Fluconazole Intravenous Infusion USP 2mg/ml Technical Specification:

Product Name:Fluconazole Intravenous Infusion USP
Brand Name:FungiShield
Strength:(0.2%w/v or 200mg/100ml or 2mg/ml)
Dosage Form:I.V. Infusion Bottle (LVP)
Packing:100mL, 200mL IV Bottle
Route of Administration:For I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antifungals (triazoles)
Indication: Fluconazole injection is used to treat fungal infections, including yeast infections of the mouth, throat, esophagus (tube leading from the mouth to the stomach), abdomen (area between the chest and waist), lungs, blood, and other organs.
Storage:Store below 25°C. Protect from light. Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Fluconazole Intravenous Infusion USP (0.2%w/v or 200mg/100ml) (FungiShield)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Fluconazole Intravenous Infusion USP (0.2% W/V or 200mg/100ml)
    Composition:
    Each 100 ml contains:
    Fluconazole USP ……………………………0.2g
    Sodium chloride USP…………………………… 0.9%w/v
    Water for Injection USP…………………………. q.s.

THERAPEUTIC INDICATIONS:

Fluconazole injection is used to treat fungal infections, including yeast infections of the mouth, throat, esophagus (tube leading from the mouth to the stomach), abdomen (area between the chest and waist), lungs, blood, and other organs.

DIRECTION OF USE:

To be used with Non-pyrogenic I.V. administration set with aseptic technique.
No preservative added.
For ingredient, dosage & precaution refer to leaflet.

CAUTION & WARNING:

CAUTION: Even Invisible damage to bottles during transit, Storage, or handling may result in contamination. Do not use if contamination is found leaking on squeezing, content not clear or contains visible solid particles.
WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store below 25°C. Protect from light. Do not freeze.
STERILE, NON-PYROGENIC, SINGLE-DOSE CONTAINER.
Keep the medicine out of reach of children.
FOR HUMAN USE ONLY
Read the enclosed leaflet before use.
Dosage: As directed by the Physician.

Why Taj Pharmaceuticals?

Proven Efficacy and Commitment to Quality: Taj Pharmaceuticals Fluconazole Intravenous Infusion is a trusted solution for treating serious fungal infections. With a strong track record of proven efficacy, our commitment to rigorous research and development ensures healthcare providers have a reliable treatment option.
High-Quality Manufacturing and Skilled Team: Our state-of-the-art facilities and skilled professionals uphold stringent quality standards throughout the manufacturing process. Taj Pharmaceuticals employs cutting-edge technology to maintain the highest levels of quality and safety.
Patient-Centric Approach: Patient well-being is paramount to us. Taj Pharmaceuticals designs its Fluconazole Intravenous Infusion for easy administration and patient comfort. We strive to minimize discomfort and enhance the overall treatment experience.
Global Accessibility and Various Quantities: We’re committed to making healthcare accessible worldwide. Our Fluconazole Intravenous Infusion comes in various quantities, catering to healthcare facilities of all sizes. We believe that quality healthcare should be accessible to all.
Continuous Innovation: Taj Pharmaceuticals remains at the forefront of healthcare advancements. We continuously invest in research and development to improve existing products and explore new treatment options. Our aim is to provide customers with the latest in medical science.
Reliable Partner for Healthcare Professionals: With a global presence and a history of excellence, Taj Pharmaceuticals is a trusted partner for healthcare professionals and institutions. We offer reliable, effective, and safe solutions for fighting serious fungal infections.
Choose Taj Pharmaceuticals for Fluconazole Intravenous Infusion and experience the difference in quality, efficacy, and patient care. We’re dedicated to supporting the medical community in the battle against fungal infections.

What is Fluconazole Intravenous Infusion and its uses:

Fluconazole Intravenous Infusion is a powerful antifungal medication administered directly into the bloodstream through an IV line. It is primarily used to combat serious fungal infections that have spread throughout the body, often posing life-threatening risks. These infections can target critical organs like the lungs, heart, brain, and kidneys.

One of its key applications is in the treatment of invasive candidiasis, a severe condition caused by Candida species entering the bloodstream. Fluconazole proves highly effective in addressing this dangerous fungal infection. Additionally, it serves as a crucial treatment for cryptococcal meningitis, an infection affecting the membranes surrounding the brain and spinal cord. This is particularly significant for individuals with compromised immune systems, notably those battling HIV/AIDS.

