Ancobon (Flucytosine)
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Ancobon (Flucytosine)

ANCOBON®
(flucytosine) Capsules

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 Ancobon (flucytosine) .

DRUG DESCRIPTION

Ancobon (flucytosine), an antifungal agent, is available as 250mg and 500mg capsules for oral administration. Each capsule also contains corn starch, lactose and talc. Gelatin capsule shells contain parabens (butyl, methyl, propyl) and sodium propionate, with the following dye systems: 250-mg capsules — black iron oxide, FD&C Blue No. 1, FD&C Yellow No. 6, D&C Yellow No. 10 and titanium dioxide; 500mg capsules — black iron oxide and titanium dioxide. 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:

ANCOBON® (flucytosine)  Structural Formula Illustration

What are the possible side effects of flucytosine (Ancobon)?

If you experience any of the following serious side effects, stop taking flucytosine and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • chest pain;
  • yellowing of the skin or eyes;
  • little or no urine;
  • confusion or hallucinations;
  • numbness or tingling; or
  • hearing loss.

Other, less serious side effects may be more likely to occur. Continue to take flucytosine and talk to your doctor if you...

Read All Potential Side Effects and See Pictures of Ancobon »

What are the precautions when taking flucytosine (Ancobon)?

Before taking flucytosine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems, decreased bone marrow function, a low number of blood cells (red or white blood cells, platelets), radiation treatment, mineral imbalance (such as low level of potassium in the blood).

Wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been...

Read All Potential Precautions of Ancobon »

Last reviewed on RxList: 10/8/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Ancobon (flucytosine) 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.

Ancobon (flucytosine) should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to Ancobon (See Microbiology).

DOSAGE AND ADMINISTRATION

The usual dosage of Ancobon (flucytosine) 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).

Ancobon (flucytosine) should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to Ancobon (See Microbiology).

HOW SUPPLIED

Capsules, 250 mg (gray and green), imprinted ANCOBON® (flucytosine) 250 ICN, bottles of 100 (NDC 0187-3554-10). Capsules, 500 mg (gray and white), imprinted ANCOBON® (flucytosine) 500 ICN, bottles of 100 (NDC 0187-3555-10). Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F).

Valeant Pharmaceuticals International, 3300 Hyland Avenue, Costa Mesa, California 92626. 714-545-0100. Rev. May 2006. FDA Rev date: 8/10/2006

Last reviewed on RxList: 10/8/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The adverse reactions which have occurred during treatment with Ancobon (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 with possible fatal outcome in debilitated patients, hepatic dysfunction, jaundice, ulcerative colitis, bilirubin elevation, increased hepatic enzymes.

Genitourinary: Azotemia, creatinine and BUN elevation, crystalluria, renal failure.

Hematologic: Anemia, agranulocytosis, aplastic anemia, eosinophilia, leukopenia, pancytopenia, thrombocytopenia

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.

Read the Ancobon (flucytosine) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Cytosine arabinoside, a cytostatic agent, has been reported to inactivate the antifungal activity of Ancobon (flucytosine) by competitive inhibition. Drugs which impair glomerular filtration may prolong the biological half-life of flucytosine.

Drug/Laboratory Test Interactions

Measurement of serum creatinine levels should be determined by the Jaffé reaction, since Ancobon (flucytosine) does not interfere with the determination of creatinine values by this method. Most automated equipment for measurement of creatinine makes use of the Jaffé reaction.

Last reviewed on RxList: 10/8/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Ancobon (flucytosine) must be given with extreme caution to patients with impaired renal function. Since Ancobon (flucytosine) is excreted primarily by the kidneys, renal impairment may lead to accumulation of the drug. Ancobon (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.

Ancobon (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.

PRECAUTIONS

General

Before therapy with Ancobon (flucytosine) is instituted, electrolytes (because of hypokalemia) and the hematologic and renal status of the patient should be determined (see WARNINGS). Close monitoring of the patient during therapy is essential.

