DIFLUCAN- fluconazole tablet DIFLUCAN- fluconazole powder, for suspension

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Roerig

INN (Διεθνής Όνομα):

FLUCONAZOLE

Σύνθεση:

FLUCONAZOLE 50 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

DIFLUCAN (fluconazole) is indicated for the treatment of: DIFLUCAN 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. DIFLUCAN (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 DIFLUCAN 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 .)

Περίληψη προϊόντος:

DIFLUCAN Tablets: Pink trapezoidal tablets containing 50, 100, or 200 mg of fluconazole are packaged in bottles or unit dose blisters. The 150 mg fluconazole tablets are pink and oval shaped, packaged in a single dose unit blister. DIFLUCAN Tablets are supplied as follows: DIFLUCAN 50 mg Tablets: Engraved with "DIFLUCAN" and "50" on the front and "ROERIG" on the back. NDC 0049-3410-30 Bottles of 30 DIFLUCAN 100 mg Tablets: Engraved with "DIFLUCAN" and "100" on the front and "ROERIG" on the back. NDC 0049-3420-30 Bottles of 30 NDC 0049-3420-41 Unit dose package of 100 DIFLUCAN 150 mg Tablets: Engraved with "DIFLUCAN" and "150" on the front and "ROERIG" on the back. NDC 0049-3500-79 Unit dose package of 1 DIFLUCAN 200 mg Tablets: Engraved with "DIFLUCAN" and "200" on the front and "ROERIG" on the back. NDC 0049-3430-30 Bottles of 30 NDC 0049-3430-41 Unit dose package of 100 Store tablets below 30°C (86°F). DIFLUCAN for Oral Suspension: DIFLUCAN for Oral Suspension is supplied as an orange-flavored powder to provide 35 mL per bottle as follows: NDC 0049-3440-19 Fluconazole 350 mg per bottle NDC 0049-3450-19 Fluconazole 1400 mg per bottle Store dry powder below 30°C (86°F). Store reconstituted suspension between 30°C (86°F) and 5°C (41°F) and discard unused portion after 2 weeks. Protect from freezing.

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

DIFLUCAN- FLUCONAZOLE TABLET
DIFLUCAN- FLUCONAZOLE POWDER, FOR SUSPENSION
ROERIG
REFERENCE LABEL SET ID: FF5F3EA4-42E2-4E8B-A594-A3964D2016ED
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DIFLUCAN®
(FLUCONAZOLE TABLETS)
(FLUCONAZOLE FOR ORAL SUSPENSION)
DESCRIPTION
DIFLUCAN (fluconazole), the first of a new subclass of synthetic
triazole antifungal
agents, is available as tablets for oral administration, 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 an empirical formula of C
H
F N O and molecular weight of 306.3.
The structural formula is:
Fluconazole is a white crystalline solid which is slightly soluble in
water and saline.
DIFLUCAN Tablets contain 50 mg, 100 mg, 150 mg, or 200 mg of
fluconazole 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.
DIFLUCAN for Oral Suspension contains 350 mg or 1400 mg of fluconazole
and the
following inactive ingredients: sucrose, sodium citrate dihydrate,
citric acid anhydrous,
sodium benzoate, titanium dioxide, colloidal silicon dioxide, xanthan
gum, and natural
orange flavor. 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
®
1
13
12 2
6
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.
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 administ