How is ondansetron used to prevent nausea and vomiting. What are the recommended dosages for adults and children. How should ondansetron be administered for chemotherapy-induced nausea. What are the potential side effects of ondansetron.

Understanding Ondansetron: A Powerful Antiemetic Medication

Ondansetron is a widely prescribed medication used to prevent nausea and vomiting associated with various medical conditions and treatments. This comprehensive guide will explore the uses, dosages, and administration methods of ondansetron for both adults and children.

Ondansetron for Chemotherapy-Induced Nausea and Vomiting

One of the primary uses of ondansetron is to prevent nausea and vomiting caused by chemotherapy. The dosage and administration method depend on the emetogenic potential of the chemotherapy regimen.

Highly Emetogenic Chemotherapy (HEC)

For adults undergoing highly emetogenic chemotherapy:

• Oral dosage: 24 mg taken 30 minutes before the start of single-day HEC (including cisplatin doses of 50 mg/m2 or greater)
• Intravenous dosage: 0.15 mg/kg IV, with the first dose infused over 15 minutes, 30 minutes before the start of chemotherapy, followed by subsequent doses at 4 and 8 hours after the initial dose

Is there a maximum dose for intravenous administration? Yes, the maximum dose per infusion is 16 mg.

Moderately Emetogenic Chemotherapy (MEC)

For adults undergoing moderately emetogenic chemotherapy:

• Oral dosage: 8 mg twice daily, with the first dose taken 30 minutes before chemotherapy starts and the second dose 8 hours later. Continue with 8 mg twice daily (every 12 hours) for 1 to 2 days after completing chemotherapy.

Ondansetron for Postoperative Nausea and Vomiting

Ondansetron is also effective in preventing postoperative nausea and vomiting. The dosage and administration method differ for adults and children.

Adult Dosage for Postoperative Nausea and Vomiting

• Oral: 16 mg taken 1 hour before anesthesia induction
• Intravenous: 4 mg IV (undiluted) immediately before anesthesia induction or postoperatively if nausea and/or vomiting occur within 2 hours after surgery
• Intramuscular: 4 mg IM (undiluted) as an alternative route

Can a second dose be administered for additional control? No, administering a second dose does not provide additional control of nausea and vomiting.

Pediatric Dosage for Postoperative Nausea and Vomiting

For children aged 1 month to 12 years:

• Less than 40 kg: 0.1 mg/kg IV over 2 to 5 minutes
• 40 kg and greater: 4 mg IV over 2 to 5 minutes

When should the dose be administered? The dose should be given immediately before or following anesthesia induction, or postoperatively if nausea and/or vomiting occur shortly after surgery.

Ondansetron for Radiation-Induced Nausea and Vomiting

Ondansetron is also effective in preventing nausea and vomiting associated with radiotherapy. The dosage and administration method vary depending on the type of radiation treatment.

Total Body Irradiation

Recommended dosage: 8 mg orally 1 to 2 hours before each fraction of radiotherapy administered daily

Single High-dose Fraction Radiotherapy to the Abdomen

Recommended dosage: 8 mg orally 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours for 1 to 2 days after completing radiotherapy

Daily Fractionated Radiotherapy to the Abdomen

Recommended dosage: 8 mg orally 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours for each day radiotherapy is given

Pediatric Dosing for Chemotherapy-Induced Nausea and Vomiting

For children aged 4 to 11 years undergoing chemotherapy:

• Oral dosage: 4 mg taken 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 initial dose

How long should this dosing regimen be continued? The duration of treatment should be determined by the healthcare provider based on the child’s response and the length of the chemotherapy regimen.

Important Considerations and Precautions

When administering ondansetron, healthcare providers should be aware of several important considerations:

• The injection formulation should be diluted prior to IV administration
• Multi-day, single-dose administration of 24 mg orally for HEC has not been studied
• Dosage adjustments may be necessary for patients with renal or hepatic impairment
• Ondansetron may interact with other medications, so a thorough review of the patient’s medication history is essential

Are there any contraindications for ondansetron use? Yes, ondansetron is contraindicated in patients with known hypersensitivity to the drug or any of its components. It should also be used with caution in patients with a history of QT interval prolongation or other cardiac rhythm disorders.

