Onseron (4mg/2ml) 2ml, 1 Ampoule Injection

Onseron (4mg/2ml) 2ml, 1 Ampoule Injection

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  • Manufacturer INDUS PHARMACEUTICALS (PVT.) LTD.
  • Generic Name Ondansetron Hydrochlorid

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Product Information

  • Description
  • Ingredients
  • Drug Class
  • Dosage Form
  • Uses
  • Dosage
  • In case of Overdose
  • Missed Dose
  • How To Use
  • When Not to Use
  • Side Effects
  • Precautions & Warnings
  • Drug Interactions
  • Food Interactions
  • Storage/Disposal
  • Control Drug
  • Quick Tips, if any
  • Description

    Ondansetron Hydrochloride 4mg/2ml injection works by selectively blocking serotonin 5-HT3 receptors in the chemoreceptor trigger zone and gastrointestinal tract. This mechanism suppresses serotonin-mediated afferent neural input to the brainstem, preventing the initiation of the vomiting reflex. By antagonizing these receptors, ondansetron effectively inhibits nausea and vomiting associated with chemotherapy, radiation therapy, and postoperative surgical procedures.

  • Ingredients

    Ondansetron Hydrochlorid
  • Drug Class

    Ondansetron is a 5-HT3 receptor antagonist.

  • Dosage Form

    Injection

  • Uses

    The following are the uses of Ondansetron Hydrochlorid 4mg/2ml injection:

    • Used for preventing and treating nausea and vomiting caused by chemotherapy or radiotherapy.
    • Used for managing post-operative nausea and vomiting.
    • Used to relieve severe nausea and vomiting in various conditions, including gastroenteritis.
    • Used to prevent and treat motion sickness-induced nausea and vomiting.
    • Used in pregnant women experiencing severe morning sickness.
    • Used to manage nausea and vomiting associated with acute migraine attacks.
    • Used as a rescue medication to control breakthrough nausea and vomiting in chronic conditions.
  • Dosage

    To be used as per doctor's prescription

  • In case of Overdose

    In the case of an overdose of Ondansetron Hydrochloride 4mg/2ml injection, individuals may experience severe symptoms including dizziness, fainting, and difficulty breathing. It is important to recognize the signs of an overdose, which can vary from person to person. If an overdose is suspected, immediate medical intervention is necessary. Treatment may involve supportive care, monitoring vital signs, and administering appropriate medications to counteract the effects of the overdose. Prompt action can help mitigate the potentially harmful consequences of an overdose.

  • Missed Dose

    In the case of a missed dose of Ondansetron Hydrochloride 4mg/2ml injection, it is important to administer the medication as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. However, if you have missed multiple doses, it is best to contact your healthcare provider for guidance on how to proceed. They may advise you to take the missed dose immediately or adjust the timing of your next dose to ensure optimal effectiveness.

  • How To Use

    To administer Ondansetron Hydrochloride 4mg/2ml injection, draw the medication into a syringe, ensuring the correct dosage, and inject it into a muscle or vein as directed by your healthcare provider, following proper aseptic techniques and guidelines for safe injection practices.

  • When Not to Use

    Following are the conditions when Ondansetron Hydrochloride 4mg/2ml injection should not be used:

    • Must not be administered to individuals with a known hypersensitivity or allergy to Ondansetron or other similar medications.
    • Contraindicated in patients with a known personal or family history of Long QT Syndrome, as it may increase the risk of irregular heartbeats.
    • Should not be used in patients with severe liver impairment, as the medication is primarily metabolized in the liver.
    • Not recommended for individuals with a history of seizures or epilepsy, as it may lower the seizure threshold.
    • Avoid using in patients with a history of phenylketonuria, as some formulations may contain phenylalanine.
    • Contraindicated during breastfeeding, as it can pass into breast milk and may harm the nursing infant.
    • Should not be used in patients with a history of severe constipation or bowel obstruction, as it can slow bowel motility.
  • Side Effects

    The side effects of Ondansetron Hydrochloride 4mg/2ml injection may include:

    • Headache
    • Dizziness
    • Constipation or diarrhea
    • Fatigue or weakness
    • Skin rash or itching
    • Transient visual disturbances (e.g., blurred vision, double vision)
    • Injection site reactions (pain, redness, swelling)
    • Rare cases of allergic reactions (difficulty breathing, hives, swelling of the face or throat)
  • Precautions & Warnings

    Following are the precautions and warnings for Ondansetron Hydrochloride 4mg/2ml Injection:

