FLUCONAZOLE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Fluconazole (UNII: 8VZV102JFY) (Fluconazole - UNII:8VZV102JFY)

Available from:

Taro Pharmaceuticals U.S.A., Inc.

INN (International Name):

Fluconazole

Composition:

Fluconazole 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluconazole Tablet, USP 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. Prophylaxis. 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 i

Product summary:

Pink rectangular tablets with rounded edges containing 50, 100, 150 or 200 mg of fluconazole are packaged in bottles or unit dose blisters and are supplied as follows: Fluconazole Tablets USP, 50 mg: Engraved with "FL50" on one side and "TARO" on the other side. Fluconazole Tablets USP, 100 mg: Engraved with "FL100" on one side and "TARO" on the other side. Fluconazole Tablets USP, 150 mg: Engraved with "FL150" on one side and "TARO" on the other side. Fluconazole Tablets USP, 200 mg: Engraved with "FL200" on one side and "TARO" on the other side. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FLUCONAZOLE- FLUCONAZOLE TABLET
Taro Pharmaceuticals U.S.A., Inc.
----------
PATIENT INFORMATION
Fluconazole Tablets, USP
This leaflet contains important information about Fluconazole Tablets,
USP. It is not meant to take the
place of your doctor's instructions. Read this information carefully
before you take Fluconazole Tablets,
USP. Ask your doctor or pharmacist if you do not understand any of
this information or if you want to
know more about Fluconazole Tablets, USP.
What is Fluconazole Tablets, USP?
Fluconazole Tablets, USP is a tablet you swallow to treat vaginal
yeast infections caused by a yeast called
Candida. Fluconazole Tablets, USP helps stop too much yeast from
growing in the vagina so the yeast
infection goes away.
Fluconazole Tablets, USP is different from other treatments for
vaginal yeast infections because it is a
tablet taken by mouth. Fluconazole Tablets, USP is also used for other
conditions. However, this leaflet is
only about using Fluconazole Tablets, USP for vaginal yeast
infections. For information about using
Fluconazole Tablets, USP for other reasons, ask your doctor or
pharmacist. See the section of this leaflet
for information about vaginal yeast infections.
What is a Vaginal Yeast Infection?
It is normal for a certain amount of yeast to be found in the vagina.
Sometimes too much yeast starts to
grow in the vagina and this can cause a yeast infection. Vaginal yeast
infections are common. About three
out of every four adult women will have at least one vaginal yeast
infection during their life.
Some medicines and medical conditions can increase your chance of
getting a yeast infection. If you are
pregnant, have diabetes, use birth control pills, or take antibiotics
you may get yeast infections more often
than other women. Personal hygiene and certain types of clothing may
increase your chances of getting a
yeast infection. Ask your doctor for tips on what you can do to help
prevent vaginal yeast infections.
If you get a vaginal yeast infection, you may have any of the
following sympto

Summary of Product characteristics

FLUCONAZOLE- FLUCONAZOLE TABLET
TARO PHARMACEUTICALS U.S.A., INC.
----------
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 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, USP contain 50, 100, 150, or 200 mg of
fluconazole and the following inactive
ingredients: colloidal silicon dioxide, D&C Red No. 6 Lake, dibasic
calcium phosphate anhydrous,
FD&C Red No. 40 Lake, magnesium stearate, microcrystalline cellulose,
sodium lauryl sulfate and
sodium starch glycolate.
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.
In fasted normal volunteers, administration of a single oral 400 mg
dose of fluconazole leads to a mean
C
of 6.72 µg/mL (range: 4.12 to 8.08 µg/mL) and after single oral
doses of 50 to 400 mg,
fluconazole plasma concentrations and AUC (area under the plasma
concentration-time curve) are dose
proportional.
1
13
12
2
6
max
max
The C
and AUC data from a food-effect study involving administration of
fluconazole tablets, USP
to healthy volunteers under fasting conditions and with a high-fat
meal indicated that