CLOPIXOL-ACUPHASE INJ 50MGML (1ML)

Pays: Malaisie

Langue: anglais

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingrédients actifs:

ZUCLOPENTHIXOL ACETATE

Disponible depuis:

Lundbeck Malaysia Sdn. Bhd.

DCI (Dénomination commune internationale):

ZUCLOPENTHIXOL ACETATE

Unités en paquet:

1ml mL

Fabriqué par:

H. LUNDBECK A/S

Notice patient

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Résumé des caractéristiques du produit

Since zuclopenthixol is partly metabolised by CYP2D6 concomitant use
of drugs known to inhibit this enzyme may lead to decreased clearance
of
zuclopenthixol.
Increases in the QT interval related to antipsychotic treatment may be
exacerbated by the co administration of other drugs known to
significantly increase the QT interval. Co-administration of such
drugs
should be avoided. Relevant classes include:
•
class Ia and III antiarrhythmics (e.g. quinidine, amiodarone,
sotalol, dofetilide)
•
some antipsychotics (e.g. thioridazine)
•
some macrolides (e.g. erythromycin)
•
some antihistamines (e.g. terfenadine, astemizole)
•
some quinolone antibiotics (e.g. gatifloxacin, moxifloxacin)
The above list is not exhaustive and other individual drugs known to
significantly increase QT interval (e.g. cisapride, lithium) should be
avoided.
Drugs known to cause electrolyte disturbances such as
thiazidediuretica
(hypokalemia) and drugs known to increase the plasma concentration of
zuclopenthixol acetate should also be used with caution as they may
increase the risk of QT prolongation and malignant arrhythmias (see
section 4.4).
4.6
Fertility, pregnancy and lactation
Pregnancy
Zuclopenthixol acetate should not be administered during pregnancy
unless the expected benefit to the patient outweighs the theoretical
risk
to the foetus.
Neonates exposed to antipsychotics (including zuclopenthixol acetate)
during the third trimester of pregnancy are at risk of adverse
reactions
including extrapyramidal and/or withdrawal symptoms that may vary in
severity and duration following delivery. There have been reports of
agitation, hypertonia, hypotonia, tremor, somnolence, respiratory
distress, or feeding disorder. Consequently, newborns should be
monitored carefully.
Animal studies have shown reproductive toxicity (see section 5.3)
Breast-feeding
As zuclopenthixol is found in breast milk in low concentrations it is
not
likely to affect the infant when therapeutic doses are used. The dose
ingested by the infant is less than 1% of the w