Each capsule
contains:
Fluconazole ........................150 mg.
Or
Fluconazole...........................50 mg.
Properties:
►Fluconazole
is a diflurophenyl bis triazole tertiary
alcohol which has a broad spectrum
antifungal activity.
►Flucoral is
very well absorbed from the GIT even in the
presence of food, antacids or H2 receptor
antagonist pretreatment.
►After oral
administration plasma levels are nearly as
high as intravenous administration.
►Flucoral is
widely distributed in tissues & body fluids.
►Concentrations
in c.s.f,saliva,sputum, vaginal fluid
approximate those attained in the plasma.
►Oral
bioavailability exceeds 90% in contrast to
other anoles antifungal which are highly
protein bound.
►Flucoral is
only 11% protein bound.
►The drug is
excreted mainly in the urine.
►Elimination
half-life is approximately 30 hours.
Indications:
►Oropharyngeal,esophageal
& vaginal Candidiasis.
►Fungal
infections of the skin & nail due to Candida
or dermatophytes.
►Serious
systemic candidal infections including,
urinary tract
infections,peritonitis,penurhonia &
Cryptococcus meningitis.
►For the
prophylaxis of fungal infections in
immuno-compromised patients.
Flucoral
and C.albicans:
Contraindications:
Is
contraindicated in patients who have shown
hypersensitivity to Fluconazole or in case
of acute impaired liver functions.
Precautions:
►In
patients who develop liver function
abnormalities or skin rash treatment should
be discontinued.
►Flucoral
may be used in pregnancy only in life
threatening infections and if the potential
benefit justifies the possible risk to the
fetus. The use of Flucoral in nursing
mothers is not recommended
Dosage and administration:
►Vaginal
Candidacies : single oral dose of 150 mg
( one capsule) is given.
►Coetaneous
fungal infections : same as above, &
treatment is repeated after one week. A
third or fourth dose on the third or fourth
week may be needed in very few cases.
►Pharyngeal &
Esophageal Candidacies : A daily dose of 150
mg (one capsule) is given.
►Serious
systemic Candidacies & Cryptococcus
meningitis : Start with a loading dose of
2-3 capsules is given i.e. 300-450 ml. The a
daily therapy of 1-2 capsules 150 - 300 mg ,
treatment is continued according to
response.
N.B
►In patients
with impaired renal functions : full dosage
of creatinine clearance exceeds 0.8 ml/sec
is recommended.
►Half dosage if
creatinine clearance is 0.35 - 0.8 ml/sec is
recommended.
►One quarter
dosage if creatinine clearance is 0.18 -
0.35 ml/sec is recommended.
Side effects::
Flucoral is
very well tolerated, nausea, headache,
abdominal discomfort may occur. Occasionally
abnormalities of liver enzymes. As with
other anoles anaphylaxis has been rarely
reported.
Storage:
Keep at temperature not exceeding 30°C
Packing:
Box of 2
capsules.(150 mg Fluconazole)
Box of 6 capsules. (50 mg Fluconazole)
