Ondansetron Hydrochloride

Ondansetron

Ondansetron is an FDA-approved antiemetic medication commonly sold under the brand Zofran. It contains Ondansetron Hydrochloride, which helps prevent nausea and vomiting linked with chemotherapy, radiation therapy, and surgery. It also helps alleviate nausea and vomiting caused by medical conditions like cancer, pregnancy, and stomach issues. Ondansetron blocks the action of serotonin, a natural chemical that triggers nausea and vomiting. It’s commonly available in oral and disintegrating tablets with 4 mg and 24 mg common strengths. It also comes in oral solution (4 mg/5 ml) and injection (2 mg/ml to 8mg/4ml). The typical prescribed dosage differs by age, weight, and condition. It is usually taken orally with or without food. Side effects may include headache, constipation, or fatigue. Store at room temperature, away from direct light and moisture.

Product Overview

Ondansetron is a prescription antiemetic medication usually available under the brand name Zofran. It contains the active ingredient Ondansetron Hydrochloride, which the FDA approves to prevent nausea and vomiting, particularly associated with chemotherapy, radiation therapy, and surgery. Nausea and vomiting can be debilitating symptoms accompanying various medical conditions or treatments, including cancer, pregnancy, and gastrointestinal disturbances. Ondansetron works by blocking the activity of serotonin, a natural substance in the body that can trigger nausea and vomiting.

Ondansetron is commonly available in orally disintegrating tablets with typical strengths of 4 mg and 8 mg. It is also available in oral solution (4 mg/5 ml) and injectable solution (2 mg/ml to 8mg/4ml). The recommended dosage differs based on the individual’s age, weight, and treatment condition. Typically, it is taken orally, with or without food. Ondansetron can be taken by adults, adolescents, and children as prescribed by a healthcare professional.

Ondansetron side effects may include headache, constipation, or fatigue. It’s advisable to inform your healthcare provider if any adverse reactions occur. Precautions should be taken in individuals with a history of certain medical conditions or allergies. In case of a missed dose, it should be taken as soon as remembered unless it’s close to the next scheduled dose. Overdose symptoms may include severe dizziness or fainting, requiring immediate medical attention. Ondansetron should be stored at room temperature, away from direct light and moisture. You should follow guidance warnings from your healthcare provider or medication label for optimal use and safety.

Uses

Targeted Treatment

• Chemotherapy-Induced Nausea and Vomiting
• Postoperative Nausea and Vomiting
• Radiation-Induced Nausea and Vomiting

Benefits

• Gastroenteritis (Stomach Flu)
• Other conditions where nausea and vomiting are problematic

[Note: Do not take Ondansetron without consulting your doctor. They will determine whether you need this medication based on your conditions.]

Ondansetron Dosage

Forms & Strengths

Form 1: Oral tablet

Strengths: 4 mg, 8 mg

Form 2: Orally disintegrating tablet (ODT)

Strengths: 4 mg, 8 mg

Form 3: Oral solution

Strength: 4 mg/5 ml

Form 4: Intravenous (IV) solution

Strengths: 2 mg/ml, 8mg/4ml

Recommended Dosage

For Chemotherapy-Induced Nausea/Vomiting

• Adults (Oral):

• • • Highly Emetogenic Cancer Chemotherapy (HEC): Taking 24 mg orally 30 minutes before a single-day HEC (including a dose of 50 mg/m2 or more of Cisplatin) is recommended.
    • Moderately Emetogenic Cancer Chemotherapy (MEC): The recommended dose is 8 mg orally twice a day, with the first dose administered 30 minutes before the start of chemotherapy and the successive dose 8 hours later; then 8 mg orally two times a day for 1-2 days after the completion of chemotherapy.

• Adults (Parenteral):

• The recommended dose is 0.15 mg/kg intravenously, with the first dose (infused over 15 minutes) 30 minutes before the start of emetogenic chemotherapy, and successive doses are taken 4 and 8 hours after the first dose.
• The maximum dose is 16 mg per dose.

• 4 to 11 Years Children (Oral):

• • • The recommended dose is 4 mg orally three times a day, with the first dose administered 30 minutes before the start of chemotherapy.
    • The subsequent doses are 4 and 8 hours after the first dose, and then 4 mg orally three times a day (every 8 hours) for 1 to 2 days after the completion of chemotherapy.

• 12 Years and Older Children (Oral):

• • The recommended dose is 8 mg orally twice a day, with the first dose administered 30 minutes before the start of chemotherapy.
  • The subsequent dose is 8 hours later, then 8 mg orally two times a day (every 12 hours) for 1 to 2 days after the completion of chemotherapy.

