FLUCONAZOLE IN SODIUM CHLORIDE 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: 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. 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 other drugs known to prolong the QT interval and which are metabo

Product summary:

Fluconazole in Sodium Chloride 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 Sodium Chloride Injection, USP in Flexible Plastic Containers are supplied in the following: NDC 0409-4688-18 Case containing 24, 100 mL flexible plastic containers 200 mg/100 mL (2 mg/mL) NDC 0409-4688-12 Case containing 24, 200 mL flexible plastic containers 400 mg/200 mL (2 mg/mL) 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 SODIUM CHLORIDE- FLUCONAZOLE IN SODIUM CHLORIDE
INJECTION,
SOLUTION
HOSPIRA, INC.
----------
FLUCONAZOLE IN SODIUM CHLORIDE
INJECTION, USP
Rx only
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 Sodium Chloride Injection, USP is an iso-osmotic,
sterile, nonpyrogenic
solution. Each mL contains 2 mg of fluconazole and 9 mg of sodium
chloride. The pH
ranges from 4.0 to 8.0 in the sodium chloride 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.
1
13
12 2
6
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.
P