FLUCONAZOLE- fluconazole tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Preferred Pharmaceuticals, Inc.

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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

Rezumat produs:

Fluconazole Tablets USP: Pink trapezoidal tablets containing 50, 100, or 200 mg of fluconazole, USP are packaged in bottles. Fluconazole tablets USP, 150 mg are pink, oval shaped, packaged in a blister card of Fluconazole tablets USP, 150 mg: Engraved with “150” on one side and plain on the other side. Bottle of 1 - 68788-9190-1 Bottle of 2 - 68788-9190-5 Bottle of 10 - 68788-9190-0 Bottle of 20 - 68788-9190-2 Bottle of 30 - 68788-9190-3 Bottle of 60 - 68788-9190-6 Bottle of 90 - 68788-9190-9 Storage: Store at 20° to 25°C (68° to 77° F) [see USP Controlled Room Temperature]. Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 [phone] www.glenmarkpharma.com/usa April 2019 Repackaged By: Preferred Pharmaceuticals Inc.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

FLUCONAZOLE- FLUCONAZOLE TABLET
PREFERRED PHARMACEUTICALS, INC.
----------
FLUCONAZOLE TABLETS, FOR ORAL USE
RX ONLY
DESCRIPTION
Fluconazole, USP the first of a new subclass of synthetic triazole
antifungal agents, is available as
tablets for oral administration.
Fluconazole, USP is designated chemically as 2,4-difluoro-1 ,1
-bis(1_H_-1,2,4-triazol-1-ylmethyl)benzyl
alcohol with an empirical formula of C
H F N O and molecular weight of 306.27. 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.
Fluconazole Tablets USP contain 50 mg, 100 mg, 150 mg, or 200 mg of
fluconazole, USP and the
following inactive ingredients: croscarmellose sodium, dibasic calcium
phosphate anhydrous, FD&C
Red No. 40 HT 15-17%, magnesium stearate, microcrystalline cellulose
and povidone K-30.
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.
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.
’
’
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