GENERIC NAME OF MEDICINAL PRODUCT:

A. Ondansetron Oral Solution USP 2mg/5ml
B. Ondansetron Oral Solution USP 4mg/5ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Ondansetron Oral Solution USP 2mg/5ml
Composition:
Each 5ml contains:
Ondansetron HCl dihydrate………2.5mg
Eq. to Ondansetron ………………...2mg
Excipients……………………...q.s.
Flavored Syrup Base


B. Ondansetron Oral Solution USP 4mg/5ml
Composition:
Each 5ml contains:
Ondansetron HCl dihydrate………5mg
Eq. to Ondansetron ………………...4mg
Excipients……………………...q.s.
Flavored Syrup Base

THERAPEUTIC INDICATION:

Ondansetron is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery.

DIRECTION OF USE:

Shake well before using. Use a medicine spoon or syringe to measure your medicine. Do not use household spoons as they may not be accurate. Do not take with carbonated drinks as it may cause throat and gastric irritation.

CAUTION & WARNING:

CAUTION: For pediatric use only.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.

STORAGE AND DOSAGE:

STORAGE: Store in a dry place at a temperature below 30°C.
Protect from light.
Store bottles upright.
DOSAGE: As directed by physician.

Ondansetron Oral Solution USP 2mg/5ml Technical Specification:

Product Name:Ondansetron Oral Solution USP 2mg/5ml
Brand Name:Entrostaj
Strength:2mg/5ml, 4mg/5ml
Dosage Form:Syrup
Packing:30ml, 50ml
Route of Administration:For Oral Syrup.
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antiemetics
Indication: Ondansetron is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery.
Storage:Store in a dry place at a temperature below 30°C. Protect from light. Store bottles upright.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Ondansetron Oral Solution USP 2mg/5ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Ondansetron Oral Solution USP 2mg/5ml
    Composition:
    Each 5ml contains:
    Ondansetron HCl dihydrate………2.5mg
    Eq. to Ondansetron …………………2mg
    Excipients………………………q.s.
    Flavored Syrup Base

THERAPEUTIC INDICATION:

Ondansetron is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery.

DIRECTION OF USE:

Shake well before using. Use a medicine spoon or syringe to measure your medicine. Do not use household spoons as they may not be accurate. Do not take with carbonated drinks as it may cause throat and gastric irritation.

CAUTION & WARNING:

CAUTION: For pediatric use only.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.

STORAGE AND DOSAGE:

STORAGE: Store in a dry place at a temperature below 30°C.
Protect from light. Store bottles upright.
DOSAGE: As directed by physician.

Why Taj Pharmaceuticals?

Selecting Taj Pharmaceuticals for Ondansetron Oral Solution can be influenced by several compelling factors that make it a preferred choice for healthcare providers and patients:

  • Quality Assurance: Taj Pharmaceuticals is renowned for its steadfast commitment to maintaining stringent standards of quality in pharmaceutical production. Ensuring the quality and safety of medications is of paramount importance, especially for oral solutions like Ondansetron. Taj Pharmaceuticals’ dedication to quality assurance instills confidence among healthcare providers and patients, ensuring the efficacy and safety of the medication.
  • Pharmaceutical Expertise: With extensive experience in the pharmaceutical industry, Taj Pharmaceuticals has amassed valuable expertise in the manufacturing and distribution of a diverse range of pharmaceutical products. This expertise bolsters the reliability and consistency of their pharmaceutical offerings, establishing them as a trusted and dependable supplier.
  • Regulatory Compliance: Taj Pharmaceuticals adheres rigorously to regulatory standards and implements robust quality control procedures. This unwavering commitment to compliance ensures that Ondansetron Oral Solution meets the essential quality and safety requirements mandated by regulatory authorities. Healthcare providers can trust that the medication conforms to critical regulations, further enhancing patient safety.
  • Global Reach and Distribution: Taj Pharmaceuticals boasts a global presence and a well-established distribution network. This expansive reach guarantees the availability of Ondansetron Oral Solution and other pharmaceutical products to healthcare providers and patients in various regions. This international accessibility elevates patient care to a global level, ensuring that essential medications are easily obtainable when needed.
  • Research and Development (R&D): Investment in research and development is pivotal for ongoing pharmaceutical innovation and enhancement. Taj Pharmaceuticals’ commitment to R&D may lead to the development of more effective and advanced formulations of Ondansetron Oral Solution, potentially improving its therapeutic benefits.
  • Reliable Supply: A consistent and dependable supply of pharmaceuticals is indispensable to ensure that healthcare institutions and patients have uninterrupted access to vital medications. Taj Pharmaceuticals’ dedication to supply chain management contributes to the dependable availability of Ondansetron Oral Solution, ensuring that it remains accessible when required.
  • Affordability: Taj Pharmaceuticals may offer competitive pricing options, making Ondansetron Oral Solution more affordable and accessible to healthcare institutions and patients. Ensuring access to essential medications without imposing financial barriers is a key consideration in patient care.
  • Patient-Centric Approach: Taj Pharmaceuticals places a strong emphasis on patient well-being and safety. This aligns seamlessly with the importance of Ondansetron Oral Solution, which is used to prevent nausea and vomiting in various clinical situations, including during chemotherapy and post-surgery recovery. Taj Pharmaceuticals’ dedication to patient safety reinforces the trust placed in their products by healthcare providers and patients, ultimately contributing to improved patient care and outcomes.

In conclusion, Taj Pharmaceuticals’ unwavering commitment to quality, compliance, research, affordability, and patient support makes it a highly appealing choice for healthcare providers seeking a reliable supplier for Ondansetron Oral Solution and other pharmaceutical needs. Their focus on patient safety aligns perfectly with the significance of this medication in managing nausea and vomiting, ultimately benefiting patient care and outcomes on a global scale.

What is Ondansetron Oral Solution and its uses?

Ondansetron Oral Solution is a medication that contains the active ingredient ondansetron. It is primarily used to prevent and treat nausea and vomiting caused by various medical conditions and treatments. Here are its primary uses:

  • Nausea and Vomiting Due to Chemotherapy: Ondansetron Oral Solution is commonly prescribed to cancer patients undergoing chemotherapy. Chemotherapy often induces nausea and vomiting as a side effect, which can significantly affect a patient’s quality of life. Ondansetron helps prevent and manage these symptoms, allowing patients to tolerate their cancer treatment more comfortably.
  • Nausea and Vomiting After Surgery: Postoperative nausea and vomiting (PONV) can occur after various surgical procedures. Ondansetron is used to reduce the risk and severity of nausea and vomiting following surgery, helping patients recover more smoothly.
  • Radiation-Induced Nausea and Vomiting: Ondansetron may also be used to alleviate nausea and vomiting caused by radiation therapy, particularly when it affects the abdominal or pelvic area.
  • Gastroenteritis and Stomach Flu: In cases of gastroenteritis (commonly referred to as the stomach flu) or other gastrointestinal infections, Ondansetron Oral Solution can be prescribed to manage nausea and vomiting, especially in pediatric patients.
  • Hyperemesis Gravidarum: Some pregnant women experience severe nausea and vomiting during pregnancy, a condition known as hyperemesis gravidarum. Ondansetron may be prescribed when other treatments have proven ineffective.
  • Other Causes of Nausea and Vomiting: Ondansetron can be used in various other situations where nausea and vomiting are problematic, such as motion sickness and certain medical conditions that cause these symptoms.

It’s important to note that Ondansetron Oral Solution should only be used under the supervision and prescription of a healthcare provider. The dosage and duration of treatment will be determined based on the specific medical condition, patient response, and individual factors. This medication is generally well-tolerated, but it can interact with other drugs, so it’s essential to inform your healthcare provider about all medications and supplements you are taking. Always follow the guidance of a healthcare professional when using Ondansetron Oral Solution.