    • Use with caution in patients with a history of QT interval prolongation, electrolyte imbalances (e.g., low potassium, magnesium), or those on medications that may prolong the QT interval.
    • Ondansetron can increase the risk of arrhythmias, including torsades de pointes.
    • Dose adjustment may be necessary for patients with severe liver impairment (Child-Pugh score > 9), as the drug is primarily metabolized by the liver.
    • Caution is required when administering ondansetron to patients with a history of bowel obstruction or other gastrointestinal issues, as it can worsen these conditions.
    • Use during pregnancy should be avoided unless absolutely necessary, particularly in the first trimester, as its safety has not been fully established.
    • It is not known whether ondansetron is excreted in breast milk, so use with caution while breastfeeding.
    • Co-administration with other serotonergic medications (e.g., SSRIs, SNRIs, MAOIs) may increase the risk of serotonin syndrome. Symptoms include agitation, hallucinations, fever, and muscle rigidity.
    • Discontinue the injection immediately and seek emergency medical care if signs of hypersensitivity (e.g., rash, itching, difficulty breathing, swelling of the face/lips/throat) occur.
    • Ondansetron may cause drowsiness or dizziness. Patients should avoid activities that require alertness, such as driving or operating machinery, until they know how the drug affects them.
    • Correct any existing electrolyte imbalances before administration, as they may increase the risk of cardiac arrhythmias when combined with ondansetron.
    • Exercise caution when prescribing ondansetron to elderly patients, as they may be more susceptible to side effects, including cardiac and gastrointestinal complications.
    • In case of overdose, symptoms may include severe constipation, dizziness, and fainting. Immediate medical attention is required.
  • Drug Interactions

    Following are the drug interactions for Ondansetron Hydrochloride 4mg/2ml Injection:

    • Use with drugs that prolong the QT interval (e.g., antiarrhythmics, antipsychotics) may increase the risk of QT prolongation and serious cardiac arrhythmias.
    • Concurrent use with apomorphine (used in Parkinson's disease) is contraindicated due to the risk of severe hypotension and loss of consciousness.
    • Ondansetron may increase the effects of other serotoninergic drugs (e.g., SSRIs, SNRIs, tricyclic antidepressants), raising the risk of serotonin syndrome, a potentially life-threatening condition.
    • Combination with other antiemetics, such as metoclopramide, may result in increased sedation and central nervous system (CNS) depression.
    • Co-administration with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may increase the plasma concentration of Ondansetron, potentially leading to increased side effects.
    • Ondansetron may decrease the effectiveness of certain anticonvulsant medications, such as carbamazepine and phenytoin, which could reduce seizure control.
    • When used with tramadol, the risk of serotonin syndrome may be increased, so caution is recommended.
    • Concurrent use with corticosteroids (e.g., dexamethasone) may be required in chemotherapy-induced nausea and vomiting regimens but should be done cautiously with careful monitoring.
    • The use of Ondansetron with benzodiazepines may increase the sedative effects of both drugs, so caution is advised, especially in older patients.
    • Ondansetron may interact with certain cytochrome P450 enzymes, particularly CYP2D6, which could affect the metabolism of other drugs processed by this pathway.
  • Food Interactions

    Following are the food interactions for Ondansetron Hydrochloride 4mg/2ml injection:

    • Ondansetron may cause a slight decrease in appetite, so eating smaller, more frequent meals can help maintain adequate nutrition.
    • It is generally recommended to avoid grapefruit and grapefruit juice as they can affect the metabolism of Ondansetron, leading to increased drug levels in the body.
    • Alcohol consumption should be minimized or avoided as it can increase the risk of certain side effects and may also decrease the effectiveness of Ondansetron.
    • Avoid caffeine-rich foods and beverages as they can potentially interact with Ondansetron, leading to increased side effects such as nervousness, anxiety, and sleep disturbances.
    • There is no specific dietary restriction with Ondansetron, but maintaining a well-balanced diet is advisable to support overall health during treatment.
    • Ensure adequate hydration by drinking plenty of fluids, especially water, to compensate for potential fluid loss due to vomiting or diarrhea.
    • If experiencing nausea and vomiting, consider a clear liquid diet, including broths, clear juices, and gelatin, until symptoms subside, then gradually reintroduce solid foods.
  • Storage/Disposal

    Ondansetron Hydrochloride 4mg/2ml injection should be stored in a controlled environment, preferably in a cool and dry place at room temperature, ensuring protection from light and moisture. The original packaging should be tightly sealed to maintain its integrity and prevent contamination. It is crucial not to expose the injection to extreme temperatures, so avoid storage near heat sources or in direct sunlight. Always check the expiry date, and dispose of any unused or expired medication responsibly. Do not dispose of it in wastewater or household waste; instead, follow local guidelines or consult a healthcare professional for appropriate disposal methods. Keep the injection out of the reach of children to prevent accidental exposure.

  • Control Drug

    No

  • Quick Tips, if any

    Following are the quick tips for Ondansetron Hydrochloride 4mg/2ml injection:

    • Administer the injection as directed by your physician or healthcare professional.
    • Ensure the injection is prepared and stored as per the instructions provided.
    • Verify the dosage and expiration date before use.
    • Inject the medication slowly and aseptically to minimize discomfort.
    • Dispose of used needles and syringes safely in designated sharps containers.
    • Inform your doctor if you experience any unusual symptoms after the injection.
    • Store the medication at room temperature, away from direct sunlight and moisture.

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