DIFLUCAN ® (Fluconazole Tablets)

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

FLUCONAZOLE

Composition:

FLUCONAZOLE 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

DIFLUCAN (fluconazole) is indicated for the treatment of: - Vaginal candidiasis (vaginal yeast infections due to Candida ). - Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, DIFLUCAN 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 DIFLUCAN (fluconazole) for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing DIFLUCAN to amphotericin B in non-HIV infected patients have not been conducted. DIFLUCAN 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)

Product summary:

DIFLUCAN Tablets: Pink trapezoidal tablets containing 200 mg of fluconazole are packaged in bottles. DIFLUCAN Tablets are supplied as follows: Packaged in bottles of 1 tablet NDC 55289-148-79 Store tablets below 86°F (30°C).

Authorization status:

New Drug Application

Summary of Product characteristics

DIFLUCAN- FLUCONAZOLE TABLET
PD-RX PHARMACEUTICALS, INC.
----------
DIFLUCAN
(FLUCONAZOLE TABLETS)
DESCRIPTION
DIFLUCAN
(fluconazole), the first of a new subclass of synthetic triazole
antifungal
agents, is available as tablets for oral administration, as a powder
for oral suspension.
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.
DIFLUCAN Tablets contain 50 mg, 100 mg, 150 mg, or 200 mg of
fluconazole and the
following inactive ingredients: microcrystalline cellulose, dibasic
calcium phosphate
anhydrous, povidone, croscarmellose sodium, FD&C Red No. 40 aluminum
lake dye, and
magnesium stearate.
DIFLUCAN for Oral Suspension contains 350 mg or 1400 mg of fluconazole
and the
following inactive ingredients: sucrose, sodium citrate dihydrate,
citric acid anhydrous,
sodium benzoate, titanium dioxide, colloidal silicon dioxide, xanthan
gum, and natural
orange flavor. 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.
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 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, administration of a single oral 400 mg
dose of DIFLUCAN
(fluconazole) leads to a mean