ancobon
Ancobon (Flucytosine) is a nucleoside analog antifungal used to treat Aspergillosis, Candidiasis, Chromoblastomycosis, Cryptococcal Meningitis.
Flucytosine · by Bausch
Key facts
- Active ingredient
- Flucytosine
- Drug class
- Nucleoside Analog Antifungal
- Form
- Capsule
- Strength
- Flucytosine 250MG · Flucytosine 500MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- aspergillosis, candidiasis, chromoblastomycosis
- Manufacturer
- Bausch
- FDA application
- NDA017001
- FDA boxed warning
- Yes — see the boxed warning
What is Ancobon?
From the FDA label:ANCOBON (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 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. 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: Chemical Structure
How to use
The usual dosage of ANCOBON 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 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 ).
Side effects
The adverse reactions which have occurred during treatment with ANCOBON 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 Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
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.
Warnings
Important safety information
ANCOBON must be given with extreme caution to patients with impaired renal function. Since ANCOBON is excreted primarily by the kidneys, renal impairment may lead to accumulation of the drug. ANCOBON 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 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 ANCOBON 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 ANCOBON treatment.
Who should not take Ancobon
ANCOBON is contraindicated in patients with a known hypersensitivity to the drug. ANCOBON is contraindicated in patients with known complete dihydropyrimidine dehydrogenase (DPD) enzyme deficiency (see WARNINGS ).
Overdose — what happens if you take too much
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). 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 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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Cytosine arabinoside, a cytostatic agent, has been reported to inactivate the antifungal activity of ANCOBON by competitive inhibition. Drugs which impair glomerular filtration may prolong the biological half-life of flucytosine.
Drug class
May treat (source: NIH RxClass)
Dosage forms
Capsule
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Request a 90-day supply
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Use copay cards
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Frequently asked questions
- What does Ancobon treat?
- Ancobon (Flucytosine) may be used to treat aspergillosis, candidiasis, chromoblastomycosis, cryptococcal meningitis, AIDS-related opportunistic infections, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Ancobon?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Ancobon. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Ancobon?
- Ancobon is marketed by Bausch. You can see Bausch's full profile, rating, and other products on pharmaranks.
- Is Ancobon a brand-name or generic drug?
- Ancobon is a brand-name product with the active ingredient Flucytosine.
- Is Ancobon available over the counter?
- No. Ancobon is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Ancobon come in?
- Ancobon is currently marketed as capsule, per the FDA's National Drug Code Directory.
- What class of drug is Ancobon?
- Ancobon is classified as nucleoside analog antifungal, per the FDA's Established Pharmacologic Class.
- Is Ancobon FDA-registered?
- Ancobon is on record with the U.S. FDA under application number NDA017001. You can verify this on its official FDA label.
- Is Ancobon safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Ancobon. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Ancobon?
- Ancobon's side effects are taken directly from its FDA label. From the label: The adverse reactions which have occurred during treatment with ANCOBON are grouped according to organ system affected. Cardiovascular: Cardiac arrest, myocardial toxicity, ventricular dysfunction. Respiratory: Respiratory arrest, chest pain, dyspnea. Dermatologic: Rash, pruritus, urticaria,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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