FLUCONAZOLE tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Dispensing Solutions, Inc.

INN (Միջազգային անվանումը):

FLUCONAZOLE

Կազմը:

FLUCONAZOLE 200 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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 was 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 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 pri

Ապրանքի ամփոփագիր:

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 1 tablet. Fluconazole Tablets USP are supplied as follows: Fluconazole Tablets USP, 50 mg: Engraved with “50” on one side and plain on the other side. NDC 68462-101-30 Bottles of 30 NDC 68462-101-10 Bottles of 1000 Fluconazole Tablets USP, 100 mg: Engraved with “100” on one side and plain on the other side. NDC 68462-102-30 Bottles of 30 NDC 68462-102-10 Bottles of 1000 Fluconazole Tablets USP, 150 mg: Engraved with “150” on one side and plain on the other side. NDC 68462-103-40 Carton of 12 blister cards of 1 tablet Fluconazole Tablets USP, 200 mg: Engraved with “200” on one side and plain on the other side. NDC 68462-104-30 Bottles of 30 NDC 68462-104-10 Bottles of 1000

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

FLUCONAZOLE- FLUCONAZOLE TABLET
DISPENSING SOLUTIONS, INC.
----------
FLUCONAZOLE TABLETS USP
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-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 USP is a white crystalline solid which is slightly soluble
in water and saline.
Fluconazole tablets USP contain 50, 100, 150, or 200 mg of fluconazole
USP and the following
inactive ingredients: croscarmellose sodium, dibasic calcium phosphate
anhydrous, FD&C Red No. 40
aluminum lake dye, magnesium stearate, microcrystalline cellulose and
povidone.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS AND METABOLISM
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Pharmacokinetics in Children
In children, the following pharmacokinetic data {Mean (%cv)} have been
reported:
Age
Studied
Dose
(mg/kg)
Clearance
(mL/min/kg)
Half-life
(Hours)
C
(μg/mL)
V dss
(L/kg)
9 Months-
13 years
Single-
Oral 2
mg/kg
0.40 (38%)
N=14
25.0
2.9 (22%)
N=16
------
9 Months-
13 years
Single-
Oral 8
mg/kg
0.51 (60%)
N=15
19.5
9.8 (20%)
N=15
------
1
13
12
2
6
max
5-15 years
Multiple
IV 2
mg/kg
0.49 (40%)
N=4
17.4
5.5 (25%)
N=5
0.722
(36%)
N=4
5-15 years
Multiple
IV 4
mg/kg
0.59 (64%)
N=5
15.2
11.4
(44%)
N=6
0.729
(33%)
N=5
5-15 years
Multiple
IV 8
mg/kg
0.66 (31%)
N=7
17.6
14.1
(22%)
N=8
1.069
(37%)
N=7
Clearance corrected for body weight was not affected by age in these
studies. Mean body clearance in
adults is reported to be 0.23 (17%) mL/min/kg.
In premature newborns (gestational age 26 to 29 weeks), the mean (%cv)
clearance within 36 hours of
birth was 0.180 (35%, N=7) mL/min/kg, which increased with time to a
mean of 0.218 (31