FLUCONAZOLE powder for suspension

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Teva Pharmaceuticals USA Inc

INN (nemzetközi neve):

FLUCONAZOLE

Összetétel:

FLUCONAZOLE 10 mg in 1 mL

Recept típusa:

PRESCRIPTION DRUG

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

FLUCONAZOLE- FLUCONAZOLE POWDER, FOR SUSPENSION
TEVA PHARMACEUTICALS USA INC
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FLUCONAZOLE FOR ORAL SUSPENSION
RX ONLY
DESCRIPTION
Fluconazole, the first of a new subclass of synthetic triazole
antifungal agents, is available for oral
administration as a powder for oral suspension.
Fluconazole USP is designated chemically as 2,4-difluoro-α,α
-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl
alcohol with the following structural formula:
C
H F N O M.W. 306.3
Fluconazole USP is a white crystalline solid which is slightly soluble
in water and saline.
Fluconazole for Oral Suspension contains 350 mg or 1400 mg of
fluconazole USP and the following
inactive ingredients: citric acid, colloidal silicon dioxide,
dl-alpha-Tocopherol, maltodextrin, natural
and artificial flavors, sodium benzoate, sodium citrate, sucrose,
titanium dioxide and xanthum gum. After
reconstitution with 26 mL or 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
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 fluconazole leads to a mean
C
of 6.72 mcg/mL (range: 4.12 to 8.08 mcg/mL) and after single oral
doses of 50 to 400 mg,
fluconazole plasma concentrations and AUC (area under the plasma
concentration-time curve) are dose
proportional.
The C
and AUC data from a food-effect study involving administration of
flucon