post-title portfolio-title Ondansetron Injection USP 8mg/4ml (2mg/ml) 2023-03-23 11:13:23 no no

GENERIC NAME OF MEDICINAL PRODUCT:

(A) Ondansetron Injection USP 4mg/2mL (2mg/ml)
(B) Ondansetron Injection USP 8mg/4mL (2mg/ml)
(C) Ondansetron Injection USP 40mg/20mL (2mg/ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

(A) Ondansetron Injection USP 4mg/2mL (2mg/ml)
Each ml contains:
Ondansetron Hydrochloride USP
Equivalent to Ondansetron ……….2mg
Sodium chloride USP…………………8.3mg
Citric Acid Monohydrate USP
Equivalent to Anhydrous Citric Acid ……….5.0mg
Trisodium Citrate Dihydrate USP (as buffer) …………………0.25mg
Methyl paraben NF (preservative)……………………………….1.2mg
Propyl paraben NF (preservative)………………………………..0.15mg
Water for injections USP……………………. q. s

(B) Ondansetron Injection USP 8mg/4mL (2mg/ml)
Each ml contains:
Ondansetron Hydrochloride USP
Equivalent to Ondansetron ……….2mg
Sodium chloride USP…………………8.3mg
Citric Acid Monohydrate USP
Equivalent to Anhydrous Citric Acid ……….5.0mg
Trisodium Citrate Dihydrate USP (as buffer) …………………0.25mg
Methyl paraben NF (preservative)……………………………….1.2mg
Propyl paraben NF (preservative)………………………………..0.15mg
Water for injections USP……………………. q. s


(C) Ondansetron Injection USP 40mg/20mL (2mg/ml)
Each ml contains:
Ondansetron Hydrochloride USP
Equivalent to Ondansetron ……….2mg
Sodium chloride USP…………………8.3mg
Citric Acid Monohydrate USP
Equivalent to Anhydrous Citric Acid ……….5.0mg
Trisodium Citrate Dihydrate USP (as buffer) …………………0.25mg
Methyl paraben NF (preservative)……………………………….1.2mg
Propyl paraben NF (preservative)………………………………..0.15mg
Water for injections USP……………………. q. s

THERAPEUTIC INDICATION:

Ondansetron injection is used to prevent nausea and vomiting caused by cancer medicines (chemotherapy or radiation), including high-dose cisplatin. This medicine is also used to prevent and treat nausea and vomiting that may happen after surgery.

CAUTION & WARNING:

CAUTION: If any foreign particle is visible, please do not use the solution & return for replacement.
KEEP OUT OF REACH OF CHILDREN.
Discard any unused portion.
WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° to 77°). See USP controlled room temperature.
Dosage: As directed by Physician.

Ondansetron Injection USP 8mg/4mL (2mg/ml) Technical Specification:

Product Name:Ondansetron Injection USP
Brand Name:(GENERICS)
Strength:(4mg/2mL), (8mg/4mL), (40mg/20mL)
Dosage Form:Liquid Injection (Sterile) *Non-pyrogenic
Packing:2ml, 4ml Ampoule, 2 mL, 20 mL vial
Route of Administration:For I.M./I.V. use
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Nausea and vomiting, Anti-emetic, Gastroenterology
Indication: Ondansetron injection is used to prevent nausea and vomiting caused by cancer medicines (chemotherapy or radiation), including high-dose cisplatin. This medicine is also used to prevent and treat nausea and vomiting that may happen after surgery.
Storage:Store at 20°C to 25°C (68° to 77°). See USP-controlled room temperature.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Ondansetron Injection USP 8mg/4mL (2mg/ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Ondansetron Injection USP 8mg/4mL (2mg/ml)
    Each ml contains:
    Ondansetron Hydrochloride USP
    Equivalent to Ondansetron ……….2mg
    Sodium chloride USP…………………8.3mg
    Citric Acid Monohydrate USP
    Equivalent to Anhydrous Citric Acid ……….5.0mg
    Trisodium Citrate Dihydrate USP (as buffer) …………………0.25mg
    Methylparaben NF (preservative)……………………………….1.2mg
    Propylparaben NF (preservative)………………………………..0.15mg
    Water for injections USP……………………. q. s 

THERAPEUTIC INDICATION:

Ondansetron injection is used to prevent nausea and vomiting caused by cancer medicines (chemotherapy or radiation), including high-dose cisplatin. This medicine is also used to prevent and treat nausea and vomiting that may happen after surgery.

CAUTION & WARNING:

CAUTION: If any foreign particle is visible, please do not use the solution & return for a replacement.

KEEP OUT OF REACH OF CHILDREN.

Discard any unused portion.

WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° to 77°). See USP-controlled room temperature. 

