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Ondansetron orally 4 mg: Ondansetron Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Ondansetron Dosage Guide + Max Dose, Adjustments

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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

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  • Reviews (471)
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  • 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

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Professional resources

  • Prescribing Information

Related treatment guides

  • Gastroenteritis
  • Nausea/Vomiting
  • Alcohol Use Disorder
  • 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 Pill Images – What does ondansetron look like?

What does Ondansetron hydrochloride look like?

Note: Multiple pictures are displayed for those medicines available in different strengths, marketed under different brand names and for medicines manufactured by different pharmaceutical companies. Multi ingredient medications may also be listed when applicable.
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Ondansetron injection 8 mg ampoule 4 ml №5

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, C max in blood plasma averages about 100 ng/ml, in persons over the age of 75 years – 170 ng/ml. With an IV infusion of 32 mg for 15 minutes, C max reaches 264 ng / ml. With intramuscular injection C max 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 pass through the liver. C max of ondansetron in plasma is reached after 1.5–1.7 hours. Eating prolongs the absorption period by 17% without affecting C max . 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, T ½ , depending on age, is 3.5–5.5 h, the total clearance is 5.9ml/(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, T ½ 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 T ½ drug. In women, C max and the bioavailability of the drug are higher, and the clearance and volume of distribution are lower than in men.

Indications

Prevention and management of nausea and vomiting in 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, etc.

Application

Tablets

When performing cytostatic therapy, the dosage regimen is set individually, depending on the severity of the emetic reaction.

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. To prevent late or 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 (concomitantly 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.

During chemotherapy in children aged 4–12 years, it is administered orally: 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 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).

Emetogenic chemotherapy and radiotherapy

For adults, administer 8 mg IV slowly immediately prior to 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 administered slowly IV just before the course of chemotherapy, then 2 IV doses of 8 mg slowly at a dose of 2-4 hours apart 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 a single IV dose of 5 mg/m 2 immediately prior to chemotherapy.

Postoperative nausea and vomiting

Adults: 4 mg may be given 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: to prevent postoperative nausea and vomiting, it can be given at a dose of 0.1 mg / kg body weight (maximum 4 mg) IV slowly before, during or after the onset of anesthesia. 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;

on the part 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;

others: 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 the start of chemotherapy.

Use with caution in patients with a history of hypersensitivity reactions to other selective serotonin 5HT 3 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.

With special use with inducers of microsomal hepatic enzymes of the P450 cytochrome system (barbiturates, carbamazepine, karizu, glutetimide, Grzeoofulvin, nitrogen oxide, papaverine, phenylbutazone, phenytoine, hydrantoins, rifampicin, tolbutamide, it is possible to reduce the clinical effectiveness of the drug that.

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 manufacturer’s recommendations, as an IV bolus injection over 5 minutes;

doxorubicin at a dose of 10-100 mg, diluted with water for injection in accordance with the manufacturer’s recommendations, as an IV bolus injection over 5 minutes;

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

The drug should not be used in the same syringe or in the same dropper with other drugs.

Overdose

In case of overdose, manifestation of side effects is possible. treatment – withdrawal of the drug and symptomatic therapy aimed at maintaining vital functions. there is no specific antidote.

Storage conditions

Tablets – in a dry, dark place at a temperature not exceeding 25 °C; ampoules – in a place protected from light at a temperature not exceeding 25 °C. expiration date – 2 years.

Translation of instructions moz

Ondansetron tablets | Borimed

In the prevention and treatment of nausea and vomiting caused by cytostatic chemotherapy or radiotherapy in adults. The choice of dosing regimen is determined by the severity of the emetogenic effect of the ongoing antitumor therapy, depends on the dose and combination of drugs used.

The recommended dose is ondansetron 8 mg 1 to 2 hours before cytostatic chemotherapy or radiotherapy, followed by 8 mg orally every 12 hours for up to 5 days. For highly emetogenic chemotherapy, a single oral dose of ondansetron is 24 mg concomitantly with dexamethasone 12 mg orally 1 to 2 hours before the start of chemotherapy.

24 hours after chemotherapy and radiotherapy, you can continue taking odinsetron for up to 5 days at a dose of 8 mg 2 times a day.

Use in special groups of patients. Elderly patients. Dose adjustment for the oral form of the drug is not required.

Patients with impaired renal function. Dose adjustment for the oral form of the drug is not required.

Patients with impaired liver function. In patients with moderate and severe hepatic impairment, the clearance of ondansetron is significantly reduced, the half-life is significantly increased. In such patients, the daily dose of ondansetron should not exceed 8 mg.

Patients with slow metabolism of sparteine-debrisoquine. In patients with a slow metabolism of sparteine-debrizoquine, the half-life of ondansetron is not changed. Therefore, upon repeated administration of ondansetron to such patients, its plasma concentration will not differ from that in patients in the general population. Therefore, adjustment of the daily dose or dosing frequency of ondansetron is not required in this case.

Prevention and treatment of nausea and vomiting caused by cytostatic chemotherapy in children over 12 years of age. In children aged 12-18 years, dose calculation is based on body surface area. On the first day, intravenous administration of the drug at a dose of 5 mg / m 9 is recommended.0081 2 (but not more than 8 mg) immediately before chemotherapy, followed by oral administration of the drug after 12 hours. Oral ondansetron may be continued for another 5 days after chemotherapy. The doses used for adults should not be exceeded.

Dose calculation chart based on body surface area in children aged 12 to 18 years for the prevention and treatment of chemotherapy-induced nausea and vomiting.

Body surface area Day 1 Day 2-6
>0.6 m 2 and <1.m 2 5 mg/m 2 IV, then 4 mg orally 12 hours later 4 mg orally every 12 hours
>1.2 m 2 5 mg/m 2 IV or 8 mg IV, then 8 mg PO every 12 hours 8 mg orally every 12 hours

Note: The intravenous dose should not exceed 8 mg. The total daily dose (administered intravenously and orally) should not exceed 32 mg.

Dosing of ondansetron for children aged 12-18 years is allowed based on body weight. In this case, the total daily dose calculated on the basis of body weight is greater than the total daily dose calculated on the basis of body surface area.

Ondansetron should be administered intravenously immediately prior to chemotherapy as a single dose of 0.15 mg/kg. A single intravenous dose should not exceed 8 mg. Two more intravenous injections at a dose of 0.15 mg / kg can be administered with an interval of 4 hours. Oral administration of the drug can begin 12 hours after the end of chemotherapy and can be continued for up to 5 days.

Dose calculation table based on body weight in children aged 12 to 18 years for the prevention and treatment of nausea and vomiting caused by chemotherapy.

Body weight Day 1 Day 2-6
Over 10 kg Up to 3 doses of 0. 15 mg/kg IV every 4 hours Ondansetron 4 mg orally every 12 hours

Note: The intravenous dose should not exceed 8 mg. The total daily dose (administered intravenously and orally) should not exceed 32 mg.

If oral administration of 4 mg of ondansetron is required, it is recommended to use a tablet of this dosage from another manufacturer.

Prevention of postoperative nausea and vomiting in adults. To prevent nausea and vomiting in the postoperative period, it is recommended to take 16 mg of ondansetron orally 1 hour before anesthesia.

Parenteral ondansetron should be used to treat postoperative nausea and vomiting.

Special patient groups

Children between the ages of 12 and 18.

No studies have been conducted on the efficacy and safety of ondansetron tablets for the prevention and treatment of nausea and vomiting in the postoperative period; for this purpose, parenteral use of ondansetron is recommended.