adult Dose for Nausea/Vomiting–Radiation Induced:

Recommended dose: 8 mg orally 3 times a day
-Total Body Irradiation: 8 mg orally 1 to 2 hours before each fraction of radiotherapy administered each day
-Single High-dose Fraction Radiotherapy to the Abdomen: 8 mg orally 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after the completion of radiotherapy
-Daily Fractionated Radiotherapy to the Abdomen: 8 mg orally 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given

Use:
-Prevention of nausea and vomiting associated with radiotherapy, either as total body irradiation, single high-dose fraction, or daily fractions to the abdomen

Usual Pediatric Dose for Nausea/Vomiting — Postoperative:

Parenteral:
1 month to 12 years:
Less than 40 kg:
-Recommended dose: 0.1 mg/kg IV over 2 to 5 minutes immediately prior to/following anesthesia induction or postoperatively (nausea and/or vomiting occurring shortly after surgery)

40 kg and greater:
-Recommended dose: 4 mg IV over 2 to 5 minutes immediately prior to/following anesthesia induction or postoperatively (nausea and/or vomiting occurring shortly after surgery)

Use:
-Prevention of postoperative nausea and vomiting

Usual Pediatric Dose for Nausea/Vomiting — Chemotherapy Induced:

Oral:
4 to 11 years:
-Recommended dose: 4 mg orally 3 times a day, with the first dose administered 30 minutes before the start of chemotherapy, and subsequent doses 4 and 8 hours after the first dose; then 4 mg orally 3 times a day (every 8 hours) for 1 to 2 days after the completion of chemotherapy

12 years and older:
-Recommended dose: 8 mg orally twice a day, with the first dose administered 30 minutes before the start of chemotherapy and the subsequent dose 8 hours later; then 8 mg orally 2 times a day (every 12 hours) for 1 to 2 days after the completion of chemotherapy

Parenteral:
6 months to 18 years:
-Recommended dose: 0.15 mg/kg IV, with the first dose (infused over 15 minutes) 30 minutes before the start of emetogenic chemotherapy, and subsequent doses given 4 and 8 hours after the first dose
-Maximum dose: 16 mg (per dose)

Comments:
-The injection formulation should be diluted in 50 mL prior to IV administration.
-This drug should be used to prevent nausea and vomiting associated with moderately to highly emetogenic chemotherapy.

Uses:
-Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy
-Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic chemotherapy

medicine to treat depression;

medicine to treat a psychiatric disorder;

a narcotic (opioid) medication; or

medicine to prevent nausea and vomiting.

Ondansetron drug interactions (in more detail)

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[Article in Japanese]

Miyamoto Y(1), Yagi K, Teramachi M, Oomasa M, Tomiyama K.

Author information:
(1)Dept. of Chest Surgery, National Himeji Hospital.

قرص ondansetron 4

We investigated the efficacy of combination of ondansetron hydrochloride
injection and tablet against nausea and vomiting in 22 lung cancer patients
(total number of chemotherapy courses: 23) receiving chemotherapy of single-dose
carboplatin (CBDCA) at a dose of 302.2 +/- 31.9 mg/m2. For suppressing emesis,
the patients were given 4 mg of ondansetron injection on the day of CBDCA
injection (Day 1), and 4 mg/day of ondansetron tablet for Days 2 to 5. The
following results were obtained 5 days after the administration of carboplatin.
1) Control of nausea graded ‘Good’ or better counted for 95% or higher of all
cases for each day of the chemotherapy. A complete nausea suppression rate was
seen in 91.3%, 81.0%, 71.4%, 63.6% and 71.4% from Day 1 to Day 5, respectively.
2) Control of vomiting graded ‘Major’ control or better was achieved in 95% or
more of all cases, for each day. The complete vomiting suppression rate observed
from Day 1 to Day 5 was 91.3%, 78.3%, 65.2%, 69.6% and 91.3%, respectively. 3)
Inhibitory effect on nausea and vomiting for each day of Days 1 to 5 graded as
‘Effective’ or better was shown in 90% or higher of all cases; based on overall
judgement for Days 1 to 5, all cases were graded as ‘Effective’ or better. 4) The
proportion of cases which was evaluated as ‘Can eat most of the meal’ was 88.0%,
73.9%, 50.7%, 50.7% and 65.2% from Days 1 to 5, respectively, against 95.7% prior
to the start of chemotherapy. 5) No adverse drug reaction or abnormal clinical
laboratory values were seen along with ondansetron. 6) In conclusion, combined
treatment with ondansetron injection and tablet was considered clinically useful
in control of nausea and vomiting during administration of carboplatin, and may
also be useful for out-patient chemotherapy.