Laboratory Tests

Since renal impairment can cause progressive accumulation of the drug, blood concentrations and kidney function should be monitored during therapy. Hematologic status (leucocyte and thrombocyte count) and liver function (alkaline phosphatase, SGOT and SGPT) should be determined at frequent intervals during treatment as indicated.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Flucytosine has not undergone adequate animal testing to evaluate carcinogenic potential. The mutagenic potential of flucytosine was evaluated in Ames-type studies with five different mutants of S. typhimurium and no mutagenicity was detected in the presence or absence of activating enzymes. Flucytosine was nonmutagenic in three different repair assay systems (i.e., rec, uvr and pol).

There have been no adequate trials in animals on the effects of flucytosine on fertility or reproductive performance. The fertility and reproductive performance of the offspring (F1 generation) of mice treated with 100 mg/kg/day (345 mg/M2/day or 0.059 times the human dose), 200 mg/kg/day (690 mg/M2/day or 0.118 times the human dose) or 400 mg/kg/day (1380 mg/M2/day or 0.236 times the human dose) of flucytosine on days 7 to 13 of gestation was studied; the in utero treatment had no adverse effect on the fertility or reproductive performance of the offspring.

Pregnancy

Teratogenic Effects. Pregnancy Category C

Flucytosine was shown to be teratogenic (vertebral fusions) in the rat at doses of 40 mg/kg/day (298 mg/M2/day or 0.051 times the human dose) administered on days 7 to 13 of gestation. At higher doses (700 mg/kg/day; 5208 mg/M2/day or 0.89 times the human dose administered on days 9 to 12 of gestation), cleft lip and palate and micrognathia were reported. Flucytosine was not teratogenic in rabbits up to a dose of 100 mg/kg/day (1423 mg/M2/day or 0.243 times the human dose) administered on days 6 to 18 of gestation. In mice, 400 mg/kg/day of flucytosine (1380 mg/M2/day or 0.236 times the human dose) administered on days 7 to 13 of gestation was associated with a low incidence of cleft palate that was not statistically significant. There are no adequate and well-controlled studies in pregnant women. Ancobon (flucytosine) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Ancobon (flucytosine) , a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The efficacy and safety of Ancobon (flucytosine) have not been systematically studied in pediatric patients. A small number of neonates have been treated with 25 to 200 mg/kg/day of flucytosine, with and without the addition of amphotericin B, for systemic candidiasis. No unexpected adverse reactions were reported in these patients. It should be noted, however, that hypokalemia and acidemia were reported in one patient who received flucytosine in combination with amphotericin B, and anemia was observed in a second patient who received flucytosine alone. Transient thrombocytopenia was noted in two additional patients, one of whom also received amphotericin B.

Last reviewed on RxList: 10/8/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

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 µg/mL may be associated with an increased incidence of toxicity, especially gastrointestinal (diarrhea, nausea, vomiting), hematologic (leukopenia, thrombocytopenia) and hepatic (hepatitis).

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 Ancobon (flucytosine) is 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.

Since hemodialysis has been shown to rapidly reduce serum concentrations in anuric patients, this method may be considered in the management of overdosage.

CONTRAINDICATIONS

Ancobon (flucytosine) should not be used in patients with a known hypersensitivity to the drug.

Last reviewed on RxList: 10/8/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Flucytosine is rapidly and virtually completely absorbed following oral administration. Ancobon (flucytosine) is 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 µg/mL were reached within 2 hours of administration of a 2g oral dose to normal subjects. Other studies revealed mean serum concentrations of approximately 70 to 80 µg/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 α-fluoro-β-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 studies have shown that 2.9% to 4% of flucytosine is protein-bound over the range of therapeutic concentrations found in the blood. Flucytosine readily penetrates the blood-brain barrier, achieving clinically significant concentrations in cerebrospinal fluid.

Pharmacokinetics in Pediatric Patients

Limited data are available regarding the pharmacokinetics of Ancobon (flucytosine) administered to neonatal patients being treated for systemic candidiasis. After five days of continuous therapy, median peak levels in infants were 19.6 µg/mL, 27.7 µg/mL, and 83.9 µg/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 ± 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 µg/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 ± 10 µg/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 µg/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.

Microbiology

Mechanism of Action

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.

Activity In Vitro

Flucytosine exhibited activity against Candida species and Cryptococcus neoformans. In vitro activity of flucytosine is affected by the test conditions. It is essential to follow the approved standard method guidelines.1

Susceptibility Tests

Cryptococcus neoformans:

No interpretive criteria have been established for Cryptococcus neoformans1.