• 6 months to 18 years Children (Parenteral):

• • The recommended dose is 0.15 mg/kg IV, with the first dose (infused over 15 minutes) 30 minutes before the start of emetogenic chemotherapy.
  • The subsequent doses were given 4 and 8 hours after the first dose.
  • The Maximum dose is 16 mg (per dose)

For Postoperative Nausea/Vomiting

• Adults (Oral): The recommended dose is 16 mg orally 1 hour before the induction of anesthesia.

• Adults (Parenteral): The recommended dose is 4 mg intravenously (undiluted) right before anesthesia injection or postoperatively (nausea/vomiting within 2 hours after surgery).

• The alternative route is 4 mg IM (undiluted)

• Children (Parenteral):

• 1 month-12 years (Less than 40 Kg): The recommended dose is 0.1 mg/kg IV over 2 to 5 minutes immediately before/after anesthesia injection or surgery.
• 1 month-12 years (40 Kg and Greater): The recommended dose is 4 mg IV over 2 to 5 minutes immediately before/following anesthesia induction or postoperatively.

For Radiation Induced Nausea/Vomiting

• Adults: The recommended dose is 8 mg orally three times daily.
• Total Body Irradiation: 8 mg orally 1 to 2 hours before each fraction of daily radiotherapy.
• Single High-dose Fraction Radiotherapy to the Stomach: Oral 8 mg on the day before radiotherapy with successive doses every 8 hours after the first dose for about 1 to 2 days after the first dose.
• Daily Fractionated Radiotherapy to the Stomach: The initial dose should be taken 1 to 2 hours before radiotherapy, with successive doses every 8 hours afterwards.

[Note: These recommendations may differ from individual to individual. Discuss it with your healthcare professional, and they’ll determine your Ondansetron dosage accordingly.]

How to Take It?

• Always take Ondansetron precisely as prescribed by your healthcare provider. 
• Make sure to carefully read the medication guide provided by your pharmacist before you start taking Ondansetron.
• If you are taking the tablet form:
  • Swallow it whole with a glass of water. 
  • You can take it with or without food.
• If you are prescribed the orally disintegrating tablet:
  • Handle it with dry hands.
  • Remove the tablet from its foil packaging by peeling back the foil.
  • Let the tablet dissolve on your tongue without chewing.
  • You can swallow it with saliva.
• If you are using the oral solution:
  • Measure the prescribed dose using a medication syringe, spoon, or cup provided with the medicine. 
  • Do not use a household spoon to measure the dose, as it may not give the correct amount. 
  • You can take the oral solution with or without food.
• If you are prescribed Ondansetron in an injectable form:
  • Healthcare professionals usually administer Ondansetron injections.
  • The injection can be given into a muscle (intramuscular) or a vein (intravenous).
• Do not crush, chew, or break the tablet form of Ondansetron. Swallow it whole.
• Take Ondansetron at the same time each day to help you remember to take it.
• Continue taking Ondansetron for the full prescribed length of treatment; consult your doctor before taking it.

[Note: Your doctor will decide the right Ondansetron dosage for you based on your condition, following guidelines and studies on the drug. They’ll adjust it as needed over time.]

How Does Ondansetron Work?

Ondansetron works by blocking the activity of serotonin, a neurotransmitter in the brain that can trigger nausea and vomiting. It primarily targets serotonin receptors known as 5-HT3 receptors, which are found in the digestive tract and the brain. By inhibiting these receptors, Ondansetron helps to prevent nausea and vomiting caused by chemotherapy, radiation therapy, surgery, or other medical conditions. This mechanism of action makes it effective in controlling nausea and vomiting associated with various treatments and conditions.

Important Safety Information

Side Effects

Common side effects of Ondansetron may include: 

• Headache
• Constipation
• Fatigue
• Dizziness
• Diarrhea
• Dry mouth

Mild side effects of Ondansetron may include:

• Blurred vision
• Flushing
• Fever
• Rash
• Urinary retention

Adverse side effects of Ondansetron may include:

• Serotonin syndrome
• QT prolongation (an abnormal heart rhythm)
• Allergic reactions (redness, irritation, swelling, severe dizziness/ lightheadedness, trouble breathing)
• Liver problems (signs may include yellowing of the skin and eyes, dark urine, severe abdominal pain)
• Severe constipation
• Seizures

[Note: This list may not cover all possible Ondansetron side effects. Always consult with your healthcare giver for medical advice about side effects.]

