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 and as a sterile solution for intravenous use
in glass and in Viaflex Plus plastic containers.
Fluconazole is designated chemically as 2,4-difluoro-a,a1-bis(1H-1,2,4-triazol-1-ylmethyl)
benzyl alcohol with an empirical formula of C13H12F2N6O
and molecular weight 306.3.
Fluconazole is a white crystalline solid which is slightly
soluble in water and saline.
Diflucan Tablets: Contain 50, 100, 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.
Diflucan Injection: It is an iso-osmotic, sterile, nonpyrogenic
solution of fluconazole in a sodium chloride or dextrose
diluent. Each ml contains 2 mg of fluconazole and 9 mg
of sodium chloride or 56 mg of dextrose, hydrous. The
pH ranges from 4.0 to 8.0 in the sodium chloride diluent
and from 3.5 to 6.5 in the dextrose diluent. Injection
volumes of 100 ml and 200 ml are packaged in glass and
in Viaflex Plus plastic containers.
The Viaflex Plus plastic container is fabricated from
a specially formulated polyvinyl chloride (PL 146 Plastic)
(Viaflex and PL 146 are registered trademarks of Baxter
International, Inc.). 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 as well as by
tissue culture toxicity studies.
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