Transcript Flucoral capsules

Flucoral capsules
Product knowledge
Pharmacokinetics of
fluconazole
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Distribution of Fluconazole is extensive
and even throughout tissues.
The high polarity of Fluconazole
increases its absorption.
Fluconazole achieves high
concentrations in CSF, saliva, sputum,
peritoneal fluid, vaginal tissues, skin,
nails and blister fluid.
The bioavailability of both oral &
intravenous preparations is extremely
high.
Pharmacokinetics of
fluconazole
Rapid & high oral absorption up to
90%.
 Absorption unaffected by food
 Long plasma half-life up to 30
hours.
 High urinary excretion of
unchanged drugs.
 Low plasma protein binding up to
12%.
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Vaginal Candidiasis
Clinical trial:
 Vaginal candidiasis is a very common
reason for gynecology consultation.
 Vaginal candidiasis has traditionally
treated with vaginal pessaries or
creams.
 New imidazoles derivatives, such as
miconazole has resulted in shorter
treatment periods without
compromising the results.
Vaginal Candidiasis
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Fluconazole was effective in patients with vaginal candidiasis.
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In a population or 146 patients,97%were cured in a short
term.
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At follow-up several weeks later, clinical response was 88 %.
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Short term Long term
Efficacy of oral fluconazole 150 mg single oral dose
Vaginal Candidiasis
Systemic treatment with oral Fluconazole:
 52 patients were affected by persistent
vulvo-vaginal candidiasis underwent
systemic therapy with oral Fluconazole
at a dose of 150 mg once a week for 3
weeks.
 31(59.61%) of the patients were cured
at the first control after therapy
 4 (7.69%) were lost at follow
Vaginal Candidiasis
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17 (32.69%) underwent a second cycle
of systemic therapy with complete
recovery confirmed at the further
controls.
The overall % of recoveries was
92.30%.
The results suggest that Fluconazole is
very effective in mycotic vulvovaginitis
with irrelevant side effects.
(Clin-Exp-Obstet Gynecol,1994)
Tinea corporis
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Successful treatment with Fluconazole
of Tinea corporis.
A student in veterinary program noted
an inflammatory tinea corporis on the
right forearm.
Culture grew Trichophyton verrucosum.
A six-day course of treatment with oral
Fluconazole,150 mg daily, resulted in
prompt resolution.
Therapy with newer antifungal agents
such as Fluconazole may offer
advantages over Griseofulvin.
Deep Mycoses
Fluconazole is an effective
antifungal drug for the treatment
of deep seted mycoses.
 In multicenter study;199 patients
with deep fungal infection were
administred Fluconazole in 41
hospitals in Japan.
 Of 125 the patients evaluable for
clinical efficacy.
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Deep Mycoses
Clinical trials:
 120 were classified as having moderate
or severe infection:
64 with candidiasis.
43 cases of aspergillosis.
13 cases of cryptococcosis.
 The evaluable patients were mostly
male and in the 50 to 70 years age
group,and 114 of them had and
underlying disease such as
cancer,Leukemia or AIDS.
 All patients exibiting candidiasis has an
underlying disease.
Deep Mycoses
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The starting dose of Fluconazole was 150
mg orally with graduate increases,where
indicated,up to a maximum of 450
mg/day.
Treatment lasted 7 days to 6 months or
longer.
Clinical cures were achived in: 88% of
patients with candidiasis.
69% of cryptococcosis cases.
44% of aspergillosis cases.
100% in one case each of mucomycosis &
fungemia due to an unspecified yeast.
Deep Mycoses
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Overall clinical efficacy was:
69% in the group where
Fluconazole given I.V.
72% in the group where
Fluconazole given orally.
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Both methods of administration
are effective.
Deep Mycoses
Side effects:
 Rash, nausea and fever were recorded
in 13 of 199 patients but most were not
severe.
 The major abnormalities including
elevations of liver enzymes such as
SGOT,SGPT,GCT and serum alkaline
phosphatase.
 These abnormalities were slight and
transient.
 The overall efficacy rate was just under
69% with particular effectiveness where
Amphotericin B had been used.
Flucoral capsules
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 capsules
Dosage :
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Vaginal Candidiasis : 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.
Oropharyngeal & Esophageal Candidiasis : A
daily dose of 150 mg (one capsule) is given.
Serious systemic Candidiasis & cryptococcal
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.