Warnings

Serotonin Syndrome: Ondansetron may raise the risk of serotonin syndrome, a life-threatening condition with symptoms like:

• Agitation
• Confusion
• Hallucinations
• Sweating
• Rapid heartbeat
• Muscle stiffness
• Tremors
• Seizures
• Jerky muscle movements
• Coma. 

Seek medical attention immediately if you experience any of these symptoms. Serotonin syndrome is more likely to occur when Ondansetron is used with other drugs that affect serotonin levels.

Severe Allergy: Ondansetron can cause a severe allergic reaction, with symptoms such as:

• Flushing
• Trouble breathing
• Swelling of the throat or tongue
• Dizziness
• Coughing

Seek emergency medical help if you develop these symptoms. Do not retake Ondansetron if you’ve had an allergic reaction to it before, as it could be fatal.

Warnings for People with Certain Health Conditions:

• Ondansetron may increase the risk of arrhythmias in individuals with conditions like heart failure or congenital long QT syndrome. Consult your doctor if you have risk factors for arrhythmias.
• Ondansetron orally disintegrating tablets contain phenylalanine, which can be harmful to individuals with phenylketonuria. Do not take the orally disintegrating tablet if you have this condition.

Warnings for Other Groups:

• For Pregnant Women: There’s limited human data on Ondansetron’s effects during pregnancy. Animal studies haven’t shown a risk, but human studies are lacking. Use during pregnancy should only be if needed.
• For Breastfeeding Women: Ondansetron may pass into breast milk and could cause side effects in breastfed infants. Discuss with your doctor whether to continue breastfeeding while taking this medication.
• For Seniors: Older adults may have slower kidney function, leading to a higher drug concentration and increased risk of side effects.
• For Children: Ondansetron has yet to be studied extensively in children younger than four years and should not be used in this age group.

Boxed Warnings

• Risk of Abnormal Heart Rhythms: Ondansetron may increase the risk of developing abnormal changes in the heart’s electrical activity. This can result in a potentially fatal abnormal heart rhythm, including a condition called Torsade de Pointes. Patients at particular risk include those with underlying heart conditions, low levels of potassium or magnesium, and those taking other medications that lead to QT prolongation. 
• Prolongation of QT Interval: Ondansetron may prolong the QT interval on an electrocardiogram (ECG), leading to a potentially fatal irregular heart rhythm known as torsades de pointes. This risk is higher in individuals with certain medical conditions, such as electrolyte abnormalities, heart rhythm disorders, or those taking other medications that prolong the QT interval.

Precautions

• Inform your doctor about any allergies or hypersensitivities you have before taking Ondansetron.
• Disclose your medical history to your doctor, including any liver or kidney problems, seizures, or heart conditions.
• Be cautious if you have a history of gastrointestinal issues like bowel obstruction or severe constipation.
• If you’re pregnant or planning to become pregnant, discuss the risks and benefits of Ondansetron with your doctor.
• Exercise caution while breastfeeding, as Ondansetron may pass into breast milk and affect your infant.
• Inform your doctor about your medications, supplements, and herbal remedies to avoid potential interactions.
• Be aware that Ondansetron may cause dizziness or drowsiness, so avoid activities requiring mental alertness until you know how it affects you.
• Follow your doctor’s instructions carefully and promptly report any unusual symptoms or side effects.

Contraindications

• Patients having hypersensitivity (e.g., anaphylaxis) to Ondansetron or any of the ingredients of the formulation.
• Avoid concomitant use of Ondansetron and apomorphine due to the risk of profound hypotension and loss of consciousness.
• People who are allergic to other 5HT3 antagonist medicines, such as Granisetron or Dolasetron.
• People with liver problems.
• Patients with a blockage in the gut (intestinal obstruction).

Missed Dose

• If you realize you missed a dose, take it immediately. 
• If your next dose time is approaching, ignore the missed dose and return to your usual dosing schedule.
• Do not take two doses at once to compensate for the missed dose.

[Note: If you have missed Ondansetron dosage and are unsure when to take the next one, immediately consult your doctor or pharmacist.]

Overdose

Symptoms of an Ondansetron overdose may include:

• Sudden loss of vision.
• Severe constipation.
• Feeling light-headed or fainting.

[Note: If you consumed more than the recommended Ondansetron dosage, get medical help immediately or call the Poison Help line at 1-800-222-1222.]

