Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Flucytosine capsules, USP are supplied as capsules containing 250 mg and 500 mg flucytosine as follows: NDC Strength Quantity Description 23155-860-03 250 mg Bottles of 30 Green opaque cap imprinted in black with "FLU" and grey opaque body imprinted in black with "250" 23155-860-01 250 mg Bottles of 100 Green opaque cap imprinted in black with "FLU" and grey opaque body imprinted in black with "250" 23155-861-03 500 mg Bottles of 30 Grey opaque cap imprinted in black with "FLU" and white opaque body imprinted in black with "500" 23155-861-01 500 mg Bottles of 100 Grey opaque cap imprinted in black with "FLU" and white opaque body imprinted in black with "500" Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Manufactured by: Strides Pharma Science Limited Bengaluru - 562106, India Manufactured for: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) Revised: 04/2023 AvetLogo; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 23155-860-03 Rx only Flucytosine Capsules, USP 250 mg 250 mg - 30s count; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 23155-861-01 Rx only Flucytosine Capsules, USP 500 mg 500 mg - 100s count
- HOW SUPPLIED Flucytosine capsules, USP are supplied as capsules containing 250 mg and 500 mg flucytosine as follows: NDC Strength Quantity Description 23155-860-03 250 mg Bottles of 30 Green opaque cap imprinted in black with "FLU" and grey opaque body imprinted in black with "250" 23155-860-01 250 mg Bottles of 100 Green opaque cap imprinted in black with "FLU" and grey opaque body imprinted in black with "250" 23155-861-03 500 mg Bottles of 30 Grey opaque cap imprinted in black with "FLU" and white opaque body imprinted in black with "500" 23155-861-01 500 mg Bottles of 100 Grey opaque cap imprinted in black with "FLU" and white opaque body imprinted in black with "500" Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Manufactured by: Strides Pharma Science Limited Bengaluru - 562106, India Manufactured for: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) Revised: 04/2023 AvetLogo
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 23155-860-03 Rx only Flucytosine Capsules, USP 250 mg 250 mg - 30s count
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 23155-861-01 Rx only Flucytosine Capsules, USP 500 mg 500 mg - 100s count
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, each capsule contains, corn starch, lactose monohydrate, and talc. The 250 mg capsule shell contains black iron oxide, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6, gelatin and titanium dioxide. The 500 mg capsule shell contains black iron oxide, gelatin and titanium dioxide. The imprinting ink Tekprint™ SW-9008 Black contains, black iron oxide, potassium hydroxide, propylene glycol and shellac. Chemically, flucytosine is 5-fluorocytosine, a fluorinated pyrimidine which is related to fluorouracil and floxuridine. It is a white to off-white powder with a molecular weight of 129.09 and the following structural formula: FDA approved dissolution specification differs from the USP dissolution specification. structural 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 capsules (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 capsules (see MICROBIOLOGY ).
Warnings & Precautions
WARNINGS Flucytosine capsules must be given with extreme caution to patients with impaired renal function. Since flucytosine capsules are excreted primarily by the kidneys, renal impairment may lead to accumulation of the drug. Flucytosine capsules 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 capsules 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 capsules are 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 capsules 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 Capsules, 250 mg and 500 mg.
Contraindications
Flucytosine capsule is contraindicated in patients with a known hypersensitivity to the drug. Flucytosine capsule is 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 capsules are 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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or go to www.avetpharma.com.
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