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Basic Drug Info
Drug Name:Fluconazole
Manufacturer:Bedford Laboratories
Other Info:

Manufactured by:                                                                                                   Manufactured for:Ben Venue Laboratories, Inc.

                                                                      Bedford Laboratories™Bedford, OH 44146                                                                                             Bedford, OH 44146November 2008                                                                                                                   FZC-P02



Clinical Trials:


Indications and Usage

Fluconazole is indicated for the treatment of:Oropharyngeal and esophageal candidiasis.

In open noncomparative studies of relatively small numbers of patients, fluconazole was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia.

Cryptococcal meningitis.

Before prescribing fluconazole for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section.

Studies comparing fluconazole to amphotericin B in non-HIV infected patients have not been conducted.

Prophylaxis.

Fluconazole 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.
Candida Esophagitis --

Urinary tract infection -- Inflammatory responses of the epithelium of the URINARY TRACT to microbial invasions. They are often bacterial infections with associated BACTERIURIA and PYURIA.

Peritonitis -- INFLAMMATION of the PERITONEUM lining the ABDOMINAL CAVITY as the result of infectious, autoimmune, or chemical processes. Primary peritonitis is due to infection of the PERITONEAL CAVITY via hematogenous or lymphatic spread and without intra-abdominal source. Secondary peritonitis arises from the ABDOMINAL CAVITY itself through RUPTURE or ABSCESS of intra-abdominal organs.

Systemic infection -- Systemic inflammatory response syndrome with a proven or suspected infectious etiology. When sepsis is associated with organ dysfunction distant from the site of infection, it is called severe sepsis. When sepsis is accompanied by HYPOTENSION despite adequate fluid infusion, it is called SEPTIC SHOCK.

Disseminated candidiasis --

Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Pneumonia -- Inflammation of any part, segment or lobe, of the lung parenchyma.

Cryptococcal meningitis -- Meningeal inflammation produced by CRYPTOCOCCUS NEOFORMANS, an encapsulated yeast that tends to infect individuals with ACQUIRED IMMUNODEFICIENCY SYNDROME and other immunocompromised states. The organism enters the body through the respiratory tract, but symptomatic infections are usually limited to the lungs and nervous system. The organism may also produce parenchymal brain lesions (torulomas). Clinically, the course is subacute and may feature HEADACHE; NAUSEA; PHOTOPHOBIA; focal neurologic deficits; SEIZURES; cranial neuropathies; and HYDROCEPHALUS. (From Adams et al., Principles of Neurology, 6th ed, pp721-2)

Candidiasis -- Infection with a fungus of the genus CANDIDA. It is usually a superficial infection of the moist areas of the body and is generally caused by CANDIDA ALBICANS. (Dorland, 27th ed)

Contraindications

Fluconazole 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 to patients with hypersensitivity to other azoles.

Coadministration of terfenadine is contraindicated in patients receiving fluconazole at multiple doses of 400 mg or higher based upon results of a multiple dose interaction study.

Coadministration of cisapride is contraindicated in patients receiving fluconazole.

(See CLINICAL PHARMACOLOGY : Drug Interaction Studies and PRECAUTIONS.)
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Hepatic injury: Fluconazole has been associated with rare cases of serious hepatic toxicity, including fatalities primarily in patients with serious underlying medical conditions.

In cases of fluconazole associated hepatotoxicity, no obvious relationship to total daily dose, duration of therapy, sex or age of the patient has been observed.

Fluconazole hepatotoxicity has usually, but not always, been reversible on discontinuation of therapy.

Patients who develop abnormal liver function tests during fluconazole therapy should be monitored for the development of more severe hepatic injury.

Fluconazole should be discontinued if clinical signs and symptoms consistent with liver disease develop that may be attributable to fluconazole.Anaphylaxis: In rare cases, anaphylaxis has been reported.Dermatologic: Patients have rarely developed exfoliative skin disorders during treatment with fluconazole.

In patients with serious underlying diseases (predominantly AIDS and malignancy), these have rarely resulted in a fatal outcome.

Patients who develop rashes during treatment with fluconazole should be monitored closely and the drug discontinued if lesions progress.
Branded Drugs
The following US Branded drugs contain Fluconazole


DIFLUCAN -- PFIZER CHEMICALS DIV PFIZER INC

DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER -- PFIZER INC

DIFLUCAN IN SODIUM CHLORIDE 0.9% -- PFIZER INC

DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER -- PFIZER INC

FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER -- APOTEX INC RICHMOND HILL

FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER -- HOSPIRA INC

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% -- ABRAXIS PHARMACEUTICAL PRODUCTS

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% -- BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% -- HIKMA FARMACEUTICA PORTUGAL LDA

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% -- TEVA PARENTERAL MEDICINES INC

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER -- APOTEX INC RICHMOND HILL

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER -- BAXTER HEALTHCARE CORP

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER -- BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER -- BEDFORD LABORATORIES

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER -- HOSPIRA INC

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER -- TEVA PARENTERAL MEDICINES INC

DIFLUCAN -- PFIZER CENTRAL RESEARCH


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