Rx Item-Ancobon 250MG 100 CAP-KEEP REFRIG- by Valeant Pharma USA

Rx Item-Ancobon 250MG flucytosine ORAL 100 CAP-Keep Refrigerated - by Valeant Pharma USA

Rx Item-Ancobon 250MG 100 CAP-Keep Refrigerated - by Valeant Pharma USA, Item No. RX096891, 096891, NDC No.: 00187-3554-10, 00187-554-10, 0018755410, 00187355410, 3554-10, 355410 UPC No. 3-01873-55410-3, 301873-554103, 301873554103, Category:RX, Brand Drug Classification: Anti-Infectives-Antifungals Drug Class: Drug Class: 8143200 PYRIMIDINE ANTIFUNGALSBrand/generic: BRAND Other Names: Flucytosine, Ancobon, Flucytosine

Part Number: RX096891

Feature: Drug Class: Drug Class: : 8143200 PYRIMIDINE ANTIFUNGALS

Feature: OMP Family:

Feature: Temparature Zone: 30 Refrige./DoNot Freez

Feature: Unit Dose Indicator: NO

Feature 5 Item Size: 100

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Description
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Clinical Information

Gen. Code and Des.

9542 flucytosine ORAL CAPSULE 250 MG

GCN and Des.

42560 flucytosine ORAL CAPSULE 250 MG

Strength

250MG

Dose Form

CAPSULE

Product Category

RX Pharmaceuticals

Fine Line Class

850085008510 All Rx Products

DEA Class

OMP Family

AHFS Class

8143200 PYRIMIDINE ANTIFUNGALS

Active Ingredients

2898 flucytosine 2022857

Inactive Ingredients

10138 blue dye

10143 yellow dye

2432 lactose 64044515

2549 gelatin 9000708

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).

Rx Item-Ancobon 250MG flucytosine ORAL 100 CAP-Keep Refrigerated - by Valeant Pharma USA

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