Candida

Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of yeasts to antimicrobial compounds. The MICs should be determined using a standardized procedure. Standardized procedures are based on a dilution method1 with standardized inoculum concentrations and standardized concentrations of flucytosine powder. The MIC values should be interpreted according to the following criteria:

MIC (µg/mL) Interpretation
≤ 4 Susceptible (S)
8-16 Intermediate (I)
≥ 32 Resistant (R)

A report of "Susceptible" indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentration usually achievable. A report of "Intermediate" indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where a high dosage of drug can be used. This category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of "Resistant" indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentration usually achievable; other therapy should be selected. Because of other significant host factors, in vitro susceptibility may not correlate with clinical outcomes.

Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. Standard flucytosine powder should provide the following MIC values:

Acceptable ranges of MICs (µg/mL) for control strains for 48-hour reference broth macrodilution testing:

Microorganism   MIC (µg/mL) [% of data included]
Candida parapsilosis ATCC 22019 0.12-0.5 [98.6%]
Candida krusei ATCC 6258 4.0-16 [96.8%]

Acceptable ranges of MICs (µg/mL) for control strains for 24-hour and 48-hour reference broth microdilution testing:

  MIC (µg/mL) ranges for microdilution testing
24-hour 48-hour
Microorganism Range Mode % of data Included Range Mode % of data included
Candida parapsilosis ATCC 22019 0.06-0.25 0.12 99% 0.12-0.5 0.25 98%
Candida krusei ATCC 6258 4.0-16 8.0 98% 8.0-32 16 99%

Drug Resistance

Flucytosine resistance may arise from a mutation of an enzyme necessary for the cellular uptake or metabolism of flucytosine or from an increased synthesis of pyrimidines, which compete with the active metabolites of flucytosine (fluorinated antimetabolites). Resistance to flucytosine has been shown to develop during monotherapy after prolonged exposure to the drug.

Drug Combination

Antifungal synergism between flucytosine and polyene antibiotics, particularly amphotericin B has been reported in vitro. Ancobon (flucytosine) is usually administered in combination with amphotericin B due to lack of cross-resistance and reported synergistic activity of both drugs.

REFERENCES

1. Clinical and Laboratory Standards Institute. Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Approved Standard-Second Edition. NCCLS Document M27-A2, 2002 Volume 22, No 15, NCCLS, Wayne, PA, August 2002.

Last reviewed on RxList: 10/8/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 10/8/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 10/8/2008
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Ancobon Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

FLUCYTOSINE - ORAL

(flew-SYE-toe-seen)

COMMON BRAND NAME(S): Ancobon

WARNING: This medication should be used with increased caution if you have kidney problems. Flucytosine may cause decreased kidney function and liver problems. In addition, this medication may decrease bone marrow function. This serious, possibly life-threatening side effect may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, and cause bleeding problems. Your doctor will check the results of your kidney, liver, and blood tests and adjust your treatment to reduce your risk for these side effects. See also Side Effects section.

USES: Flucytosine is used to treat serious fungal infections in the body. It belongs to a class of drugs known as antifungal drugs. It is often used with other medications. It works by slowing the growth of certain types of fungus.

HOW TO USE: Take this medication by mouth, usually 4 times a day (every 6 hours), or as directed by your doctor. To reduce stomach upset, do not swallow all of the capsules for one dose at the same time. It may be best to swallow the capsules for each dose over a 15-minute period until the full dose is taken.

The dosage is based on your medical condition, weight, and response to treatment.

This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same times each day.

Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may allow the fungus to continue to grow, which may result in a return of the infection.

Tell your doctor immediately if your condition persists or worsens.

Disclaimer

Ancobon Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, or diarrhea may occur. See the How to Use section about how to reduce stomach upset. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: change in the amount of urine, signs of liver problems (such as persistent nausea/vomiting, stomach/abdominal pain, dark urine, yellowing eyes/skin), signs of anemia (such as unusual tiredness, fast breathing, pale skin, fast heartbeat), signs of infection (such as fever, chills, cough, persistent sore throat), signs of bleeding (such as easy bruising/bleeding, nose bleeds, bleeding gums, bloody/black/tarry stools, vomit that looks like coffee grounds), muscle weakness/cramping.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Ancobon (flucytosine) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking flucytosine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems, decreased bone marrow function, a low number of blood cells (red or white blood cells, platelets), radiation treatment, mineral imbalance (such as low level of potassium in the blood).

Wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, older adults may be more sensitive to the side effects of this drug.

During pregnancy, this medication should be used only when clearly needed. This medication is not recommended for use during the first 3 months of pregnancy. It may harm an unborn baby. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. It may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Disclaimer

Ancobon Consumer (continued)

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: cytarabine, other drugs that may affect the kidneys (including NSAIDs such as ibuprofen or naproxen), other drugs that decrease bone marrow function or lower your number of blood cells or weaken the immune system (such as cancer chemotherapy, trimethoprim/sulfamethoxazole).

This medication may interfere with certain laboratory tests (including serum creatinine), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

OVERDOSE: If overdose is suspected, contact a local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as kidney and liver function, blood cell counts, blood mineral levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised May 2010. Copyright(c) 2010 First Databank, Inc.

Ancobon Patient Information Including Side Effects

Brand Names: Ancobon

Generic Name: flucytosine (Pronunciation: floo SYE toe seen)

What is flucytosine (Ancobon)?

Flucytosine is an antifungal medication. It is like an antibiotic but is used to treat fungal infections.

Flucytosine is used to treat serious fungal infections of the blood, lungs, heart, central nervous system, and urinary tract.

Flucytosine may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of flucytosine (Ancobon)?

If you experience any of the following serious side effects, stop taking flucytosine and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • chest pain;
  • yellowing of the skin or eyes;
  • little or no urine;
  • confusion or hallucinations;
  • numbness or tingling; or
  • hearing loss.

Other, less serious side effects may be more likely to occur. Continue to take flucytosine and talk to your doctor if you experience

  • nausea, vomiting, decreased appetite, or diarrhea;
  • a dry mouth;
  • headache;
  • sedation; or
  • weakness or poor coordination.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

Read the Ancobon (flucytosine) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about flucytosine (Ancobon)?

Take all of the flucytosine that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated.

Flucytosine may cause nausea and vomiting. You can reduce this side effect by taking the capsules a few at a time over a 15-minute period.

Side Effects Centers

Ancobon Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking flucytosine (Ancobon)?

Before taking flucytosine, tell your doctor if you

  • have kidney disease,
  • have a blood or bone marrow disease, or
  • are being treated with radiation or a drug that causes bone marrow suppression.

You may not be able to take flucytosine or you may need a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Flucytosine is in the FDA pregnancy category C. This means that it is not known whether flucytosine will be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether flucytosine passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take flucytosine (Ancobon)?

Take flucytosine exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass (8 ounces) of water.

Flucytosine may cause nausea and vomiting. You can reduce this side effect by taking the capsules a few at a time over a 15-minute period. Notify your doctor if nausea and vomiting become unbearable.

Take all of the flucytosine that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated.

It is important to take flucytosine regularly to get the most benefit.

Your doctor may want you to have blood tests or other medical evaluations during treatment with flucytosine to monitor progress and side effects.

Store this medication at room temperature away from moisture and heat.

Side Effects Centers

Ancobon Patient Information including If I Miss a Dose

What happens if I miss a dose (Ancobon)?

Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take a double dose of this medication.

What happens if I overdose (Ancobon)?

Seek emergency medical attention if an overdose is suspected.

Symptoms of a flucytosine overdose are not well known but might include nausea, vomiting, diarrhea, and abdominal pain.

What should I avoid while taking flucytosine (Ancobon)?

There are no restrictions on foods, beverages, or activities during treatment with flucytosine unless your doctor directs otherwise.

What other drugs will affect flucytosine (Ancobon)?

Before taking flucytosine, tell your doctor if you are taking any of the following medicines:

  • amphotericin B (another antifungal medication). This drug may decrease the effects of flucytosine.
  • cytosine (Cytosar-U), a chemotherapy medication. This drug may inactivate flucytosine.

Drugs other than those listed here may also interact with flucytosine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Where can I get more information?

Your pharmacist can provide more information about flucytosine.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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