Storage

• Store Ondansetron at room temperature (68°F to 77°F or 20°C to 25°C).
• Keep it away from moisture, heat, and light.
• Ensure the container is tightly closed.
• Store it out of reach of children and pets.
• Do not store it in the bathroom or near the kitchen sink.
• Follow any specific storage instructions provided by your pharmacist or healthcare provider.

[Note: Discuss with your healthcare professional the proper disposal of unused Ondansetron medicine and any questions you may have regarding its storage.]

Ondansetron Interactions

• Opioid Analgesics:
  • Codeine
  • Dextropropoxyphene
  • Nalbuphine
  • Tramadol
  • Norco (acetaminophen/hydrocodone)
• Antiarrhythmic Drugs:
  • Amiodarone
  • Dofetilide
  • Procainamide
  • Quinidine
  • Sotalol
• Erythromycin
• NSAIDs:
  • Aspirin
  • Paracetamol (acetaminophen)
  • Tylenol (acetaminophen)
• Antihistamines:
  • Benadryl (diphenhydramine)
  • Zyrtec (cetirizine)
• Selective Serotonin Reuptake Inhibitors (SSRIs):
  • Cymbalta (duloxetine)
  • Lexapro (escitalopram)
• Antidepressants:
  • Cymbalta (duloxetine)
  • Lexapro (escitalopram)
  • Lyrica (pregabalin)
• Beta Blockers:
  • Metoprolol Succinate ER (metoprolol)
  • Metoprolol Tartrate (metoprolol)
• MiraLAX (polyethylene glycol 3350)
• Nexium (esomeprazole)
• Bronchodilators:
  • ProAir HFA (albuterol)
  • Ventolin HFA (albuterol)
• Probiotic Formula (bifidobacterium infantis / lactobacillus acidophilus)
• Singulair (montelukast)
• Symbicort (budesonide / formoterol)
• Synthroid (levothyroxine)
• Xanax (alprazolam)
• Vitamins and Supplements:
  • Vitamin B12 (cyanocobalamin)
  • Vitamin C (ascorbic acid)
  • Vitamin D2 (ergocalciferol)
  • Vitamin D3 (cholecalciferol)
  • Fish Oil (omega-3 polyunsaturated fatty acids)
• Flexeril (cyclobenzaprine)
• Flonase (fluticasone nasal)
• Linzess (linaclotide)
• Apomorphine
• Pimozide

Disease Interactions:

• QT Interval Prolongation
• Liver Disease

[Note: This isn’t a complete list, and there could be other drugs that interact with Ondansetron. Tell your doctor any prescription, over-the-counter medicines, and herbal products you’re taking.]

Ondansetron Alternatives

• Phenergan (promethazine)
• Reglan (metoclopramide hydrochloride)
• Anzemet (dolasetron)
• Kytril (granisetron)
• Compazine (prochlorperazine)
• Tigan (trimethobenzamide)
• Scopolamine (scopolamine)

[Note: Your doctor will choose the best Ondansetron alternative for you. Only use these alternative medications after consulting your healthcare provider. Taking them by yourself may cause serious side effects.] 

Frequently Asked Questions

1. Can I take Ondansetron during pregnancy?

Ondansetron is generally considered safe to use during pregnancy, especially for managing nausea and vomiting. While it’s not explicitly FDA-approved for morning sickness, studies suggest minimal risks. Some research indicates a slight increase in heart defects and orofacial malformations when taken in the first trimester. Still, the FDA and CDC maintain that it doesn’t significantly impact fetal health. Always consult your healthcare provider for personalized advice.

2. How long does it take for Ondansetron to work?

Ondansetron begins to work within approximately 30 minutes. It reaches peak blood concentrations in about 2 hours, and its effects can last 8 to 12 hours.

3. Can I take Ondansetron with food?

Yes, you can take Ondansetron with food. It is generally well-tolerated and can be ingested either with or without food. However, consult your healthcare provider for personalized advice if you experience any discomfort or have specific concerns.

4. Can Ondansetron be used for motion sickness?

Ondansetron is not that effective for treating motion sickness. While it helps with nausea, it does not alleviate other symptoms associated with motion sickness. Instead, use scopolamine or first-generation antihistamines like dimenhydrinate or chlorpheniramine for better results.

5. Is it safe to take Ondansetron while breastfeeding?

Ondansetron is generally considered safe to use while breastfeeding. It is less likely to pass into breast milk, and any amount transferred is unlikely to harm the nursing infant. However, as with any medication, you must consult your healthcare provider for personalized advice. 

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