Potential Side Effects of Ondansetron

While ondansetron is generally well-tolerated, patients should be aware of potential side effects, which may include:

• Headache
• Constipation
• Dizziness
• Fatigue
• Diarrhea
• QT interval prolongation (rare but serious)

Should patients report all side effects to their healthcare provider? Yes, patients should be encouraged to report any unusual or persistent side effects to their healthcare provider promptly.

Monitoring and Follow-up

Proper monitoring and follow-up are essential when using ondansetron:

• Regular assessment of the patient’s response to treatment
• Monitoring for potential side effects or adverse reactions
• Adjusting the dosage or treatment plan as needed based on the patient’s response and tolerance
• Periodic evaluation of the need for continued ondansetron therapy, especially in long-term use cases

How often should patients be monitored while taking ondansetron? The frequency of monitoring should be determined by the healthcare provider based on the individual patient’s condition, treatment regimen, and risk factors.

Alternative Antiemetic Options

While ondansetron is highly effective, there are other antiemetic medications available that may be considered in certain situations:

• Granisetron
• Palonosetron
• Dolasetron
• Aprepitant
• Dexamethasone (often used in combination with ondansetron)

When might alternative antiemetic options be considered? Alternative options may be explored if a patient experiences inadequate relief with ondansetron, develops intolerable side effects, or has contraindications to its use.

Patient Education and Counseling

Proper patient education is crucial for the effective use of ondansetron:

• Explain the importance of taking the medication as prescribed
• Instruct patients on the correct timing of doses, especially in relation to chemotherapy or radiation treatments
• Advise patients on potential side effects and when to seek medical attention
• Discuss potential drug interactions and the importance of informing all healthcare providers about ondansetron use
• Provide guidance on lifestyle modifications that may help manage nausea and vomiting in conjunction with medication

What resources can be provided to patients for additional information? Patients can be directed to reliable online resources, patient education materials from reputable medical organizations, or support groups for individuals undergoing similar treatments.

Ondansetron in Special Populations

The use of ondansetron may require special considerations in certain patient populations:

Elderly Patients

Older adults may be more sensitive to the effects of ondansetron and may require dose adjustments. Careful monitoring for side effects is essential in this population.

Pregnant Women

The use of ondansetron during pregnancy should be carefully evaluated. While it is sometimes prescribed for severe morning sickness, the potential risks and benefits must be weighed carefully.

Breastfeeding Mothers

Ondansetron is excreted in breast milk. The decision to use ondansetron while breastfeeding should be made in consultation with a healthcare provider, considering the potential risks to the infant and the benefits of the medication for the mother.

Patients with Liver or Kidney Impairment

Dose adjustments may be necessary for patients with hepatic or renal dysfunction. Close monitoring of these patients is important to ensure safe and effective use of ondansetron.

How should ondansetron dosing be adjusted in patients with liver impairment? For patients with severe hepatic impairment, the total daily dose should not exceed 8 mg.

Future Directions in Antiemetic Therapy

Research in the field of antiemetic therapy continues to evolve, with ongoing studies focusing on:

• Development of new antiemetic agents with improved efficacy and safety profiles
• Optimization of combination therapies for enhanced nausea and vomiting control
• Personalized approaches to antiemetic therapy based on genetic factors and individual patient characteristics
• Exploration of non-pharmacological interventions to complement medication-based treatments

What potential advancements in antiemetic therapy are on the horizon? Researchers are investigating novel drug delivery methods, such as long-acting formulations and targeted therapies, to improve patient convenience and treatment outcomes.

