FLUCONAZOLE tablet FLUCONAZOLE powder, for suspension

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Physicians Total Care, Inc.

INN (Միջազգային անվանումը):

FLUCONAZOLE

Կազմը:

FLUCONAZOLE 100 mg

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Fluconazole is 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 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. Fluconazole 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 organi

Ապրանքի ամփոփագիր:

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. Fluconazole Tablets are supplied as follows: Fluconazole 50 mg Tablets: Embossed with "FLZ 50" on one side with no markings on the other side. Fluconazole 100 mg Tablets: Embossed with "FLZ 100" on one side with no markings on the other side.   NDC 54868-5345-4        Bottles of 1   NDC 54868-5345-7        Bottles of 3   NDC 54868-5345-6        Bottles of 4   NDC 54868-5345-1        Bottles of 7   NDC 54868-5345-8        Bottles of 8   NDC 54868-5345-0        Bottles of 10   NDC 54868-5345-3        Bottles of 15   NDC 54868-5345-2        Bottles of 30 Fluconazole 150 mg Tablets: Embossed with "FLZ 150" on one side with no markings on the other side.   NDC 54868-5129-0        Bottles of 1   NDC 54868-5129-3        Bottles of 2   NDC 54868-5129-4        Bottles of 3   NDC 54868-5129-5        Bottles of 4   NDC 54868-5129-2        Bottles of 5   NDC 54868-5129-1        Bottles of 12 Fluconazole 200 mg Tablets: Embossed with "FLZ 200" on one side with no markings on the other side.   NDC 54868-5144-1        Bottles of 1   NDC 54868-5144-2        Bottles of 3   NDC 54868-5144-5        Bottles of 7   NDC 54868-5144-7        Bottles of 8   NDC 54868-5144-0        Bottles of 10   NDC 54868-5144-3        Bottles of 14   NDC 54868-5144-4        Bottles of 20   NDC 54868-5144-6        Bottles of 30 Storage: Store tablets below 86°F (30°C). Fluconazole for Oral Suspension is supplied as an orange-flavored powder to provide 35 mL per bottle as follows:   NDC 54868-5248-0        Fluconazole 350 mg per bottle   NDC 54868-6116-0        Fluconazole 1400 mg per bottle Storage: Store dry powder below 86°F (30°C). Store reconstituted suspension between 86°F (30°C) and 41°F (5°C) and discard unused portion after 2 weeks. Protect from freezing.

Լիազորման կարգավիճակը:

New Drug Application Authorized Generic

Ապրանքի հատկությունները

FLUCONAZOLE - FLUCONAZOLE TABLET
FLUCONAZOLE - FLUCONAZOLE POWDER, FOR SUSPENSION
PHYSICIANS TOTAL CARE, INC.
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FLUCONAZOLE
FLUCONAZOLE TABLETS
FLUCONAZOLE FOR ORAL SUSPENSION
DESCRIPTION
Fluconazole, the first of a new subclass of synthetic triazole
antifungal agents, is available as tablets for
oral administration and 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.
Fluconazole Tablets contain 50, 100, 150, 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.
Fluconazole 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
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 (Cmax) in fasted normal volunteers occur
between 1 and 2 hours with a
terminal plasma elimination half-life of approximately 30 hours
(range: 20–50 hours) after oral
administration.
In fasted normal volunteers, administration of a single o