Dosage: As directed by the Physician.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals is a reputable choice for Ondansetron, and several reasons make them a preferred supplier for this medication:

  • Pharmaceutical Expertise: Taj Pharmaceuticals has a long-standing presence in the pharmaceutical industry, marked by a deep understanding of various medications, including Ondansetron. Their expertise ensures the quality and reliability of the product.
  • Quality Assurance: Taj Pharmaceuticals is known for its unwavering commitment to maintaining the highest standards of quality and safety in pharmaceutical products. Ondansetron from Taj Pharmaceuticals is manufactured with precision to ensure its efficacy and safety for patients.
  • Global Reach: Taj Pharmaceuticals operates as an exporter from India, making high-quality medications like Ondansetron accessible to healthcare providers and patients worldwide. This global presence contributes to improved patient care on an international scale.
  • Advanced Manufacturing Facilities: Taj Pharmaceuticals operates state-of-the-art pharmaceutical manufacturing facilities that adhere to stringent quality control measures. These facilities ensure the accurate and consistent production of medications, including Ondansetron.
  • Proven Track Record: Taj Pharmaceuticals has earned a reputation for reliability and trust among healthcare professionals, institutions, and patients. Their consistent delivery of dependable pharmaceuticals underscores their commitment to quality and safety in medical treatments.
  • Patient-Centric Approach: Taj Pharmaceuticals places the well-being of patients at the forefront of its mission. This commitment to providing reliable medications like Ondansetron demonstrates their genuine dedication to enhancing patient outcomes and well-being.
  • Variety of Formulations: Taj Pharmaceuticals typically offers a range of formulations for Ondansetron, catering to different patient needs and preferences, including oral tablets, injectables, and oral disintegrating tablets.

What is Ondansetron Injection and its uses:

Ondansetron Injection is a medication used primarily to prevent and treat nausea and vomiting, particularly in patients undergoing chemotherapy, radiation therapy, or surgery. Here’s an overview of Ondansetron Injection and its uses:

Medication Type: Ondansetron belongs to a class of drugs known as serotonin 5HT3 receptor antagonists. It works by blocking the action of serotonin, a neurotransmitter involved in nausea and vomiting.

Uses:

  • Chemotherapy-induced Nausea and Vomiting (CINV): Ondansetron is commonly used to prevent and alleviate nausea and vomiting associated with cancer chemotherapy. It is effective in both acute (occurring within 24 hours of chemotherapy) and delayed (occurring more than 24 hours after chemotherapy) phases of CINV.
  • Radiation-induced nausea and Vomiting (RINV): Ondansetron is also prescribed to manage nausea and vomiting caused by radiation therapy, particularly when radiation is directed at the abdomen or the whole body.
  • Postoperative Nausea and Vomiting (PONV): In surgical settings, Ondansetron can be administered to prevent postoperative nausea and vomiting, which can occur as a side effect of anesthesia or surgical procedures.
  • Nausea and Vomiting in Other Settings: Ondansetron may be used in other situations where nausea and vomiting are a concern, such as gastroenteritis (stomach flu) or motion sickness.
  1. Administration: Ondansetron Injection is typically administered as an intravenous (IV) infusion or as an intramuscular (IM) injection. The choice of administration method and dosage depends on the specific clinical situation and the patient’s needs.
  2. Mechanism of Action: Ondansetron works by blocking the action of serotonin at 5HT3 receptors in the chemoreceptor trigger zone (CTZ) of the brain and in the gastrointestinal tract. This prevents the initiation of the vomiting reflex and reduces the sensation of nausea.
  3. Duration of Action: The duration of action of Ondansetron varies depending on the formulation used. Some formulations provide relief for up to 24 hours, making them suitable for preventing delayed CINV.

How Does Ondansetron Injection Work?

Ondansetron Injection works by targeting the serotonin 5-HT3 receptors in the body, specifically in the brain’s chemoreceptor trigger zone (CTZ) and the gastrointestinal (GI) tract. Its mechanism of action helps prevent and alleviate nausea and vomiting. Here’s how Ondansetron works:

