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Fluconazole (Fluconazole)

Trade Name : Fluconazole

Baxter Healthcare Corporation

INJECTION, SOLUTION

Strength 400 mg/200mL

FLUCONAZOLE Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]

Delivery Process

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Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Fluconazole (Fluconazole) which is also known as Fluconazole and Manufactured by Baxter Healthcare Corporation. It is available in strength of 400 mg/200mL per ml. Read more

Fluconazole (Fluconazole) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as a sterile solution for intravenous use in INTRAVIA plastic container.
  • Fluconazole is designated chemically as 2,4-difluoro-u03b1,u03b1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of CHFNO and molecular weight 306.3. The structural formula is:
  • Fluconazole is a white crystalline solid which is slightly soluble in water and saline.
  • Fluconazole in Sodium Chloride Injection, USP is an iso-osmotic, sterile, nonpyrogenic solution of fluconazole in a sodium chloride diluent. Each mL contains 2 mg of fluconazole and 9 mg of sodium chloride. The pH ranges from 4.0 to 6.5. Injection volumes of 100 mL and 200 mL are packaged in INTRAVIA plastic containers.
  • The flexible container is manufactured from a specially designed multilayer plastic (PL 2408). Solutions in contact with the plastic container leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. The flexible container has a foil overwrap. Water can permeate the plastic into the overwrap, but the amount is insufficient to significantly affect the premixed solution.
  • Fluconazole in Sodium Chloride Injection, USP meets USP Organic Impurities Procedure 3.
  • No data
  • Fluconazole in Sodium Chloride Injection, USP is indicated for the treatment of:
  • Prophylaxis - Fluconazole in Sodium Chloride Injection, USP is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.
  • Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
  • 3
  • Oropharyngeal candidiasis An open-label, comparative study of the efficacy and safety of fluconazole (2-3 mg/kg/day) and oral nystatin (400,000 I.U. 4 times daily) in immunocompromised children with oropharyngeal candidiasis was conducted. Clinical and mycological response rates were higher in the children treated with fluconazole.
  • Clinical cure at the end of treatment was reported for 86% of fluconazole treated patients compared to 46% of nystatin treated patients. Mycologically, 76% of fluconazole treated patients had the infecting organism eradicated compared to 11% for nystatin treated patients.
  • The proportion of patients with clinical relapse 2 weeks after the end of treatment was 14% for subjects receiving fluconazole and 16% for subjects receiving nystatin. At 4 weeks after the end of treatment, the percentages of patients with clinical relapse were 22% for fluconazole and 23% for nystatin.
  • Fluconazole in Sodium Chloride Injection, USP is contraindicated in patients who have shown hypersensitivity to fluconazole or to any of its excipients. There is no information regarding cross-hypersensitivity between fluconazole and other azole antifungal agents. Caution should be used in prescribing Fluconazole in Sodium Chloride Injection, USP to patients with hypersensitivity to other azoles. Coadministration of terfenadine is contraindicated in patients receiving Fluconazole in Sodium Chloride Injection, USP at multiple doses of 400 mg or higher based upon results of a multiple dose interaction study. Coadministration of other drugs known to prolong the QT interval and which are metabolized via the enzyme CYP3A4 such as cisapride, astemizole, erythromycin, pimozide, and quinidine are contraindicated in patients receiving fluconazole. (See and .)
  • No data
  • No data
  • Fluconazole in Sodium Chloride Injection, USP is generally well tolerated.
