ANCOBON- flucytosine capsule
Valeant Pharmaceuticals North America LLC
WARNING
Use with extreme caution in patients with impaired renal function. Close monitoring of hematologic, renal and hepatic status of all patients is essential. These instructions should be thoroughly reviewed before administration of Ancobon.
DESCRIPTION
Ancobon (flucytosine), an antifungal agent, is available as 250 mg and 500 mg capsules for oral administration. Each capsule also contains corn starch, lactose and talc. Gelatin capsule shells contain parabens (butyl, methyl, propyl) and sodium propionate, with the following dye systems: 250 mg capsules black iron oxide, FD&C Blue No. 1, FD&C Yellow No. 6, D&C Yellow No. 10 and titanium dioxide; 500 mg capsules black iron oxide and titanium dioxide. Chemically, flucytosine is 5-fluorocytosine, fluorinated pyrimidine which is related to fluorouracil and floxuridine. It is white to off-white crystalline powder with molecular weight of 129.09
Mechanism of Action
Flucytosine is taken up by fungal organisms via the enzyme cytosine permease. Inside the fungal cell, flucytosine is rapidly converted to fluorouracil by the enzyme cytosine deaminase. Fluorouracil exerts its antifungal activity through the subsequent conversion into several active metabolites, which inhibit protein synthesis by being falsely incorporated into fungal RNA or interfere with the biosynthesis of fungal DNA through the inhibition of the enzyme thymidylate synthetase.
ANCOBON Indications and USAge
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.
Ancobon should be used in combination with amphotericin for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to Ancobon
WARNINGS
Ancobon must be given with extreme caution to patients with impaired renal function
Ancobon must be given with extreme caution to patients with bone marrow depression.
PRECAUTIONS
General
Before therapy with Ancobon is instituted, electrolytes (because of hypokalemia) and the hematologic and renal status of the patient should be determined
Drug Interactions
Cytosine arabinoside, cytostatic agent, has been reported to inactivate the antifungal activity of Ancobon by competitive inhibition. Drugs which impair glomerular filtration may prolong the biological half-life of flucytosine.
Pregnancy
Teratogenic Effects. Pregnancy Category C
DOSAGE AND ADMINISTRATION
The usual dosage of Ancobon is 50 to 150 mg/kg/day administered in divided doses at 6-hour intervals. Nausea or vomiting may be reduced or avoided if the capsules are given few at time over 15-minute period. If the BUN or the serum creatinine is elevated, or if there are other signs of renal impairment, the initial dose should be at the lower leve
Ancobon should be used in combination with amphotericin for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to Ancobon
Capsules, 250 mg (gray and green), imprinted ANCOBON? 250 ICN, bottles of 100 (NDC 0187-3554-10). Capsules 500 mg (gray and white), imprinted ANCOBON? 500 ICN, bottles of 100 (NDC 0187-3555-10).
Store at 25?C (77?F); excursions permitted to 15?C 30?C (59?F 86?F).