FLUCONAZOLE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvPAK

INN (International Name):

FLUCONAZOLE

Composition:

FLUCONAZOLE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluconazole tablets USP 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 USP 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 USP for AIDS patients with cryptococcal meningitis , please see CLINICAL STUDIES section. Studies comparing fluconazole tablets USP to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: Fluconazole tablets USP 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 terfenadine is contraindicated in patients receiving fluconazole tablets at multiple doses of 400 mg/day or higher based upon results of a multiple dose interaction study. Coadministration of other drugs known to prolong the QT interval and which are metabolized via the enzyme CYP3A4 such as cisapride, astemizole, erythromycin, pimozide, and quinidine are contraindicated in patients receiving fluconazole. (See CLINICAL PHARMACOLOGY: Drug Interaction Studies and PRECAUTIONS .)

Product summary:

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. 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. NDC 50268-337-15 (10 tablets per card, 5 cards per carton) 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. 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. NDC 50268-339-15 (10 tablets per card, 5 cards per carton). 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]. Maalox ® is a registered trademark of Novartis Consumer Health, Inc. XELJANZ ® is a registered trademark of Pfizer Inc. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 04/18 AV Rev. 02/19 (P) AvPAK

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUCONAZOLE- FLUCONAZOLE TABLET
AVPAK
----------
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 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.
1
13
12
2
6
max
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 area
under the
plasma concentration-time curve (AUC) are dose proportional.
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 affected by food. Therefore,
fluconazole