  • In some patients, particularly those with serious underlying diseases such as AIDS and cancer, changes in renal and hematological function test results and hepatic abnormalities have been observed during treatment with fluconazole and comparative agents, but the clinical significance and relationship to treatment is uncertain.
  • There have been reports of overdose with fluconazole accompanied by hallucination and paranoid behavior.
  • In the event of overdose, symptomatic treatment (with supportive measures and gastric lavage if clinically indicated) should be instituted.
  • Fluconazole is largely excreted in urine. A three-hour hemodialysis session decreases plasma levels by approximately 50%.
  • In mice and rats receiving very high doses of fluconazole, clinical effects in both species included decreased motility and respiration, ptosis, lacrimation, salivation, urinary incontinence, loss of righting reflex, and cyanosis; death was sometimes preceded by clonic convulsions.
  • No data
  • Do not remove unit from overwrap until ready for use. The overwrap is a moisture barrier. The inner bag maintains the sterility of the product.
  • CAUTION:
  • Fluconazole in Sodium Chloride Injection, USP for intravenous infusion administration is formulated as sterile iso-osmotic solution containing 2 mg/mL of fluconazole. It is supplied in INTRAVIA plastic containers containing volumes of 100 mL or 200 mL affording doses of 200 mg and 400 mg of fluconazole, respectively.
  • Fluconazole in Sodium Chloride Injection, USP in INTRAVIA Plastic Containers:
  • Store between 77u00b0F (25u00b0C) and 41u00b0F (5u00b0C). Brief exposure up to 104u00b0F (40u00b0C) does not adversely affect the product. Protect from freezing. Avoid excessive heat.
  • Rx only
  • Baxter Healthcare Corporation
  • 07-19-00-0354
  • Rev. May 2018
  • Baxter and Intravia are registered trademarks of Baxter International Inc.
  • Maalox is a registered trademark of Novartis Consumer Health, Inc.
  • LOT EXP
  • Fluconazole n- in Sodium Chloriden- Injection, USP
  • 400 mg / 200 mL
  • ISO-OSMOTIC SODIUM CHLORIDE DILUENT
  • CAUTIONS
  • RX ONLY
  • Arrayn- Baxter Logo
  • BAXTER AND INTRAVIA ARE TRADEMARKS OF BAXTER INTERNATIONAL INC
  • Lot: T123456 Exp: JAN 2020
  • QTY: 10 x 200 mL Single Dose INTRAVIA Containersn n NDC 0338-6045-37
  • FLUCONAZOLE IN SODIUM CHLORIDEINJECTION, USPn- 400 mg/200 mLn- ISO-OSMOTIC SODIUM CHLORIDE DILUENT
  • Recommended storage: Store between 77u00b0F (25u00b0C) and 41u00b0F (5u00b0C). Brief exposure up to 104u00b0F (40u00b0C) does not adversely affect the product. Protect from freezing. Avoid excessive heat.
  • Bar Code(01)50303386045371(17)200131(21)000000032019(10)T123456
  • 08/22/19 11:18:40 PLIS#1
  • Bar Code(01) 50303386045371(17)200131(21)000000032019(10)T123456
  • Fluconazole n- in Sodium Chloriden- Injection, USP
  • 200 mg / 100 mL (2mg/mL)*
  • ISO-OSMOTIC SODIUM CHLORIDE DILUENT
  • *EACH 100 mL CONTAINS 200 mg OF FLUCONAZOLE USP AND 900 mg OF SODIUM CHLORIDE USP IN WATER FORINJECTION USP OSMOLARITY 315 mOsmol/L (CALC)pH 5.5 (4.0 to 6.5) NO PRESERVATIVE IS ADDED
  • USUAL DOSAGE
  • CAUTIONS
  • RX ONLY
  • BAXTER AND INTRAVIA ARE TRADEMARKS OF BAXTER INTERNATIONAL INC
  • Lot: T123456 Exp: JAN 2020
  • QTY: 10 x 100 mL Single Dose INTRAVIA Containersn n NDC 0338-6046-48
  • FLUCONAZOLE IN SODIUM CHLORIDEINJECTION, USPn- 200 mg/100 mLn- ISO-OSMOTIC SODIUM CHLORIDE DILUENT
  • Recommended storage: Store between 77u00b0F (25u00b0C) and 41u00b0F (5u00b0C). Brief exposure up to 104u00b0F (40u00b0C) does not adversely affect the product. Protect from freezing. Avoid excessive heat.
  • Bar Code(01)50303386046484(17)200131(21)00000059094(10)T123456
  • 06/08/19 12:30:21 PALI#1
  • (01)50303386046484(17)200131(21)000000059094(10)T123456

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Comparator Sourcing for Clinical Trials

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Validated Cold Chain Shipment

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