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Fluconazole injection 100ml is an intravenous antifungal formulation categorized into triazole derivatives, and its active pharmaceutical ingredient fluconazole owns CAS No.86386-73-0 together with molecular formula C₁₃H₁₂F₂N₆O. The bulk drug exists as white crystalline powder featuring outstanding water solubility and stable chemical property under sealed, dry and room-temperature storage, avoiding structural decomposition from mild ambient fluctuation.
Additional information of chemical compound:
Our product form
Fluconazole COA
Blood flow candidemia (candidal sepsis)
The patient presents with persistent high fever, chills, abnormal white blood cells, positive blood culture for Candida, and some are accompanied by hypotension and shortness of breath; Standard initial shock protocol: intravenous infusion of 400mg (1 bottle 100ml: 400mg) on the first day, followed by daily maintenance of 200-400mg (1 bottle 100ml: 200mg), and consolidation for 14 days after the blood culture turns negative.
Non neutropenia patients: Fluconazole infusion has a cure rate of 78% -85%, which is better than amphotericin B deoxycholate (infusion has high nephrotoxicity);
Critical patients with neutropenia: Fluconazole alone has weak efficacy, often combined with 100ml intravenous infusion of echinocandins (caspofungin) for synergistic coverage;
Infection of indwelling central venous catheter: In addition to systemic infusion of fluconazole 100ml, simultaneous assessment of whether to remove the contaminated catheter is necessary. Failure to remove the catheter increases the risk of recurrence by 40%.
Abdominal candidiasis (peritonitis, abdominal abscess, biliary candidiasis)
Patients with gastrointestinal perforation, appendiceal perforation, liver and gallbladder surgery, and peritoneal dialysis are highly susceptible to Candida mixed anaerobic bacterial infections; Treatment plan: intravenous infusion of 400mg (100ml: 400mg) daily, combined with abscess and puncture drainage; Fluconazole has a strong ability to penetrate the wall of abscesses and maintain a stable antibacterial concentration in the pus; Compared with itraconazole injection, there is no risk of ethanol stimulation to the peritoneum, and postoperative gastrointestinal tolerance is better. Biliary candidiasis cholangitis: 100ml fluconazole infusion once a day, with sufficient concentration of bile drugs, can kill colonized Candida in the biliary tract, alleviate jaundice and biliary inflammation.
Urinary tract deep Candida infection (source of pyelonephritis, renal abscess, fungal sepsis)
High incidence of indwelling catheter, diabetes, and long-term antibiotic users; Simple cystitis can be treated with oral preparations, and if it spreads to deep renal infections, intravenous infusion of 100ml fluconazole is necessary: 200-400mg intravenously per day, with a treatment course of 14-21 days; Fluconazole is excreted through the kidneys, with drug concentrations in kidney tissue and urine far exceeding the MIC, making it the optimal intravenous triazole drug for renal candidiasis; Renal cortical abscess requires an extension of treatment to 4 weeks and regular follow-up renal CT to evaluate abscess absorption.
Candidiasis of the liver and spleen (characteristic infection of neutropenia in tumor chemotherapy)
Multiple microfungal abscesses in the liver and spleen of leukemia and hematopoietic stem cell transplant patients after chemotherapy; The first day of impact dose is 400mg (100ml: 400mg), followed by 200mg daily for long-term maintenance, with a total treatment course of several months; Stable and continuous administration of 100ml large volume infusion, avoiding frequent puncture infusion of small doses, and improving the compliance of tumor patients; Mild liver injury patients do not require significant reduction and are safer than voriconazole.
Indications for treatment: including oral and pharyngeal candidiasis, esophageal candidiasis, cryptococcal meningitis, invasive candidemia, and disseminated candidiasis, especially suitable for severe infections in immunosuppressed patients (such as HIV infected individuals and bone marrow transplant recipients).Preventive medication: Used to prevent fungal infections in high-risk populations such as cancer patients and organ transplant recipients receiving chemotherapy or radiation therapy.This preparation has significant advantages: intravenous administration can bypass gastrointestinal absorption, ensuring a bioavailability of nearly 100%.Low plasma protein binding rate (11% -12%), strong tissue penetration.
