Flucytosine 250 mg/1
Flucytosine · CAPSULE · AvPAK
Flucytosine is a capsule containing flucytosine at 250 mg/1, taken oral. Manufactured by AvPAK.
Key Facts
- Brand Name
- Flucytosine
- Generic Name
- Flucytosine
- NDC Code (Product)
50268-331- Manufacturer
- AvPAK
- Strength
- 250 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA204652
- Drug Class
- Nucleoside Analog Antifungal [EPC]
- Marketing Start
- 04/12/2021
Recall History
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Flucytosine Capsules USP 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. Flucytosine Capsules USP 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 USP (See MICROBIOLOGY ).
Dosage & Administration
DOSAGE AND ADMINISTRATION The usual dosage of Flucytosine Capsules USP 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 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 USP 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 USP (See MICROBIOLOGY ).
Warnings
WARNINGS Flucytosine Capsules USP must be given with extreme caution to patients with impaired renal function. Since Flucytosine Capsules USP is excreted primarily by the kidneys, renal impairment may lead to accumulation of the drug. Flucytosine Capsules USP 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 USP 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 …
Contraindications
CONTRAINDICATIONS Flucytosine Capsules, USP is contraindicated in patients with a known hypersensitivity to the drug. Flucytosine Capsules, USP is contraindicated in patients with known complete dihydropyrimidine dehydrogenase (DPD) enzyme deficiency (see WARNINGS ).
Drug Interactions
Drug Interactions Cytosine arabinoside, a cytostatic agent, has been reported to inactivate the antifungal activity of Flucytosine Capsules USP by competitive inhibition. Drugs which impair glomerular filtration may prolong the biological half-life of flucytosine.
Adverse Reactions
ADVERSE REACTIONS The adverse reactions which have occurred during treatment with Flucytosine Capsules USP 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 s…
Frequently Asked Questions
What is Flucytosine used for?
Flucytosine contains Flucytosine. It is a capsule taken oral. Consult your doctor for specific uses.
Is Flucytosine a controlled substance?
Flucytosine is not classified as a controlled substance by the DEA.
What is the generic name for Flucytosine?
The generic name for Flucytosine is Flucytosine. There are 3 other brand versions of Flucytosine.
What is the NDC code for Flucytosine 250 mg/1?
The NDC (National Drug Code) for Flucytosine 250 mg/1 is 50268-331, listed by AvPAK.