FLUCONAZOLE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sagent Pharmaceuticals

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 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 t

Product summary:

Fluconazole Injection, USP (in 0.9% Sodium Chloride) is supplied as follows: Fluconazole Injection, USP (in 0.9% Sodium Chloride) for intravenous infusion administration is formulated as iso-osmotic solutions containing 2 mg per mL of fluconazole. Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. Maalox® is a registered trademark of Aventis Pharmaceuticals Products Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUCONAZOLE- FLUCONAZOLE INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
----------
FLUCONAZOLE INJECTION, USP
(IN 0.9% SODIUM CHLORIDE)
FOR INTRAVENOUS INFUSION ONLY
SAGENT™
Rx only
DESCRIPTION
Fluconazole Injection, USP (in 0.9% Sodium Chloride), 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 Injection, USP (in 0.9% Sodium Chloride) 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 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.
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 concentrations (C
) in fa