FLUCONAZOLE powder, for suspension

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Aurobindo Pharma Limited

INN (International Name):

FLUCONAZOLE

Sammensætning:

FLUCONAZOLE 10 mg in 1 mL

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Fluconazole for oral suspension is indicated for the treatment of: 1.  Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole for oral suspension was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 2.  Cryptococcal meningitis . Before prescribing fluconazole for oral suspension for AIDS patients with cryptococcal meningitis , please see CLINICAL STUDIES  section. Studies comparing fluconazole for oral suspension to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole for oral suspension is 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 for oral suspension 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 for oral suspension to patients with hypersensitivity to other azoles. Coadministration of other drugs known to prolong the QT interval and which are metabolized via the enzyme CYP3A4 such as erythromycin, pimozide, and quinidine are contraindicated in patients receiving fluconazole. (See CLINICAL PHARMACOLOGY: Drug Interaction Studies and PRECAUTIONS .)

Produkt oversigt:

Fluconazole for Oral Suspension USP, 10 mg/mL is supplied as an orange flavored white to off-white powder to provide 35 mL per bottle as follows:                      35 mL Bottle                           NDC 65862-299-35 Fluconazole for Oral Suspension USP, 40 mg/mL is supplied as an orange flavored white to off-white powder to provide 35 mL per bottle as follows:                      35 mL Bottle                           NDC 65862-300-35 Before Reconstitution: Store dry powder at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. After Reconstitution: Store reconstituted suspension between 5°C (41°F) and 25°C (77°F). Protect from freezing. Discard unused portion after 2 weeks. Maalox® is a registered trademark of Novartis Consumer Health, Inc. XELJANZ® is a registered trademark of Pfizer Inc. LYNPARZA® is a registered trademark of AstraZeneca group of companies. Distributed by: Aurobindo Pharma USA, Inc . 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 03/2024

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

FLUCONAZOLE - FLUCONAZOLE POWDER, FOR SUSPENSION
AUROBINDO PHARMA LIMITED
----------
FLUCONAZOLE FOR ORAL SUSPENSION USP
RX ONLY
DESCRIPTION
Fluconazole, the first of a new subclass of synthetic triazole
antifungal agents, is
available as a powder for oral suspension.
Fluconazole is designated chemically as 2,4-difluoro-α,α
-bis(1H-1,2,4-triazol-1-ylmethyl)
benzyl alcohol with a 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 slightly soluble in
water and saline.
Fluconazole for oral suspension USP contains 350 mg or 1400 mg of
fluconazole USP
and the following inactive ingredients: sodium benzoate, citric acid
anhydrous, sodium
citrate, xanthan gum, titanium dioxide, natural orange flavor,
colloidal silicon dioxide, and
sucrose. 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.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS AND METABOLISM
The pharmacokinetic properties (PK) 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
1
13
12 2
6
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 or
multiple oral doses of 50 to 400 mg, fluconazole plasma concentrations
and area under
the plasma concentration time curve (AUC) are dose proportional (Table
1).
The C
and AUC data from a food-effect study involv