FLUCONAZOLE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

FLUCONAZOLE

Composition:

FLUCONAZOLE 2 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluconazole Injection, USP 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 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 ins

Product summary:

Fluconazole Injection, USP for intravenous infusion administration is formulated as a sterile iso-osmotic solution containing 2 mg/mL of Fluconazole, USP.  It is supplied in glass vials containing a volume of 100 mL, affording a dose of 200 mg of Fluconazole, USP. It is also supplied in plastic containers containing volumes of 100 mL or 200 mL, affording doses of 200 mg and 400 mg of Fluconazole, USP, respectively. Fluconazole Injection, USP in plastic containers are available in both Sodium Chloride, USP and Dextrose, USP diluents. Fluconazole in Sodium Chloride Injection, USP in glass vials: NDC 0143-9899-91 Fluconazole in iso-osmotic Sodium Chloride Diluent 200 mg/100 mL packaged in cartons of 6 vials. Storage: Store at 5º to 30ºC (41º to 86ºF). Protect from freezing. Fluconazole Injections in Plastic Containers: NDC 0143-9669-10 Fluconazole in Sodium Chloride Diluent 200 mg/100 mL           Carton of 10   NDC 0143-9668-10 Fluconazole in Sodium Chloride Diluent 400 mg/200 mL           Carton of 10   NDC 0143-9667-06 Fluconazole in Dextrose Diluent 200 mg/100 mL                      Carton of 6  NDC 0143-9666-06 Fluconazole in Dextrose Diluent 400 mg/200 mL                      Carton of 6  Storage: 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. Brands listed are the trademarks of their respective owners.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUCONAZOLE- FLUCONAZOLE INJECTION
HIKMA PHARMACEUTICALS USA INC.
----------
FLUCONAZOLE INJECTION, USP
Rx Only
DESCRIPTION
Fluconazole Injection, USP, the first of a new subclass of synthetic
triazole antifungal
agents, is available as a sterile solution for intravenous use in
glass and in 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 Injection, USP is an iso-osmotic, sterile, nonpyrogenic
solution of
Fluconazole, USP in a sodium chloride or dextrose diluent. Each mL
contains 2 mg of
Fluconazole, USP and 9 mg of Sodium Chloride, USP or 56 mg of
Dextrose, hydrous.
The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from
3.5 to 6.5 in the
dextrose diluent. Injection volume of 100 mL is packaged in glass and
in plastic
containers. Injection volume of 200 mL is packed in plastic
containers.
The plastic container is fabricated from polypropylene. 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., cis-13-
docosenoicamide (Erucamide), up to 32 mcg/mL. The Erucamide is an
authorized
additive listed in the 21 CFR 175.105 "Indirect Food Additives".
However, the suitability of
the plastic has been confirmed in tests in animals according to USP
biological tests for
plastic containers.
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.
Bioequiv