Conclusion: The Importance of Tailored Antiemetic Therapy

Ondansetron plays a crucial role in managing nausea and vomiting associated with various medical conditions and treatments. Its effectiveness, coupled with a generally favorable safety profile, makes it a valuable tool in improving patient quality of life and treatment adherence. However, the key to successful antiemetic therapy lies in tailoring the treatment approach to each individual patient’s needs, considering factors such as:

• The underlying cause of nausea and vomiting
• Patient age and overall health status
• Concurrent medications and potential interactions
• Patient preferences and lifestyle factors

By carefully considering these factors and utilizing the appropriate dosing regimens, healthcare providers can optimize the use of ondansetron and other antiemetic agents to provide the best possible outcomes for their patients. As research in this field continues to advance, we can look forward to even more effective and personalized approaches to managing nausea and vomiting in various clinical settings.

Ondansetron Dosage Guide + Max Dose, Adjustments

Print

Save

Medically reviewed by Drugs.com. Last updated on Nov 28, 2022.

Applies to the following strengths: 4 mg/5 mL; 32 mg/50 mL-D5%; 2 mg/mL; 4 mg; 8 mg; 24 mg; 32 mg/50 mL-NaCl 0.9%

Usual Adult Dose for:

• Nausea/Vomiting – Chemotherapy Induced
• Nausea/Vomiting
• Nausea/Vomiting – Postoperative
• Nausea/Vomiting – Radiation Induced

Usual Pediatric Dose for:

• Nausea/Vomiting – Postoperative
• Nausea/Vomiting – Chemotherapy Induced

Additional dosage information:

• Renal Dose Adjustments
• Liver Dose Adjustments
• Precautions
• Dialysis
• Other Comments

Usual Adult Dose 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 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)

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 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

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

• Mild to moderate hepatic impairment (Child-Pugh less than 10): No adjustment recommended.
• Severe hepatic impairment: (Child-Pugh 10 or greater): 8 mg IV over 30 minutes before the start of emetogenic chemotherapy; maximum 8 mg per day

Precautions

Safety and efficacy have not been established in patients younger than 6 months (parenteral formulations) and 4 years (oral formulations).

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Do not push oral dissolving tablets (ODTs) through the foil backing.
• ODT and film formulations should be used with dry hands and immediately placed on the tongue. The dosage form should dissolve in saliva. Administration with additional liquid is not necessary. In patients requiring multiple films per dose, each film should be allowed to completely dissolve before administering the next film.
• IV doses greater than 8 mg should be slowly injected over at least 15 minutes. Single IV doses greater than 16 mg should be avoided.
• IM doses should be administered undiluted at a rate slower than 30 seconds (e.g., 2 to 5 minutes).
• The suppository formulation is not recommended for use in children.

Storage requirements:

• The manufacturer product information should be consulted.

Reconstitution/preparation techniques:

• The manufacturer product information should be consulted.

IV compatibility:

• The manufacturer product information should be consulted.

General:

• The lowest effective dose should be used.
• Oral, rectal, IV, and IM routes have shown to be equally effective over the first 24 hours of chemotherapy.
• Use of the ODT formulation in the prevention of nausea and vomiting associated with highly-emetogenic chemotherapy, radiotherapy, or in postoperative situations has not been studied in pediatric patients.
• Concomitant use with dexamethasone may potentiate the antiemetic effects of this drug.
• Routine prophylaxis is not recommended for postoperative patients with little expectation of nausea and vomiting; however, use is recommended for patients who should avoid postoperative nausea and vomiting, even with low risk of postoperative nausea and vomiting.

Monitoring:

• Electrolyte levels, especially in patients at risk for hypomagnesemia or hypokalemia
• ECG, especially in patients with a history of QT prolongation, bradycardia, congestive heart failure, or those on drugs which could prolong the QT interval or result in electrolyte abnormalities
• Signs/symptoms of respiratory events or hypersensitivity reactions

Patient advice:

• Inform patients that this drug may cause drowsiness, and they should avoid driving or operating machinery until the full effects of the drug are seen.
• Patients should be advised to immediately report any signs/symptoms associated with serotonin syndrome or hypersensitivity reactions to their prescribers. Patients should also report lightheadedness, syncope episodes, or any perceived changes in heart rate.
• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.
• Tell patients to report all concurrent prescription and nonprescription medications or herbal products they are taking.

Frequently asked questions

• Can you take ondansetron while pregnant?

