Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Flucytosine capsules, USP are supplied as capsules containing 250 mg and 500 mg flucytosine as follows: 250 mg: Green opaque/grey opaque size ‘2’ hard gelatin capsules imprinted with ‘LL’ on cap and ‘250’ on body with black ink, filled with white to off-white granular powder. Bottles of 100 42385-983-01 Carton with 100 (10 x 10) Unit-Dose Capsules containing PVC/PE/PVDC blisters 42385-983-27 500 mg: Grey opaque/White opaque size ‘0’ hard gelatin capsules imprinted with ‘LL’ on cap and ‘500’ on body with black ink, filled with white to off-white granular powder. Bottles of 100 42385-984-01 Carton with 100 (10 x 10) Unit-Dose Capsules containing PVC/PE/PVDC blisters 42385-984-27 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.] Manufactured for: Laurus Generics Inc. 400 Connell Drive Suite 5200 Berkeley Heights, NJ 07922 Manufactured by: Laurus Labs Limited Anakapalli-531011 India Revised: 5/2024; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL- 250 mg- Container Label (100's Count) NDC 42385-983-01 Flucytosine Capsules, USP 250 mg 100 Capsules Rx only Laurus Labs flucytosine-figure-1.jpg; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-250 mg-Blister-1x10's count (PVC/PE/PVDC) Rx only NDC 42385-983-10 Flucytosine Capsule, USP 250 mg LAURUS LABS figure-2; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-250 mg-Blister Carton-100 (10 x 10) Unit-Dose Capsules NDC 42385-983-27 Flucytosine Capsules, USP 250 mg For institution use only 100 (10x10) Unit-Dose Capsules Rx only LAURUS LABS flucytosine-figure-3.jpg; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL- 500 mg- Container Label (100's Count) NDC 42385-984-01 Flucytosine Capsules, USP 500 mg 100 Capsules Rx only LAURUS Labs flucytosine-figure-4.jpg; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-500 mg-Blister-1x10's count (PVC/PE/PVDC) Rx only NDC 42385-984-10 Flucytosine capsule, USP 500 mg LAURUS LABS figure-5; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-500 mg-Blister Carton-100 (10 x 10) Unit-Dose Capsules NDC 42385-984-27 Flucytosine Capsules, USP 500 mg For institution use only 100 (10x10) Unit-Dose Capsules Rx only LAURUS LABS flucytosine-figure-6.jpg
- HOW SUPPLIED Flucytosine capsules, USP are supplied as capsules containing 250 mg and 500 mg flucytosine as follows: 250 mg: Green opaque/grey opaque size ‘2’ hard gelatin capsules imprinted with ‘LL’ on cap and ‘250’ on body with black ink, filled with white to off-white granular powder. Bottles of 100 42385-983-01 Carton with 100 (10 x 10) Unit-Dose Capsules containing PVC/PE/PVDC blisters 42385-983-27 500 mg: Grey opaque/White opaque size ‘0’ hard gelatin capsules imprinted with ‘LL’ on cap and ‘500’ on body with black ink, filled with white to off-white granular powder. Bottles of 100 42385-984-01 Carton with 100 (10 x 10) Unit-Dose Capsules containing PVC/PE/PVDC blisters 42385-984-27 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.] Manufactured for: Laurus Generics Inc. 400 Connell Drive Suite 5200 Berkeley Heights, NJ 07922 Manufactured by: Laurus Labs Limited Anakapalli-531011 India Revised: 5/2024
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL- 250 mg- Container Label (100's Count) NDC 42385-983-01 Flucytosine Capsules, USP 250 mg 100 Capsules Rx only Laurus Labs flucytosine-figure-1.jpg
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-250 mg-Blister-1x10's count (PVC/PE/PVDC) Rx only NDC 42385-983-10 Flucytosine Capsule, USP 250 mg LAURUS LABS figure-2
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-250 mg-Blister Carton-100 (10 x 10) Unit-Dose Capsules NDC 42385-983-27 Flucytosine Capsules, USP 250 mg For institution use only 100 (10x10) Unit-Dose Capsules Rx only LAURUS LABS flucytosine-figure-3.jpg
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL- 500 mg- Container Label (100's Count) NDC 42385-984-01 Flucytosine Capsules, USP 500 mg 100 Capsules Rx only LAURUS Labs flucytosine-figure-4.jpg
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-500 mg-Blister-1x10's count (PVC/PE/PVDC) Rx only NDC 42385-984-10 Flucytosine capsule, USP 500 mg LAURUS LABS figure-5
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-500 mg-Blister Carton-100 (10 x 10) Unit-Dose Capsules NDC 42385-984-27 Flucytosine Capsules, USP 500 mg For institution use only 100 (10x10) Unit-Dose Capsules Rx only LAURUS LABS flucytosine-figure-6.jpg
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 5-Fluorocytosine (Flucytosine) USP, each capsule contains colloidal silicon dioxide, lactose monohydrate, maize starch B, sodium starch glycolate and talc. The 250 mg capsule shell contains D&C Yellow 10, FD&C Blue 1, FD&C Yellow 6, gelatin, iron oxide black and titanium dioxide. The 500 mg capsule shell contains gelatin, iron oxide black and titanium dioxide. The capsules are printed with edible ink containing black iron oxide, shellac and potassium hydroxide. Chemically, flucytosine is 4-Amino-5-fluoropyrimidin-2(1 H )-one; Cytosine, 5-fluoro-. It is a white to off white crystalline solid with a molecular weight of 129.09 g/mol and the following structural formula: FDA approved dissolution test specifications differ from the USP. flucytosine-structure
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
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 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. To report SUSPECTED ADVERSE REACTIONS, contact Laurus Generics Inc. at 1-833-3-LAURUS (1-833-352-8787) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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