Flucytosine (Flucytosine)

Trade Name : FLUCYTOSINE

Vensun Pharmaceuticals, Inc.

CAPSULE

Strength 500 mg/1

FLUCYTOSINE Nucleoside Analog [EXT],Nucleoside Analog Antifungal [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Flucytosine (Flucytosine) which is also known as FLUCYTOSINE and Manufactured by Vensun Pharmaceuticals, Inc.. It is available in strength of 500 mg/1 per ml. Read more

Flucytosine (Flucytosine) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

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, USP.

Flucytosine, 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 and talc. The 250mg capsule shell contains FD&C Blue 1, titanium dioxide, FD&C Yellow 6, D&C Yellow 10, gelatin, and water. The 500 mg capsule shell contains black iron oxide, titanium dioxide, gelatin, and water.n Chemically, flucytosine is 5-fluorocytosine, a fluorinated pyrimidine which is related to fluorouracil and floxuridine. It is a white to off-white crystalline powder with a molecular weight of 129.09 and the following structural formula:

Flucytosine is rapidly and virtually completely absorbed following oral administration. Flucytosine Capsules are not metabolized significantly when given orally to man. Bioavailability estimated by comparing the area under the curve of serum concentrations after oral and intravenous administration showed 78% to 89% absorption of the oral dose. Peak serum concentrations of 30 to 40 mcg/mL were reached within 2 hours of administration of a 2 g oral dose to normal subjects. Other studies revealed mean serum concentrations of approximately 70 to 80 mcg/mL 1 to 2 hours after a dose in patients with normal renal function receiving a 6-week regimen of flucytosine (150 mg/kg/day given in divided doses every 6 hours) in combination with amphotericin B. The half-life in the majority of healthy subjects ranged between 2.4 and 4.8 hours. Flucytosine is excreted via the kidneys by means of glomerular filtration without significant tubular reabsorption. More than 90% of the total radioactivity after oral administration was recovered in the urine as intact drug. Flucytosine is deaminated (probably by gut bacteria) to 5-fluorouracil. The area under the curve (AUC) ratio of 5-fluorouracil to flucytosine is 4%. Approximately 1% of the dose is present in the urine as the u03b1-fluoro-u03b2-ureido-propionic acid metabolite. A small portion of the dose is excreted in the feces.
The half-life of flucytosine is prolonged in patients with renal insufficiency; the average half-life in nephrectomized or anuric patients was 85 hours (range: 29.9 to 250 hours). A linear correlation was found between the elimination rate constant of flucytosine and creatinine clearance.
In vitro
Pharmacokinetics in Pediatric Patients
Limited data are available regarding the pharmacokinetics of Flucytosine Capsules, USP administered to neonatal patients being treated for systemic candidiasis. After five days of continuous therapy, median peak levels in infants were 19.6 mcg/mL, 27.7 mcg/mL, and 83.9 mcg/mL at doses of 25 mg/kg (N=3), 50 mg/kg (N=4), and 100 mg/kg (N=3), respectively. Mean time to peak serum levels was of 2.5 u00b1 1.3 hours, similar to that observed in adult patients. A good deal of interindividual variability was noted, which did not correlate with gestational age. Some patients had serum levels > 100 mcg/mL, suggesting a need for drug level monitoring during therapy. In another study, serum concentrations were determined during flucytosine therapy in two patients (total assays performed =10). Median serum flucytosine concentrations at steady state were calculated to be 57 u00b1 10 mcg/mL (doses of 50 to 125 mg/kg/day, normalized to 25 mg/kg per dose for comparison). In three infants receiving flucytosine 25 mg/kg/day (four divided doses), a median flucytosine half-life of 7.4 hours was observed, approximately double that seen in adult patients. The concentration of flucytosine in the cerebrospinal fluid of one infant was 43 mcg/mL 3 hours after a 25 mg oral dose, and ranged from 20 to 67 mg/L in another neonate receiving oral doses of 120 to 150 mg/kg/day.n n n 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.n n n Flucytosine has been shown to be active against most strains of the following microorganisms n
Candida albicansn Cryptococcus neoformansn n n- but their clinical significance is unknown.n
Flucytosine exhibits in vitro minimum inhibitory concentrations (MIC values) of 4 mcg/mL, or less against most (u226590%) strains of the following microorganisms, however, the safety and effectiveness of flucytosine in treating clinical infections due to these microorganisms have not been established in adequate and well control trials.
Candida dubliniensisn Candida glabratan Candida guilliermondiin Candida lusitaniaen Candida parapsilosisn Candida tropicalisn- Candida krusein- In vitron- Susceptibility Testing Methodsn n n- Drug Resistancen n n- Candida krusein- Drug Combinationn n