More about ondansetron

• Check interactions
• Compare alternatives
• Pricing & coupons
• Reviews (473)
• Drug images
• Side effects
• Patient tips
• During pregnancy
• Support group
• Drug class: 5HT3 receptor antagonists
• Breastfeeding

Patient resources

• Drug Information
• Ondansetron injection
• Ondansetron (Injection) (Advanced Reading)
• Ondansetron (Oral, Oromucosal) (Advanced Reading)
• Ondansetron Oral Soluble Film

Other brands

Zofran, Zofran ODT, Zuplenz

Professional resources

• Prescribing Information

Related treatment guides

• Gastroenteritis
• Alcohol Use Disorder
• Nausea/Vomiting
• Nausea/Vomiting, Chemotherapy Induced

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Ondansetron Interactions Checker – Drugs.com

Print

Save

There are 338 drugs known to interact with
ondansetron, along with
2 disease interactions.

Of the total drug interactions,
122 are major, 212 are moderate, and 4 are minor.

Does ondansetron interact with my other drugs?

Enter other medications to view a detailed report.

• View all 338 medications that may interact with ondansetron
• View ondansetron disease interactions (2)

Most frequently checked interactions

View interaction reports for ondansetron and the medicines listed below.

• Major
• Moderate
• Minor
• Unknown

• Adderall (amphetamine / dextroamphetamine)
• Aspirin Low Strength (aspirin)
• Benadryl (diphenhydramine)
• Cymbalta (duloxetine)
• Eliquis (apixaban)
• Fish Oil (omega-3 polyunsaturated fatty acids)
• Flexeril (cyclobenzaprine)
• Flonase (fluticasone nasal)
• Lexapro (escitalopram)
• Linzess (linaclotide)
• Lyrica (pregabalin)
• Metoprolol Succinate ER (metoprolol)
• Metoprolol Tartrate (metoprolol)
• MiraLAX (polyethylene glycol 3350)
• Nexium (esomeprazole)
• Norco (acetaminophen / hydrocodone)
• Paracetamol (acetaminophen)
• ProAir HFA (albuterol)
• Probiotic Formula (bifidobacterium infantis / lactobacillus acidophilus)
• Singulair (montelukast)
• Symbicort (budesonide / formoterol)
• Synthroid (levothyroxine)
• Tylenol (acetaminophen)
• Ventolin HFA (albuterol)
• Vitamin B12 (cyanocobalamin)
• Vitamin C (ascorbic acid)
• Vitamin D2 (ergocalciferol)
• Vitamin D3 (cholecalciferol)
• Xanax (alprazolam)
• Zyrtec (cetirizine)

Ondansetron disease interactions

There are 2 disease interactions with ondansetron which include:

• QT interval prolongation
• liver disease

Report options

Loading. ..

QR code containing a link to this page

More about ondansetron

• ondansetron consumer information
• Compare alternatives
• Pricing & coupons
• Reviews (473)
• Drug images
• Side effects
• Dosage information
• Patient tips
• During pregnancy
• Support group
• Drug class: 5HT3 receptor antagonists
• Breastfeeding

Related treatment guides

• Gastroenteritis
• Alcohol Use Disorder
• Nausea/Vomiting
• Nausea/Vomiting, Chemotherapy Induced

Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.

Major	Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate	Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor	Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown	No interaction information available.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Ondansetron: Pediatric Medication | Memorial Sloan Kettering Cancer Center

Pediatric Medicine

Share

Provided by Lexicomp ^® , this document contains all the information you need to know about this medicine, including indications, directions for use, side effects, and when your healthcare provider should be contacted.

Trade names: USA

Zofran; Zuplenz [DSC]

Trade names: Canada

ACCEL-Ondansetron; APO-Ondansetron; ATHENA-Ondansetron ODT; AURO-Ondansetron; Auro-Ondansetron ODT; CCP-Ondansetron; JAMP Ondansetron; JAMP-Ondansetron; Mar-Ondansetron; MAR-Ondansetron ODT; MINT-Ondansetron; MINT-Ondansetron ODT; MYLAN-Ondansetron; NAT-Ondansetron; Ondansetron ODT; Ondissolve ODF; PMS-Ondansetron; PMS-Ondansetron ODT; SANDOZ Ondansetron; TEVA Ondansetron; VAN-Ondansetron [DSC]; Zofran ODT; Zofran [DSC]

What is this drug used for?

