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.
CATEGORIES, BRAND NAMES
CATEGORIES: Candidiasis; Candidiasis, oral; Meningitis,
cryptococcal; Transplantation, bone
marrow, adjunct; Pregnancy Category C; FDA Class 1A ("Important Therapeutic
Advantage"); FDA Approved 1990 Jan; Top 200 Drugs
FDA Drug Classes: Antifungals
BRAND NAMES:
BRAND NAMES: Alflucoz; Baten; Biozolene;
Canzol; Cryptal; Diflucan; Flucazol; Flukezol;
Flunizol; Fluzone; Forcan; Fungata; Govazol;
Mutum; Nobzol-1; Nobzol-2; Oxifugol; Plunazol;
Pritenzol; Syscan; Tavor; Triflucan; Zemyc;
Zonal
(Foreign Brand names outside U.S. in italics)
FOREIGN BRAND AVAILABILITY:
Alflucoz (India)
Baten (Colombia)
Biozolene (Italy)
Canzol (Bahrain; Cyprus; Egypt; Iran; Iraq; Jordan; Kuwait; Lebanon; Libya;
Oman; Qatar; Republic-of-Yemen; Saudi-Arabia; Syria; United-Arab-Emirates)
Cryptal (Indonesia)
Flucazol (Bahrain; Cyprus; Egypt; Iran; Iraq; Israel; Jordan; Kuwait;
Lebanon; Libya; Oman; Qatar; Republic-of-Yemen; Saudi-Arabia; Syria; United-Arab-Emirates)
Flukezol (Mexico)
Flunizol (Peru)
Fluzone (Benin; Burkina-Faso; Ethiopia; Gambia; Ghana; Guinea; Ivory-Coast;
Kenya; Liberia; Malawi; Mali; Mauritania; Mauritius; Morocco; Niger; Nigeria;
Senegal; Seychelles; Sierra-Leone; South-Africa; Sudan; Tanzania; Tunia;
Uganda; Zambia; Zimbabwe)
Forcan (India)
Fungata (Austria; Germany)
Govazol (Indonesia)
Mutum (Peru)
Nobzol-1 (Colombia)
Nobzol-2 (Colombia)
Oxifugol (Mexico)
Plunazol (Korea)
Pritenzol (Colombia)
Syscan (India)
Tavor (Colombia)
Triflucan (France; Turkey)
Zemyc (Indonesia)
Zonal (Mexico)
COST OF THERAPY: $112.05 (Candidiasis; Diflucan Tablet;
100 mg; 1/day; 15 days)
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