Psytixol 20mg/1ml solution for injection ampoules

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Flupentixol decanoate

MAH:

Viatris UK Healthcare Ltd

ATC_code:

N05AF01

INN:

Flupentixol decanoate

dosage:

20mg/1ml

pharmaceutical_form:

Solution for injection

administration_route:

Intramuscular

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 04020200; GTIN: 5016695320236

PIL

PSYTIXOL 20 MG/ML, 100 MG/ML & 200 MG/ML INJECTION
(flupentixol decanoate)
INFORMATION FOR THE HEALTHCARE PROFESSIONAL
CONSULT THE SUMMARY OF PRODUCT CHARACTERISTICS FOR FULL
INFORMATION ON THIS PRODUCT
PHARMACEUTICAL FORM
Solution for injection.
A clear, colourless to pale yellow, oily solution for deep
intramuscular use.
THERAPEUTIC INDICATIONS
Psytixol is indicated for the treatment of schizophrenia and other
psychoses.
Use of flupentixol should be restricted to those stabilised on oral
therapy.
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS - The usual dosage of Psytixol is between 50 mg every 4 weeks
and 300 mg every 2
weeks. However, some patients may require up to 400 mg weekly. The
maximum single dose
at any one time is 400 mg. For example, 800 mg every 2 weeks should
not be given. Other
patients may be adequately maintained on dosages of 20-40 mg Psytixol
every 2-4 weeks. For
patients who have not previously received depot antipsychotic,
treatment is usually started
with a small dose (e.g. 20 mg) to assess tolerability. An interval of
at least one week should
be allowed before the second injection is given at a dose consistent
with the patient’s
condition.
Adequate control of severe psychotic symptoms may take up to 4 to 6
months at high enough
dosage. Once stabilized, lower maintenance doses may be considered,
but must be sufficient
to prevent relapse. The appropriate presentation of Psytixol should be
selected to achieve an
injection volume which does not exceed 2 ml. Volumes greater than 2 ml
should be
distributed between two injection sites. When transferring patients
from oral to depot
neuroleptic treatment, the oral medication should not be discontinued
immediately, but
gradually withdrawn over a period of several days after administering
the first injection.
ELDERLY - In accordance with standard medical practice, initial dosage
may need to be reduced
to a quarter or half the normal starting dose in the frail or older
people.
PAEDIATRIC POPULATION - Psytixol is not indicated for children due to
lac

SPC

OBJECT 1
PSYTIXOL 20 MG/ML INJECTION
Summary of Product Characteristics Updated 25-Sep-2017 | Generics UK
T/A Mylan
1. Name of the medicinal product
Psytixol 20 mg/ml injection
2. Qualitative and quantitative composition
Each 1 ml ampoule contains 20 mg flupentixol decanoate.
Each 2 ml ampoule contains 40 mg flupentixol decanoate.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Solution for injection.
A clear, colourless to pale yellow, oily solution for deep
intramuscular use.
4. Clinical particulars
4.1 Therapeutic indications
Psytixol is indicated in the treatment of schizophrenia and other
psychoses.
Use of flupentixol should be restricted to those stabilised on oral
therapy.
4.2 Posology and method of administration
_Posology _
_Adults:_
The usual dosage of Psytixol is between 50 mg every 4 weeks and 300 mg
every 2 weeks. However, some
patients may require up to 400 mg weekly. The maximum single dose at
any one time is 400 mg. For
example, 800 mg every 2 weeks should not be given.
Other patients may be adequately maintained on dosages of 20-40 mg
Psytixol every 2-4 weeks. For
patients who have not previously received depot neuroleptics,
treatment is usually started with a small
dose (e.g. 20 mg) to assess tolerability. An interval of at least one
week should be allowed before the
second injection is given at a dose consistent with the patient's
condition.
Adequate control of severe psychotic symptoms may take up to 4 to 6
months at high enough dosage.
Once stabilised, lower maintenance doses may be considered but must be
sufficient to prevent relapse.
The appropriate presentation of Psytixol should be selected to achieve
an injection volume which does not
exceed 2 ml. Volumes greater than 2 ml should be distributed between
two injection sites.
_Elderly:_
In accordance with standard medical practice, initial dosage may need
to be reduced to a quarter or half
the normal starting dose in the frail or older people.
_Paediatric population:_
Psytixol is not indicated for children due to lac