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Flucoral capsules

Flucoral capsules

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Flucoral capsules

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  1. Flucoral capsules Product knowledge

  2. Pharmacokinetics of fluconazole • 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.

  3. 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%.

  4. 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.

  5. Vaginal Candidiasis • 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 %.

  6. 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

  7. 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)

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.