• It is used to treat and prevent nausea and vomiting.

What do I need to tell the doctor BEFORE my child takes this drug?

• If your child has an allergy to this drug, any of its ingredients, other drugs, foods, or substances. Tell the doctor about the allergy and how it manifested itself in the child.
• If your child has a prolonged QT interval on the ECG.
• If your child is taking apomorphine.

This list of drugs and conditions that may interact with this drug is not exhaustive.

Talk to your doctor or pharmacist about all medicines your child is taking (prescription and over-the-counter, natural, and vitamins) and any health problems. You need to make sure that this drug is safe to use for your child’s illnesses and in combination with other drugs he or she is already taking. Do not start, stop taking, or change the dosage of any drug your child is taking without the doctor’s approval.

What do I need to know or do while my child is taking this drug?

• Tell all health care providers who care for your child that your child is taking this drug. These are your child’s doctors, nurses, pharmacists and dentists.
• If your child has phenylketonuria, talk to your doctor. Some foods contain phenylalanine.

If your daughter is pregnant or breastfeeding:

• Consult physician if your daughter is pregnant, pregnant, or breastfeeding. The benefits and risks for your daughter and her baby will need to be discussed.

What side effects should I report to my child’s doctor right away?

WARNING/CAUTION: Although rare, some people may have very serious and sometimes deadly side effects of this drug. Call your child’s doctor right away or seek medical attention if your child has any of the following signs or symptoms that could be associated with a very bad side effect:

• Signs of an allergic reaction, such as rash, hives, itching, red and swollen skin with blisters or peeling, possibly accompanied by fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue or throat.
• Obstruction of the urinary tract.
• Dizziness.
• Sudden pain or tightness in the chest.
• A type of abnormal heart rhythm (QT prolongation) has happened with this drug. Sometimes it caused another type of heart rhythm disturbance (polymorphic ventricular tachycardia of the “pirouette” type). Call your doctor right away if your child has tachycardia, abnormal heart rhythms, or fainting.
• A severe and sometimes deadly complication called serotonin syndrome can occur. This risk may be increased if the child is also taking certain other drugs. Call your child’s healthcare provider right away if your child has agitation, balance problems, confusion, hallucinations, high fever, tachycardia or abnormal heart rhythm, flushing, muscle twitching or stiffness, seizures, tremors or tremors, excessive sweating, severe diarrhea, nausea or vomiting, a very severe headache.
• This drug may make it difficult to detect signs of bowel obstruction after abdominal surgery, as well as nausea and vomiting after chemotherapy. If your child has abdominal pain or swelling in the abdomen, see a doctor immediately.

What are some other side effects of this drug?

Any drug can cause side effects. However, for many people, side effects are either minor or non-existent. Contact your child’s doctor or seek medical attention if any of these or other side effects bother your child or if they persist:

• Headache.
• Feeling tired or weak.
• Diarrhea or constipation.
• Drowsiness.
• Anxiety.

This list of possible side effects is not exhaustive. If you have any questions about side effects, ask your child’s doctor. Talk to your child’s doctor about side effects.

You can report side effects to the National Health Board.

What is the best way to give this drug?

Give this drug to your child as directed by your doctor. Read all the information provided to you. Strictly follow all instructions.

All oral preparations:

• Give this drug with or without food.

Lozenge:

• If the tablets are supplied in a foil blister, do not squeeze the foil tablet when opening it. The tablet should be removed from the foil with dry hands.
• Open immediately before use.
• Put the tablet on the child’s tongue and let it dissolve. It is not necessary to drink water. Make sure that the child does not swallow the drug whole. Make sure that the child does not chew, break or crush the tablet.

Liquid (solution):

• Liquid doses should be measured with caution. Use the dispenser that comes with the medicine. If the dispenser is not provided in the package, ask the pharmacist for a dosing agent for this drug.

