Posaconazole Gastro-Resistant Tablets 100mg Technical Specification:

Product Name:Posaconazole Gastro-Resistant Tablets
Brand Name:Noxitaj
Strength:100mg
Dosage Form:Tablets (Gastro-resistant)
Route of Administration:Via Oral Route
Packing:10s, 100s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-fungal
Indication: Posaconazole is used to prevent certain fungal infections in patients who have severely weakened immune systems (such as patients who have had chemotherapy).
It belongs to a class of drugs known as antifungals. It works by stopping the growth of fungi. It is approved for the prophylaxis of invasive fungal infections in patients with neutropenia or in haematopoietic stem cell transplant recipients undergoing high- dose immunosuppressive therapy for graft-versus-host disease, and for the treatment of fungal infections.
Storage:Store at a temperature not exceeding 25°C. Protect from light & moisture. Keep in cool, dry & dark place.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Posaconazole Gastro-Resistant Tablets 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Posaconazole Gastro-Resistant Tablets 100mg
    Each Gastro Resistant tablet contains:

    Posaconazole ………………100mg
    Excipients…………………………. q.s.
    Colours: Titanium Dioxide USP

 THERAPEUTIC INDICATIONS:

Posaconazole is used to prevent certain fungal infections in patients who have severely weakened immune systems (such as patients who have had chemotherapy).

It belongs to a class of drugs known as antifungals. It works by stopping the growth of fungi.

It is approved for the prophylaxis of invasive fungal infections in patients with neutropenia or in hematopoietic stem cell transplant recipients undergoing high- dose immunosuppressive therapy for graft-versus-host disease, and for the treatment of fungal infections.

CAUTION & WARNING:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH

Read enclosed leaflet before use.

Preserve in tight container.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

WARNING: The most common side effects of Posaconazole injection include: anaemia, abdominal pain, diarrhoea.

Posaconazole use to treat (or prevent) serious fungal infections. Posaconazole (Noxitaj) is a broad-spectrum triazole antifungal.

Keep medicine out of reach of children.

STORAGE & DOSAGE:

Storage:  Store at a temperature not exceeding 25°C. Protect from light & moisture. Keep in cool, dry & dark place.

Dosage: As directed by the physician.

Attach dispensing label as per end country.

Why Taj Pharmaceuticals?

Taj Pharma is the trusted name for Posaconazole Gastro-Resistant Tablets, offering a comprehensive solution for antifungal treatment. Our commitment to your health is unwavering, backed by a legacy of excellence in pharmaceuticals. Taj Pharma’s Posaconazole Gastro-Resistant Tablets are a testament to cutting-edge research and quality assurance, ensuring you receive the most effective and reliable antifungal therapy available. With Taj Pharma, you’re not just choosing medication; you’re choosing a partner that prioritizes your well-being. Our dedication extends beyond delivering innovative pharmaceuticals; it encompasses our commitment to global health initiatives, ensuring that essential medications like Posaconazole are accessible to those who need them most. Trust Taj Pharma to provide the precision and efficacy you deserve in antifungal treatment. Your health is our top priority, and we are dedicated to supporting your journey towards better health outcomes. When it comes to Posaconazole Gastro-Resistant Tablets, Taj Pharma stands as your beacon of trust and excellence.

Choose Taj Pharma for Posaconazole Gastro-Resistant Tablets and experience a trusted source for cutting-edge antifungal medication. With a commitment to quality and global health, Taj Pharma ensures your well-being is prioritized. Trust in Taj Pharma for effective and reliable antifungal treatment.

What is Posaconazole Gastro-Resistant Tablets and its use?

Posaconazole Gastro-Resistant Tablets are a prescription medication used to treat a variety of fungal infections. Posaconazole belongs to a class of antifungal drugs known as triazoles, which are effective against a wide range of fungal pathogens. Here’s more information about Posaconazole and its common uses:

Use of Posaconazole Gastro-Resistant Tablets:

  • Treatment of Invasive Fungal Infections: Posaconazole is used to treat invasive fungal infections caused by various fungi, including Aspergillus, Candida, and Zygomycetes. These infections can be serious and occur in individuals with weakened immune systems, such as those undergoing chemotherapy, organ transplantation, or with advanced HIV/AIDS.
  • Prophylaxis Against Fungal Infections: Posaconazole is also used for prophylactic (preventive) treatment to reduce the risk of invasive fungal infections in individuals with a high risk of developing these infections due to medical conditions or treatments that weaken the immune system.
  • Oral Solution vs. Gastro-Resistant Tablets: Posaconazole is available in both oral solution and gastro-resistant tablet forms. The gastro-resistant tablets are designed to be taken with food, which can enhance the absorption of the medication in the gastrointestinal tract.

