FLUCONAZOLE- fluconazole tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Preferred Pharmaceuticals, Inc.

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Fluconazole Tablets USP are indicated for the treatment of: 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 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 patie

Ապրանքի ամփոփագիր:

Fluconazole Tablets USP, 150 mg are available as pink, modified oval-shaped, unscored tablets, debossed “5412” on one side and “150” on the other side. Blister Pack of 1- 68788-9926-1 Bottle of 2 - 68788-9926-2 Bottle of 12 - 68788-9926-12 Fluconazole Tablets USP, 200 mg are available as pink, modified oval-shaped, unscored tablets, debossed “5413” on one side and “200” on the other side. Bottles of 1 - 68788-9927-0 Bottles of 2 - 68788-9927-5 Bottles of 10 - 68788-9927-1 Bottles of 20 - 68788-9927-2 Bottles of 30 - 68788-9927-3 Bottles of 60 - 68788-9927-6 Bottles of 90 - 68788-9927-9 Store at 20˚ to 25˚C (68˚ to 77˚F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Տեղեկատվական թերթիկ

FLUCONAZOLE- FLUCONAZOLE TABLET
Preferred Pharmaceuticals, Inc.
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MEDICATION GUIDE
Fluconazole Tablets USP
This leaflet contains important information about fluconazole
(floo-KON-a-zole). It is not meant to take
the place of your doctor's instructions. Read this information
carefully before you take fluconazole. Ask
your doctor or pharmacist if you do not understand any of this
information or if you want to know more
about fluconazole.
What Is Fluconazole?
Fluconazole is a tablet you swallow to treat vaginal yeast infections
caused by a yeast called Candida.
Fluconazole helps stop too much yeast from growing in the vagina so
the yeast infection goes away.
Fluconazole is different from other treatments for vaginal yeast
infections because it is a tablet taken by
mouth. Fluconazole is also used for other conditions. However, this
leaflet is only about using
fluconazole for vaginal yeast infections. For information about using
fluconazole 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 symptoms:
•
itching
•
a burning feeling when you urinate
•
redness
•
soreness
•
a thick white vaginal discharge th

Ապրանքի հատկությունները

FLUCONAZOLE- FLUCONAZOLE TABLET
PREFERRED PHARMACEUTICALS, INC.
----------
FLUCONAZOLE TABLETS USP
5410
5411
5412
5413
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(1H-1,2,4-triazol-1-ylmethyl)
benzyl alcohol and has the following structural formula:
C H F N O M.W. 306.27
Fluconazole, USP is a white crystalline solid which is slightly
soluble in water and saline.
Fluconazole Tablets USP, for oral administration, contain 50, 100,
150, or 200 mg of fluconazole, USP
and have the following inactive ingredients: colloidal silicon
dioxide, corn starch, croscarmellose
sodium, FD&C red #40 aluminum lake, lactose monohydrate, magnesium
stearate, microcrystalline
cellulose, and talc.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS AND METABOLISM
The pharmacokinetic properties of fluconazole are similar following
administration by the intravenous
13
12
2
6
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 mcg/mL (range: 4.12 to 8.08 mcg/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.
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 not affected by fo