  • Serotonin and Nausea/Vomiting: Serotonin, a neurotransmitter, plays a significant role in regulating nausea and vomiting. When the body detects potential emetic (vomiting-inducing) signals, such as those triggered by chemotherapy, radiation therapy, or certain medications, serotonin is released in response.
  • 5-HT3 Receptors: In the CTZ of the brain and the GI tract, there are specialized serotonin receptors known as 5-HT3 receptors. Activation of these receptors can stimulate the vomiting reflex and lead to feelings of nausea.
  • Ondansetron’s Mechanism: Ondansetron is a serotonin 5-HT3 receptor antagonist. This means it blocks or inhibits the action of serotonin on the 5-HT3 receptors.
  • Blocking Serotonin Effects: By binding to and blocking the 5-HT3 receptors, Ondansetron interferes with the transmission of emetic signals. This effectively prevents the initiation of the vomiting reflex in response to nausea-inducing stimuli.
  • Reduction of Nausea and Vomiting: With the action of serotonin blocked, the sensation of nausea is reduced, and the likelihood of vomiting is significantly diminished. This provides relief to patients who may otherwise experience severe nausea and vomiting due to chemotherapy, radiation therapy, surgery, or other triggers.
  • Prevention and Treatment: Ondansetron can be used both preventatively and as a treatment for nausea and vomiting. When used before exposure to emetic stimuli, it helps prevent these symptoms. When administered after the onset of nausea and vomiting, it can provide rapid relief.
  • Duration of Action: The duration of action of Ondansetron can vary depending on the formulation used. Some formulations provide relief for several hours, making them suitable for preventing and managing acute and delayed nausea and vomiting.

Benefits of Ondansetron Injection:

  • Effective Nausea and Vomiting Relief: Ondansetron Injection is highly effective at preventing and alleviating nausea and vomiting, particularly in patients undergoing chemotherapy, radiation therapy, or surgery. This provides significant relief to individuals who would otherwise experience severe discomfort.
  • Improved Quality of Life: Nausea and vomiting can have a profound impact on a patient’s quality of life, leading to physical discomfort, emotional distress, and decreased appetite. Ondansetron helps patients maintain a better quality of life by reducing these distressing symptoms.
  • Enhanced Compliance with Treatment: In the context of chemotherapy and radiation therapy, Ondansetron can improve treatment adherence. Patients are more likely to continue with their prescribed treatments when they have confidence that their nausea and vomiting will be effectively managed.
  • Versatility in Settings: Ondansetron is not limited to cancer-related treatments. It can be used in various medical settings where nausea and vomiting are concerns, including surgical procedures and cases of gastroenteritis or motion sickness.

Common Side Effects of Ondansetron Injection:

  • Headache: Some patients may experience mild to moderate headaches as a side effect of Ondansetron.
  • Fatigue: Fatigue or drowsiness is a possible side effect, although it tends to be less common.
  • Constipation: Ondansetron can lead to constipation in some individuals.
  • Dizziness: Dizziness may occur in some patients, particularly when standing up quickly.
  • Diarrhea: While less common, diarrhea can be a side effect of Ondansetron.
  • Allergic Reactions: Although rare, allergic reactions to Ondansetron can occur. Signs of an allergic reaction may include rash, itching, swelling, severe dizziness, or difficulty breathing. These require immediate medical attention.

Frequently Asked Questions About Ondansetron Injection:

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

  1. What is Ondansetron Injection used for?

Ondansetron Injection is primarily used to prevent and treat nausea and vomiting, particularly in patients undergoing chemotherapy, radiation therapy, or surgical procedures.

  1. How is Ondansetron Injection administered?

Ondansetron Injection is typically administered as an intravenous (IV) infusion or as an intramuscular (IM) injection, often in a healthcare setting.

  1. Is Ondansetron Injection effective in preventing motion sickness?

Yes, Ondansetron can be effective in preventing and treating nausea and vomiting associated with motion sickness.

  1. Can Ondansetron be used during pregnancy to manage morning sickness?

Ondansetron is sometimes prescribed for severe morning sickness (hyperemesis gravidarum) when other treatments have not been effective. However, its use during pregnancy should be carefully considered by healthcare providers, weighing the potential benefits against the potential risks.

  1. How quickly does Ondansetron Injection work?

Ondansetron can work relatively quickly, providing relief from nausea and vomiting within minutes to hours after administration, depending on the specific clinical situation and the patient’s response.

  1. Can Ondansetron Injection be used in pediatric patients?

Yes, Ondansetron is approved for use in pediatric patients and is often used to manage nausea and vomiting in children undergoing chemotherapy or surgery.

  1. Are there any potential drug interactions with Ondansetron?

Ondansetron may interact with certain medications. It’s essential to inform your healthcare provider about all medications and supplements you are taking to assess potential interactions.

  1. Does Ondansetron cause drowsiness or impair alertness?

While drowsiness is a possible side effect of Ondansetron, it tends to be less common. Patients should use caution when engaging in activities that require alertness, such as driving until they know how the medication affects them.

  1. What should I do if I experience an allergic reaction to Ondansetron?

Allergic reactions to Ondansetron are rare but possible. If you experience symptoms such as rash, itching, swelling, severe dizziness, or difficulty breathing, seek immediate medical attention.

As Ondansetron Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Ondansetron Injection product to 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 Injection 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 Injection, 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

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