FLUCONAZOLE injection

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Baxter Healthcare Corporation

INN (Международно Name):

FLUCONAZOLE

Композиция:

FLUCONAZOLE 2 mg in 1 mL

Вид предписание :

PRESCRIPTION DRUG

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

FLUCONAZOLE- FLUCONAZOLE INJECTION
BAXTER HEALTHCARE CORPORATION
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FLUCONAZOLE INJECTION, USP
FOR INTRAVENOUS USE ONLY
RX ONLY
DESCRIPTION
Fluconazole, the first of a new subclass of synthetic triazole
antifungal agents, is available as a sterile
solution for intravenous use in glass and in plastic containers.
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 306.3. The structural
formula is:
Fluconazole is a white crystalline solid which is slightly soluble in
water and saline.
Fluconazole 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 50 mL,
100 mL & 200 mL in plastic containers.
The plastic container is fabricated from a specially formulated
polyvinyl chloride. 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.
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 suspens