Ancotil 2.5g/250ml solution for infusion bottles

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Flucytosine

Available from:

Viatris UK Healthcare Ltd

ATC code:

J02AX01

INN (International Name):

Flucytosine

Dosage:

10mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous; Intraperitoneal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05020000; GTIN: 5000471002089

Patient Information leaflet

THIS LEAFLET PROVIDES TECHNICAL INFORMATION ABOUT ANCOTIL FOR THE
HEALTHCARE PROFESSIONAL.
THE TEAR-OFF PORTION ATTACHED IS INTENDED FOR THE PATIENT.
PRESENTATION
Infusion bottles containing 2.5 g flucytosine in 250 ml isotonic
sodium chloride
solution.
Other excipients are sodium chloride, tromethamine, hydrochloric acid
and
water for injections.
The solution is colourless to slightly yellow.
USES
_Properties_
Ancotil is a fluorinated pyrimidine effective in the treatment of
certain
systemic fungal infections.
In fungi sensitive to the preparation, it acts as a competitive
inhibitor of uracil
metabolism.
_Pharmacokinetics_
Bioavailability after a 2 g oral dose varies between individuals and
ranges from
76-98%. Peak plasma concentrations are reached within 1-2 hours after
oral
administration but may be delayed in subjects with renal impairment to
4-6
hours. Food and antacids decrease the absorption rate, but the total
extent
absorbed is not relevantly affected. Ancotil is widely distributed in
body
tissues and fluids (including cerebrospinal fluid). The volume of
distribution is
0.5-1.0 l/kg. Binding to plasma proteins is minimal (<5%). Typical
maximum
serum concentrations are 30-50 ug/ml after oral intake or IV
administration of
2 g flucytosine. Concentrations in cerebrospinal fluid, saliva and
peritoneal
fluid are slightly lower. Flucytosine crosses the human placenta and
accumulation
in amniotic fluid has been observed. Urinary concentrations may be up
to 100
times higher than plasma concentrations (normal renal function). Only
a small
proportion of flucytosine is metabolised. Enteric bacteria may be
responsible
for some metabolism of flucytosine to 5-FU. Additionally 5-FU is
released from
killed fungi cells. The 5-FU/5-FC ratio of plasma concentrations is
low (4%).
The plasma half-life is 3-6 hours in patients with normal renal
function but this
value increases in renal failure (30-250 hours). Excretion is almost
exclusively
through glomerular filtration. About 90% of the dose administered is
excreted
unchang

Summary of Product characteristics

OBJECT 1
ANCOTIL 2.5G/250ML SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 29-May-2018 | Mylan
Products Limited
1. Name of the medicinal product
Ancotil 2.5 g/250 ml Solution for Infusion.
2. Qualitative and quantitative composition
Flucytosine Ph. Eur. 2.5 g in 250 ml.
3. Pharmaceutical form
Infusion bottles containing 2.5 g flucytosine Ph. Eur. in 250 ml
isotonic sodium chloride solution.
4. Clinical particulars
4.1 Therapeutic indications
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.
4.2 Posology and method of administration
_ADULTS AND CHILDREN_
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