FLUCONAZOLE injection, solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

Fluconazole (UNII: 8VZV102JFY) (Fluconazole - UNII:8VZV102JFY)

זמין מ:

Sagent Pharmaceuticals

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Fluconazole in Sodium Chloride 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 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

leaflet_short:

Fluconazole in Sodium Chloride Injection, USP is supplied as follows: Fluconazole in Sodium Chloride Injection, USP for intravenous infusion administration is formulated as iso-osmotic solutions containing 2 mg per mL of fluconazole. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] AVOID EXCESSIVE HEAT. PROTECT FROM FREEZING. Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free. The container and container closure are not made with natural rubber latex. Brands listed are the trademarks of their respective owners. Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in Switzerland novaplus TM + Novaplus is a registered trademark of Vizient, Inc. Revised: June 2022

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

FLUCONAZOLE- FLUCONAZOLE INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
----------
FLUCONAZOLE IN SODIUM CHLORIDE INJECTION, USP
FOR INTRAVENOUS USE
NOVAPLUS
RX ONLY
DESCRIPTION
Fluconazole in Sodium Chloride Injection, USP, the first of a new
subclass of synthetic
triazole antifungal agents, is available as a sterile solution for
intravenous use 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 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
8.0. Injection
volumes of 100 mL and 200 mL are packaged in plastic containers.
The flexible bag container is fabricated from a specially formulated
non-plasticized
thermoplastic co-polyolefin. The amount of water that can permeate
from the container
into the overwrap is insufficient to affect the solution
significantly. The suitability of the
container material has been confirmed in tests in animals according to
USP biological
tests for plastic containers.
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
TM
+
1
13
12 2
6
administered as a single 200 mg dose.
Peak plasma concentrations (C
) in fasted normal volunteers occur between 1 and 2
hours with a terminal plasma elimination half-life of approximately 30
hours (range: 20 to
50 hours) after oral administration.
In fasted normal volunteers, adm