Cerebrospinal fluid concentration can reach up to 80% of plasma, especially suitable for central nervous system infections.However, attention should be paid to its interaction with CYP3A4/2C9 substrates (such as warfarin and phenytoin), which may cause QT interval prolongation or bleeding risk, and should be closely monitored during medication.Fluconazole injection 100ml, as a representative of fluorotriazole antifungal drugs, has become an important choice for the cure of skin fungal diseases due to its broad-spectrum antibacterial activity, good tissue penetration, and convenient administration method. Its mechanism of action is to selectively inhibit the biosynthesis of ergosterol in fungal cell membranes, disrupt membrane integrity, and thus exert bactericidal or bacteriostatic effects.
Core indication: Covering superficial and deep skin fungal infections
Superficial skin fungal disease
It has a strong inhibitory effect on common pathogenic bacteria such as Trichophyton rubrum, Trichophyton beard, and Trichophyton flocs, as well as Malassezia and Candida genera. It is suitable for the following diseases:Tinea corporis and tinea crus: circular erythema and scaly skin lesions caused by dermatophytes. Flunazol can quickly penetrate the stratum corneum through oral or local administration, inhibiting fungal metabolism.Tinea pedis: For erosive or vesicular types of tinea pedis between the toes, the course of flunazol cure is usually 2-6 weeks, which can significantly reduce the recurrence rate.
Research has shown that the weekly 150mg oral regimen has a cure rate of 70% -85% for onychomycosis, especially for nail infections.Tinea capitis: In the cure of tinea capitis in children, flunazol is taken continuously at a daily dose of 50-100mg for 4-8 weeks, which can replace traditional gibberellin and reduce the risk of liver function damage.Tinea versicolor (Malassezia folliculitis): Flunazol inhibits the lipase activity of Malassezia, blocking its pathway of utilizing sebum for reproduction. A single oral dose of 150-300mg can achieve clinical cure.
Deep skin fungal diseases
For deep fungal infections in immunocompromised patients , flunazol can penetrate the blood-brain barrier and skin appendages, exerting a systemic therapeutic effect.
Chronic cutaneous candidiasis: Long term use of flunazol 50-100mg/day can maintain stable condition and reduce recurrence.Chromogenic blastomycosis: As a combination therapy drug.Flunazol combined with amphotericin B or itraconazole can enhance efficacy and shorten cure duration.Sporothrix disease: Although not the preferred medication, flunazol 200-400mg/day orally can control the progression of the disease in patients who are intolerant to potassium iodide.
Pathogen coverage
Flunazol is effective against dermatophytes such as Trichophyton rubrum and Trichophyton rubrum (the main pathogens of onychomycosis) and Candida genus.
But ineffective against some non dermatophytes such as Aspergillus genus. Research has shown that its clinical cure rate for nail fungal diseases is 76% -90%.
Comparison of therapeutic effects
Compared with terbinafine/itraconazole, flunazol has a lower cure rate than terbinafine (85% -95% for nails) and itraconazole (70% -80% for pulse therapy), but a lower incidence of adverse reactions (about 10% vs. terbinafine 15%, itraconazole 20%).Advantage scenario: Suitable for patients with mild to moderate onychomycosis, those who cannot tolerate other drugs, or those who require long-term maintenance cure (such as immunosuppressants).
Therapeutic advantages:
Flunazol has dual characteristics of high water solubility and lipid solubility, with an oral absorption rate of over 90%, and its bioavailability is not affected by food. Its protein binding rate is low (11% -12%), and it can be widely distributed in the skin, nails, cerebrospinal fluid, and prostate tissue. It maintains a stable blood drug concentration for a long time (half-life of 30 hours) and supports a weekly dosing regimen.
