FLUCONAZOLE IN DEXTROSE- fluconazole in dextrose injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FLUCONAZOLE (UNII: 8VZV102JFY) (FLUCONAZOLE - UNII:8VZV102JFY)

Available from:

Hospira, Inc.

INN (International Name):

FLUCONAZOLE

Composition:

FLUCONAZOLE 2 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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

Product summary:

Fluconazole in Dextrose injections for intravenous infusion administration are formulated as sterile iso-osmotic solutions containing 2 mg/mL of fluconazole. They are supplied in flexible plastic containers containing volumes of 100 mL or 200 mL affording doses of 200 mg and 400 mg of fluconazole, respectively. Fluconazole in Dextrose Injection, USP in Flexible Plastic Containers are supplied in the following: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUCONAZOLE IN DEXTROSE- FLUCONAZOLE IN DEXTROSE INJECTION, SOLUTION
HOSPIRA, INC.
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FLUCONAZOLE IN DEXTROSE
INJECTION, USP
FOR INTRAVENOUS INFUSION ONLY
DESCRIPTION
Fluconazole, the first of a new subclass of synthetic triazole
antifungal agents, is available as a sterile
solution for intravenous use in flexible plastic containers.
Fluconazole is designated chemically as 2,4-difluoro-α,α
-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl
alcohol with an empirical formula of C
H F N O and molecular weight of 306.3. The structural
formula is:
Fluconazole is a white crystalline solid which is slightly soluble in
water and saline.
Fluconazole in Dextrose Injection, USP is an iso-osmotic, sterile,
nonpyrogenic solution of fluconazole
in a dextrose diluent. Each mL contains 2 mg of fluconazole and 56 mg
of dextrose, hydrous. The pH
ranges from 3.5 to 6.5 in the dextrose diluent. Injection volumes of
100 mL and 200 mL are packaged in
flexible plastic containers.
The flexible plastic container is fabricated from a specially
formulated polyvinyl chloride. The amount
of water that can permeate from inside the container into the overwrap
is insufficient to affect the
solution significantly. Solutions in contact with the plastic
container can leach out certain of its
chemical components in very small amounts within the expiration
period, e.g., di-2-ethylhexylphthalate
(DEHP), up to 5 parts per million. However, the suitability of the
plastic has been confirmed in tests in
animals according to USP biological tests for plastic containers as
well as by tissue culture toxicity
studies.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS AND METABOLISM
The pharmacokinetic properties of fluconazole are similar following
administration by the intravenous
or oral routes. In normal volunteers, the bioavailability of orally
administered fluconazole is over 90%
compared with intravenous administration. Bioequivalence was
established between the 100 mg tablet
and both suspension strengths when administered as a single 200 mg
dose.
Peak plasma conc