Oral strips:

• Open immediately before use.
• Do not touch the preparation with wet hands.
• Place the strip on your tongue and let it dissolve. It is not necessary to drink water. If more than 1 strip is used, it is necessary to wait until the previous strip is completely dissolved before using the next one.
• Do not allow the child to chew or swallow.
• Wash your hands after use.

Injection:

• For intravenous injections.
• This drug can be given intramuscularly or by intravenous infusion over a period of time.

What if my child misses a dose of medication?

All oral preparations:

• If the child takes the drug regularly, give him the missed dose as soon as you remember about it.
• If it is time for your child to take the next dose, do not take the missed dose and then go back to your child’s normal schedule.
• Do not give a double dose at the same time or additional doses.
• In most cases, this drug is used as needed. Do not give your child the drug more often than prescribed by the doctor.

Injection:

• Contact your child’s doctor to find out the next steps.

How do I store and/or discard this drug?

All oral preparations:

• Store at room temperature, protected from light. Store in a dry place. Do not store in the bathroom.

Oral strips:

• Store in primary container.

Liquid (solution):

• Store upright with cap closed.

Injection:

• If you need to store this drug at home, check with your child’s doctor, nurse, or pharmacist about how to store it.

All forms:

• Keep all medicines in a safe place. Keep all medicines out of the reach of children and pets.
• Dispose of unused or expired drugs. Do not empty into a toilet or sewer unless instructed to do so. If you have any questions about disposing of medicines, ask your pharmacist. Drug disposal programs may be in place in your area.

General information about medicines

• If your child’s symptoms or health problems do not improve, or worsen, contact your child’s doctor.
• Do not share your child’s medicine with others and do not give anyone else’s medicine to your child.
• Some medicines may come with other patient information leaflets. If you have questions about this drug, talk with your child’s doctor, nurse, pharmacist, or other health care professional.
• If you think you have overdosed, call a poison control center or get medical help right away. Be prepared to tell or show what drug you took, how much, and when it happened.

Consumer Use of Information and Limitation of Liability

This summary information includes a summary of the diagnosis, treatment, and/or drug product. It is not intended to be a comprehensive source of data and should be used as a tool to help the user understand and/or evaluate potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a particular patient. It should not be considered medical advice or a substitute for medical advice, diagnosis or treatment provided by a physician based on a medical examination and assessment of the patient’s specific and unique circumstances. Patients should consult with their physician for full information about their health, medical issues, and treatment options, including any risks or benefits regarding the use of medications. This information is not a guarantee that a treatment or drug is safe, effective, or approved for a particular patient. UpToDate, Inc. and its subsidiaries disclaim any warranties or liabilities related to this information or its use. The use of this information is subject to the Terms of Use found at https://www.wolterskluwer.com/en/know/clinical-effectiveness-terms.

Last revision date

2021-11-12

Copyright

© UpToDate, Inc. and its affiliates and/or licensors, 2023. All rights reserved.

Date last updated

Monday, December 12, 2022

Ondansetron film-coated tablets 8 mg blister №10

Pharmacological properties

Pharmacodynamics. antiemetic. the mechanism of action is due to a competitive highly selective blockade of central and peripheral serotonin 5ht3 receptors (receptors of the trigger zone, vomiting center). suppresses the gag reflex, eliminating and preventing nausea when using cytotoxic chemotherapeutic agents, radiation therapy, in the postoperative period. with repeated use, it slows down peristalsis and the passage of contents through the intestines.

Pharmacokinetics. When administered intravenously at a dose of 0.15 mg/kg of body weight to adults under the age of 75 years, Cmax in blood plasma averages about 100 ng/ml, in persons over the age of 75 years – 170 ng/ml. With an intravenous infusion of 32 mg for 15 minutes, Cmax reaches 264 ng / ml. With intramuscular injection, Cmax of ondansetron in blood plasma (about 25 ng / ml) is noted 10 minutes after injection.