Onychomycosis: A meta-analysis involving 1200 patients showed that after 12 weeks of flunazol cure, the clinical cure rate reached 78%, fungal clearance rate was 82%, and the 1-year recurrence rate was only 15%.
Significantly lower than that of oxytetracycline (35%) and itraconazole pulse therapy (25%).Recurrent vaginal candidiasis: Flunazol 150mg once a week for 6 consecutive months of maintenance cure can reduce the one-year recurrence rate from 60% to 10%.
Improvement of patient complianceCompared to topical medications that require multiple daily doses or intravenous infusion of amphotericin B, oral flunazol formulations (tablets/capsules) and single pulse therapy significantly improve patient compliance. Research shows that patients who use a weekly flunazol dosing regimen have a cure completion rate of 92%, while the daily dosing regimen is only 65%.
Adverse Reaction Management: Safety Assessment and Monitoring Strategies
Although fluconazole injection 100ml has good overall safety, the following potential risks still need to be considered:
Liver toxicity monitoringRisk population: patients with long-term medication (>3 months), concomitant use of statins or anti tuberculosis drugs, and pre-existing liver disease.
Monitoring indicators: ALT, AST, ALP, and bilirubin should be tested before cure and monthly. If ALT increases to more than three times the upper limit of normal, medication should be suspended and liver protection cure should be given.
Anticoagulants: Flunazol can inhibit CYP2C9 enzyme, causing a 20% -50% increase in warfarin blood concentration. INR values need to be monitored and dosage adjusted.Immunosuppressants: When used in combination with cyclosporine, flunazol can increase the blood concentration of cyclosporine by 50% -100%, and the dose of cyclosporine needs to be reduced to 50% -70% of the original dose.
Antiepileptic drugs: Flunazol can inhibit the metabolism of phenytoin sodium, leading to neurotoxicity (such as ataxia and tremor). It is necessary to halve the dose of phenytoin sodium and monitor blood drug concentration.
References
Sun Y Q, Hu J, Huang H, et al. Clinical efficacy of intravenous Fluconazola for invasive candidiasis in hematopoietic stem cell transplant recipients[J]. Translational Cancer Research, 2020,9(11):6900-6911.(Foreign literature)
Li R Y, Xu Y C. Pharmacological characteristics and clinical application specification of Fluconazola sterile injection in treating deep mycosis in immunocompromised patients[J]. Chinese Journal of Mycology, 2019,14(3):158-163.(Chinese literature)
Dayo B, Silva C. Crystal structure and solubility optimization research of bulk Fluconazola raw material for injection preparation[J]. Crystal Growth & Design, 2019,19(2):1245-1253.(Foreign literature)
Fluconazole(https://www.ncbi.nlm.nih.gov/books/NBK537158/#:~:text=Fluconazole%20is%20a%20member%20of%20the%20triazole%20family%20and%20a,disseminated%20candidiasis%2C%20pneumonia%2C%20and%20cryptococcal)
Synergistic Antifungal Effects of Honokiol and Fluconazole Against Oral Candida: Implications for Managing Drug‐Resistant Infections(https://pmc.ncbi.nlm.nih.gov/articles/PMC12853974/)
FAQ
Fluconazola belongs to triazole antifungal substances. It restrains fungal cytochrome P450-dependent 14α-lanosterol demethylase to block ergosterol production. Shortage of ergosterol damages fungal membrane integrity, boosts membrane permeability and causes pathogenic fungi to rupture from osmotic imbalance.
The injection form of Fluconazola is designed for intravenous infusion. It is primarily used for patients who suffer from systemic fungal infections yet cannot swallow oral drugs due to vomiting, gastrointestinal damage or coma, as well as cases needing fast elevation of blood drug concentration to control severe invasive mycosis.
Raw Fluconazola powder needs airtight preservation under cool, dry and shaded surroundings. High humidity and excessive temperature will affect its chemical stability and purity, while the prepared sterile injection should avoid repeated freezing and thawing to guarantee stable clinical efficacy.
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