It’s important to note that the choice between Posaconazole oral solution and gastro-resistant tablets may depend on the specific patient’s condition and treatment plan, as well as the healthcare provider’s recommendations.

Posaconazole works by inhibiting the growth and replication of fungal cells, ultimately leading to the elimination of the fungal infection. The choice of Posaconazole as a treatment option is determined by the type of fungal infection, the patient’s overall health, and other factors considered by the healthcare provider.

How does Posaconazole Gastro-Resistant Tablets work?

Posaconazole Gastro-Resistant Tablets work as antifungal agents to combat various fungal infections. The mechanism of action of Posaconazole involves disrupting the integrity of fungal cell membranes and interfering with fungal cell replication. Here’s a more detailed explanation of how Posaconazole works:

  • Inhibition of Ergosterol Synthesis: Fungi, including common pathogens like Candida and Aspergillus, have cell membranes that contain a specific type of sterol called ergosterol. Ergosterol is essential for maintaining the integrity and fluidity of fungal cell membranes, similar to how cholesterol functions in human cell membranes. Posaconazole inhibits an enzyme called lanosterol 14-alpha-demethylase, which is critical for the synthesis of ergosterol in fungal cells.
  • Disruption of Fungal Cell Membranes: By inhibiting ergosterol synthesis, Posaconazole disrupts the normal composition and structure of fungal cell membranes. This disruption weakens the integrity of the membranes, making them more permeable and less functional.
  • Altered Ion Transport: The compromised fungal cell membranes result in altered ion transport and nutrient uptake by the fungal cells. This disruption of normal cellular processes weakens the fungal cells and interferes with their ability to thrive and multiply.
  • Fungal Growth Inhibition: Posaconazole’s actions collectively lead to the inhibition of fungal growth and replication. Without functional cell membranes and disrupted cellular processes, the fungi cannot maintain their viability, and their numbers decline.
  • Fungal Cell Death: Ultimately, Posaconazole’s interference with ergosterol synthesis and fungal cell membrane function leads to fungal cell death. This process is fundamental in eliminating the fungal infection.

It circulates throughout the body to target fungal infections wherever they may be present. The choice of Posaconazole as a treatment option depends on the specific type of fungal infection, the patient’s overall health, and the healthcare provider’s assessment.

Benefits and Side effects of Posaconazole Gastro-Resistant Tablets:

Posaconazole Gastro-Resistant Tablets offer benefits in the treatment and prevention of serious fungal infections, particularly in individuals with compromised immune systems. However, like all medications, they can have potential side effects. Here’s an overview of the benefits and common side effects associated with Posaconazole:

Benefits:

  • Treatment of Invasive Fungal Infections: Posaconazole is effective in treating various invasive fungal infections, including those caused by Candida, Aspergillus, and Zygomycetes. These infections can be life-threatening, especially in individuals with weakened immune systems due to conditions like cancer or organ transplantation.
  • Prophylaxis Against Fungal Infections: Posaconazole is used as prophylactic (preventive) treatment to reduce the risk of invasive fungal infections in high-risk individuals, such as those undergoing chemotherapy, stem cell transplantation, or with advanced HIV/AIDS.
  • Oral Formulation: Posaconazole Gastro-Resistant Tablets are designed for oral administration, which can be more convenient and less invasive than other forms of antifungal treatment, such as intravenous therapy.
  • Effective Alternative: Posaconazole may be used as an alternative or in combination with other antifungal medications when the primary treatment is ineffective or contraindicated.

Side Effects:

  • Nausea and Vomiting: Nausea and vomiting are common side effects of Posaconazole. Taking the medication with food can help alleviate these symptoms.
  • Diarrhea: Some individuals may experience diarrhea while taking Posaconazole.
  • Headache: Headache is a relatively common side effect of the medication.
  • Rash: Skin rashes or itching may occur in some users.
  • Elevated Liver Enzymes: Posaconazole can lead to elevated levels of liver enzymes in the blood, which may require monitoring.
  • Electrolyte Imbalance: Posaconazole can affect electrolyte levels in the body, potentially leading to disturbances like low potassium (hypokalemia) or low magnesium (hypomagnesemia). Regular monitoring is important.
  • Gastrointestinal Discomfort: Some individuals may experience abdominal pain or discomfort while taking Posaconazole.
  • Fatigue: Fatigue or weakness may occur in some users.

