Flucoral capsules
Product knowledge





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.






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%.

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.


Fluconazole was effective in patients with vaginal candidiasis.

In a population or 146 patients,97%were cured in a short term.

At follow-up several weeks later, clinical response was 88 %.
100
80
% response
60
40
20
Clinical
Mycological
0
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



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





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.

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


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

Overall clinical efficacy was:
69% in the group where
Fluconazole given I.V.
72% in the group where
Fluconazole given orally.

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 :

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.