Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Flucytosine Capsules, USP 250 mg are grey opaque cap and green opaque body size ‘2’ hard gelatin capsules, imprinted FLU on cap and 250 on body filled with white to off white powder. Unit dose packages of 30 (3 x 10) NDC 60687-599-21 Flucytosine Capsules, USP 500 mg are grey opaque cap and white opaque body size ‘0’ hard gelatin capsules, imprinted FLU on cap and 500 on body filled with white to off white powder. Unit dose packages of 30 (3 x 10) NDC 60687-610-21 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken; Package/Label Display Panel – Carton – 250 mg NDC 60687- 599 -21 Flucytosine Capsules, USP 250 mg 30 Capsules (3 x 10) Rx Only Each Capsule Contains: Flucytosine USP..................................................................... 250 mg Usual Dosage: See full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 59651-331, Aurobindo Pharma USA, Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217 759921 0459901/1124 250 mg Flucytosine Tablets Cartons; Package/Label Display Panel – Blister – 250 mg Flucytosine Capsule, USP 250 mg 250 mg Flucytosine Tablet Blister; Package/Label Display Panel – Carton – 500 mg NDC 60687- 610 -21 Flucytosine Capsules, USP 500 mg 30 Capsules (3 x 10) Rx Only Each Capsule Contains: Flucytosine USP..................................................................... 500 mg Usual Dosage: See full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 59651-332, Aurobindo Pharma USA, Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217 761021 0461021/1124 500 mg Flucytosine Tablets Carton; Package/Label Display Panel – Blister – 500 mg Flucytosine Capsule, USP 500 mg 500 mg Flucytosine Tablet Blister
- HOW SUPPLIED Flucytosine Capsules, USP 250 mg are grey opaque cap and green opaque body size ‘2’ hard gelatin capsules, imprinted FLU on cap and 250 on body filled with white to off white powder. Unit dose packages of 30 (3 x 10) NDC 60687-599-21 Flucytosine Capsules, USP 500 mg are grey opaque cap and white opaque body size ‘0’ hard gelatin capsules, imprinted FLU on cap and 500 on body filled with white to off white powder. Unit dose packages of 30 (3 x 10) NDC 60687-610-21 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken
- Package/Label Display Panel – Carton – 250 mg NDC 60687- 599 -21 Flucytosine Capsules, USP 250 mg 30 Capsules (3 x 10) Rx Only Each Capsule Contains: Flucytosine USP..................................................................... 250 mg Usual Dosage: See full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 59651-331, Aurobindo Pharma USA, Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217 759921 0459901/1124 250 mg Flucytosine Tablets Cartons
- Package/Label Display Panel – Blister – 250 mg Flucytosine Capsule, USP 250 mg 250 mg Flucytosine Tablet Blister
- Package/Label Display Panel – Carton – 500 mg NDC 60687- 610 -21 Flucytosine Capsules, USP 500 mg 30 Capsules (3 x 10) Rx Only Each Capsule Contains: Flucytosine USP..................................................................... 500 mg Usual Dosage: See full prescribing information. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. The drug product contained in this package is from NDC # 59651-332, Aurobindo Pharma USA, Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217 761021 0461021/1124 500 mg Flucytosine Tablets Carton
- Package/Label Display Panel – Blister – 500 mg Flucytosine Capsule, USP 500 mg 500 mg Flucytosine Tablet Blister
Overview
Flucytosine Capsules USP, an antifungal agent, is available as 250 mg and 500 mg capsules for oral administration. In addition to the active ingredient of flucytosine USP, each capsule contains anhydrous lactose, gelatin, iron oxide black, potassium hydroxide, potato starch, shellac, silicon dioxide, talc and titanium dioxide. In addition, the 250 mg capsule shell contains D&C yellow 10, FD&C blue 1 and FD&C yellow 6. Chemically, flucytosine is 5-fluorocytosine, a fluorinated pyrimidine which is related to fluorouracil and floxuridine. It is a white or almost white crystalline powder with a molecular weight of 129.09 and the following structural formula: Structrual Formula
Indications & Usage
Flucytosine capsules are 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. Flucytosine capsules should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to flucytosine (see MICROBIOLOGY ).
Dosage & Administration
The usual dosage of flucytosine capsules are 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 a few at a time over a 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 level (see WARNINGS ). Flucytosine capsules should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to flucytosine (see MICROBIOLOGY ).
Warnings & Precautions
WARNINGS Flucytosine must be given with extreme caution to patients with impaired renal function. Since flucytosine is excreted primarily by the kidneys, renal impairment may lead to accumulation of the drug. Flucytosine serum concentrations should be monitored to determine the adequacy of renal excretion in such patients. Dosage adjustments should be made in patients with renal insufficiency to prevent progressive accumulation of active drug. Flucytosine must be given with extreme caution to patients with bone marrow depression. Patients may be more prone to depression of bone marrow function if they: 1) have a hematologic disease, 2) are being treated with radiation or drugs which depress bone marrow, or 3) have a history of treatment with such drugs or radiation. Bone marrow toxicity can be irreversible and may lead to death in immunosuppressed patients. Frequent monitoring of hepatic function and of the hematopoietic system is indicated during therapy. 5-Fluorouracil is a metabolite of flucytosine. Dihydropyrimidine dehydrogenase is a key enzyme involved in the metabolism and elimination of 5-fluorouracil. Therefore, the risk of severe drug toxicity is increased when flucytosine is used in individuals with deficiency in DPD. Possible drug toxicities include mucositis, diarrhea, neutropenia, and neurotoxicity. Determination of DPD activity may be considered where drug toxicity is confirmed or suspected. In the event of suspected drug toxicity, consider stopping flucytosine treatment.
Boxed 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 flucytosine.
Contraindications
Flucytosine capsules are contraindicated in patients with a known hypersensitivity to the drug. Flucytosine capsules are contraindicated in patients with known complete dihydropyrimidine dehydrogenase (DPD) enzyme deficiency (see WARNINGS ).
Adverse Reactions
The adverse reactions which have occurred during treatment with flucytosine is grouped according to organ system affected. Cardiovascular: Cardiac arrest, myocardial toxicity, ventricular dysfunction. Respiratory: Respiratory arrest, chest pain, dyspnea. Dermatologic: Rash, pruritus, urticaria, photosensitivity. Gastrointestinal: Nausea, emesis, abdominal pain, diarrhea, anorexia, dry mouth, duodenal ulcer, gastrointestinal hemorrhage, acute hepatic injury including hepatic necrosis with possible fatal outcome in debilitated patients, hepatic dysfunction, jaundice, ulcerative colitis, enterocolitis, bilirubin elevation, increased hepatic enzymes. Genitourinary: Azotemia, creatinine and BUN elevation, crystalluria, renal failure. Hematologic: Anemia, agranulocytosis, aplastic anemia, eosinophilia, leukopenia, pancytopenia, thrombocytopenia, and fatal cases of bone marrow aplasia. Neurologic: Ataxia, hearing loss, headache, paresthesia, parkinsonism, peripheral neuropathy, pyrexia, vertigo, sedation, convulsions. Psychiatric: Confusion, hallucinations, psychosis. Miscellaneous: Fatigue, hypoglycemia, hypokalemia, weakness, allergic reactions, Lyell’s syndrome. To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Drug Interactions
Cytosine arabinoside, a cytostatic agent, has been reported to inactivate the antifungal activity of flucytosine by competitive inhibition. Drugs which impair glomerular filtration may prolong the biological half-life of flucytosine.
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