FLUCONAZOLE tablet 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:

Greenstone LLC

INN (International Name):

FLUCONAZOLE

Composition:

FLUCONAZOLE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluconazole is indicated for the treatment of: 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 is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Fluconazole 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. Coadministration of other drugs known to prolong the QT interval and which are metabo

Product summary:

Pink trapezoidal tablets containing 50, 100, or 200 mg of fluconazole are packaged in bottles or unit dose blisters. The 150 mg fluconazole tablets are pink and oval shaped, packaged in a single dose unit blister. Fluconazole Tablets are supplied as follows: Fluconazole 50 mg Tablets: Embossed with "FLZ 50" on one side with no markings on the other side. NDC 59762-5015-1 Bottles of 30 Fluconazole 100 mg Tablets: Embossed with "FLZ 100" on one side with no markings on the other side. NDC 59762-5016-1 Bottles of 30 Fluconazole 150 mg Tablets: Embossed with "FLZ 150" on one side with no markings on the other side. NDC 59762-5017-1 Unit dose package of 12 Fluconazole 200 mg Tablets: Embossed with "FLZ 200" on one side with no markings on the other side. NDC 59762-5018-1 Bottles of 30 Store tablets below 30°C (86°F). Fluconazole for Oral Suspension is supplied as an orange-flavored powder to provide 35 mL per bottle as follows: NDC 59762-5029-1 Fluconazole 350 mg per bottle NDC 59762-5030-1 Fluconazole 1400 mg per bottle Store dry powder below 30°C (86°F). Store reconstituted suspension between 30°C (86°F) and 5°C (41°F) and discard unused portion after 2 weeks. Protect from freezing.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

FLUCONAZOLE- FLUCONAZOLE TABLET
FLUCONAZOLE- FLUCONAZOLE POWDER, FOR SUSPENSION
GREENSTONE LLC
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FLUCONAZOLE
FLUCONAZOLE TABLETS
FLUCONAZOLE FOR ORAL SUSPENSION
DESCRIPTION
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.
Fluconazole 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.
Fluconazole 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