When taken orally, the drug is well absorbed in the gastrointestinal tract, bioavailability is about 60% due to the effect of the first passage through the liver. Cmax of ondansetron in plasma is reached after 1.5–1.7 hours. Eating prolongs the absorption period by 17% without affecting Cmax. Binding to plasma proteins – 70-76%.

The main part of the administered dose (85–90%) is hydroxylated in the liver with the participation of cytochrome P450 to indole ring compounds, and then conjugated with glucuronic and sulfuric acids. The total volume of distribution is 1.9 l / kg of body weight, T½, depending on age, is 3.5–5.5 h, the total clearance is 5.9 ml / (min kg). The drug is excreted from the body by the kidneys, while 5% of the administered dose is excreted unchanged. The pharmacokinetic parameters of ondansetron do not change with repeated use.

In children, as well as in persons with liver damage, the total clearance decreases, in elderly patients, T½ and the total clearance of the drug increase. In patients with moderate renal insufficiency (creatinine clearance – 15-60 ml / min), systemic clearance and volume of distribution of ondansetron are reduced, resulting in a clinically insignificant small increase in the half-life of the drug. In women, Cmax and bioavailability of the drug are higher, and clearance and volume of distribution are lower than in men.

Readings

Prevention and management of nausea and vomiting during cytotoxic chemotherapy (initial and repeat courses, including high dose cisplatin) and radiotherapy (whole body irradiation, partial single high dose or daily abdominal irradiation) in oncology. prevention and elimination of nausea and vomiting in the postoperative period in general surgery, ophthalmology and others.

Moderate emetogenic chemotherapy and radiotherapy

Adults and children over 12 years of age, by mouth: Initially 8 mg 1 to 2 hours before anticancer therapy, followed by another 8 mg 8 to 12 hours later. prolonged nausea and vomiting after the first 24 hours, the use of the drug should be continued at 8 mg every 12 hours. With partial high-dose irradiation of the abdominal region, 8 mg every 8 hours is prescribed. The drug is taken during the entire course of chemotherapy and radiation therapy, as well as 1-2 days (if necessary – 3-5 days) after its completion.

Highly emetogenic chemotherapy

Adults and children over 12 years of age are given ondansetron 24 mg orally (simultaneously with dexamethasone phosphate) 1 to 2 hours before starting chemotherapy. For the prevention of late vomiting in the following days, 8 mg 2 times a day during the entire course of chemotherapy, as well as 5 days after its completion.

For chemotherapy in children aged 4-12 years, by mouth: initially 4 mg 3 times a day (30 minutes before the start of the course, then after 4 and 8 hours). To prevent late vomiting, 4 mg is prescribed every 8 hours 1-2 days, then 4 mg 2 times a day during the entire course, as well as 5 days after its completion.

Postoperative nausea and vomiting

Adults and children over 12 years of age are given 16 mg 1 hour before anesthesia. Children under the age of 12 are not prescribed.

The maximum daily dose of ondansetron is 32 mg, for patients with severe hepatic impairment – 8 mg.

Injection solution

Injection solution may be administered IM or IV as a single slow injection or by infusion. To prepare the ondansetron solution for infusion, you can use 0.9% sodium chloride solution, 5% glucose solution, Ringer solution. Solution of ondansetron for infusion administration is prepared immediately before administration; however, if necessary, it can be stored until fully used for no more than 24 hours at a temperature of 2–8 °C. During the infusion, protection from light is not required (under normal lighting).

Emethogenic chemotherapy and radiotherapy

For adults, use the solution at a dose of 8 mg IV slowly immediately before chemotherapy.

Highly emetogenic chemotherapy

• a single dose of 8–32 mg given IV slowly immediately before chemotherapy; when administered at a dose above 8 mg, ondansetron must be dissolved in 50-100 ml of 0.9% sodium chloride solution or other compatible solution for intravenous administration and an infusion should be carried out for at least 15 minutes;

• a dose of 8 mg is given slowly intravenously immediately before chemotherapy, then 2 slow IV doses of 8 mg at a 2-4 hour interval or IV drip at a dose of 1 mg/hour for 24 hours.

The choice of dosing regimen is set individually depending on the severity of the emetogenic effect.