How does Ondansetron Oral Solution work?

Ondansetron Oral Solution works by targeting a specific area in the body that triggers nausea and vomiting. It belongs to a class of drugs known as serotonin (5-HT3) receptor antagonists. Here’s how Ondansetron Oral Solution works:

  • Serotonin Receptor Blockade: When the body detects a potential threat to the digestive system, such as toxins or the side effects of chemotherapy or radiation therapy, it releases a neurotransmitter called serotonin (5-HT) in the gut. Serotonin binds to specific receptors called 5-HT3 receptors located on nerve cells in the gut and in the brain’s vomiting center.
  • Nausea and Vomiting Trigger: Activation of the 5-HT3 receptors in the gut and brain stimulates nerve signals that lead to nausea and vomiting. This response is the body’s way of protecting itself from potentially harmful substances.
  • Ondansetron’s Mechanism: Ondansetron, the active ingredient in Ondansetron Oral Solution, works by blocking the 5-HT3 receptors in the gut and the brain. By binding to these receptors and preventing serotonin from activating them, ondansetron inhibits the transmission of signals that trigger nausea and vomiting.
  • Prevention of Nausea and Vomiting: By blocking the 5-HT3 receptors, ondansetron effectively prevents or reduces the sensations of nausea and the urge to vomit. This makes it an effective medication for managing nausea and vomiting induced by various triggers, including chemotherapy, radiation therapy, surgery, and certain medical conditions.
  • Duration of Action: Ondansetron Oral Solution is typically formulated as an oral liquid with a relatively rapid onset of action. This means that it can start working relatively quickly to alleviate nausea and vomiting.

It’s important to note that ondansetron primarily targets nausea and vomiting triggered by the activation of serotonin receptors. It may not be effective for all types of nausea and vomiting, such as those caused by inner ear problems (motion sickness), gastrointestinal blockages, or other unrelated factors. Ondansetron should only be used under the supervision and prescription of a healthcare provider to ensure it is appropriate for the specific situation and medical condition.

Benefits of Ondansetron Oral Solution:

  • Effective Nausea and Vomiting Control: Ondansetron Oral Solution is highly effective in preventing and managing nausea and vomiting associated with various triggers, including chemotherapy, radiation therapy, surgery, and gastrointestinal infections. It provides significant relief to patients, improving their overall comfort and well-being during these challenging situations.
  • Enhanced Quality of Life: For individuals undergoing chemotherapy or radiation therapy, nausea and vomiting can be distressing and debilitating. Ondansetron can significantly improve the quality of life by allowing patients to better tolerate their treatments, reducing treatment-related anxiety, and helping them maintain their nutritional status.
  • Reduced Risk of Dehydration: Severe vomiting can lead to dehydration, especially in cases of gastroenteritis or hyperemesis gravidarum during pregnancy. Ondansetron can help prevent excessive vomiting, reducing the risk of dehydration and its associated complications.
  • Improved Compliance with Treatment: By minimizing the side effects of treatment, Ondansetron Oral Solution can enhance patient compliance with chemotherapy, radiation therapy, or surgical procedures. This can lead to better treatment outcomes and increased chances of successful recovery.

Side Effects of Ondansetron Oral Solution:

  • Headache: Headache is a common side effect of ondansetron, but it is usually mild and transient.
  • Fatigue: Some individuals may experience fatigue or tiredness while taking ondansetron.
  • Constipation: Ondansetron can occasionally cause constipation, which can be managed with dietary adjustments, increased fluid intake, or over-the-counter remedies if necessary.
  • Diarrhea: In rare cases, diarrhea may occur as a side effect of ondansetron.
  • Dizziness: Dizziness or lightheadedness may occur, especially when rising from a sitting or lying position. It’s important to stand up slowly to minimize this risk.
  • Allergic Reactions: Although rare, some individuals may experience allergic reactions to ondansetron, such as rash, itching, swelling, severe dizziness, or difficulty breathing. Seek immediate medical attention if any of these symptoms occur.
  • QT Prolongation: Ondansetron has the potential to prolong the QT interval on the electrocardiogram (ECG), which may lead to abnormal heart rhythms in rare cases. It is essential to inform your healthcare provider of any pre-existing heart conditions or medications that could increase this risk.
  • Serotonin Syndrome: While uncommon, ondansetron may contribute to serotonin syndrome, particularly when used in combination with other medications that affect serotonin levels. Symptoms may include agitation, hallucinations, rapid heartbeat, fever, muscle stiffness, and coordination problems. Seek immediate medical attention if you experience these symptoms.

It’s important to use Ondansetron Oral Solution under the guidance and prescription of a healthcare provider. The benefits of nausea and vomiting control often outweigh the potential side effects, but it’s crucial to be aware of and report any unusual or severe side effects to your healthcare provider. Adjustments to the medication regimen or alternative treatments may be considered if necessary.

Frequently Asked Questions About Ondansetron Oral Solution:

Certainly, here are some frequently asked questions (FAQs) about Ondansetron Oral Solution:

  1. What is Ondansetron Oral Solution used for?

Ondansetron Oral Solution is primarily used to prevent and manage nausea and vomiting induced by various triggers, including chemotherapy, radiation therapy, surgery, gastrointestinal infections, and pregnancyrelated conditions like hyperemesis gravidarum.

  1. How does Ondansetron Oral Solution work?

Ondansetron Oral Solution belongs to the class of drugs known as serotonin (5HT3) receptor antagonists. It works by blocking the action of serotonin in the gut and brain, preventing the signals that trigger nausea and vomiting.

  1. How should I take Ondansetron Oral Solution?

Follow your healthcare provider’s instructions carefully. Ondansetron Oral Solution is usually taken orally, and the dosage and frequency depend on the specific situation and medical condition. It can be taken with or without food.

  1. Can Ondansetron Oral Solution be used to prevent motion sickness?

While Ondansetron is primarily indicated for certain types of nausea and vomiting, it may also be used offlabel to prevent motion sickness in some cases. However, other medications are typically more commonly prescribed for this purpose.

  1. What are the common side effects of Ondansetron Oral Solution?

Common side effects may include headache, fatigue, constipation, and, in rare cases, diarrhea. Some individuals may also experience dizziness or lightheadedness when standing up.

  1. Can Ondansetron Oral Solution be used during pregnancy?

Ondansetron may be prescribed during pregnancy when the benefits outweigh the risks, especially for conditions like hyperemesis gravidarum. However, its use during pregnancy should be carefully considered and supervised by a healthcare provider.

  1. Can I drink alcohol while taking Ondansetron Oral Solution?

It’s generally best to avoid alcohol while taking Ondansetron Oral Solution, as alcohol can exacerbate the risk of side effects such as dizziness and lightheadedness.

  1. Is Ondansetron Oral Solution habitforming or addictive?

No, Ondansetron is not known to be habitforming or addictive.

  1. Can Ondansetron Oral Solution interact with other medications?

Ondansetron may interact with certain medications, particularly those that affect serotonin levels. It’s important to inform your healthcare provider about all medications and supplements you are taking to avoid potential interactions.

  1. How quickly does Ondansetron Oral Solution work?

Ondansetron Oral Solution is typically formulated for relatively rapid onset of action. It can start working within a short time after ingestion, providing relief from nausea and vomiting.

These FAQs provide valuable information about Ondansetron Oral Solution, its uses, potential side effects, and considerations for its safe and effective use. Always consult with your healthcare provider for personalized guidance regarding this medication.

As Ondansetron Oral Solution Exporters; We can cater to export business queries from the following geographies. We are exporting our Ondansetron Oral Solution product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Ondansetron Oral Solution Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Ondansetron Oral Solution, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com 
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274