Furthermore, Fluconazole Intravenous Infusion may be prescribed for high-risk patients as a preventive measure, a strategy known as prophylaxis. This approach is commonly adopted for individuals undergoing treatments like chemotherapy, organ transplantation, or those with underlying medical conditions that render them susceptible to fungal infections.

Beyond these critical applications, Fluconazole can also be employed in the treatment of various other fungal infections, encompassing those impacting the skin, nails, urinary tract, and oral cavity. However, the usage of Fluconazole Intravenous Infusion should always be guided by a healthcare professional, who will assess factors such as the specific type and severity of the infection, the patient’s overall health, and potential interactions or side effects. It is typically administered under careful supervision in a clinical setting due to its intravenous nature. Patients must diligently adhere to their healthcare provider’s instructions when using Fluconazole Intravenous Infusion.

How does Fluconazole Intravenous Infusion Work:

Fluconazole Intravenous Infusion operates by impeding the growth of fungal organisms through a targeted mechanism of action. Its primary focus lies in disrupting the fungal cell membrane and hindering the synthesis of ergosterol, a crucial component in the membrane’s structure. This is achieved by inhibiting the enzyme lanosterol 14-alpha-demethylase, which plays a pivotal role in ergosterol production. The consequence of this inhibition is a destabilized fungal cell membrane, rendering it less capable of regulating the flow of substances in and out of the cell. Ultimately, this membrane disruption weakens the fungal cell, making it susceptible to damage and eventual cell death.

One of Fluconazole’s notable attributes is its selective toxicity, which means it primarily targets fungal cells while having a reduced impact on human cells. This selectivity stems from the fact that human cells employ cholesterol rather than ergosterol in their cell membranes. As a result, Fluconazole demonstrates a greater affinity for the fungal enzyme lanosterol 14-alpha-demethylase, allowing it to exert its antifungal effects with minimal harm to human cells.

The outcome of Fluconazole treatment can vary. It may act as either fungistatic, inhibiting fungal growth without immediate cell death, or fungicidal, actively killing fungal cells, depending on factors like the type of fungus, the location of the infection, and the patient’s immune system.

It’s worth noting that while Fluconazole Intravenous Infusion proves highly effective against many fungal infections, resistance can occur in some fungal strains. In such instances, healthcare professionals may explore alternative antifungal medications. In practice, Fluconazole is a valuable tool in treating a wide spectrum of fungal infections, particularly those of a systemic or organ-involved nature. However, its usage should always be guided by healthcare experts to ensure correct dosing and monitoring, especially in cases of severe or complex fungal infections.

Benefits of Fluconazole Intravenous Infusion:

Fluconazole Intravenous Infusion offers numerous advantages in the treatment of fungal infections. First and foremost, it is an exceptionally effective antifungal medication, renowned for its ability to combat a wide spectrum of fungal infections, including those that can pose life-threatening risks. Its broad-spectrum activity encompasses various fungal species, making it a versatile choice for treating diverse infections. The intravenous form of Fluconazole provides a convenient means of delivering the medication directly into the bloodstream, ensuring rapid and precise absorption in critical cases. Importantly, Fluconazole demonstrates selective toxicity, primarily targeting fungal cells while sparing human cells, which reduces the potential for harm to the patient’s own tissues. With a long history of successful use, Fluconazole is a trusted and well-established treatment option for fungal infections.

Common Side Effects of Fluconazole Intravenous Infusion:

While Fluconazole offers significant benefits, it is not without potential side effects. The most frequently reported side effects include gastrointestinal disturbances such as nausea, vomiting, diarrhea, and abdominal discomfort, although these symptoms are generally mild and transient. Headaches may also occur in some cases. Skin rashes are another potential side effect, though typically not severe. Occasionally, Fluconazole may lead to elevated liver enzyme levels, necessitating regular monitoring of liver function during treatment. Rarely, individuals may experience allergic reactions, including hives, itching, facial or throat swelling, and breathing difficulties, requiring immediate medical attention. Interaction with other medications is possible, so patients should inform their healthcare provider of any other drugs they are taking. In very rare instances, serious side effects like severe skin reactions, heart rhythm changes, and liver toxicity may occur, necessitating immediate medical intervention.

Ultimately, the decision to use Fluconazole Intravenous Infusion is made by healthcare professionals who carefully assess the balance between its benefits and potential side effects. Patient safety is a priority, and individuals taking this medication should be vigilant in reporting any unusual or severe side effects to their healthcare provider for appropriate evaluation and management.

