DIFLUCAN®
(fluconazole) Tablets
(fluconazole) Injection - for Intravenous Infusion Only
(fluconazole) for Oral Suspension
(fluconazole) Tablets
(fluconazole) Injection - for Intravenous Infusion Only
(fluconazole) for Oral Suspension
DRUG 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-α,α1-bis(1H-1,2,4-triazol-1-ylmethyl)
benzyl alcohol with an empirical formula of C13H12F2N6O
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, 100, 150, 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 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.
What are the possible side effects of fluconazole (Diflucan)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- fever, chills, body aches, flu symptoms;
- severe blistering, peeling, and red skin rash;
- easy bruising or bleeding, unusual weakness; or
- seizure (convulsions).
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Read All Potential Side Effects and See Pictures of Diflucan »
What are the precautions when taking fluconazole (Diflucan)?
Before taking fluconazole, tell your doctor or pharmacist if you are
allergic to it; or to other azole antifungal drugs (such as
ketoconazole, itraconazole); or if you have any other allergies. This
product may contain inactive ingredients, which can cause allergic
reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease.
Fluconazole may cause a condition that affects the heart rhythm
(QT prolongation). QT prolongation can infrequently result in serious
(rarely fatal) fast/irregular heartbeat and other symptoms (such as
severe dizziness, fainting) that need medical attention right away. The
risk of QT prolongation may be increased if...
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