DEPIXOL CONC. 100MG/ML SOLUTION FOR INJECTION

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

FLUPENTIXOL DECANOATE

Tilgjengelig fra:

Lundbeck Limited

ATC-kode:

N05AF01

INN (International Name):

FLUPENTIXOL DECANOATE

Dosering :

100 Micromol

Legemiddelform:

Solution for Injection

Resept typen:

Product subject to prescription which may not be renewed (A)

Terapeutisk område:

flupentixol

Autorisasjon status:

Marketed

Autorisasjon dato:

1988-01-25

Informasjon til brukeren

•
Medicines such as diuretics (water tablets) that cause a disturbed
water or salt balance (too little potassium or magnesium in your
blood)
•
Medicines known as phenothiazines used to treat mental illness
(e.g. chlorpromazine, fluphenazine).
•
Medicines known as neuromuscular blocking agents (e.g.
suxamethonium) as concomitant treatment with this medicine may
prolong the effect of neuromuscular blocking agents
•
Adrenergic medicines (e.g. atenolol) as concomitant treatment with
this medicine may reduce their effect
The following medicines should not be taken with this medicine:
•
Medicines for heart rhythm problems such as medicines used to treat
irregular heartbeats (e.g. quinidine, amiodarone, sotalol,
dofetilide),
certain antibiotics (e.g. erythromycin, gatifloxacin, moxifloxacin),
certain antihistamines (e.g. astemizole, terfenadine) and other
medicines such as cisapride and lithium
•
Other antipsychotic medicines (e.g. thioridazine)
Depixol Conc. Injection with alcohol
Depixol Conc. Injection may increase the sedative effects of alcohol
making you drowsier. It is recommended not to drink alcohol during
treatment with this medicine.
Pregnancy, breast-feeding and fertility
If you are pregnant or think you might be pregnant or planning to have
a
baby, ask your doctor, pharmacist or nurse for advice before taking
this
medicine.
Pregnancy
If you are pregnant or think you might be pregnant, tell your doctor.
Depixol Conc. Injection should not be used during pregnancy unless
clearly necessary.
The following symptoms may occur in newborn babies of mothers that
have used this medicine in the last trimester (last three months of
their
pregnancy): shaking, muscle stiffness and/or weakness, sleepiness,
agitation, breathing problems, and difficulty in feeding. If your baby
develops any of these symptoms you may need to contact your doctor.
Breast-feeding
If you are breast-feeding, ask your doctor for advice. You should not
this
medicine when breast-feeding, as small amounts of the medicine can
pass into the

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Depixol Conc. 100mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml
ampoule contains 100 mg (10% w/v) cis(Z)-flupentixol decanoate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection (injection)
Clear, yellowish to yellow oil, practically free from particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The management of schizophrenia and allied paranoid psychoses.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The usual dosage is between 50 mg every 4 weeks and 300 mg every two
weeks. Subsequent dosage can be adjusted on
the basis of the individual patient response and may reach 400mg
weekly before a reduction can be made to
maintenance levels.
In 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 patients'
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 Depixol 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.
_Older people_
Older people should receive dosages in the lower end of the dosage
range.
_Reduced renal function_
Flupentixol decanoate can be given in usual doses to patients with
reduced renal function.
_Reduced hepatic function_
Dose reduction (relative to the degree of hepatic impairment) should
be considered. If possible