Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Mylan Products Ltd., Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Ancotil is indicated for the treatment of systemic yeast and fungal infections due to sensitive organisms: such infections include cryptococcosis, candidiasis, chromomycosis and infections due to torulopsis glabrata and hansenula.
In the treatment of cryptococcal meningitis and severe systemic candidiasis it is recommended that Ancotil should be given in combination with amphotericin-B. Amphotericin-B may also be given in combination with Ancotil in severe or long-standing infections due to other organisms. In cases of cryptococcal meningitis, where toxicity of amphotericin B, or a combination of flucytosine with amphotericin B is dose limiting, a combination of flucytosine with fluconazole has demonstrated successful cure, but at a lower rate than in combination with amphotericin B.
Ancotil for Infusion should be administered using a giving set. It may be administered directly into a vein, through a central venous catheter, or by intra-peritoneal infusion. The recommended daily dosage in adults and children is 200 mg/kg body-weight divided into four doses over 24 hours. In patients harboring extremely sensitive organisms a total daily dose of 100 to 150 mg/kg body-weight may be sufficient. Adequate effects can, however, often be obtained with a lower dose.
It is suggested that the duration of the infusion should be of the order of 20 to 40 minutes provided this is balanced with the fluid requirements of the patient. As a rule, treatment with Ancotil for Infusion should rarely be required for periods of more than one week.
Since Ancotil is excreted primarily by the kidneys, patients with renal impairment should be given smaller doses. The following is suggested as a guide for dosage in patients with severe infection associated with renal impairment:
In patients with:
Creatinine clearance <40 to >20 ml /min: 50 mg/kg every 12 hours.
Creatinine clearance <20 to >10 ml /min: 50 mg/kg every 24 hours.
Creatinine clearance <10 ml /min: an initial single dose of 50 mg/kg; subsequent doses should be calculated according to the results of regular monitoring of the serum concentration of the drug, which should not be allowed to exceed 80 micrograms/ml. Blood levels of 25 to 50 micrograms/ml are normally effective.
The duration of treatment should be determined on an individual basis.
The outcome of therapy will be affected by variations in the sensitivity of the infection organism, its accessibility and its susceptibility to Ancotil, as well as by differences in the response of individual patients. In cases of cryptococcal meningitis, treatment should last for at least four months.
Available data are not sufficient to support evidence based dosing recommendations in paediatric patients, including term and preterm neonates.
Flucytosine should not be used as first line or monotherapy in paediatric patients. Flucytosine should be used in combination with other appropriate anti-fungal agents when other suitable drugs are not available and are not likely to be effective.
Although no specific studies have been performed to establish the use of Ancotil in the elderly, documented use indicated that the dosage requirements and side effects profile are similar to those of younger patients. Particular attention should be paid to renal function in this group.
Ancotil for Infusion may be given concurrently with other infusions of normal saline, glucose or glucose/saline. No other agent should be added to or mixed with Ancotil for Infusion.
Haemodialysis produces a rapid fall in the serum concentration of Ancotil.
Shelf life: 2 years.
Ancotil for Infusion should be stored between 18°C and 25°C. If stored below 18°C, precipitation of Ancotil substance may occur.
Prolonged storage above 25°C could lead to the decomposition of Ancotil resulting in the formation of 5-fluorouracil.
250 ml neutral glass bottle (DIN 58363) with a teflon coated butyl rubber stopper and aluminium crimping cap. Bottles are in packs of 5.
Ancotil for Infusion is available to hospitals only.
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