FLUCONAZOLE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Proficient Rx LP

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Fluconazole tablets are indicated for the treatment of: Prophylaxis: Fluconazole tablets are also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly. Fluconazole is contraindicated in patients who have shown hypersensitivity to fluconazole or to any of its excipients. There is no information regarding cross-hypersensitivity between fluconazole and other azole antifungal agents. Caution should be used in prescribing fluconazole to patients with hypersensitivity to other azoles. Coadministration of terfenadine is contraindicated in

Περίληψη προϊόντος:

Fluconazole Tablets USP, 150 mg are light pink to pink colored, may be spotted, modified oval shaped, biconvex, uncoated tablets, debossed with '1139' on one side and plain on the other side and are supplied as follows: NDC 71205-081-01 in unit-dose blister pack of 01 tablet NDC 71205-081-02 in unit-dose blister pack of 02 tablets NDC 71205-081-04 in unit-dose blister pack of 04 tablets Storage:  Store  at  20º  to  25º  C  (68º  to  77º  F)  [See  USP  Controlled  Room  Temperature].   Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 03/18 Relabeled By; Proficient Rx LP Thousand Oaks CA 91320

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

FLUCONAZOLE- FLUCONAZOLE TABLET
PROFICIENT RX LP
----------
FLUCONAZOLE TABLETS, USP
RX ONLY
DESCRIPTION
Fluconazole, the first of a new subclass of synthetic triazole
antifungal agents, is available as tablets for
oral administration.
Fluconazole is designated chemically as 2,4-difluoro-α,α
-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl
alcohol with an molecular formula of C
H F N O and molecular weight of 306.3. The structural
formula is:
Fluconazole USP is a white or almost white crystalline powder which is
freely soluble in methanol,
soluble in alcohol and in acetone, sparingly soluble in isopropanol
and in chloroform, slightly soluble
in water, very slightly soluble in toluene.
Each fluconazole tablet, USP intended for oral administration contains
50 mg, 100 mg, 150 mg, or 200
mg of fluconazole USP. In addition, each tablet contains the following
inactive ingredients:
croscarmellose sodium, dibasic calcium phosphate anhydrous, fd&c red
no. 40 aluminum lake,
magnesium stearate, microcrystalline cellulose and povidone.
Fluconazole tablet meets USP Dissolution Test 2.
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.
1
13
12
2
6
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 mcg/mL to 8.08 mcg/mL) and after single
oral doses of 50 mg to 400
mg, fluconazole plasma concentrations and area under the plasma
concentration-time curve (AUC) are
dose propo