FLUCONAZOLE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Baxter Healthcare Corporation

INN (International Name):

FLUCONAZOLE

Composition:

FLUCONAZOLE 200 mg in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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 other drugs known to prolong the QT interval and which are metabolized via the enzyme CYP3A4 such as erythromycin, pimozide, and quinidine are contraindicated in patients receiving fluconazole. (See CLINICAL PHARMACOLOGY: Drug Interaction Studies and PRECAUTIONS.)

Product summary:

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: 2J1446 NDC 0338-6046-48 Fluconazole in Sodium Chloride Diluent 200 mg/100 mL x 10 2J1445 NDC 0338-6045-37 Fluconazole in Sodium Chloride Diluent 400 mg/200 mL x 10 Store between 77°F (25°C) and 41°F (5°C). Brief exposure up to 104°F (40°C) does not adversely affect the product. Protect from freezing. Avoid excessive heat. Rx only

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUCONAZOLE- FLUCONAZOLE INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
----------
FLUCONAZOLE IN SODIUM CHLORIDE INJECTION, USP
FOR INTRAVENOUS INFUSION ONLY
IN INTRAVIA PLASTIC CONTAINER
DESCRIPTION
Fluconazole, the first of a new subclass of synthetic triazole
antifungal agents, is
available as a sterile solution for intravenous use in INTRAVIA
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 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
in the sodium
chloride diluent. 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 can 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.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS AND METABOLISM
1
13
12 2
6
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 p