Registered Rwanda · Rwanda FDA

EMITOSS SOLUTION

ONDANSENTRON HYDROCHLORIDE DIHYDRATE

Rwanda FDA-HMP-MA-2194 Oral Solution 2MG/5ML

What it does

Ondansetron is a medication used to prevent nausea and vomiting caused by certain treatments, such as chemotherapy or surgery.

Commonly used for: nausea and vomiting from chemotherapy, nausea and vomiting from surgery, nausea and vomiting from radiotherapy

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
Rwanda FDA-HMP-MA-2194
Registration date
09/01/2025
Expiry date
08/01/2030
Status
Registered
Active ingredient
ONDANSENTRON HYDROCHLORIDE DIHYDRATE
Dosage form
Oral Solution
Strength
2MG/5ML
Pack size
30 ml
Therapeutic class
-
Manufacturer / MAH
Enicar Pharmaceuticals
Country of origin
INDIA
Manufacturer location
J-214/215/216, M.I.D.C. Tarapur, Tarapur M.I.D.C., Saravali, Maharashtra 401506, India

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:03 · updated 2026-09-21 02:30:19

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About this medicine

Ondansetron is a medication used to prevent nausea and vomiting caused by certain treatments, such as chemotherapy or surgery.

What it treats

  • nausea and vomiting from chemotherapy
  • nausea and vomiting from surgery
  • nausea and vomiting from radiotherapy

How it works

Ondansetron works by blocking signals in the brain that trigger nausea and vomiting.

Who it's for

It is suitable for adults and children who need help managing nausea and vomiting.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: ondansentron

Ondansetron is a selective serotonin 5-HT3 receptor antagonist that is primarily used to prevent nausea and vomiting associated with chemotherapy, radiation therapy, and postoperative recovery. It works by blocking the action of serotonin, a natural substance in the body that can cause nausea and vomiting. Ondansetron is effective in both adults and children, making it a versatile choice in clinical settings.

Indications

  • Chemotherapy-induced nausea and vomiting
  • Radiotherapy-induced nausea and vomiting
  • Postoperative nausea and vomiting
  • Nausea and vomiting associated with gastroenteritis

Dosage

Children: Refer to the BNF for Children for specific dosing guidelines for paediatric patients, as doses are determined by the child's age and weight.

Adults: Refer to the BNF for specific dosing guidelines for adults, as dosages vary based on the condition being treated and the patient's response.

Mechanism of action

Ondansetron exerts its antiemetic effects by selectively antagonizing the 5-HT3 receptors located in the central nervous system, particularly in the area postrema of the medulla oblongata and in the gastrointestinal tract. By blocking these receptors, ondansetron inhibits the signaling pathways that lead to the sensation of nausea and the act of vomiting.

Pharmacodynamics

The pharmacodynamics of ondansetron involves its ability to prevent the binding of serotonin at 5-HT3 receptors. This action not only reduces the incidence of chemotherapy-induced nausea and vomiting but also helps manage nausea associated with other medical conditions. Ondansetron has a rapid onset of action, typically within 30 minutes to 2 hours, and its effects can last for several hours, depending on the route of administration.

Pharmacokinetics

Ondansetron is well absorbed after oral administration, with peak plasma concentrations occurring approximately 1-2 hours post-dose. It undergoes first-pass metabolism in the liver and has a bioavailability of about 60-70%. The drug is primarily metabolized by cytochrome P450 enzymes, particularly CYP3A4, CYP2D6, and CYP1A2, and the elimination half-life is approximately 3-6 hours. Ondansetron is excreted mainly in the urine, with a small percentage eliminated unchanged.

Contra-indications

  • Hypersensitivity to ondansetron or any of its components
  • Concomitant use with apomorphine due to risk of hypotension and loss of consciousness

Adverse effects

  • Headache
  • Constipation
  • Dizziness
  • Fatigue
  • Transient visual disturbances
  • Hypotension
  • QT prolongation
  • Serotonin syndrome (when used with other serotonergic agents)

Interactions

  • May interact with other medications that prolong the QT interval
  • Caution with serotonergic agents, as ondansetron may enhance the risk of serotonin syndrome
  • Concomitant use with apomorphine may lead to severe hypotension

Precautions

  • Use with caution in patients with a history of cardiac arrhythmias or electrolyte disturbances
  • Monitor for signs of serotonin syndrome when used with other serotonergic drugs
  • Caution in patients with hepatic impairment, as dose adjustment may be necessary

Pregnancy

Ondansetron should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Ondansetron is excreted in breast milk. Caution is recommended when administering to nursing mothers.

Storage

Store below 25 degrees Celsius. Protect from light and moisture. Do not freeze.

Formulations

  • Oral tablets
  • Oral solution
  • Injectable solution

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.