Patients prescribed Posaconazole should follow their healthcare provider’s instructions, report any unusual or severe side effects, and attend regular check-ups to ensure the medication’s safety and effectiveness.

Frequently asked questions (FAQs) about Posaconazole Gastro-Resistant Tablets:

  1. What is Posaconazole Gastro-Resistant Tablets used for?

Posaconazole Gastro-Resistant Tablets are primarily used to treat invasive fungal infections and to prevent fungal infections in individuals at high risk, particularly those with compromised immune systems.

  1. How do I take Posaconazole Gastro-Resistant Tablets?

Posaconazole is typically taken as directed by your healthcare provider. It is usually administered with food to enhance absorption. Follow the prescribed dosage and instructions carefully.

  1. What types of fungal infections can Posaconazole treat?

Posaconazole is effective against a wide range of fungal infections, including those caused by Candida, Aspergillus, and Zygomycetes. It is often used when other anti-fungal medications are not suitable or have been ineffective.

  1. Can Posaconazole Gastro-Resistant Tablets be used for prophylaxis?

Yes, Posaconazole can be prescribed as prophylactic treatment to prevent fungal infections in individuals with a high risk of developing such infections. This is common in individuals undergoing certain medical treatments or procedures.

  1. What should I do if I miss a dose of Posaconazole?

If you miss a dose, take it as soon as you remember. However, if it’s close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double up on doses.

  1. What are the common side effects of Posaconazole?

Common side effects may include nausea, vomiting, diarrhea, headache, rash, and elevated liver enzymes. These side effects are usually mild and can often be managed with guidance from your healthcare provider.

  1. Can I drink alcohol while taking Posaconazole?

It’s generally advisable to avoid alcohol while taking Posaconazole, as alcohol may interact with the medication and increase the risk of side effects.

  1. Is Posaconazole safe during pregnancy or breastfeeding?

Posaconazole should be used during pregnancy or breastfeeding only if the potential benefits outweigh the risks. Consult with your healthcare provider for personalized guidance.

  1. Can I take other medications along with Posaconazole Gastro-Resistant Tablets?

Some medications may interact with Posaconazole, potentially affecting its effectiveness or increasing the risk of side effects. It’s essential to inform your healthcare provider about all medications, supplements, and herbal products you are taking.

  1. How long should I take Posaconazole?

The duration of Posaconazole treatment will depend on the specific fungal infection being treated and the patient’s response to therapy. Your healthcare provider will provide guidance on the length of treatment.

As Posaconazole Gastro-Resistant Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Posaconazole Gastro-Resistant Tablets 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

Posaconazole Gastro-Resistant Tablets 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 Posaconazole Gastro-Resistant Tablets, 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

GENERIC NAME OF THE MEDICINAL PRODUCT:

Posaconazole Gastro-Resistant Tablets 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Posaconazole Gastro-Resistant Tablets 100mg
Each Gastro Resistant tablet contains:
Posaconazole ………………100mg
Excipients…………………………. q.s.
Colours: Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

Posaconazole is used to prevent certain fungal infections in patients who have severely weakened immune systems (such as patients who have had chemotherapy).
It belongs to a class of drugs known as antifungals. It works by stopping the growth of fungi.
It is approved for the prophylaxis of invasive fungal infections in patients with neutropenia or in hematopoietic stem cell transplant recipients undergoing high- dose immunosuppressive therapy for graft-versus-host disease, and for the treatment of fungal infections.

CAUTION & WARNING:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
Read enclosed leaflet before use.
Preserve in tight container.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
WARNING: The most common side effects of Posaconazole injection include: anaemia, abdominal pain, diarrhoea.
Posaconazole use to treat (or prevent) serious fungal infections. Posaconazole (Noxitaj) is a broad-spectrum triazole antifungal.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE & DOSAGE:

Storage: Store at a temperature not exceeding 25°C.
Protect from light & moisture.
Keep in cool, dry & dark place.
Dosage: As directed by the physician.
Attach dispensing label as per end country.