ANCOBON SUMMARY
ANCOBON® (flucytosine) CAPSULES
Ancobon (flucytosine), an antifungal agent, is available as 250-mg and 500-mg capsules for oral administration.
Ancobon is indicated only in the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus.
Candida:
Septicemia, endocarditis and urinary system infections have been effectively treated with flucytosine. Limited trials in pulmonary infections justify the use of flucytosine.
Cryptococcus:
Meningitis and pulmonary infections have been treated effectively. Studies in septicemias and urinary tract infections are limited, but good responses have been reported.
With the exception of urinary tract infection, Ancobon should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of rapid emergence of resistance to Ancobon in Candida and Cryptococcus isolates in patients receiving Ancobon alone.
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NEWS HIGHLIGHTS
Published Studies Related to Ancobon (Flucytosine)
High-dose amphotericin B with flucytosine for the treatment of cryptococcal meningitis in HIV-infected patients: a randomized trial. [2008.07.01] BACKGROUND: The standard therapy for human immunodeficiency virus (HIV)-associated cryptococcal meningitis of amphotericin B (AmB; 0.7 mg/kg per day) plus flucytosine frequently takes >2 weeks to sterilize the cerebral spinal fluid, and acute mortality remains high. A dosage range for AmB of 0.7-1 mg/kg per day is noted in current guidelines, but there are no data comparing 0.7 mg/kg per day with 1 mg/kg per day... CONCLUSIONS: AmB, 1 mg/kg per day, plus flucytosine is more rapidly fungicidal than is standard-dose AmB plus flucytosine. Because of its size, this study provides limited data on any difference in toxicity between the regimens, but toxicities were manageable and reversible. CLINICAL TRIALS REGISTRATION NUMBER: ISRCTN68133435 (http://www.controlled-trials.com).
Oral versus intravenous flucytosine in patients with human immunodeficiency virus-associated cryptococcal meningitis. [2007.03] In a randomized controlled trial of amphotericin B-based therapy for human immunodeficiency virus (HIV)-associated cryptococcal meningitis in Thailand, we also compared the mycological efficacy, toxicity, and pharmacokinetics of oral versus intravenous flucytosine at 100 mg/kg of body weight/day for the initial 2 weeks...
Oral versus intravenous flucytosine in patients with HIV-associated cryptococcal meningitis. [2006.12.28] In a randomized controlled trial of amphotericin B based therapy for HIV-associated cryptococcal meningitis in Thailand, we also compared the mycological efficacy, toxicity, and pharmacokinetics of oral versus intravenous flucytosine at 100 mg/kg/d for the initial 2 weeks... Concentrations of flucytosine with intravenous formulation at 100 mg/kg/d may be in excess of those required for maximal fungicidal activity.
Early empiric antifungal therapy of infections in neutropenic patients comparing fluconazole with amphotericin B/flucytosine. [1999] We compared the efficacy and tolerability of fluconazole (FCA) with amphotericin B/flucytosine (ABF) in neutropenic patients with haematological malignancies. Antifungal therapy started on day 4 when fever was unresponsive to antibiotics or on day 1 together with the antibiotics, if there was evidence of mycosis...
Combination therapy with fluconazole and flucytosine for cryptococcal meningitis in Ugandan patients with AIDS. [1998.06] We performed a randomized trial in which combination therapy with fluconazole and short-term flucytosine was compared with fluconazole monotherapy in 58 patients with AIDS-associated cryptococcal meningitis (CM). Thirty of these patients were randomized to receive combination therapy with fluconazole, 200 mg once a day for 2 months, and flucytosine, 150 mg/(kg.d) for the first 2 weeks, and 28 were randomized to receive monotherapy with fluconazole at the same dose for 2 months...
Clinical Trials Related to Ancobon (Flucytosine)
A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis. [Completed]
To evaluate and estimate the safety and efficacy of the combination of fluconazole and
flucytosine as treatment for acute cryptococcal meningitis in patients with AIDS.
Fluconazole and flucytosine have different mechanisms of action. Since fluconazole has not
been associated with hematologic suppression and does not produce renal impairment that can
result in higher serum flucytosine levels, this combination may be better tolerated than is
amphotericin B plus flucytosine.
A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis [Completed]
To evaluate the effectiveness and safety of amphotericin B plus flucytosine
(5-fluorocytosine) compared to amphotericin B alone for a first episode of acute cryptococcal
meningitis in AIDS patients, and to compare the effectiveness and safety of fluconazole
versus itraconazole.
At least 10 percent of patients with a low CD4 count and HIV infection will develop
meningitis due to Cryptococcus neoformans. More effective treatments than the standard
therapy need to be explored.
Trial of TG4023 Combined With Flucytosine in Liver Tumors [Recruiting]
This trial is a phase I, open-label, dose-escalating study of the safety or percutaneous
intra-tumoral injection of TG4023 (MVA-FCU1) combined with systemic administration of
5-fluorocytosine in patients with primary or secondary hepatic tumors.
Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis [Completed]
To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in
combination with flucytosine, as treatment for acute cryptococcal meningitis.
A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis [Completed]
To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in
combination with flucytosine, as treatment for acute cryptococcal meningitis.
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