FLUCONAZOLE tablet

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 50 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Fluconazole tablets are indicated for the treatment of: - Vaginal candidiasis (vaginal yeast infections due to Candida ). - Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida  urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. - Cryptococcal meningitis . Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. 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 tablets are 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 tablets 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 Tablets USP, 50 mg are pink mottled, biconvex, capsule shaped uncoated tablets with “C” debossed on one side and “04” debossed on other side.             Bottles of 30                            NDC 65862-058-30 Fluconazole Tablets USP, 100 mg are pink mottled, biconvex, capsule shaped uncoated tablets with “C” debossed on one side and “05” debossed on other side.             Bottles of 30                            NDC 65862-059-30             Bottles of 100                          NDC 65862-059-01             Bottles of 500                          NDC 65862-059-05 Fluconazole Tablets USP, 150 mg are pink mottled, biconvex, capsule shaped uncoated tablets with “C” debossed on one side and “10” debossed on other side.             Unit dose package of 1          NDC 65862-060-11 Fluconazole Tablets USP, 200 mg are pink mottled, biconvex, capsule shaped uncoated tablets with “C” debossed on one side and “07” debossed on other side.             Bottles of 30                            NDC 65862-061-30             Bottles of 100                          NDC 65862-061-01             Bottles of 500                          NDC 65862-061-05  Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

FLUCONAZOLE - FLUCONAZOLE TABLET
AUROBINDO PHARMA LIMITED
----------
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 a molecular formula of C
H
F N O and molecular weight of 306.3.
The structural formula is:
Fluconazole USP is a white crystalline solid which is slightly soluble
in water and saline.
Fluconazole tablets USP contain 50 mg, 100 mg, 150 mg, or 200 mg of
fluconazole
USP 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.
Meets USP Dissolution Test 2.
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
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 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 involving administration of
fluconazole
tablets to healthy volunteers under fasting conditions and with a
high-fat meal indicated
that exposure to the drug is not