Children may be given as a single IV dose of 5 mg/m2 immediately prior to chemotherapy.

Postoperative nausea and vomiting

Adults: May give 4 mg as a slow IV or IM injection during induction of anesthesia. To eliminate the development of postoperative nausea and vomiting, a single injection of 4 mg intramuscularly or intravenously is recommended.

Children: May be given at a dose of 0.1 mg/kg body weight (maximum 4 mg) IV slowly before, during or after initiation of anesthesia to prevent postoperative nausea and vomiting. To eliminate the development of postoperative nausea and vomiting, a single dose of 0.1 mg/kg (maximum 4 mg) intramuscularly or intravenously is recommended.

Contraindications

Hypersensitivity to drug components; the period of pregnancy (especially the first trimester) and breastfeeding; insufficiency of liver function, surgical operations on the abdominal cavity; the drug is not prescribed to children under the age of 4 years during chemotherapy and radiation therapy; during anesthesia, tablets cannot be prescribed to children under the age of 12 years; injection solution – up to 2 years.

Side effects

From the side of the central nervous system: headache, dizziness, temporary impairment of visual acuity (with rapid intravenous administration), spontaneous movement disorders, seizures, depression of the central nervous system function, paresthesia, weakness, extrapyramidal symptoms, syncope;

from the side of the cardiovascular system: a feeling of heat and a rush of blood to the face, arrhythmia, tachycardia or bradycardia, arterial hypo- or hypertension;

from the digestive system: constipation, diarrhea, hiccups, dry mouth, transient increase in aminotransferase activity, liver failure;

allergic reactions: urticaria, bronchospasm, in isolated cases – anaphylactic reactions;

other: cough, chest pain (anginal type), redness and burning at the injection site.

Special instructions

During treatment with ondansetron, breast-feeding should be discontinued.

For parenteral use of the drug in patients with moderate and severe hepatic impairment, it is not recommended to exceed a dose of 8 mg / day.

In the event of a very severe vomiting reaction as a result of chemotherapy, the effectiveness of the drug can be increased by a single intravenous administration of corticosteroids (for example, 20 mg of dexamethasone sodium phosphate) before starting chemotherapy.

Use with caution in patients with a history of hypersensitivity reactions to other selective serotonin 5HT3 receptor antagonists. With caution and under close medical supervision, the drug is used in the treatment of patients with signs of subacute intestinal obstruction.

Interactions

Simultaneous use of inhibitors of microsomal hepatic enzymes of the cytochrome p450 system may increase t½ and reduce the overall clearance of the drug.

When combined with inducers of microsomal hepatic enzymes of the cytochrome P450 system (barbiturates, carbamazepine, carisoprodol, glutethimide, griseofulvin, nitrous oxide, papaverine, phenylbutazone, phenytoin, hydantoins, rifampicin, tolbutamide, etc. ), the clinical efficacy of the drug may decrease.

The drug in the form of an infusion solution at a concentration of ondansetron 16-160 mcg / ml (8 mg / 500 ml – 8 mg / 50 ml) can be administered through a Y-shaped catheter in combination with the following drugs:

• cisplatin up to 0.48 mg/ml for 1-8 hours;

• carboplatin at a concentration of 0.18-9.90 mg/ml for 10-60 minutes;

• fluorouracil at concentrations up to 0.8 mg/ml at a rate of at least 20 ml/h, bearing in mind that higher concentrations of fluorouracil may cause precipitation of ondansetron;

• etoposide at a concentration of 0.14-0.25 mg/ml for 30-60 minutes;

• ceftazidime 0.025-2 g, diluted with water for injection according to the manufacturer’s recommendations, as an IV bolus injection over 5 minutes;

• cyclophosphamide 0.1-1 g, diluted with water for injection according to the manufacturer’s recommendations, as an IV bolus injection over 5 minutes;

• doxorubicin 10-100 mg, diluted with water for injection according to manufacturer’s recommendations, as an IV bolus injection over 5 minutes;

• Dexamethasone 20 mg IV slowly over 2-5 minutes in combination with 8-32 mg ondansetron in 50-100 ml solution.