Flucytosine Capsules, USP are indicated only in the treatment of serious infections caused by susceptible strains of and/or .n n : Septicemia, endocarditis and urinary system infections have been effectively treated with flucytosine. Limited trials in pulmonary infections justify the use of flucytosine.n n : Meningitis and pulmonary infections have been treated effectively. Studies in septicemias and urinary tract infections are limited, but good responses have been reported.n 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 ).

Flucytosine Capsules, USP should not be used in patients with a known hypersensitivity to the drug.

Flucytosine Capsules, USP must be given with extreme caution to patients with impaired renal function. Since Flucytosine Capsules, USP are 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.

No data

The adverse reactions which have occurred during treatment with Flucytosine Capsules, USP are grouped according to organ system affected.n n : Cardiac arrest, myocardial toxicity, ventricular dysfunction.n n : Respiratory arrest, chest pain, dyspnea.n n : Rash, pruritus, urticaria, photosensitivity.n n : 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.n n : Azotemia, creatinine and BUN elevation, crystalluria, renal failure.n n : Anemia, agranulocytosis, aplastic anemia, eosinophilia, leukopenia, pancytopenia, thrombocytopenia, and fatal cases of bone marrow aplasia.n n : Ataxia, hearing loss, headache, paresthesia, parkinsonism, peripheral neuropathy, pyrexia, vertigo, sedation, convulsions.n n : Confusion, hallucinations, psychosis.n n : Fatigue, hypoglycemia, hypokalemia, weakness, allergic reactions, Lyell's syndrome.n n n n n

There is no experience with intentional overdosage. It is reasonable to expect that overdosage may produce pronounced manifestations of the known clinical adverse reactions. Prolonged serum concentrations in excess of 100 mcg/mL may be associated with an increased incidence of toxicity, especially gastrointestinal (diarrhea, nausea, vomiting), hematologic (leukopenia, thrombocytopenia) and hepatic (hepatitis).n In the management of overdosage, prompt gastric lavage or the use of an emetic is recommended. Adequate fluid intake should be maintained, by the intravenous route if necessary, since Flucytosine Capsules, USP are excreted unchanged via the renal tract. The hematologic parameters should be monitored frequently; liver and kidney function should be carefully monitored. Should any abnormalities appear in any of these parameters, appropriate therapeutic measures should be instituted.n Since hemodialysis has been shown to rapidly reduce serum concentrations in anuric patients, this method may be considered in the management of overdosage.

The usual dosage of Flucytosine Capsules, USP 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 ).n 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 ).

Flucytosine Capsules, USP are supplied as capsules containing 250 mg and 500 mg flucytosine.n n Capsule with green body and green cap imprinted with 'K' on cap and '110' on body of capsule, available in bottles of 100 (NDC 42543-902-01)n n Capsule with gray body and gray cap imprinted with 'K' on cap and '111' on body of capsule, available in bottles of 100 (NDC 42543-901-01): n Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted between 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F). [See USP Controlled Room Temperature]n Dispense in a tight, light-resistant container.
Manufactured for:n Yardley, PA 19067n Manufactured by:n Bangalore, India
Rev. 00, Mar 2018

NDC 42543-902-01 100 Capsules Flucytosine Capsules, USP 250 mg Rx Only Vensun Pharmaceuticals, Inc.n n n n n NDC 42543-901-01 100 Capsules Flucytosine Capsules, USP 500 mg Rx Only Vensun Pharmaceuticals, Inc.n n n

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Flucytosine (Flucytosine)

Trade Name : FLUCYTOSINE

CAPSULE

Delivery Process

Product information is meant for

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

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Flucytosine (Flucytosine)

Trade Name : FLUCYTOSINE

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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Disclaimer

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US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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