FLUCONAZOLE powder, for suspension

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 10 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluconazole for Oral Suspension, USP is indicated for the treatment of: 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 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 for Oral Suspension 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 to patients with hypersensitivity to other azoles. Co-administration of te

Product summary:

Fluconazole for Oral Suspension, USP Fluconazole for Oral Suspension, USP is supplied as a (orange-flavored) white to almost white powder to provide 35 mL per bottle: NDC 0054-0002-85: Bottle of 350 mg NDC 0054-0003-85: Bottle of 1400 mg Each mL contains 10 mg or 40 mg of fluconazole after reconstitution as directed. Storage Before Reconstitution: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] After Reconstitution: Store suspension at 5° to 25°C (41° to 77°F). Discard unused portion after 2 weeks. Protect from freezing. Distr. by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50000567/02 Revised September 2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUCONAZOLE- FLUCONAZOLE POWDER, FOR SUSPENSION
HIKMA PHARMACEUTICALS USA INC.
----------
FLUCONAZOLE FOR ORAL SUSPENSION, USP
RX ONLY
DESCRIPTION
Fluconazole, the first of a new subclass of synthetic triazole
antifungal agents, is available as a powder
for oral suspension.
Fluconazole is designated chemically as
[α-(2,4-difluorophenyl)-α-(1H-1,2,4-triazol-1-ylmethyl)-1-H-
1, 2, 4- triazole-1-ethanol] with a molecular formula of C
H F N O and molecular weight of 306.27.
The structural formula is:
Fluconazole, USP is a white or almost white powder which is freely
soluble in methanol, soluble in
alcohol and acetone, sparingly soluble in isopropanol and in
chloroform, slightly soluble in water, very
slightly soluble in toluene.
Fluconazole for Oral Suspension, USP is available for oral
administration containing either 350 mg or
1400 mg of fluconazole, USP and the following inactive ingredients:
citric acid anhydrous, natural
orange flavor, silicon dioxide, sodium benzoate, sodium citrate,
sucrose, titanium dioxide, and xanthan
gum. After reconstitution with 24 mL of distilled water or Purified
Water (USP), each mL of
reconstituted suspension contains 10 mg or 40 mg of fluconazole, USP.
The reconstituted suspension meets the requirements of the Test 2
Dissolution in the USP monograph
for Fluconazole for Oral Suspension, USP.
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 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.
13
12
2
6
max
In fasted normal volunteers, administration of