Frequently Asked Questions About Fluconazole Intravenous Infusion:

Certainly, here are some frequently asked questions (FAQs) about Fluconazole Intravenous Infusion:

  1. What is Fluconazole Intravenous Infusion used for?

Fluconazole Intravenous Infusion is primarily used to treat serious fungal infections, including systemic infections, invasive candidiasis, cryptococcal meningitis, and other fungal conditions.

  1. How does Fluconazole Intravenous Infusion work?

Fluconazole inhibits fungal growth by disrupting the cell membrane and interfering with the synthesis of ergosterol, a critical component in fungal cell membranes. This disruption weakens fungal cells and can lead to their death.

  1. Is Fluconazole Intravenous Infusion safe?

Fluconazole is generally considered safe when used as prescribed by a healthcare professional. However, like all medications, it can have side effects. Patients should follow their healthcare provider’s instructions and report any unusual or severe side effects.

  1. What are the common side effects of Fluconazole Intravenous Infusion?

Common side effects may include nausea, vomiting, diarrhea, abdominal pain, headache, and skin rashes. Most of these side effects are mild and resolve on their own.

  1. Are there any serious side effects associated with Fluconazole Intravenous Infusion?

While rare, serious side effects such as severe skin reactions, changes in heart rhythm, and liver toxicity have been reported. Patients should seek immediate medical attention if they experience any severe or unusual symptoms.

  1. Can Fluconazole Intravenous Infusion interact with other medications?

Yes, Fluconazole can interact with certain medications, including anticoagulants, antidiabetic drugs, and certain antibiotics. Patients should inform their healthcare provider of all medications they are taking to avoid potential interactions.

  1. How is Fluconazole Intravenous Infusion administered?

Fluconazole Intravenous Infusion is typically administered by a healthcare professional in a clinical setting. The dosage and duration of treatment depend on the type and severity of the fungal infection.

  1. Can Fluconazole Intravenous Infusion be used during pregnancy and breastfeeding?

The use of Fluconazole during pregnancy and breastfeeding should be carefully evaluated by a healthcare provider, as it may carry risks to the fetus or infant. The decision to use this medication in such cases should be made based on a thorough risk benefit assessment.

  1. Is Fluconazole available in other forms besides intravenous infusion?

Yes, Fluconazole is available in various forms, including oral tablets and liquid formulations. The choice of formulation depends on the specific fungal infection and the patient’s condition.

  1. How long should Fluconazole treatment continue?

The duration of Fluconazole treatment varies depending on the type and severity of the fungal infection. Healthcare providers will determine the appropriate treatment course and may adjust it based on the patient’s response to therapy.

Patients should consult their healthcare provider for personalized information and guidance on the use of Fluconazole Intravenous Infusion for their specific medical condition.

Fluconazole Intravenous Infusion Exporters; We can cater to export business queries from the following geographies. We are exporting our Fluconazole Intravenous Infusion product in 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

Fluconazole Intravenous Infusion 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 Fluconazole Intravenous Infusion, 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:

Fluconazole Intravenous Infusion USP (0.2%w/v or 200mg/100ml) (FungiShield)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Fluconazole Intravenous Infusion USP (0.2% W/V or 200mg/100ml)
Composition:
Each 100 ml contains:
Fluconazole USP ……………………………0.2g
Sodium chloride USP…………………………… 0.9%w/v
Water for Injection USP…………………………. q.s.

THERAPEUTIC INDICATIONS:

Fluconazole injection is used to treat fungal infections, including yeast infections of the mouth, throat, esophagus (tube leading from the mouth to the stomach), abdomen (area between the chest and waist), lungs, blood, and other organs.

DIRECTION OF USE:

To be used with Non-pyrogenic I.V. administration set with aseptic technique.
No preservative added.
For ingredient, dosage & precaution refer to leaflet.

CAUTION & WARNING:

CAUTION: Even Invisible damage to bottle during transit, Storage or handling may result in contamination. Do not use if contamination is found leaking on squeezing, content not clear or contains visible solid particle.
WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

STORAGE & DOSAGE:

Storage: Store below 25°C.
Protect from light.
Do not freeze.
STERILE, NON-PYROGENIC, SINGLE DOSE CONTAINER.
Keep medicine out of reach of children.
FOR HUMAN USE ONLY
Read enclosed leaflet before use.
Dosage: As directed by the Physician.